chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lethargy, Nightmare, Rash
Clinical narrative: FLU-LIKE SYMPTOMS; LETHARGIC; NIGHTMARES; CHILLS; BUMP ON FOREHEAD; This spontaneous report received from a consumer concerned a 5 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced lethargic. On OCT-2021, the patient experienced nightmares. On OCT-2021, the patient experienced chills. On OCT-2021, the patient experienced bump on forehead. On an unspecified date, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, chills, lethargic, bump on forehead, and nightmares. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Increased tendency to bruise, Lymphopenia, Skin discolouration, Thrombocytopenia
Clinical narrative: LOW LEVEL OF WHITE BLOOD CELLS; WBC IN URINE; RBC IN URINE; THROMBOCYTOPENIA; LYMPHOCYTOPENIA; MARKS AND PURPERA UNDER THE SKIN; GET EASILY BRUISED; This spontaneous report received from a patient concerned a 69-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: back fusion, and concurrent conditions included: lung damage due to pollution and inhaling snow ash, arthritis, and genetic abnormality. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 01 total administered to left arm on 07-OCT-2021 for prophylactic vaccination. Concomitant medications included Methyl folate (calcium levomefolate) for genetic abnormality, Vitamin B12 amino (cyanocobalamin), Vitamin B6 (pyridoxine hydrochloride), and Vitamin B1 (thiamine) for unknown indication. The patient was taking unspecified injection subcutaneously for arthritis. None of her concomitant conditions or her medication interfered or contraindicated from taking the vaccine. After receiving vaccine, the patient did not experience any side effect not even a pain in site of injection. She had only normal pain for receiving an injection. On 01-NOV-2021, she went to do some pre-operation blood and urine test as she was scheduled to get a morphine pump implanted in mid-December due to her previous condition of back fusion. The blood test came back with low level of White Blood Cells (WBC) (absolute white blood cell count that was low), thrombocytopenia and lymphocytopenia. The urine test came back with WBC and Red Blood Cells (RBC) in urine but no blood in urine as per caller. Her doctor repeated the urine test on 03-NOV-2021 or 04-NOV-2021 and it was the same. The blood test was re-done on 04-NOV-2021 and came back with the same result. Both her surgeon and her doctor recommended her to urgently see a hematologist. Her surgery was put on hold until she saw her hematologist. She never had anything close to this. Her doctor was against her taking any vaccine and wanted her to wait for nova vax. But she took vaccine due to her lung condition (lung damage due to pollution and inhaling snow ash to the point that she lost her voice). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombocytopenia, lymphocytopenia, marks and purpera under the skin, low level of white blood cells, WBC in urine, RBC in urine and get easily bruised was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211118705-covid-19 vaccine ad26.cov2.s-thrombocytopenia. 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: Urine analysis
Clinical narrative: LOW LEVEL OF WHITE BLOOD CELLS; WBC IN URINE; RBC IN URINE; THROMBOCYTOPENIA; LYMPHOCYTOPENIA; MARKS AND PURPERA UNDER THE SKIN; GET EASILY BRUISED; This spontaneous report received from a patient concerned a 69-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: back fusion, and concurrent conditions included: lung damage due to pollution and inhaling snow ash, arthritis, and genetic abnormality. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 01 total administered to left arm on 07-OCT-2021 for prophylactic vaccination. Concomitant medications included Methyl folate (calcium levomefolate) for genetic abnormality, Vitamin B12 amino (cyanocobalamin), Vitamin B6 (pyridoxine hydrochloride), and Vitamin B1 (thiamine) for unknown indication. The patient was taking unspecified injection subcutaneously for arthritis. None of her concomitant conditions or her medication interfered or contraindicated from taking the vaccine. After receiving vaccine, the patient did not experience any side effect not even a pain in site of injection. She had only normal pain for receiving an injection. On 01-NOV-2021, she went to do some pre-operation blood and urine test as she was scheduled to get a morphine pump implanted in mid-December due to her previous condition of back fusion. The blood test came back with low level of White Blood Cells (WBC) (absolute white blood cell count that was low), thrombocytopenia and lymphocytopenia. The urine test came back with WBC and Red Blood Cells (RBC) in urine but no blood in urine as per caller. Her doctor repeated the urine test on 03-NOV-2021 or 04-NOV-2021 and it was the same. The blood test was re-done on 04-NOV-2021 and came back with the same result. Both her surgeon and her doctor recommended her to urgently see a hematologist. Her surgery was put on hold until she saw her hematologist. She never had anything close to this. Her doctor was against her taking any vaccine and wanted her to wait for nova vax. But she took vaccine due to her lung condition (lung damage due to pollution and inhaling snow ash to the point that she lost her voice). