chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: LOSING CONSCIOUSNESS; This spontaneous report received from a patient via social media 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced losing consciousness 25 minutes after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Losing consciousness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-losing consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: SWOLLEN-WIDTH OF A GOLFBALL SLIGHT PROTRUDING; LIGHT RED AREA AROUND THE INJECTION AREA; ENTIRE BODY ACHE/PAIN; 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: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced entire body ache/pain. On 10-APR-2021, the subject experienced swollen-width of a golfball slight protruding. On 10-APR-2021, the subject experienced light red area around the injection area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from entire body ache/pain on 09-APR-2021, and had not recovered from swollen-width of a golfball slight protruding, and light red area around the injection area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported,1 total administered on an unspecified date in 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date in 2021, the patient experienced suspected covid-19 vaccination failure and covid-19 infection. The reporter mentioned a news story she saw on 11-APR-2021, that reported a family of 4 who received covid-19 vaccine ad26.cov2.s a few weeks ago, ended up getting covid-19 infection after vaccination. The reporter did not had any other details. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection and lack of effect was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be voided based on the product quality complaint evaluation/investigation performed. This case, from the same reporter is linked to 20210422603 and 20210422632.; Sender's Comments: V0: 20210422928- 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dysmenorrhoea, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: INFLAMED LYMPH NODES; VACCINE SITE INFLAMMATION; MENSTRUAL CRAMPS; ASTHMA SYMPTOMS; EXCESSIVE PERIOD BLEEDING AND LONG PERIODS; SHORTNESS OF BREATH; FELT  LOOPY; BODY ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included seasonal allergy. The patient experienced drug allergy when treated with cetirizine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: salbutamol.  On 08-APR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced felt loopy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excessive period bleeding and long periods. On 09-APR-2021, the subject experienced menstrual cramps. On 09-APR-2021, the subject experienced asthma symptoms. On 10-APR-2021, the subject experienced inflamed lymph nodes. On 10-APR-2021, the subject experienced vaccine site inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt loopy on 08-APR-2021, was recovering from body aches, and had not recovered from fatigue, headache, shortness of breath, excessive period bleeding and long periods, asthma symptoms, vaccine site inflammation, inflamed lymph nodes, and menstrual cramps. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Lymphadenitis, Pain, Vaccination site inflammation
Clinical narrative: INFLAMED LYMPH NODES; VACCINE SITE INFLAMMATION; MENSTRUAL CRAMPS; ASTHMA SYMPTOMS; EXCESSIVE PERIOD BLEEDING AND LONG PERIODS; SHORTNESS OF BREATH; FELT  LOOPY; BODY ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included seasonal allergy. The patient experienced drug allergy when treated with cetirizine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: salbutamol.  On 08-APR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced felt loopy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excessive period bleeding and long periods. On 09-APR-2021, the subject experienced menstrual cramps. On 09-APR-2021, the subject experienced asthma symptoms. On 10-APR-2021, the subject experienced inflamed lymph nodes. On 10-APR-2021, the subject experienced vaccine site inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt loopy on 08-APR-2021, was recovering from body aches, and had not recovered from fatigue, headache, shortness of breath, excessive period bleeding and long periods, asthma symptoms, vaccine site inflammation, inflamed lymph nodes, and menstrual cramps. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES INFECTION (FEVER, CHILLS, BODY ACHES AND INTERNAL PAIN, FEEL UNCOMFORTABLE AROUND THE BREAST AREA  AND ON BACK LIKE AN IRRITATION); This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included some breast issues, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced shingles infection (fever, chills, body aches and internal pain, feel uncomfortable around the breast area and on back like an irritation). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles infection (fever, chills, body aches and internal pain, feel uncomfortable around the breast area and on back like an irritation) was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID SYMPTOMS; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The consumer called to report the events he read from an article he was sent. He informed writer that he read after the patient received the covid-19 vaccine ad26.cov2.s, he got real sick, struggling in the hospital to survive and had Covid symptoms. The reporter did not had any more details. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210423090-covid-19 vaccine ad26.cov2.s -COVID symptoms. 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: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced Suspected COVID-19 infection and Suspected clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Suspected COVID-19 infection and Suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210423108. This report was associated with product quality complaint: 90000176123; Sender's Comments: V0: 20210423095-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia, Product administration error, Sneezing
