chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Blood test, Hypokinesia
Clinical narrative: DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JOINT PAIN IN LOWER EXTREMITIES/KNEE PAIN/HIP PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included hypothyroidism, alcohol use, non-smoker, and autoimmune disease/vitiligo/skin disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced pain on lower back. On JUN-2021, the subject experienced hurting neck. On JUN-2021, the subject experienced muscle weakness. On JUN-2021, the subject experienced joint pain in lower extremities/knee pain/hip pain. On JUN-2021, the subject experienced leg pain. On 22-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative. On an unspecified date, the subject experienced difficulty in bending, and weakness in lower body. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, joint pain in lower extremities/knee pain/hip pain, hurting neck, pain on lower back, and leg pain, and the outcome of difficulty in bending and weakness in lower body was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JOINT PAIN IN LOWER EXTREMITIES/KNEE PAIN/HIP PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included hypothyroidism, alcohol use, non-smoker, and autoimmune disease/vitiligo/skin disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced pain on lower back. On JUN-2021, the subject experienced hurting neck. On JUN-2021, the subject experienced muscle weakness. On JUN-2021, the subject experienced joint pain in lower extremities/knee pain/hip pain. On JUN-2021, the subject experienced leg pain. On 22-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative. On an unspecified date, the subject experienced difficulty in bending, and weakness in lower body. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, joint pain in lower extremities/knee pain/hip pain, hurting neck, pain on lower back, and leg pain, and the outcome of difficulty in bending and weakness in lower body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Jaundice
Clinical narrative: JAUNDICE; VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced jaundice, and vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jaundice and vaccine exposure via breast milk was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chills, Coeliac disease, Cold sweat, Gait disturbance
Clinical narrative: CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. 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). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Hypertension, Malaise, Paraesthesia
Clinical narrative: CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. 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). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. 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). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy, Pain, Syncope
Clinical narrative: FAINTED; LETHARGY; PAIN; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female patient 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: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 or 03-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 02-APR-2021 the patient fainted 12 hours post COVID-19 vaccine as well as fever, lethargy and pain. She woke up about a minute after. The following day (03-APR-2021), she experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 02-APR-2021, and lethargy, and pain, and the outcome of flu like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210745222-covid-19 vaccine ad26.cov2.s-Fainting . These events are considered unassessable. The events 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 events.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Headache, Heart rate increased, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART OF BOTH LEGS; TINGLING IN LOWER PART OF LEGS/TINGLING IN TOES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. 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 known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced tingling in lower part of legs/tingling in toes. On 23-APR-2021, the subject experienced increased heart rate which got worse with physical activity. On 23-APR-2021, the subject experienced pain in lower part of both legs. On MAY-2021, Laboratory data included: Blood test (NR: not provided) Unspecified, MRI brain (NR: not provided) Unspecified, and Magnetic resonance imaging spinal (NR: not provided) Unspecified. On 03-MAY-2021, the subject experienced swelling in spine. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate which got worse with physical activity on 28-MAY-2021, and headache on 23-APR-2021, was recovering from pain in lower part of both legs, and tingling in lower part of legs/tingling in toes, and had not recovered from swelling in spine. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Swelling
