chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Medication error
Clinical narrative: ACCIDENTAL OVERDOSE; MEDICAL ADMINISTRATION ERROR; This spontaneous report received from a health care professional (HCP) 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, and batch number: 206A21A expiry: 11-SEP-2021) 3 dosage, 1 total, administered on 06-AUG-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-AUG-2021, the patient experienced accidental overdose and medical administration error. The HCP accidentally gave a patient 3 doses of Covid-19 vaccine instead of one dose. She reported that she thought there was only 1 dose left in the vial. HCP was in a rush and did not provide patient information. Patient was notified, but she doesn't know if he contacted his physician or any other party. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the accidental overdose and medical administration error was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210815416- covid-19 vaccine ad26.cov2.s-Accidental overdose.This event(s) is  considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and  has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 71 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, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified day on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-AUG-2021, patient developed symptoms of mimic flu, on 06-AUG-2021, patient developed no taste and no smell (suspected covid-19 infection) and suspected clinical vaccination failure. Reporter was stating that someone with whom he or she was staying also took the vaccination on same month (APR-2021) and had developed COVID (Coronavirus disease). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210815452-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Body temperature abnormal, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: NO TEMPERATURE SINCE YESTERDAY; SO UNWELL; ARM IS STILL REALLY SORE; NAUSEA; HEADACHE; 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 31-JUL-2021, the patient experienced so unwell. On 31-JUL-2021, the patient experienced arm is still really sore. On 31-JUL-2021, the patient experienced nausea. On 31-JUL-2021, the patient experienced headache. On 31-JUL-2021, the patient experienced no temperature since yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no temperature since yesterday on 05-AUG-2021, and had not recovered from so unwell, arm is still really sore, nausea, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; RUNNY NOSE; FOGGY HEAD/THINKING; EXHAUSTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: respiratory problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-AUG-2021, the patient experienced shortness of breath. On 01-AUG-2021, the patient experienced runny nose. On 01-AUG-2021, the patient experienced foggy head/thinking. On 01-AUG-2021, the patient experienced exhaustion. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, runny nose, exhaustion, and foggy head/thinking. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Neuralgia, Pain in extremity
Clinical narrative: SEVERE NERVE PAIN; BATCHES THAT LOOK LIKE BRUISES IN LEGS AND ARM; WORSENING BURNING SENSATION IN BODY; LEGS ARMS HANDS AND FINGERS PAIN WITH WORSENING RIGHT LEG AND LEFT HAND PAIN; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, non smoker, and drinks alcohol, and other pre-existing medical conditions included: The patient has no known allergies and no drug abuse or illicit drug usage. The patient was on unspecified inhaler for asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the patient experienced severe nerve pain. On 27-JUL-2021, the patient experienced batches that look like bruises in legs and arm. On 27-JUL-2021, the patient experienced worsening burning sensation in body. On 27-JUL-2021, the patient experienced legs arms hands and fingers pain with worsening right leg and left hand pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe nerve pain, batches that look like bruises in legs and arm, worsening burning sensation in body, and legs arms hands and fingers pain with worsening right leg and left hand pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 71 year old female of unknown ethnic origin. Initial information was processed with additional information received from complaint vigilance on 10-AUG-2021.   The patient's weight was 190 pounds, and height was 67 inches. The patient's concurrent conditions included: blood pressure, sulfa drug allergy, non smoker, non alcohol user, and thyroid, and other pre-existing medical conditions included: Patient was on Blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: Unknown) frequency one total, dose was not reported, administered at left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  Six weeks later after vaccination patient reported negative for antibody test. On MAY-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: Antibody test negative (NR: not provided) Negative. 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). This report was associated with product quality complaint: 90000188999.; Sender's Comments: V0: 20210817330-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: PASSED AWAY; COVID-19; This spontaneous report received from a physician concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, and considered obese. 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, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2021 (a month prior to this report), the patient had covid-19 was sent home from the hospital with no treatment and told to quarantine. He was seemingly getting better, but after a few days his condition worsened and the ambulance would not pick him up. The patient decided and tried himself to sleep, but unfortunately on 09-AUG-2021, he passed away in sleep. The patient died from unknown cause of death on 09-AUG-2021. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 09-AUG-2021, and the outcome of covid-19 was not reported. This report was serious (Death).; Sender's Comments: V0: 20210817359-COVID-19 VACCINE AD26.COV2.S.- Passed away. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: SEVERE STROKE; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was strong and was still capable old man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and start therapy date was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210817368-covid-19 vaccine ad26.cov2.s severe stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISING ON THE BACK OF THE KNEE AND TOP PART OF THE CALF; This spontaneous report received from a patient concerned a 52 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced bruising on the back of the knee and top part of the calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising on the back of the knee and top part of the calf was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; 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) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Computerised tomogram, Electrocardiogram, Phlebitis, Ultrasound scan
