chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: BLOWS  THE NOSE; SORE THROAT; LIKE I HAVE A COLD; WATER GETS OUT FROM EYES; LEG FELT ICKY; LEG HURTS ALL THE TIME; DIARRHEA; COUGH WAS WITH SPUTUM AND  BLOOD COMES; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 73 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included CHF, heart surgery, hospitalized for gall bladder issue, heart surgery for chronic AIFB, circulation problem, stomach issue, seasonal allergy, strawberry allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Laboratory data included: Headache (NR: not provided). On 09-APR-2021, treatment medications included: guaifenesin. On 12-APR-2021, the subject experienced cough was with sputum and blood comes. On 14-APR-2021, Laboratory data included: Headache (NR: not provided) SCALE 2. On an unspecified date, the subject experienced diarrhea, blows the nose, sore throat, like I have a cold, water gets out from eyes, leg felt icky, and leg hurts all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and the outcome of diarrhea, headache, cough was with sputum and blood comes, blows the nose, sore throat, like i have a cold, water gets out from eyes, leg felt icky and leg hurts all the time was not reported. This report was non-serious.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: BLOWS  THE NOSE; SORE THROAT; LIKE I HAVE A COLD; WATER GETS OUT FROM EYES; LEG FELT ICKY; LEG HURTS ALL THE TIME; DIARRHEA; COUGH WAS WITH SPUTUM AND  BLOOD COMES; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 73 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included CHF, heart surgery, hospitalized for gall bladder issue, heart surgery for chronic AIFB, circulation problem, stomach issue, seasonal allergy, strawberry allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Laboratory data included: Headache (NR: not provided). On 09-APR-2021, treatment medications included: guaifenesin. On 12-APR-2021, the subject experienced cough was with sputum and blood comes. On 14-APR-2021, Laboratory data included: Headache (NR: not provided) SCALE 2. On an unspecified date, the subject experienced diarrhea, blows the nose, sore throat, like I have a cold, water gets out from eyes, leg felt icky, and leg hurts all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and the outcome of diarrhea, headache, cough was with sputum and blood comes, blows the nose, sore throat, like i have a cold, water gets out from eyes, leg felt icky and leg hurts all the time was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Headache, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; FEVER; HEADACHE; 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: Unknown) dose was not reported, administered on 12-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 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-APR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Ear pain, Feeling abnormal
Clinical narrative: RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN TO RIGHT LUNG; COULDNT SLEEP; BODY ACHES; THROAT PAIN; EAR PAIN; KNEES TO BOTTOM FELT HOT FOR SIX  DAYS; FEELS LIKE LEG IS  ASLEEP; LOCALIZED HEAT TO RIGHT INNER KNEE; This spontaneous report received from a patient concerned a 45 year old Hispanic or Latino female. The patient's weight was 185 pounds, and height was 63 inches. The patient's past medical history included hypothyroidism, and concurrent conditions included pollen allergy, alcohol user twice a year, and non smoker, and other pre-existing medical conditions included the patient had mecroabenola hitosesiario (in Spanish). The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination.  No concomitant medications were reported.  On MAR-2021, the patient experienced weakness and rash on face. On 25-MAR-2021 patient felt really bad On 27-MAR-2021, patient was menstruating but at the same time she had rectal bleeding but was not sure. That Saturday (27-MAR-2021) she though had abundant rectal bleeding twice. The second episode came two hours after the first one. She also had bleeding on Sunday (28-MAR-2021) but it was mild. Patient had fever, chills, pain to her right lung, joint pain, she could not sleep, She had body aches, throat pain, ear pain, headaches, (took Tylenol as treatment drug with specified dose) and her knees to the bottom felt hot for six days. Now that has resolved except she had localized heat to the right inner knee. It felt like spiders, like her leg was asleep. Lung pain was on and off, can be mild sometimes stronger. The rest of the side effects resolved  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rectal bleeding, could not sleep, body aches, throat pain, ear pain, knees to bottom felt hot for six days, joint pain, chills, rash on face, headache, fever, and weakness on 2021, had not recovered from pain to right lung, localized heat to right inner knee, and feels like leg is asleep, and the outcome of felt really bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-rectal bleeding. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypoaesthesia, Insomnia, Oropharyngeal pain