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombocytopenia, lymphocytopenia, marks and purpera under the skin, low level of white blood cells, WBC in urine, RBC in urine and get easily bruised was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211118705-covid-19 vaccine ad26.cov2.s-thrombocytopenia. 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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A, expiry: unknown) dose was not reported, 01 total administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-NOV-2021, the patient experienced suspected coronavirus disease-19 (covid-19) infection hence patient had received only two months protection from covid-19. On an unspecified date the patient experienced suspected clinical vaccination failure. The patient's asthma symptoms were also addressed for which she received the monoclonal antibodies and was doing well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000201218.  T; Sender's Comments: V0: 20211119221-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: MILD GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient concerned a 53 year old male The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included: bees allergy, non smoker, and alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug use. The patient had excellent health before this. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) 1 total, dose was not reported, administered on 14-AUG-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported on AUG-2021, About a week or ten days after the vaccination, he started experiencing muscle weakness and pain in his arms, and the sensation was more dominant in his left arm. It is not continuous, but he had noticed a significant difference in his grip. It was reported that If patient took a drive for an hour or more, he notice a pressure in legs behind the knee and upper calf. Had been taking fish oil to help. Had gone to PCP, and she thought it was possibly a Mild case of GBS (Mild Guillain Barre Syndrome). Treatment medications (dates unspecified) included: fish oil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Mild Guillain Barre Syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211121450-COVID-19 VACCINE AD26.COV2.S - Mild Guillain Barre Syndrome. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Body temperature, Gastrointestinal disorder, HIV test, Hyperpyrexia
Clinical narrative: FEVERS OF 106 DEGREES F; GI PROBLEMS; WEIGHT LOSS; TRANSIENT VISUAL DISTURBANCES; TINNITUS; MYALGIAS; This spontaneous report received from a physician concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was reported to be healthy prior to receiving the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. The physician reported that the patient was Medical mystery to them. It was reported that on an unspecified date the patient experienced fevers, myalgias, significant headache, difficulty hearing with tinnitis, fevers of 106 degrees F, transient visual disturbances, GI problems, and weight loss and has been hospitalized (dates unspecified), multiple times for unspecified days. The physician reported that they have done a million-dollar work-up on her, including 3 lumbar punctures which have come back negative. They have worked her up for AIDS (HIV test), ANA (Antinuclear antibody), sent out an encephalitis panel to clinic, and had checked viral panels which have all ended up negative. The patient had consistently been experiencing these symptoms. When she was put on 60 mg of prednisone, she improved, but the benefits go away once they start to taper her dosage. The patient had returned to the hospital. The Reporter said they are currently consulting ENT, and are suspecting something that was autoimmune in nature, but everything has been negative thus far. Laboratory data (dates unspecified) included: AIDS (NR: not provided) Negative, ANA (NR: not provided) Negative, Body temperature (NR: not provided) 106 F, Lumbar puncture (NR: not provided) Negative, and Viral test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgias, fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances, and tinnitus. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211121646-covid-19 vaccine ad26.cov2.s- fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances. 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).  20211121646 -covid-19 vaccine ad26.cov2.s- tinnitus, myalgia. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Myalgia, Tinnitus, Viral test, Visual impairment