Clinical narrative: BURNING SENSATION UNDER ARMPIT; TINGLING OF THE ARM - FELT LIKE SLEEPING ARM WRIST TO HAND; WIGGLING THE NEEDLE WHILE INJECTED IN THE ARM; SNEEZING; PAIN; 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 lymphoma, socially consumed alcohol, and non smoker. The patient had no known allergies and 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: 1805022 and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 05:42 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sneezing. On MAR-2021, the subject experienced pain. On 09-MAR-2021 05:42, the subject experienced wiggling the needle while injected in the arm. On 16-MAR-2021, the subject experienced burning sensation under armpit. On 16-MAR-2021, the subject experienced tingling of the arm - felt like sleeping arm wrist to hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation under armpit, and tingling of the arm - felt like sleeping arm wrist to hand, and the outcome of sneezing, pain and wiggling the needle while injected in the arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Constipation, Faeces soft, Frequent bowel movements
Clinical narrative: HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; 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 hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperchlorhydria, Hypertension, Pain, Pulmonary congestion, Sinus congestion
Clinical narrative: HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; 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 hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Injection site mass, Injection site warmth, Pain, Tenderness
Clinical narrative: 2X GRAND MAL SEIZURE; TENDER; SORE; LUMP AT INJECTION SITE; INJECTION SITE FELT HOT; This spontaneous report received from a patient concerned a white, not hispanic or latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure which was under control with medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A,expiry: UNKNOWN) dose was not reported,1 total administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced tender, sore, lump at injection site, injection site felt hot to touch. On 11-APR-2021, the patient had two grand mal seizure and and had to visit an emergency room/hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump at injection site, and injection site felt hot on 11-APR-2021, was recovering from tender, and sore, and the outcome of 2x grand mal seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210424069- covid-19 vaccine ad26.cov2.s -2x grand mal seizure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Malaise, Pain
Clinical narrative: LOOSING WEIGHT; PAIN ALL OVER THE BODY; MALAISE; CHILLS; WEAKNESS; HEADACHE; 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 concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced loosing weight, pain all over the body, malaise, chills, weakness and headache. The patient had not contacted Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache, and had not recovered from malaise, pain all over the body, weakness, and loosing weight. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210424184.; Sender's Comments: V0 20210424121-Covid-19 vaccine ad26.cov2.s -Losing weight. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: LOOSING WEIGHT; PAIN ALL OVER THE BODY; MALAISE; CHILLS; WEAKNESS; HEADACHE; 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 concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced loosing weight, pain all over the body, malaise, chills, weakness and headache. The patient had not contacted Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache, and had not recovered from malaise, pain all over the body, weakness, and loosing weight. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210424184.; Sender's Comments: V0 20210424121-Covid-19 vaccine ad26.cov2.s -Losing weight. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Bradycardia, Dyspnoea, Echocardiogram
Clinical narrative: BRADYCARDIA; RAPID ATRIAL FLUTTER; RAPID ATRIAL FIBRILLATION; TACHYCARDIA; SHORTNESS OF BREATH; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 66 year old female. 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: 1805031, and expiry: UNKNOWN) dose was not reported, once total, administered on 10-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 10-MAR-2021, patient had echocardiogram and the rhythm was normal. On 29-MAR-2021, the patient experienced rapid atrial flutter which became rapid atrial fibrillation and had tachycardia and shortness of breath. On same day patient was hospitalized for monitoring and On 30-MAR-2021, the patient developed bradycardia. It was stated that patient was bouncing between tachycardia and bradycardia which he never experienced before. Also patient stated that if symptoms doesn't resolve he had to have cardioversion procedure. On 31-Mar-2021, patient got discharged from hospital. It was reported that patient's medical doctor was aware about the adverse events and cardiologist does not know about the administration of vaccine. It was also reported that clinician who administered the vaccine to patient advised to take Motrin. Treatment medications (dates unspecified) included: Motrin(ibuprofen) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid atrial flutter, rapid atrial fibrillation, shortness of breath, tachycardia, and bradycardia, and the outcome of did not feel well was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210424129-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, Bradycardia and  Atrial flutter. These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Tachycardia