Clinical narrative: AUTOIMMUNE RESPONSE; IMMUNE RESPONSE DAMAGED THE VALVES OF VEINS AND REFLUXING BLOOD; VEIN INFLAMMATION AROUND BOTH WRISTS/HANDS, EYES AND CHEEKS; VEIN INFLAMMATION ON BOTH ANKLES AND FEET; This spontaneous report received from a patient concerned a 54 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, intramuscular, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, one month after vaccination the patient experienced vein inflammation on both ankles. Next day on 22-APR-2021, the patient experienced vein inflammation around both feet, and wrists/hands. The patient was unable to put on socks and was using compression socks for the first time in his life. He stated that the vaccine works well but it generates an autoimmune response (immune response damaged the valves of his veins). On 26-APR-2021, the patient experienced vein inflammation around both eyes and cheeks, autoimmune response and immune response damaged the valves of veins and refluxing blood. The patient also saw a cardiologist who did, Electrocardiogram (EKG), Venous CT (computerized tomogram) scan with contrast but they did not show any cause and did a test possible venogram which showed that the valves in the veins were damaged and refluxing blood and the patient stated that this all occurred overnight, and the physicians could not put a cause to why this occurred. The patient underwent ultrasound of legs with result of no clots but showed varicose veins overnight. The patient referred to an immunologist in June who stated that it was a possible autoimmune response from the Covid-19 vaccine. The immunologist also stated that the proteins work well but he may have residual spike proteins in the blood causing an autoimmune response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein inflammation on both ankles and feet, autoimmune response, vein inflammation around both wrists/hands, eyes and cheeks, and immune response damaged the valves of veins and refluxing blood. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817503-COVID-19 VACCINE AD26.COV2.S-autoimmune response. 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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Varicophlebitis, Venogram, Venous valve ruptured
Clinical narrative: AUTOIMMUNE RESPONSE; IMMUNE RESPONSE DAMAGED THE VALVES OF VEINS AND REFLUXING BLOOD; VEIN INFLAMMATION AROUND BOTH WRISTS/HANDS, EYES AND CHEEKS; VEIN INFLAMMATION ON BOTH ANKLES AND FEET; This spontaneous report received from a patient concerned a 54 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, intramuscular, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, one month after vaccination the patient experienced vein inflammation on both ankles. Next day on 22-APR-2021, the patient experienced vein inflammation around both feet, and wrists/hands. The patient was unable to put on socks and was using compression socks for the first time in his life. He stated that the vaccine works well but it generates an autoimmune response (immune response damaged the valves of his veins). On 26-APR-2021, the patient experienced vein inflammation around both eyes and cheeks, autoimmune response and immune response damaged the valves of veins and refluxing blood. The patient also saw a cardiologist who did, Electrocardiogram (EKG), Venous CT (computerized tomogram) scan with contrast but they did not show any cause and did a test possible venogram which showed that the valves in the veins were damaged and refluxing blood and the patient stated that this all occurred overnight, and the physicians could not put a cause to why this occurred. The patient underwent ultrasound of legs with result of no clots but showed varicose veins overnight. The patient referred to an immunologist in June who stated that it was a possible autoimmune response from the Covid-19 vaccine. The immunologist also stated that the proteins work well but he may have residual spike proteins in the blood causing an autoimmune response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein inflammation on both ankles and feet, autoimmune response, vein inflammation around both wrists/hands, eyes and cheeks, and immune response damaged the valves of veins and refluxing blood. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817503-COVID-19 VACCINE AD26.COV2.S-autoimmune response. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple patients (nine patients). 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, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure (tested negative for antibodies). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817551-COVID-19 VACCINE AD26.COV2.S - Suspected immunological vaccine failure . This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Bone disorder, Joint stiffness, Pain in extremity, Paraesthesia