Clinical narrative: SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART OF BOTH LEGS; TINGLING IN LOWER PART OF LEGS/TINGLING IN TOES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. 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 known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced tingling in lower part of legs/tingling in toes. On 23-APR-2021, the subject experienced increased heart rate which got worse with physical activity. On 23-APR-2021, the subject experienced pain in lower part of both legs. On MAY-2021, Laboratory data included: Blood test (NR: not provided) Unspecified, MRI brain (NR: not provided) Unspecified, and Magnetic resonance imaging spinal (NR: not provided) Unspecified. On 03-MAY-2021, the subject experienced swelling in spine. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate which got worse with physical activity on 28-MAY-2021, and headache on 23-APR-2021, was recovering from pain in lower part of both legs, and tingling in lower part of legs/tingling in toes, and had not recovered from swelling in spine. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cold sweat, Decreased appetite, Dry mouth
Clinical narrative: FLU-LIKE SYMPTOMS/FEVER/BODY ACHE/CHILLS BUMPS/SLIGHT COUGH; SUPER DROWSY; EYES HOT/ON FIRE; COLD SWEATS; HOT SWEATS; THIRSTY; DRY THROAT; NO APPETITE LAST NIGHT AND THIS MORNING; BLOOD PRESSURE NOT HIGH; COULDN'T GET MUCH SLEEP LAST NIGHT; DRY MOUTH; HIVES; UNABLE TO SMOKE AS IT MAKES HIM NAUSEOUS; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced flu-like symptoms/fever/body ache/chills bumps/slight cough. On 20-JUL-2021, the subject experienced super drowsy. On 20-JUL-2021, the subject experienced eyes hot/on fire. On 20-JUL-2021, the subject experienced cold sweats. On 20-JUL-2021, the subject experienced hot sweats. On 20-JUL-2021, the subject experienced thirsty. On 20-JUL-2021, the subject experienced dry throat. On 20-JUL-2021, the subject experienced no appetite last night and this morning. On 20-JUL-2021, the subject experienced blood pressure not high. On 20-JUL-2021, the subject experienced couldn't get much sleep last night. On 20-JUL-2021, the subject experienced dry mouth. On 20-JUL-2021, the subject experienced hives. On 20-JUL-2021, the subject experienced unable to smoke as it makes him nauseous. Laboratory data included: Blood pressure increased (NR: not provided) Little high. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: tetryzoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from super drowsy, cold sweats, hot sweats, flu-like symptoms/fever/body ache/chills bumps/slight cough, eyes hot/on fire, thirsty, dry throat, couldn't get much sleep last night, hives, and dry mouth, had not recovered from no appetite last night and this morning, and unable to smoke as it makes him nauseous, and the outcome of blood pressure not high was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Eye irritation, Hyperhidrosis, Influenza like illness, Initial insomnia
Clinical narrative: FLU-LIKE SYMPTOMS/FEVER/BODY ACHE/CHILLS BUMPS/SLIGHT COUGH; SUPER DROWSY; EYES HOT/ON FIRE; COLD SWEATS; HOT SWEATS; THIRSTY; DRY THROAT; NO APPETITE LAST NIGHT AND THIS MORNING; BLOOD PRESSURE NOT HIGH; COULDN'T GET MUCH SLEEP LAST NIGHT; DRY MOUTH; HIVES; UNABLE TO SMOKE AS IT MAKES HIM NAUSEOUS; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced flu-like symptoms/fever/body ache/chills bumps/slight cough. On 20-JUL-2021, the subject experienced super drowsy. On 20-JUL-2021, the subject experienced eyes hot/on fire. On 20-JUL-2021, the subject experienced cold sweats. On 20-JUL-2021, the subject experienced hot sweats. On 20-JUL-2021, the subject experienced thirsty. On 20-JUL-2021, the subject experienced dry throat. On 20-JUL-2021, the subject experienced no appetite last night and this morning. On 20-JUL-2021, the subject experienced blood pressure not high. On 20-JUL-2021, the subject experienced couldn't get much sleep last night. On 20-JUL-2021, the subject experienced dry mouth. On 20-JUL-2021, the subject experienced hives. On 20-JUL-2021, the subject experienced unable to smoke as it makes him nauseous. Laboratory data included: Blood pressure increased (NR: not provided) Little high. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: tetryzoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from super drowsy, cold sweats, hot sweats, flu-like symptoms/fever/body ache/chills bumps/slight cough, eyes hot/on fire, thirsty, dry throat, couldn't get much sleep last night, hives, and dry mouth, had not recovered from no appetite last night and this morning, and unable to smoke as it makes him nauseous, and the outcome of blood pressure not high was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Somnolence, Thirst, Urticaria