Clinical narrative: FEVERS OF 106 DEGREES F; GI PROBLEMS; WEIGHT LOSS; TRANSIENT VISUAL DISTURBANCES; TINNITUS; MYALGIAS; This spontaneous report received from a physician concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was reported to be healthy prior to receiving the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. The physician reported that the patient was Medical mystery to them. It was reported that on an unspecified date the patient experienced fevers, myalgias, significant headache, difficulty hearing with tinnitis, fevers of 106 degrees F, transient visual disturbances, GI problems, and weight loss and has been hospitalized (dates unspecified), multiple times for unspecified days. The physician reported that they have done a million-dollar work-up on her, including 3 lumbar punctures which have come back negative. They have worked her up for AIDS (HIV test), ANA (Antinuclear antibody), sent out an encephalitis panel to clinic, and had checked viral panels which have all ended up negative. The patient had consistently been experiencing these symptoms. When she was put on 60 mg of prednisone, she improved, but the benefits go away once they start to taper her dosage. The patient had returned to the hospital. The Reporter said they are currently consulting ENT, and are suspecting something that was autoimmune in nature, but everything has been negative thus far. Laboratory data (dates unspecified) included: AIDS (NR: not provided) Negative, ANA (NR: not provided) Negative, Body temperature (NR: not provided) 106 F, Lumbar puncture (NR: not provided) Negative, and Viral test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgias, fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances, and tinnitus. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211121646-covid-19 vaccine ad26.cov2.s- fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances. 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).  20211121646 -covid-19 vaccine ad26.cov2.s- tinnitus, myalgia. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: FEVERS OF 106 DEGREES F; GI PROBLEMS; WEIGHT LOSS; TRANSIENT VISUAL DISTURBANCES; TINNITUS; MYALGIAS; This spontaneous report received from a physician concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was reported to be healthy prior to receiving the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. The physician reported that the patient was Medical mystery to them. It was reported that on an unspecified date the patient experienced fevers, myalgias, significant headache, difficulty hearing with tinnitis, fevers of 106 degrees F, transient visual disturbances, GI problems, and weight loss and has been hospitalized (dates unspecified), multiple times for unspecified days. The physician reported that they have done a million-dollar work-up on her, including 3 lumbar punctures which have come back negative. They have worked her up for AIDS (HIV test), ANA (Antinuclear antibody), sent out an encephalitis panel to clinic, and had checked viral panels which have all ended up negative. The patient had consistently been experiencing these symptoms. When she was put on 60 mg of prednisone, she improved, but the benefits go away once they start to taper her dosage. The patient had returned to the hospital. The Reporter said they are currently consulting ENT, and are suspecting something that was autoimmune in nature, but everything has been negative thus far. Laboratory data (dates unspecified) included: AIDS (NR: not provided) Negative, ANA (NR: not provided) Negative, Body temperature (NR: not provided) 106 F, Lumbar puncture (NR: not provided) Negative, and Viral test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgias, fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances, and tinnitus. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211121646-covid-19 vaccine ad26.cov2.s- fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances. 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).  20211121646 -covid-19 vaccine ad26.cov2.s- tinnitus, myalgia. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Fear, Loss of consciousness, Muscle spasms
Clinical narrative: PASSED OUT AND FELL DOWN ON KITCHEN FLOOR; HUGE AMOUNT OF PAIN; GETTING SCARED; BODY CRAMPING AND LEG CRAMPING; FELT LIKE BURNING; BAD REACTION; HIGH AMOUNT OF FEVER; This spontaneous report received from a consumer concerned a 27 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 08-NOV-2021 10:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-NOV-2021, at 02:00, patient experienced huge amount of pain, got scared, body was cramping with high amount of fever. She felt like she was burning and passed out on kitchen floor. She was in huge amount of pain in her whole body, legs were cramping, bad reaction, passed out and fell down. Laboratory data included: Body temperature (NR: not provided) High. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from huge amount of pain, getting scared, body cramping and leg cramping, high amount of fever, felt like burning, passed out and fell down on kitchen floor, and bad reaction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211121883-COVID-19 VACCINE AD26.COV2.S- passed out and fell down on kitchen floor. 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: Nonspecific reaction, Pain, Pyrexia