Clinical narrative: STIFFNESS IN JOINTS, LIGAMENTS OF BOTH HANDS AND FEET; STIFFNESS IN  BONES OF BOTH HANDS AND  FEET; TINGLING IN FINGERS OF BOTH HANDS/TINGLING IN ALL TOES BOTH FEET/TINGLING IN BOTH HANDS; SHARP PAIN IN ALL FINGERS OF BOTH HANDS/SHARP PAIN IN ALL THE TOES BOTH FEET; This spontaneous report received from a patient concerned a 47 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, intramuscular, and batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the patient experienced stiffness in joints, ligaments of both hands and feet. On 19-JUN-2021, the patient experienced stiffness in bones of both hands and feet. On 19-JUN-2021, the patient experienced tingling in fingers of both hands/tingling in all toes both feet/tingling in both hands. On 19-JUN-2021, the patient experienced sharp pain in all fingers of both hands/sharp pain in all the toes both feet. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in fingers of both hands/tingling in all toes both feet/tingling in both hands, sharp pain in all fingers of both hands/sharp pain in all the toes both feet, stiffness in joints, ligaments of both hands and feet, and stiffness in bones of both hands and feet. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Migraine, Pain, Sensory disturbance
Clinical narrative: MIGRAINES; HEARING A CONSTANT HIGH PITCHED RINGING OR WHINE IN THE LEFT EAR (POSSIBLY TINNITUS); DIARRHEA; FULL BODY ACHE; LETHARGIC; DIFFICULTY WAKING UP; FELT LIKE HIT BY BUS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced full body ache. On 07-JUL-2021, the patient experienced lethargic. On 07-JUL-2021, the patient experienced difficulty waking up. On 07-JUL-2021, the patient experienced felt like hit by bus. On 07-JUL-2021, the patient experienced diarrhea. On 03-AUG-2021, the patient experienced migraines. On 03-AUG-2021, the patient experienced hearing a constant high pitched ringing or whine in the left ear (possibly tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from full body ache, lethargic, difficulty waking up, and diarrhea, had not recovered from hearing a constant high pitched ringing or whine in the left ear (possibly tinnitus), and migraines, and the outcome of felt like hit by bus was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: MIGRAINES; HEARING A CONSTANT HIGH PITCHED RINGING OR WHINE IN THE LEFT EAR (POSSIBLY TINNITUS); DIARRHEA; FULL BODY ACHE; LETHARGIC; DIFFICULTY WAKING UP; FELT LIKE HIT BY BUS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced full body ache. On 07-JUL-2021, the patient experienced lethargic. On 07-JUL-2021, the patient experienced difficulty waking up. On 07-JUL-2021, the patient experienced felt like hit by bus. On 07-JUL-2021, the patient experienced diarrhea. On 03-AUG-2021, the patient experienced migraines. On 03-AUG-2021, the patient experienced hearing a constant high pitched ringing or whine in the left ear (possibly tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from full body ache, lethargic, difficulty waking up, and diarrhea, had not recovered from hearing a constant high pitched ringing or whine in the left ear (possibly tinnitus), and migraines, and the outcome of felt like hit by bus was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Sinus operation
Clinical narrative: NASAL DRAINAGE; FEELING CHILLS; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and 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: 1805022 and expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced nasal drainage. On 06-AUG-2021, the patient experienced feeling chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal drainage, and feeling chills on AUG-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, age group, race and ethnic origin. 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 unspecified date MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome-CoV-2) test (NR: not provided). On an unknown date, the patient was diagnosed with a breakthrough case of COVID. The patient experienced suspected vaccination failure, and suspected covid19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected vaccination failure and suspected covid19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210817422.; Sender's Comments: V0':20210818073-covid-19 vaccine ad26.cov2.s-Suspected 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: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: SLEPT MORE THAN USUAL; SLIGHT FEVER OF 99F; INCREASED TIREDNESS/FEELING DRAINED; This spontaneous report received from a consumer concerned multiple patients.  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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced slept more than usual, slight fever of 99f, and increased tiredness/feeling drained. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever of 99f, increased tiredness/feeling drained and slept more than usual was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817805, 20210818021, 20210818107 and 20210818401.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; This spontaneous report received from a consumer concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's past medical history included: stress relapse, could not see, and fall, and concurrent conditions included: sinus infections, multiple sclerosis is getting worse, seasonal allergies, depression, short term memory loss, difficulty walking, imbalance, anxiety, difficulty sleeping, difficulty swallowing, tired, and secondary progressive multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. Concomitant medications included buspirone, escitalopram, fampridine, fluticasone, montelukast, and trazodone. On JUN-2021, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Somnolence
Clinical narrative: 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. Batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced felt sleepy, tired, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sleepy, tired, and mild fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: WHOLE BODY WAS IN PAIN; FEVER; 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 patient experienced whole body was in pain, and fever. Treatment medications (dates unspecified) included: paracetamol, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body was in pain, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; 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. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick. This report was non-serious. This case, from the same reporter is linked to 20210817417 and 20210815700.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; 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 patient experienced body aches, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.4 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye swelling, Headache, Hypersensitivity, Lip swelling
