chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: DAWNED WITHOUT TASTE; DAWNED WITHOUT SMELL; 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, 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 dawned without taste, and dawned without smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dawned without taste and dawned without smell was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: CHIPPED BACK MOLAR; VOMITING; BODY ACHES; CHILLS/ HARD TEETH CHATTERING; SICKER THAN EVER BEEN AFTER SIX HOURS; NAUSEA; FEVER; 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. 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, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced chipped back molar. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills/ hard teeth chattering. On MAR-2021, the subject experienced sicker than ever been after six hours. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sicker than ever been after six hours, fever, chills/ hard teeth chattering, nausea, body aches, vomiting and chipped back molar was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture, Vomiting
Clinical narrative: CHIPPED BACK MOLAR; VOMITING; BODY ACHES; CHILLS/ HARD TEETH CHATTERING; SICKER THAN EVER BEEN AFTER SIX HOURS; NAUSEA; FEVER; 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. 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, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced chipped back molar. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills/ hard teeth chattering. On MAR-2021, the subject experienced sicker than ever been after six hours. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sicker than ever been after six hours, fever, chills/ hard teeth chattering, nausea, body aches, vomiting and chipped back molar was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: COULD NOT GET UP IN THE MORNING/UNABLE TO GET OUT OF BED; FELT VERY TIRED /TIRED FAST AFTER PHYSICAL WORK; NOT ENERGIZED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980L, expiry: 20-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced could not get up in the morning/unable to get out of bed. On 08-APR-2021, the subject experienced felt very tired /tired fast after physical work. On 08-APR-2021, the subject experienced not energized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not get up in the morning/unable to get out of bed on 09-APR-2021, and was recovering from felt very tired /tired fast after physical work, and not energized. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: SUPER ILL; REALLY HIGH FEVER IT WAS TERRIBLE; 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 was not reported, administered on 02-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 02-JUL-2021, the subject experienced super ill. On 02-JUL-2021, the subject experienced really high fever it was terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super ill and really high fever it was terrible was not reported. This report was non-serious.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS TO THE INJECTION SITE OF THE LEFT ARM; This spontaneous report received from a health care professional concerned a 99 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced soreness to the injection site of the left arm. On 02-JUL-2021, the subject experienced swelling at injection site. On 02-JUL-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from soreness to the injection site of the left arm on 22-JUN-2021, and had not recovered from swelling at injection site, and redness at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Ear pain, Extrasystoles, Mitral valve prolapse, Pain
Clinical narrative: UNEXPECTED THERAPEUTIC EFFECT; MINOR ACHES AND PAIN; EAR ACHE; SPLEEN PAIN; HEARTBEATS SKIPPED; MITRAL VALVE PROLAPSE; 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, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced minor aches and pain. On MAY-2021, the subject experienced ear ache. On MAY-2021, the subject experienced spleen pain. On MAY-2021, the subject experienced heartbeats skipped. On MAY-2021, the subject experienced mitral valve prolapse. On an unspecified date, the subject experienced unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor aches and pain, ear ache, spleen pain, heartbeats skipped, and mitral valve prolapse on MAY-2021, and was recovering from unexpected therapeutic effect. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC EFFECT; MINOR ACHES AND PAIN; EAR ACHE; SPLEEN PAIN; HEARTBEATS SKIPPED; MITRAL VALVE PROLAPSE; 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, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced minor aches and pain. On MAY-2021, the subject experienced ear ache. On MAY-2021, the subject experienced spleen pain. On MAY-2021, the subject experienced heartbeats skipped. On MAY-2021, the subject experienced mitral valve prolapse. On an unspecified date, the subject experienced unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor aches and pain, ear ache, spleen pain, heartbeats skipped, and mitral valve prolapse on MAY-2021, and was recovering from unexpected therapeutic effect. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer 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: Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was on XARELTO (rivaroxaban) because patient got blood clots from the J and J vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210713145- Covid-19 vaccine ad26.cov2.s- Blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