Clinical narrative: PASSED OUT AND FELL DOWN ON KITCHEN FLOOR; HUGE AMOUNT OF PAIN; GETTING SCARED; BODY CRAMPING AND LEG CRAMPING; FELT LIKE BURNING; BAD REACTION; HIGH AMOUNT OF FEVER; This spontaneous report received from a consumer concerned a 27 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 08-NOV-2021 10:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-NOV-2021, at 02:00, patient experienced huge amount of pain, got scared, body was cramping with high amount of fever. She felt like she was burning and passed out on kitchen floor. She was in huge amount of pain in her whole body, legs were cramping, bad reaction, passed out and fell down. Laboratory data included: Body temperature (NR: not provided) High. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from huge amount of pain, getting scared, body cramping and leg cramping, high amount of fever, felt like burning, passed out and fell down on kitchen floor, and bad reaction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211121883-COVID-19 VACCINE AD26.COV2.S- passed out and fell down on kitchen floor. 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: Arthralgia, Myalgia, Palmar-plantar erythrodysaesthesia syndrome
Clinical narrative: MILD HAND AND FOOT SYNDROME; JOINT PAIN; BODY/MUSCLE PAIN; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight was 155 pounds, and height was 69.5 inches. The patient's concurrent conditions included: metastases to brain, metastases to right lung and left lung, metastases to intra-abdominal lymph nodes, seasonal allergic rhinitis, hypertension, major depressive disorder, fluid overload, toxic gastroenteritis, toxic colitis, acute renal failure, pericarditis, and malignant neoplasm of right kidney except renal pelvis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included lenvatinib mesilate for malignant neoplasm of right kidney except renal pelvis, amlodipine besilate, everolimus, fluticasone propionate, levothyroxine sodium, loratadine/pseudoephedrine sulfate, losartan potassium, and zinc. On 30-SEP-2021, the patient experienced joint pain. On 30-SEP-2021, the patient experienced body/muscle pain. On an unspecified date, the patient experienced mild hand and foot syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body/muscle pain, joint pain and mild hand and foot syndrome was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: FULL BLOWN TYPE 2 DIABETES THAT SEEMS NOT TO BE TREATABLE BY ANY MEDICATION; 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: full blown type 2 diabetes. 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, with frequency 1 total administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient reported that he had full blown type 2 diabetes that seems to not be treatable by any medications and upon researching, the vaccine was responsible for an increase of victims to an extent of 42 percentage. Also stated that three months and he had no signs of this going into remission, diet, exercise and medications did not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from full blown type 2 diabetes that seems not to be treatable by any medication. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211122616-COVID-19 VACCINE AD26.COV2.S-Full blown type 2 diabetes that seems not to be treatable by any medication. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bladder disorder, Dysstasia, Gait disturbance, Hypoaesthesia
Clinical narrative: ERECTING; BLADDER ISSUES; TROUBLE WALKING; BOTH LEGS ARE WEAK; NUMBNESS IN FEET AND ANKLES; HAVING PROBLEM GETTING OUT OF BED; WEAKNESS IN RIGHT LEG; PAIN SHOOTING DOWN RIGHT LEG/ SHOOTING PAIN FROM HIP DOWN THE RIGHT LEG/ PAIN IN CALF; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, latex allergy, and swallowing problems, and other pre-existing medical conditions included: Patient does not take flu vaccines. Patient was allergic to leviditin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the patient experienced weakness in right leg. On 10-JUN-2021, the patient experienced pain shooting down right leg/ shooting pain from hip down the right leg/ pain in calf. On 07-JUL-2021, the patient experienced having problem getting out of bed. On 21-JUL-2021, the patient experienced bladder issues. On 21-JUL-2021, the patient experienced trouble walking. On 21-JUL-2021, the patient experienced both legs are weak. On 21-JUL-2021, the patient experienced numbness in feet and ankles. On 06-AUG-2021, the patient experienced erecting. Treatment medications (dates unspecified) included: gabapentin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness in right leg, having problem getting out of bed, both legs are weak, numbness in feet and ankles, bladder issues, pain shooting down right leg/ shooting pain from hip down the right leg/ pain in calf, trouble walking, and erecting. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Physical disability