Clinical narrative: RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN TO RIGHT LUNG; COULDNT SLEEP; BODY ACHES; THROAT PAIN; EAR PAIN; KNEES TO BOTTOM FELT HOT FOR SIX  DAYS; FEELS LIKE LEG IS  ASLEEP; LOCALIZED HEAT TO RIGHT INNER KNEE; This spontaneous report received from a patient concerned a 45 year old Hispanic or Latino female. The patient's weight was 185 pounds, and height was 63 inches. The patient's past medical history included hypothyroidism, and concurrent conditions included pollen allergy, alcohol user twice a year, and non smoker, and other pre-existing medical conditions included the patient had mecroabenola hitosesiario (in Spanish). The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination.  No concomitant medications were reported.  On MAR-2021, the patient experienced weakness and rash on face. On 25-MAR-2021 patient felt really bad On 27-MAR-2021, patient was menstruating but at the same time she had rectal bleeding but was not sure. That Saturday (27-MAR-2021) she though had abundant rectal bleeding twice. The second episode came two hours after the first one. She also had bleeding on Sunday (28-MAR-2021) but it was mild. Patient had fever, chills, pain to her right lung, joint pain, she could not sleep, She had body aches, throat pain, ear pain, headaches, (took Tylenol as treatment drug with specified dose) and her knees to the bottom felt hot for six days. Now that has resolved except she had localized heat to the right inner knee. It felt like spiders, like her leg was asleep. Lung pain was on and off, can be mild sometimes stronger. The rest of the side effects resolved  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rectal bleeding, could not sleep, body aches, throat pain, ear pain, knees to bottom felt hot for six days, joint pain, chills, rash on face, headache, fever, and weakness on 2021, had not recovered from pain to right lung, localized heat to right inner knee, and feels like leg is asleep, and the outcome of felt really bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-rectal bleeding. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pulmonary pain, Pyrexia, Rash, Rectal haemorrhage
Clinical narrative: RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN TO RIGHT LUNG; COULDNT SLEEP; BODY ACHES; THROAT PAIN; EAR PAIN; KNEES TO BOTTOM FELT HOT FOR SIX  DAYS; FEELS LIKE LEG IS  ASLEEP; LOCALIZED HEAT TO RIGHT INNER KNEE; This spontaneous report received from a patient concerned a 45 year old Hispanic or Latino female. The patient's weight was 185 pounds, and height was 63 inches. The patient's past medical history included hypothyroidism, and concurrent conditions included pollen allergy, alcohol user twice a year, and non smoker, and other pre-existing medical conditions included the patient had mecroabenola hitosesiario (in Spanish). The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination.  No concomitant medications were reported.  On MAR-2021, the patient experienced weakness and rash on face. On 25-MAR-2021 patient felt really bad On 27-MAR-2021, patient was menstruating but at the same time she had rectal bleeding but was not sure. That Saturday (27-MAR-2021) she though had abundant rectal bleeding twice. The second episode came two hours after the first one. She also had bleeding on Sunday (28-MAR-2021) but it was mild. Patient had fever, chills, pain to her right lung, joint pain, she could not sleep, She had body aches, throat pain, ear pain, headaches, (took Tylenol as treatment drug with specified dose) and her knees to the bottom felt hot for six days. Now that has resolved except she had localized heat to the right inner knee. It felt like spiders, like her leg was asleep. Lung pain was on and off, can be mild sometimes stronger. The rest of the side effects resolved  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rectal bleeding, could not sleep, body aches, throat pain, ear pain, knees to bottom felt hot for six days, joint pain, chills, rash on face, headache, fever, and weakness on 2021, had not recovered from pain to right lung, localized heat to right inner knee, and feels like leg is asleep, and the outcome of felt really bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-rectal bleeding. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Body temperature fluctuation, Haemoglobin, Headache, Myalgia
Clinical narrative: ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia secondary to menstruation. 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) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. 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: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per  and is therefore considered potentially related.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral, Platelet count, Pyrexia
Clinical narrative: ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia secondary to menstruation. 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) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. 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: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per  and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male 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: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, chills, joint pain, muscle pain, nausea, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle pain, joint pain, nausea, fatigue, headache and dizziness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male 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: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, chills, joint pain, muscle pain, nausea, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle pain, joint pain, nausea, fatigue, headache and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Nodule