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 54 year old male. Initial information was processed with the additional information received on 07-JUL-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: Unknown) 45 mg, frequency was not reported, strength was 45 mg per 0.5 ml from JUL-2020 for psoriasis. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The batch number was not reported and has been requested. No concomitant medications were reported.  In JUN-2021, the patient had lab work done and did not have any antibodies to COVID. On 16-JUN-2021, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185149 and 90000185150.; Sender's Comments: V0: 20210713254 - 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    20210713254 Stelara - 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: BURNING HEADACHE; BLURRY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 46 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: 1821288, expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced dizziness. On 20-JUN-2021, the subject experienced blurry vision. On 02-JUL-2021, the subject experienced burning headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning headache, blurry vision, and dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOT BLOOD; This spontaneous report received from a consumer via a (other manufacturer Pfizer) 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 were 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, the patient experienced clot blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210713681-COVID-19 VACCINE AD26.COV2.S-Clot blood . 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Culture, Streptococcal infection, Streptococcus test
Clinical narrative: CONFIRMED COVID-19 INFECTION; STREPTOCOCCUS BACTERIAL INFECTION; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have had any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 25-JUN-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUL-2021, the subject experienced streptococcus bacterial infection. Laboratory data included: Streptococcus identification test (NR: not provided) Positive. On 05-JUL-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: Culture nose (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of streptococcus bacterial infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: INFLAMMATION OF LEG / LITTLE INFLAMMATION IN BODY; 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, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced inflammation of leg / little inflammation in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of leg / little inflammation in body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: CAN HARDLY USE ELBOWS; This spontaneous report received from a patient concerned a 42 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced can hardly use elbows. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can hardly use elbows was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PART OF THE VACCINE WENT OUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced part of the vaccine went out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of part of the vaccine went out was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Computerised tomogram, Decreased appetite, Headache, Mobility decreased
Clinical narrative: BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. . The patient's past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown)  frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen consumption, Thrombosis, Ultrasound Doppler
Clinical narrative: BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. . The patient's past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown)  frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Dyspnoea, Electrocardiogram
Clinical narrative: SHORTNESS OF BREATH-A LITTLE; CHEST PAIN; CHILLS; NAUSEA; FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-JUL-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the subject experienced shortness of breath-a little. On 07-JUL-2021, the subject experienced chest pain. On 07-JUL-2021, the subject experienced chills. On 07-JUL-2021, the subject experienced nausea. On 07-JUL-2021, the subject experienced fever. On 07-JUL-2021, the subject experienced muscle pain. On 08-JUL-2021, Laboratory data included: Chest X-ray (NR: not provided) Not reported, and EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, chills, muscle pain, shortness of breath-a little, and chest pain. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: SHORTNESS OF BREATH-A LITTLE; CHEST PAIN; CHILLS; NAUSEA; FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-JUL-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the subject experienced shortness of breath-a little. On 07-JUL-2021, the subject experienced chest pain. On 07-JUL-2021, the subject experienced chills. On 07-JUL-2021, the subject experienced nausea. On 07-JUL-2021, the subject experienced fever. On 07-JUL-2021, the subject experienced muscle pain. On 08-JUL-2021, Laboratory data included: Chest X-ray (NR: not provided) Not reported, and EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, chills, muscle pain, shortness of breath-a little, and chest pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Pyrexia
Clinical narrative: BODY ACHES; ALLERGIC REACTION; FEVER ON AND OFF; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, allergic reaction, and fever on and off. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction, and the outcome of body aches and fever on and off was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Blood test, Body temperature, Chills, Computerised tomogram