Clinical narrative: ERECTING; BLADDER ISSUES; TROUBLE WALKING; BOTH LEGS ARE WEAK; NUMBNESS IN FEET AND ANKLES; HAVING PROBLEM GETTING OUT OF BED; WEAKNESS IN RIGHT LEG; PAIN SHOOTING DOWN RIGHT LEG/ SHOOTING PAIN FROM HIP DOWN THE RIGHT LEG/ PAIN IN CALF; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, latex allergy, and swallowing problems, and other pre-existing medical conditions included: Patient does not take flu vaccines. Patient was allergic to leviditin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the patient experienced weakness in right leg. On 10-JUN-2021, the patient experienced pain shooting down right leg/ shooting pain from hip down the right leg/ pain in calf. On 07-JUL-2021, the patient experienced having problem getting out of bed. On 21-JUL-2021, the patient experienced bladder issues. On 21-JUL-2021, the patient experienced trouble walking. On 21-JUL-2021, the patient experienced both legs are weak. On 21-JUL-2021, the patient experienced numbness in feet and ankles. On 06-AUG-2021, the patient experienced erecting. Treatment medications (dates unspecified) included: gabapentin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness in right leg, having problem getting out of bed, both legs are weak, numbness in feet and ankles, bladder issues, pain shooting down right leg/ shooting pain from hip down the right leg/ pain in calf, trouble walking, and erecting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: BLOOD CLOTS; EYE STROKE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, 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, it was reported that right after the vaccination, the patient had developed with blood clots which gave an eye stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and eye stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211124769-covid-19 vaccine ad26.cov2.s-blood clots and eye stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Myalgia, Sleep disorder due to general medical condition, insomnia type
Clinical narrative: SWOLLEN TINY RED LUMP AT SITE OF INJECTION; SORE ARM AT THE SITE OF INJECTION; MUSCLE ACHES (DOWN FROM THIGHS); UNABLE TO SLEEP DUE TO MUSCLE PAIN; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism.  On JUN-2021, the patient experienced unable to sleep due to muscle pain. On 01-JUN-2021, the patient experienced muscle aches (down from thighs). On an unspecified date, the patient experienced swollen tiny red lump at site of injection, and sore arm at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep due to pain, swollen tiny red lump at site of injection, and muscle aches (down from thighs), and the outcome of sore arm at the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124984.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS/ 3 OR 4 WOMEN THAT DIED FROM BLOOD CLOTS; This spontaneous report received from a patient via a company representative via a social media post concerned 3 or 4 female patients of unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. These patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the reporter stated that "I really Hope you do not get the J and J there have been 3 or 4 Women that Died from Blood Clots". On an unspecified date, the patients died from blood clots. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211125101.; Sender's Comments: V0: 20211124990-covid-19 vaccine ad26.cov2.s -blood clots/ 3 or 4 women that died from blood clots. 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).; Reported Cause(s) of Death: BLOOD CLOTS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID 19; This spontaneous report received from a physician via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 25-OCT-2021, the patient experienced tested positive for covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid 19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM STILL SORE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced arm still sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still sore. This report was non-serious. This case, from the same reporter is linked to 20211110578.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Ear pain, Insomnia, Otorrhoea
Clinical narrative: HEARING LOSS IN LEFT EAR; PAIN IN LEFT EAR; PRESSURE IN LEFT EAR; WETNESS IN THE LEFT EAR; DISRUPTING SLEEP; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anaphylaxis, and concurrent conditions included: allergies undefined, non smoker, and non alcoholic. The 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: 211D21A expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-NOV-2021 within 15 minutes of vaccination, the patient experienced pressure in her left ear like it needed to pop as if she was in an elevator and had pressure which got worse with time. On 09-NOV-2021 (last night), the patient went to the emergency room, they examined and told there was wetness in her left ear and recommended to make an appointment with an eye, ear, throat specialist. The patient reported ringing in her ear along with a muffling sound where the patient cannot hear clearly. She reported sound was muffled and ringing was disrupting her sleep.     The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hearing loss in left ear, pain in left ear, pressure in left ear, and the outcome of wetness in the left ear and disrupting sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211125661-COVID-19 VACCINE AD26.COV2.S-hearing loss in left ear. 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: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE/ VACCINE ADMINISTERED 6 HOURS AND 40 MINUTES AFTER FIRST PUNCTURE OF THE VIAL; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced incorrect product storage. On 11-NOV-2021, the patient experienced out of specification product use/ vaccine administered 6 hours and 40 minutes after first puncture of the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use/ vaccine administered 6 hours and 40 minutes after first puncture of the vial was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea exertional, Fatigue, Pain