Clinical narrative: HEART ATTACK; KNOT ON LEG(SORE); This spontaneous report received from a patient and 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack, and had a knot on leg which was sore for over 3 weeks.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, knot on leg(sore) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine ad26.cov2.s-heart attack. 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: Arthralgia, Asthenia, Back pain, Blood pressure measurement, Blood test
Clinical narrative: SHORTNESS OF BREATH WHILE WALKING; FEELING LIKE HE WAS GOING TO DIE; HIGH BLOOD PRESSURE; SEVERE CHEST PAIN/ON AND OFF CHEST PAIN; SEVERE BACK PAIN; DIFFICULTY SLEEPING; TIREDNESS; NUMBNESS IN LEFT ARM; WEAKNESS; CRAZY JOINT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, no alcohol use, and smoker (smokes cigarettes twice a day), and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced crazy joint pain in left arm. On 21-MAR-2021, the subject experienced weakness. On 23-MAR-2021, the subject experienced numbness in left arm. On 28-MAR-2021, the subject experienced tiredness. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) up, Blood test (NR: not provided) negative, CBC (NR: not provided) negative, ECG (NR: not provided) unknown, Imaging procedure (NR: not provided) negative, Troponin (NR: not provided) negative, and X-ray NOS (NR: not provided) unknown. On 04-APR-2021, the subject experienced shortness of breath while walking. On 04-APR-2021, the subject experienced feeling like he was going to die. On 04-APR-2021, the subject experienced high blood pressure. On 04-APR-2021, the subject experienced severe chest pain/on and off chest pain. On 04-APR-2021, the subject experienced severe back pain. On 04-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left arm on 26-MAR-2021, and difficulty sleeping on 06-APR-2021, was recovering from shortness of breath while walking, and severe back pain, had not recovered from weakness, tiredness, severe chest pain/on and off chest pain, and crazy joint pain in left arm, and the outcome of high blood pressure and feeling like he was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: SHORTNESS OF BREATH WHILE WALKING; FEELING LIKE HE WAS GOING TO DIE; HIGH BLOOD PRESSURE; SEVERE CHEST PAIN/ON AND OFF CHEST PAIN; SEVERE BACK PAIN; DIFFICULTY SLEEPING; TIREDNESS; NUMBNESS IN LEFT ARM; WEAKNESS; CRAZY JOINT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, no alcohol use, and smoker (smokes cigarettes twice a day), and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced crazy joint pain in left arm. On 21-MAR-2021, the subject experienced weakness. On 23-MAR-2021, the subject experienced numbness in left arm. On 28-MAR-2021, the subject experienced tiredness. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) up, Blood test (NR: not provided) negative, CBC (NR: not provided) negative, ECG (NR: not provided) unknown, Imaging procedure (NR: not provided) negative, Troponin (NR: not provided) negative, and X-ray NOS (NR: not provided) unknown. On 04-APR-2021, the subject experienced shortness of breath while walking. On 04-APR-2021, the subject experienced feeling like he was going to die. On 04-APR-2021, the subject experienced high blood pressure. On 04-APR-2021, the subject experienced severe chest pain/on and off chest pain. On 04-APR-2021, the subject experienced severe back pain. On 04-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left arm on 26-MAR-2021, and difficulty sleeping on 06-APR-2021, was recovering from shortness of breath while walking, and severe back pain, had not recovered from weakness, tiredness, severe chest pain/on and off chest pain, and crazy joint pain in left arm, and the outcome of high blood pressure and feeling like he was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Hypertension, Hypoaesthesia, Imaging procedure, Insomnia
Clinical narrative: SHORTNESS OF BREATH WHILE WALKING; FEELING LIKE HE WAS GOING TO DIE; HIGH BLOOD PRESSURE; SEVERE CHEST PAIN/ON AND OFF CHEST PAIN; SEVERE BACK PAIN; DIFFICULTY SLEEPING; TIREDNESS; NUMBNESS IN LEFT ARM; WEAKNESS; CRAZY JOINT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, no alcohol use, and smoker (smokes cigarettes twice a day), and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced crazy joint pain in left arm. On 21-MAR-2021, the subject experienced weakness. On 23-MAR-2021, the subject experienced numbness in left arm. On 28-MAR-2021, the subject experienced tiredness. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) up, Blood test (NR: not provided) negative, CBC (NR: not provided) negative, ECG (NR: not provided) unknown, Imaging procedure (NR: not provided) negative, Troponin (NR: not provided) negative, and X-ray NOS (NR: not provided) unknown. On 04-APR-2021, the subject experienced shortness of breath while walking. On 04-APR-2021, the subject experienced feeling like he was going to die. On 04-APR-2021, the subject experienced high blood pressure. On 04-APR-2021, the subject experienced severe chest pain/on and off chest pain. On 04-APR-2021, the subject experienced severe back pain. On 04-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left arm on 26-MAR-2021, and difficulty sleeping on 06-APR-2021, was recovering from shortness of breath while walking, and severe back pain, had not recovered from weakness, tiredness, severe chest pain/on and off chest pain, and crazy joint pain in left arm, and the outcome of high blood pressure and feeling like he was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Troponin, X-ray