Clinical narrative: FLU-LIKE SYMPTOMS/FEVER/BODY ACHE/CHILLS BUMPS/SLIGHT COUGH; SUPER DROWSY; EYES HOT/ON FIRE; COLD SWEATS; HOT SWEATS; THIRSTY; DRY THROAT; NO APPETITE LAST NIGHT AND THIS MORNING; BLOOD PRESSURE NOT HIGH; COULDN'T GET MUCH SLEEP LAST NIGHT; DRY MOUTH; HIVES; UNABLE TO SMOKE AS IT MAKES HIM NAUSEOUS; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced flu-like symptoms/fever/body ache/chills bumps/slight cough. On 20-JUL-2021, the subject experienced super drowsy. On 20-JUL-2021, the subject experienced eyes hot/on fire. On 20-JUL-2021, the subject experienced cold sweats. On 20-JUL-2021, the subject experienced hot sweats. On 20-JUL-2021, the subject experienced thirsty. On 20-JUL-2021, the subject experienced dry throat. On 20-JUL-2021, the subject experienced no appetite last night and this morning. On 20-JUL-2021, the subject experienced blood pressure not high. On 20-JUL-2021, the subject experienced couldn't get much sleep last night. On 20-JUL-2021, the subject experienced dry mouth. On 20-JUL-2021, the subject experienced hives. On 20-JUL-2021, the subject experienced unable to smoke as it makes him nauseous. Laboratory data included: Blood pressure increased (NR: not provided) Little high. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: tetryzoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from super drowsy, cold sweats, hot sweats, flu-like symptoms/fever/body ache/chills bumps/slight cough, eyes hot/on fire, thirsty, dry throat, couldn't get much sleep last night, hives, and dry mouth, had not recovered from no appetite last night and this morning, and unable to smoke as it makes him nauseous, and the outcome of blood pressure not high was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Biopsy, Colonoscopy, Diverticulitis, Injection site pain
Clinical narrative: DIVERTICULITIS; INJECTION SITE PAIN; WEIGHT LOSS 13 POUND; HAIR LOSS/THINNING A LOT IN THE SHOWER; This spontaneous report received from a patient concerned a 50 year old white Hispanic or Latino female. The patient's weight was 137 pounds, and height was 68 inches. The patient's past medical history included flares, and concurrent conditions included occasional alcohol user, and cigarettes smoker 1/2 pack per day. The patient had no medical history of diagnosed diverticulitis, but patient believes that she had two flares up in the past that went up undiagnosed, may had two episodes in the last 10 years. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported that since receiving the vaccine on 01-APR-2021, she had 13 pounds weight loss, that was unusual for patient, only dietary change made by the patient was cutting back on sodas, that was not drinking crazy amount before also. On 06-APR-2021, the patient experienced injection site pain. On 07-APR-2021, the patient started symptoms of diverticulitis and started treatment with her primary care prescribed metronidazole for the diverticulitis bloody stools. On 11-APR-2021, patient was treated in the emergency room and diagnosed with diverticulitis. The patient was discharged to home after being treated with fluids for hydration and to continue with the antibiotics. The patient diverticulitis symptoms improved drastically by the 19- APR-2021 but did not fully resolve until the last 3 to 4 weeks before reporting. On unspecified date in APR-2021 patient experienced hair loss and patient described it as she could see thinning, just a lot in the shower, she states this was new and unusual. On 18-MAY-2021, patient underwent to colonoscopy with biopsies, the report was received and Doctor of Medicine states normal, but report states precancerous.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 08-APR-2021, and hair loss thinning a lot in the shower on MAY-2021, was recovering from diverticulitis with bloody stool, and the outcome of weight loss 13 pound was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745377-covid-19 vaccine ad26.cov2.s -Diverticulitis. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: DIVERTICULITIS; INJECTION SITE PAIN; WEIGHT LOSS 13 POUND; HAIR LOSS/THINNING A LOT IN THE SHOWER; This spontaneous report received from a patient concerned a 50 year old white Hispanic or Latino female. The patient's weight was 137 pounds, and height was 68 inches. The patient's past medical history included flares, and concurrent conditions included occasional alcohol user, and cigarettes smoker 1/2 pack per day. The patient had no medical history of diagnosed diverticulitis, but patient believes that she had two flares up in the past that went up undiagnosed, may had two episodes in the last 10 years. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported that since receiving the vaccine on 01-APR-2021, she had 13 pounds weight loss, that was unusual for patient, only dietary change made by the patient was cutting back on sodas, that was not drinking crazy amount before also. On 06-APR-2021, the patient experienced injection site pain. On 07-APR-2021, the patient started symptoms of diverticulitis and started treatment with her primary care prescribed metronidazole for the diverticulitis bloody stools. On 11-APR-2021, patient was treated in the emergency room and diagnosed with diverticulitis. The patient was discharged to home after being treated with fluids for hydration and to continue with the antibiotics. The patient diverticulitis symptoms improved drastically by the 19- APR-2021 but did not fully resolve until the last 3 to 4 weeks before reporting. On unspecified date in APR-2021 patient experienced hair loss and patient described it as she could see thinning, just a lot in the shower, she states this was new and unusual. On 18-MAY-2021, patient underwent to colonoscopy with biopsies, the report was received and Doctor of Medicine states normal, but report states precancerous.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 08-APR-2021, and hair loss thinning a lot in the shower on MAY-2021, was recovering from diverticulitis with bloody stool, and the outcome of weight loss 13 pound was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745377-covid-19 vaccine ad26.cov2.s -Diverticulitis. 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving the vaccine, the patient underwent antibody test ((SARS COV 2 AB IgG Spike Semi quantitative (SARS-CoV-2 IgG) antibody test )) conducted on 16-JUL-2021 which was negative (the value was less than 1.00). The patient experienced confirmed immunological vaccine failure (therapy non-responder).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The report was associated with product quality complaint: 90000186856; Sender's Comments: V0-20210745802-Covid-19 vaccine ad26.cov2.s- CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 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 the patient had no known drug or non-drug allergies and the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 10/JUL/2021 patient tested positive for COVID after starting with symptoms on 05/JUL/2021. Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745821-covid-19 vaccine ad26.cov2.s -Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: FLU-LIKE SYMPTOMS; HEAD COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) 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 subject experienced flu-like symptoms, and head cold. Treatment medications (dates unspecified) included: oseltamivir phosphate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and head cold. This report was non-serious. This case, from the same reporter is linked to 20210705017.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: SEVERE JOINT PAIN; FEVER; HEADACHE; SEVERE FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder. 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 subject experienced severe joint pain, fever, headache, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe joint pain, fever, headache and severe fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: REALLY UNCOMFORTABLE BODY ACHES; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of an 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. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced really uncomfortable body aches, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really uncomfortable body aches, and slight fever. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Fatigue, Feeling abnormal, Headache