Clinical narrative: BODY ACHES; SLIGHTLY OUT OF BREATH WHEN CLIMBING THE STAIRS; CHILLS; FEELING RUN DOWN, LIKE PATIENT WAS ABOUT TO COME DOWN WITH FLU; SLIGHTLY FEVERISH (100.0F); This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, and positive antibodies, and other pre-existing medical conditions included: he claimed to be in good shape. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced body aches. On 11-NOV-2021, the patient experienced slightly out of breath when climbing the stairs. On 11-NOV-2021, the patient experienced chills. On 11-NOV-2021, the patient experienced feeling run down, like patient was about to come down with flu. On 11-NOV-2021, the patient experienced slightly feverish (100.0f). Laboratory data included: Body temperature (NR: not provided) 100.0 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, feeling run down, like patient was about to come down with flu, slightly feverish (100.0f), and slightly out of breath when climbing the stairs. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; SLIGHTLY OUT OF BREATH WHEN CLIMBING THE STAIRS; CHILLS; FEELING RUN DOWN, LIKE PATIENT WAS ABOUT TO COME DOWN WITH FLU; SLIGHTLY FEVERISH (100.0F); This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, and positive antibodies, and other pre-existing medical conditions included: he claimed to be in good shape. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced body aches. On 11-NOV-2021, the patient experienced slightly out of breath when climbing the stairs. On 11-NOV-2021, the patient experienced chills. On 11-NOV-2021, the patient experienced feeling run down, like patient was about to come down with flu. On 11-NOV-2021, the patient experienced slightly feverish (100.0f). Laboratory data included: Body temperature (NR: not provided) 100.0 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, feeling run down, like patient was about to come down with flu, slightly feverish (100.0f), and slightly out of breath when climbing the stairs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Miliaria, Rash
Clinical narrative: HEAT RASH ON CHEST STOMACH AND BACK; UPPER TORSO BROKEN OUT IN A RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-OCT-2021, the patient experienced heat rash on chest stomach and back. On 29-OCT-2021, the patient experienced upper torso broken out in a rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the upper torso broken out in a rash and heat rash on chest stomach and back was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain
Clinical narrative: SIGNIFICANTLY ELEVATED TEMPERATURE (NOT SURE WHAT THE TEMPERATURE WAS); PAIN IN THE ENTIRE BODY (TEETH HURTS, HAIR AND HEAD HURTS, LAYING ON THE PILLOW, CRYING DUE TO THE PAIN); This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Hashimoto's thyroiditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1855194, expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, treatment medications included: ibuprofen. On 10-NOV-2021, the patient experienced pain in the entire body (teeth hurts, hair and head hurts, laying on the pillow, crying due to the pain). On 11-NOV-2021, the patient experienced significantly elevated temperature (not sure what the temperature was). Laboratory data included: Body temperature (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the entire body (teeth hurts, hair and head hurts, laying on the pillow, crying due to the pain) on NOV-2021, and had not recovered from significantly elevated temperature (not sure what the temperature was). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia, Tremor, Vision blurred
Clinical narrative: BLURRED VISION; SWEATING WHILE EATING; SHAKING WHILE EATING; DIZZY FOR 8 WEEKS STRAIGHT; NUMBNESS IN HAND AND ARMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced blurred vision. On AUG-2021, the patient experienced sweating while eating. On AUG-2021, the patient experienced shaking while eating. On AUG-2021, the patient experienced dizzy for 8 weeks straight. On AUG-2021, the patient experienced numbness in hand and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision, sweating while eating, shaking while eating, dizzy for 8 weeks straight, and numbness in hand and arms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: A LITTLE AMOUNT OF INFLAMMATION IN ARMPIT ON SIDE OF JAB TAKEN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: cervical neck issue. 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. 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 a little amount of inflammation in armpit on side of jab taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little amount of inflammation in armpit on side of jab taken was not reported. This report was non-serious.