Clinical narrative: BRADYCARDIA; RAPID ATRIAL FLUTTER; RAPID ATRIAL FIBRILLATION; TACHYCARDIA; SHORTNESS OF BREATH; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 66 year old female. 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: 1805031, and expiry: UNKNOWN) dose was not reported, once total, administered on 10-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 10-MAR-2021, patient had echocardiogram and the rhythm was normal. On 29-MAR-2021, the patient experienced rapid atrial flutter which became rapid atrial fibrillation and had tachycardia and shortness of breath. On same day patient was hospitalized for monitoring and On 30-MAR-2021, the patient developed bradycardia. It was stated that patient was bouncing between tachycardia and bradycardia which he never experienced before. Also patient stated that if symptoms doesn't resolve he had to have cardioversion procedure. On 31-Mar-2021, patient got discharged from hospital. It was reported that patient's medical doctor was aware about the adverse events and cardiologist does not know about the administration of vaccine. It was also reported that clinician who administered the vaccine to patient advised to take Motrin. Treatment medications (dates unspecified) included: Motrin(ibuprofen) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid atrial flutter, rapid atrial fibrillation, shortness of breath, tachycardia, and bradycardia, and the outcome of did not feel well was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210424129-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, Bradycardia and  Atrial flutter. These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Headache, Malaise
Clinical narrative: SEVERE BACK PAIN; PAIN ALL OVER; MALAISE; WEAK; CHILLS; HEADACHE; WEIGHT LOST; This spontaneous report received from a parent concerned a 21 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: 1888979 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced weight lost. On 04-APR-2021, the subject experienced pain all over. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced weak. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced severe back pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from severe back pain on APR-2021, was recovering from headache, and weight lost, and had not recovered from chills, malaise, pain all over, and weak. This report was non-serious. This parent/child case is linked.; Sender's Comments: V0-Medical assessment comment is not required as per standard operating procedures.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Weight decreased
Clinical narrative: SEVERE BACK PAIN; PAIN ALL OVER; MALAISE; WEAK; CHILLS; HEADACHE; WEIGHT LOST; This spontaneous report received from a parent concerned a 21 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: 1888979 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced weight lost. On 04-APR-2021, the subject experienced pain all over. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced weak. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced severe back pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from severe back pain on APR-2021, was recovering from headache, and weight lost, and had not recovered from chills, malaise, pain all over, and weak. This report was non-serious. This parent/child case is linked.; Sender's Comments: V0-Medical assessment comment is not required as per standard operating procedures.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included no previous medical history and no known allergies. no drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced slight arm pain. On 09-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) PCR was positive on 10-APR-2021. On 10-APR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 2021, and had not recovered from confirmed covid-19 infection. This report was non-serious. This case is associated with product quality complaint (PQC) number 90000176134.The suspected product quality complaint has been confirmed to be this report indicated a patient who received a positive covid-19 test result after vaccination, with 9 days elapsed between vaccine and test. Sufficient time was not elapsed for the patient to achieve immunity therefore, this report was not considered a lack of effect. case was approved for void, based on the pqc evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; 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, 1 total administered on 08-APR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the patient experienced seizure which lasted for one minute 30 seconds. The patient did not take any medication for her seizure. She never had a seizure before and did not know if there was a correlation with vaccine or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 12-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210424312-covid-19 vaccine ad26.cov2. s-seizure. 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: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: UNDERAGE ADMINISTRATION (17 YEARS OF AGE); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced underage administration (17 years of age). On 09-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the underage administration (17 years of age) and off label use 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Gastrointestinal haemorrhage
Clinical narrative: HIGH BLOOD SUGAR; GI BLEED; This spontaneous report received from a consumer concerned a 71 years old  female. The patient's height, and weight were not reported. The patient's past medical history included NIDDM (Non-Insulin-Dependent Diabetes Mellitus Diabetes).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  In APR-2021, the patient experienced GI (gastrointestinal) bleed. On an unspecified date, the patient experienced high blood sugar. It was reported that the reporter was not sure if the GI (gastrointestinal) bleed was just coincidence because the patient passed so soon after getting the covid-19 vaccine ad26.cov2.s. The patient had to go to her Doctor to get an unknown shot on the day of or close to the day of the vaccine, probably insulin because the patient had a 475 blood sugar. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 475 mg/dL. On an unspecified date the patient died from GI (gastrointestinal) bleed. Patient was lying there for a while. Patient had been bleeding when it was discovered on 11-APR-2021 that she had expired. Coroner's report said it was from GI (gastrointestinal) bleed. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of GI (gastrointestinal) bleed on an unspecified date, and the outcome of high blood sugar was not reported. This report was serious (Death).; Sender's Comments: covid-19 vaccine ad26.cov2.s-GI bleed. 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). covid-19 vaccine ad26.cov2.s-high blood sugar. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: GI BLEEDING