Clinical narrative: SHORTNESS OF BREATH WHILE WALKING; FEELING LIKE HE WAS GOING TO DIE; HIGH BLOOD PRESSURE; SEVERE CHEST PAIN/ON AND OFF CHEST PAIN; SEVERE BACK PAIN; DIFFICULTY SLEEPING; TIREDNESS; NUMBNESS IN LEFT ARM; WEAKNESS; CRAZY JOINT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, no alcohol use, and smoker (smokes cigarettes twice a day), and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced crazy joint pain in left arm. On 21-MAR-2021, the subject experienced weakness. On 23-MAR-2021, the subject experienced numbness in left arm. On 28-MAR-2021, the subject experienced tiredness. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) up, Blood test (NR: not provided) negative, CBC (NR: not provided) negative, ECG (NR: not provided) unknown, Imaging procedure (NR: not provided) negative, Troponin (NR: not provided) negative, and X-ray NOS (NR: not provided) unknown. On 04-APR-2021, the subject experienced shortness of breath while walking. On 04-APR-2021, the subject experienced feeling like he was going to die. On 04-APR-2021, the subject experienced high blood pressure. On 04-APR-2021, the subject experienced severe chest pain/on and off chest pain. On 04-APR-2021, the subject experienced severe back pain. On 04-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left arm on 26-MAR-2021, and difficulty sleeping on 06-APR-2021, was recovering from shortness of breath while walking, and severe back pain, had not recovered from weakness, tiredness, severe chest pain/on and off chest pain, and crazy joint pain in left arm, and the outcome of high blood pressure and feeling like he was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED IN SLEEP; This spontaneous report received from a consumer via social media concerned a 42-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) with unknown dose, on unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up required for this case. No concomitant medications were reported. On 04-APR-2021, the patient died in his sleep and the cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This case was linked to 20210428967 (same reporter) This report was serious (Death).; Sender's Comments: V0:20210429895-COVID-19 VACCINE AD26.COV2.S- Died in sleep. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Fibrin D dimer, Fibrin D dimer increased, Ultrasound scan
Clinical narrative: D DIMER POSITIVE; DIZZY; FEELS TERRIBLE; This spontaneous report received from a company representative via media post and concerned an adult female (age approximately 30).  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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient reported dizzy and felt terrible. On an unspecified date, the patient went to urgent care and tested positive for D-Dimer (PT of Fibrin D dimer increased). The patient went to emergency room for full body ultrasound to look for clots.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, feels terrible and d dimer positive was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: BILATERAL BLOOD CLOTS IN LEFT AND RIGHT LOWER LUNGS; This spontaneous report received from a patient via a company representative concerned a 46 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-APR-2021, the patient experienced mild chest pain and dyspnea. On 14-APR-2021, the patient visited to emergency room and diagnosed with bilateral blood clots in left and right lower lungs. The patient had no prior medical history of blood clot and pulmonary issues. On 14-MAR-2021, treatment medications included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral blood clots in left and right lower lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 46 male patient, unspecified ethnicity who was noted, at the emergency room (ER), to have bilateral blood clots in left and right lower lungs 9 days after receiving the covid-19 vaccine ad26.cov2.s. Weight and height were not reported. Medical history, smoking history and concomitant medications were not reported.  Six (6) days prior to the visit to the emergency room, the patient experienced mild chest pains and dyspnea. Patient was sent home from the ER with Rivaroxaban. Based on the available information and considering the temporal causality, this is assessed as indeterminate per WHO causality classification of adverse reaction following immunization.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Liver injury