Clinical narrative: LESS ACTIVE; MORE TIRED; STOMACH ACID; MOUTH IS GETTING VERY DRY; NOT ABLE TO EAT/DID NOT FEEL LIKE EATING; FEELING VERY WEIRD; NOT ABLE TO TASTE/NO TASTE OF MY MOUTH; FEVER; CHILLS FELT VERY COLD; LOSING WEIGHT; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 100 pounds, and height was 59 inches. The patient's concurrent conditions included high blood pressure, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and there was 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: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure, and losartan for blood pressure. On MAR-2021, the subject experienced losing weight. On MAR-2021, the subject experienced not feeling good. Laboratory data included: Coronavirus test (NR: not provided) Negative. On 08-MAR-2021, the subject experienced chills felt very cold. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 deg. On 09-MAR-2021, the subject experienced not able to eat/did not feel like eating. On 09-MAR-2021, the subject experienced feeling very weird. On 09-MAR-2021, the subject experienced not able to taste/no taste of my mouth. On 09-MAR-2021, the subject experienced stomach acid. On 09-MAR-2021, the subject experienced mouth is getting very dry. On 11-MAR-2021, Laboratory data included: CT scan (NR: not provided) Normal. On 23-MAR-2021, Laboratory data included: Endoscopy (NR: not provided) Normal. On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Coronavirus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced less active. On 01-APR-2021, the subject experienced more tired. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to eat/did not feel like eating, and feeling very weird on 15-APR-2021, and chills felt very cold, and fever on 09-MAR-2021, had not recovered from not able to taste/no taste of my mouth, losing weight, stomach acid, mouth is getting very dry, less active, and more tired, and the outcome of not feeling good was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Decreased activity, Dry mouth, Endoscopy, Fatigue
Clinical narrative: LESS ACTIVE; MORE TIRED; STOMACH ACID; MOUTH IS GETTING VERY DRY; NOT ABLE TO EAT/DID NOT FEEL LIKE EATING; FEELING VERY WEIRD; NOT ABLE TO TASTE/NO TASTE OF MY MOUTH; FEVER; CHILLS FELT VERY COLD; LOSING WEIGHT; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 100 pounds, and height was 59 inches. The patient's concurrent conditions included high blood pressure, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and there was 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: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure, and losartan for blood pressure. On MAR-2021, the subject experienced losing weight. On MAR-2021, the subject experienced not feeling good. Laboratory data included: Coronavirus test (NR: not provided) Negative. On 08-MAR-2021, the subject experienced chills felt very cold. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 deg. On 09-MAR-2021, the subject experienced not able to eat/did not feel like eating. On 09-MAR-2021, the subject experienced feeling very weird. On 09-MAR-2021, the subject experienced not able to taste/no taste of my mouth. On 09-MAR-2021, the subject experienced stomach acid. On 09-MAR-2021, the subject experienced mouth is getting very dry. On 11-MAR-2021, Laboratory data included: CT scan (NR: not provided) Normal. On 23-MAR-2021, Laboratory data included: Endoscopy (NR: not provided) Normal. On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Coronavirus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced less active. On 01-APR-2021, the subject experienced more tired. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to eat/did not feel like eating, and feeling very weird on 15-APR-2021, and chills felt very cold, and fever on 09-MAR-2021, had not recovered from not able to taste/no taste of my mouth, losing weight, stomach acid, mouth is getting very dry, less active, and more tired, and the outcome of not feeling good was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Hyperchlorhydria, Malaise, Pyrexia
Clinical narrative: LESS ACTIVE; MORE TIRED; STOMACH ACID; MOUTH IS GETTING VERY DRY; NOT ABLE TO EAT/DID NOT FEEL LIKE EATING; FEELING VERY WEIRD; NOT ABLE TO TASTE/NO TASTE OF MY MOUTH; FEVER; CHILLS FELT VERY COLD; LOSING WEIGHT; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 100 pounds, and height was 59 inches. The patient's concurrent conditions included high blood pressure, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and there was 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: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure, and losartan for blood pressure. On MAR-2021, the subject experienced losing weight. On MAR-2021, the subject experienced not feeling good. Laboratory data included: Coronavirus test (NR: not provided) Negative. On 08-MAR-2021, the subject experienced chills felt very cold. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 deg. On 09-MAR-2021, the subject experienced not able to eat/did not feel like eating. On 09-MAR-2021, the subject experienced feeling very weird. On 09-MAR-2021, the subject experienced not able to taste/no taste of my mouth. On 09-MAR-2021, the subject experienced stomach acid. On 09-MAR-2021, the subject experienced mouth is getting very dry. On 11-MAR-2021, Laboratory data included: CT scan (NR: not provided) Normal. On 23-MAR-2021, Laboratory data included: Endoscopy (NR: not provided) Normal. On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Coronavirus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced less active. On 01-APR-2021, the subject experienced more tired. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to eat/did not feel like eating, and feeling very weird on 15-APR-2021, and chills felt very cold, and fever on 09-MAR-2021, had not recovered from not able to taste/no taste of my mouth, losing weight, stomach acid, mouth is getting very dry, less active, and more tired, and the outcome of not feeling good was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: LESS ACTIVE; MORE TIRED; STOMACH ACID; MOUTH IS GETTING VERY DRY; NOT ABLE TO EAT/DID NOT FEEL LIKE EATING; FEELING VERY WEIRD; NOT ABLE TO TASTE/NO TASTE OF MY MOUTH; FEVER; CHILLS FELT VERY COLD; LOSING WEIGHT; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 100 pounds, and height was 59 inches. The patient's concurrent conditions included high blood pressure, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and there was 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: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure, and losartan for blood pressure. On MAR-2021, the subject experienced losing weight. On MAR-2021, the subject experienced not feeling good. Laboratory data included: Coronavirus test (NR: not provided) Negative. On 08-MAR-2021, the subject experienced chills felt very cold. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 deg. On 09-MAR-2021, the subject experienced not able to eat/did not feel like eating. On 09-MAR-2021, the subject experienced feeling very weird. On 09-MAR-2021, the subject experienced not able to taste/no taste of my mouth. On 09-MAR-2021, the subject experienced stomach acid. On 09-MAR-2021, the subject experienced mouth is getting very dry. On 11-MAR-2021, Laboratory data included: CT scan (NR: not provided) Normal. On 23-MAR-2021, Laboratory data included: Endoscopy (NR: not provided) Normal. On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Coronavirus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced less active. On 01-APR-2021, the subject experienced more tired. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to eat/did not feel like eating, and feeling very weird on 15-APR-2021, and chills felt very cold, and fever on 09-MAR-2021, had not recovered from not able to taste/no taste of my mouth, losing weight, stomach acid, mouth is getting very dry, less active, and more tired, and the outcome of not feeling good was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: EXPERIENCING MORE ENERGY POST VACCINATION; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included pneumonia, and laryngitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 15-AUG-2021) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced experiencing more energy post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experiencing more energy post vaccination was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORE ARM; This spontaneous report received from a patient concerned a 75 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the subject experienced injection site sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: LATE PERIODS; HEAVY BLEEDING DURING PERIOD/LONGER PERIODS/LASTING 7-9 DAYS EVER SINCE THE VACCINE; 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 pre-existing medical conditions included the patients normally periods would last for 5 days.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 12-APR-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 late periods, and heavy bleeding during period/longer periods/lasting 7-9 days ever since the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from late periods, and heavy bleeding during period/longer periods/lasting 7-9 days ever since the vaccine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Injection site pain
Clinical narrative: INCREASED HEART RATE; SORE ARM AT THE INJECTION SITE; HEADACHE; TIREDNESS; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced increased heart rate, sore arm at the injection site, headache, and tiredness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm at the injection site, headache, tiredness and increased heart rate was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Migraine, Peripheral swelling
Clinical narrative: STOMACH ACHE; SWOLLEN LEG; CHEST PAIN; MIGRAINES / HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stomach ache, swollen leg, chest pain, and migraines / headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and swollen leg, and the outcome of migraines / headaches and chest pain was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Peripheral coldness
Clinical narrative: LOST CONSCIOUSNESS; COLD TO THE TOUCH; SWEATY; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 07-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, few minutes after the vaccination, the patient lost consciousness and regained it a minute later. The patient was also cold to the touch and sweaty. The patient had visited the doctor/healthcare professional office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, cold to the touch, and sweaty on 07-JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210718535- covid-19 vaccine ad26.cov2.s-Lost consciousness. This event(s) is considered un-assessable. 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED TIME EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287 expiry: 15-SEP-2021) dose was not reported, administered on 02-JUL-2021 10:41 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced administered time expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered time expired vaccine was not reported. This report was non-serious.