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: HIGH BLOOD SUGAR; GI BLEED; This spontaneous report received from a consumer concerned a 71 years old  female. The patient's height, and weight were not reported. The patient's past medical history included NIDDM (Non-Insulin-Dependent Diabetes Mellitus Diabetes).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  In APR-2021, the patient experienced GI (gastrointestinal) bleed. On an unspecified date, the patient experienced high blood sugar. It was reported that the reporter was not sure if the GI (gastrointestinal) bleed was just coincidence because the patient passed so soon after getting the covid-19 vaccine ad26.cov2.s. The patient had to go to her Doctor to get an unknown shot on the day of or close to the day of the vaccine, probably insulin because the patient had a 475 blood sugar. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 475 mg/dL. On an unspecified date the patient died from GI (gastrointestinal) bleed. Patient was lying there for a while. Patient had been bleeding when it was discovered on 11-APR-2021 that she had expired. Coroner's report said it was from GI (gastrointestinal) bleed. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of GI (gastrointestinal) bleed on an unspecified date, and the outcome of high blood sugar was not reported. This report was serious (Death).; Sender's Comments: covid-19 vaccine ad26.cov2.s-GI bleed. 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). covid-19 vaccine ad26.cov2.s-high blood sugar. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: GI BLEEDING
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old white and not Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced mild cough, leg pain, tiredness and lack of appetite. The patient had contacted an health care professional who advised him to monitor his symptoms. On 11-APR-2021, patient took polymerase chain reaction (PCR) test, Laboratory data included: Covid-19 PCR test (NR: not provided) Positive. On an unspecified date, the patient experienced confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210424495-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: PAIN IN LEGS; CHILLS; FEVER; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in legs, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in legs, fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: BLOOD FROM RECTUM; BLOOD FROM VAGINA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause for about 3 years.  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 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-MAR-2021 after a long morning walk, the patient had bleeding from her vagina and from rectum (anus); it was big dollops of bright red blood in two distinct regions about the size of half dollars. The patient also had the usual soreness at the injection site had lasted for about three to four days, however the bleeding was unusual for her. The patient reported the events to her primary care physician, who responded that the events must be coincidental. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from vagina, and blood from rectum on 31-MAR-2021, and injection site soreness on APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210424821- covid-19 vaccine ad26.cov2.s-Blood from rectum. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Erythema, Fatigue, Feeding disorder
Clinical narrative: INJECTION SITE PURPLE; SWOLLEN ARM; REDNESS ON ARM; ITCHY ON INJECTION SITE; VOMITING BLOOD; DIZZY; UNABLE TO EAT; VOMITING; PAIN IN ARM/ UNABLE TO LIFT ARM ABOVE HEAD; SORENESS AT INJECTION SITE; TIRED; FEVER; 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, and batch number: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the patient felt dizzy, was tired, had a fever and soreness at injection site. The patient could not lift her arm above head without being in pain. She was unable to eat anything the entire day. The patient attempted to eat some soup but, threw it up. On 07-APR-2021 at 03:00, the patient woke up and drank some water but within ten minutes she threw that up along with blood and later her temperature was 104.8 (unit unspecified). On 07-APR-2021 afternoon, the patient was not able to eat anything but she drank some gatorade. On 08-APR-2021 afternoon, the patient's fever broke. On 09-APR-2021, the patient was able to go to work; however the patient's arms still hurt and was red and swollen. The patient's injection site began to itch and it continued up to that weekend. On 11-APR-2021, the injection arm was swollen for about an hour. On 13-APR-2021, the patient felt fine but her injection site was purple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting blood, dizzy, unable to eat, redness on arm, itchy on injection site, vomiting, pain in arm/ unable to lift arm above head, soreness at injection site, and tired on APR-2021, swollen arm on 11-APR-2021, and fever on 08-APR-2021, and had not recovered from injection site purple. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210425153-covid-19 vaccine ad26.cov2. s- vomiting blood. 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.