Clinical narrative: LIVER DAMAGE; PAIN IN LOWER RIGHT ABDOMINAL  AREA; This spontaneous report received from a patient concerned a 3 decade (in twenties)old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and other pre-existing medical conditions included patient had no history of drugs/prescription drugs. 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 and has been requested. No concomitant medications were reported.  After vaccine, on an unspecified date, the patient was rushed to the emergency room. The doctors could not diagnose the pain in lower right abdominal area but found that the liver had been severely damaged (coded as liver damage) in a short period of time. Patient stated that his medical group would like him to undergo further testing and had scheduled him for the same since their concerns were whether the patient's liver would fail or cause immune system disorders in the future. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from liver damage, and the outcome of pain in lower right abdominal area was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210430986 - covid-19 vaccine ad26.cov2.s - liver damage. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Testicular mass
Clinical narrative: LUMP ON RIGHT TESTICLE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported No concomitant medications were reported. On an unspecified date, the subject experienced lump on right testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump on right testicle. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Epistaxis, Fatigue, Sinus headache
Clinical narrative: NOSE BLEED WITH BIG CLOT WHEN BLOWING NOSE; SINUS TYPE HEADACHE; TIREDNESS; STOMACH CRAMPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201921A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prevention of covid-19. No concomitant medications were reported. On 07-APR-2021, the subject experienced stomach cramps. On 07-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced sinus type headache. On 10-APR-2021, the subject experienced nose bleed with big clot when blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed with big clot when blowing nose on 10-APR-2021, stomach cramps, and tiredness on 08-APR-2021, and sinus type headache on 11-APR-2021. This report was non-serious.; Sender's Comments: V0:  This 53-year-old male patient sho reported nose bleeding with big clot of blood when eh blew his nose 3 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient also reported stomach cramps and tiredness on the day of vaccination and sinus type of headache 2 days after vaccination.  The patient denies any history of headache.  The patient recovered from the events.  No other details reported.   Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  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 is requested
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: DIZZINESS; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 48 year old of unspecified 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, and fever on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery occlusion
Clinical narrative: HEART ATTACK FROM BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a Not Hispanic or Latino and Asian male 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, 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 heart attack from blood clot and  the patient died. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: This is an Asian male, unspecified age, who experienced a heart attack from a blood clot on an unspecified date after receiving the covid-19 vaccine ad26.cov2.s also on an unspecified date. No other details given. The information provided precludes a meaningful medical assessment. Additional information will be requested.; Reported Cause(s) of Death: DEATH
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Chills, Dizziness
Clinical narrative: INTERMITTENT SHORT OF BREATH; UNCONTROLLABLE CHILLS; SEVERE HEADACHE; FEVER; FATIGUE; LIGHT-HEADED; EXCORIATING BACK PAIN; PROFUSE SWEATING; VOMITING; STOMACH PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced light-headed. On 20-MAR-2021, the subject experienced excoriating back pain. On 20-MAR-2021, the subject experienced profuse sweating. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced stomach pain. On 20-MAR-2021, the subject experienced severe headache. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021 20:00, the subject experienced uncontrollable chills. On 21-MAR-2021, the subject experienced intermittent short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed, and uncontrollable chills on 20-MAR-2021, excoriating back pain, profuse sweating, severe headache, and fever on 22-MAR-2021, vomiting on 21-MAR-2021, and intermittent short of breath, and fatigue on MAR-2021, and had not recovered from stomach pain. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: INTERMITTENT SHORT OF BREATH; UNCONTROLLABLE CHILLS; SEVERE HEADACHE; FEVER; FATIGUE; LIGHT-HEADED; EXCORIATING BACK PAIN; PROFUSE SWEATING; VOMITING; STOMACH PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced light-headed. On 20-MAR-2021, the subject experienced excoriating back pain. On 20-MAR-2021, the subject experienced profuse sweating. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced stomach pain. On 20-MAR-2021, the subject experienced severe headache. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021 20:00, the subject experienced uncontrollable chills. On 21-MAR-2021, the subject experienced intermittent short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed, and uncontrollable chills on 20-MAR-2021, excoriating back pain, profuse sweating, severe headache, and fever on 22-MAR-2021, vomiting on 21-MAR-2021, and intermittent short of breath, and fatigue on MAR-2021, and had not recovered from stomach pain. This report was non-serious.