Clinical narrative: BRAIN FOG; WANT TO SLEEP DUE TO RESTLESSNESS; FEVERISH LIKE FLUSHED/HOT FLASH; TIREDNESS; LITTLE NAUSEATED AS LIKE A FLU BUG; HEADACHE; RESTLESS; LEFT ARM THROBBING/ACHY; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 165 pounds, and height was 62 inches. The patient's past medical history included cough, fever, and penicillin allergy, and concurrent conditions included low thyroid, alcoholic, non smoker, and seasonal allergy. The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included thyroid for low thyroid. On FEB-2020, Laboratory data included: Body temperature (NR: not provided) 103 temperature.  On 21-JUL-2021, the subject experienced restless. On 21-JUL-2021, the subject experienced left arm throbbing/achy. On 21-JUL-2021, the subject experienced did not sleep well. On 21-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced brain fog. On 22-JUL-2021, the subject experienced want to sleep due to restlessness. On 22-JUL-2021, the subject experienced feverish like flushed/hot flash. On 22-JUL-2021, the subject experienced tiredness. On 22-JUL-2021, the subject experienced little nauseated as like a flu bug. Laboratory data included: Body temperature (NR: not provided) 101.5 or 101.9 degrees Fahrenheit, 99 F, 99.8 F. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish like flushed/hot flash on 22-JUL-2021, was recovering from restless, headache, tiredness, brain fog, and little nauseated as like a flu bug, had not recovered from left arm throbbing/achy, and want to sleep due to restlessness, and the outcome of did not sleep well was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pyrexia, Restlessness
Clinical narrative: BRAIN FOG; WANT TO SLEEP DUE TO RESTLESSNESS; FEVERISH LIKE FLUSHED/HOT FLASH; TIREDNESS; LITTLE NAUSEATED AS LIKE A FLU BUG; HEADACHE; RESTLESS; LEFT ARM THROBBING/ACHY; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 165 pounds, and height was 62 inches. The patient's past medical history included cough, fever, and penicillin allergy, and concurrent conditions included low thyroid, alcoholic, non smoker, and seasonal allergy. The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included thyroid for low thyroid. On FEB-2020, Laboratory data included: Body temperature (NR: not provided) 103 temperature.  On 21-JUL-2021, the subject experienced restless. On 21-JUL-2021, the subject experienced left arm throbbing/achy. On 21-JUL-2021, the subject experienced did not sleep well. On 21-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced brain fog. On 22-JUL-2021, the subject experienced want to sleep due to restlessness. On 22-JUL-2021, the subject experienced feverish like flushed/hot flash. On 22-JUL-2021, the subject experienced tiredness. On 22-JUL-2021, the subject experienced little nauseated as like a flu bug. Laboratory data included: Body temperature (NR: not provided) 101.5 or 101.9 degrees Fahrenheit, 99 F, 99.8 F. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish like flushed/hot flash on 22-JUL-2021, was recovering from restless, headache, tiredness, brain fog, and little nauseated as like a flu bug, had not recovered from left arm throbbing/achy, and want to sleep due to restlessness, and the outcome of did not sleep well was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: BRAIN FOG; WANT TO SLEEP DUE TO RESTLESSNESS; FEVERISH LIKE FLUSHED/HOT FLASH; TIREDNESS; LITTLE NAUSEATED AS LIKE A FLU BUG; HEADACHE; RESTLESS; LEFT ARM THROBBING/ACHY; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 165 pounds, and height was 62 inches. The patient's past medical history included cough, fever, and penicillin allergy, and concurrent conditions included low thyroid, alcoholic, non smoker, and seasonal allergy. The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included thyroid for low thyroid. On FEB-2020, Laboratory data included: Body temperature (NR: not provided) 103 temperature.  On 21-JUL-2021, the subject experienced restless. On 21-JUL-2021, the subject experienced left arm throbbing/achy. On 21-JUL-2021, the subject experienced did not sleep well. On 21-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced brain fog. On 22-JUL-2021, the subject experienced want to sleep due to restlessness. On 22-JUL-2021, the subject experienced feverish like flushed/hot flash. On 22-JUL-2021, the subject experienced tiredness. On 22-JUL-2021, the subject experienced little nauseated as like a flu bug. Laboratory data included: Body temperature (NR: not provided) 101.5 or 101.9 degrees Fahrenheit, 99 F, 99.8 F. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish like flushed/hot flash on 22-JUL-2021, was recovering from restless, headache, tiredness, brain fog, and little nauseated as like a flu bug, had not recovered from left arm throbbing/achy, and want to sleep due to restlessness, and the outcome of did not sleep well was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chest pain, Dyspnoea, Eye irritation
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Pain in extremity, Peripheral coldness
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.