Clinical narrative: EYE SWELLING, FACE UNDER EYE WAS SWELLED DOWN; ITCHY ALL OVER, ON ARMS, BACK, LEGS, AND HEAD; MOUTH WAS GETTING BIG/SWELLING; COUGHING; UNCOMFORTABLE IN THROAT, LIKE ITCHING; LIPS SWELLING; HEADACHE; ALLERGIC REACTION; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received tylenol (coated tablet, oral, batch number was not reported) dose and frequency were not reported from 10-AUG-2021 for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 09-AUG-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced eye swelling, face under eye was swelled down. On 10-AUG-2021, the patient experienced itchy all over, on arms, back, legs, and head. On 10-AUG-2021, the patient experienced mouth was getting big/swelling. On 10-AUG-2021, the patient experienced coughing. On 10-AUG-2021, the patient experienced uncomfortable in throat, like itching. On 10-AUG-2021, the patient experienced lips swelling. On 10-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced allergic reaction. Treatment medications included: cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol was not reported. The patient was recovering from eye swelling, face under eye was swelled down, mouth was getting big/swelling, and lips swelling, and had not recovered from headache, itchy all over, on arms, back, legs, and head, allergic reaction, coughing, and uncomfortable in throat, like itching. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pruritus, Throat irritation
Clinical narrative: EYE SWELLING, FACE UNDER EYE WAS SWELLED DOWN; ITCHY ALL OVER, ON ARMS, BACK, LEGS, AND HEAD; MOUTH WAS GETTING BIG/SWELLING; COUGHING; UNCOMFORTABLE IN THROAT, LIKE ITCHING; LIPS SWELLING; HEADACHE; ALLERGIC REACTION; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received tylenol (coated tablet, oral, batch number was not reported) dose and frequency were not reported from 10-AUG-2021 for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 09-AUG-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced eye swelling, face under eye was swelled down. On 10-AUG-2021, the patient experienced itchy all over, on arms, back, legs, and head. On 10-AUG-2021, the patient experienced mouth was getting big/swelling. On 10-AUG-2021, the patient experienced coughing. On 10-AUG-2021, the patient experienced uncomfortable in throat, like itching. On 10-AUG-2021, the patient experienced lips swelling. On 10-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced allergic reaction. Treatment medications included: cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol was not reported. The patient was recovering from eye swelling, face under eye was swelled down, mouth was getting big/swelling, and lips swelling, and had not recovered from headache, itchy all over, on arms, back, legs, and head, allergic reaction, coughing, and uncomfortable in throat, like itching. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal discomfort, Nausea, Secretion discharge
Clinical narrative: Severe headache, blur vision, nausea that does not go away, burning of nose, and persistent cough with mucus.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Severe headache, blur vision, nausea that does not go away, burning of nose, and persistent cough with mucus.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; LOW GRADE FEVER; 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 APR-2021 for prophylactic vaccination. The batch number was not reported. Per Procedure, no follow up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and low grade fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: COLD SYMPTOMS/COUGH; This spontaneous report received from a consumer concerned multiple patients. 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 is not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cold symptoms/cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms/cough was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Paranasal sinus discomfort, Pyrexia
Clinical narrative: SINUS PRESSURE; NASAL CONGESTION; CHILLS; FEVER; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa fulser allergy. 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 05-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-AUG-2021, the patient experienced chills. On 05-AUG-2021, the patient experienced fever. On 09-AUG-2021, the patient experienced sinus pressure. On 09-AUG-2021, the patient experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 06-AUG-2021, and had not recovered from sinus pressure, and nasal congestion. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Pain, Pain in extremity
Clinical narrative: WRIST/HAND SORE TO TOUCH; JOINT, HIP, KNEE, ANKLE, SHOULDER  ELBOW ARE ACHY; SORE ARM; TIRED; FEVERISH; This spontaneous report received from a consumer concerned a 24 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) dose was not reported, administered on 10-AUG-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 10-AUG-2021, the patient experienced wrist/hand sore to touch. On 10-AUG-2021, the patient experienced joint, hip, knee, ankle, shoulder elbow are achy. On 10-AUG-2021, the patient experienced sore arm. On 10-AUG-2021, the patient experienced tired. On 10-AUG-2021, the patient experienced feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint, hip, knee, ankle, shoulder elbow are achy, wrist/hand sore to touch, tired, feverish, and sore arm. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: WRIST/HAND SORE TO TOUCH; JOINT, HIP, KNEE, ANKLE, SHOULDER  ELBOW ARE ACHY; SORE ARM; TIRED; FEVERISH; This spontaneous report received from a consumer concerned a 24 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) dose was not reported, administered on 10-AUG-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 10-AUG-2021, the patient experienced wrist/hand sore to touch. On 10-AUG-2021, the patient experienced joint, hip, knee, ankle, shoulder elbow are achy. On 10-AUG-2021, the patient experienced sore arm. On 10-AUG-2021, the patient experienced tired. On 10-AUG-2021, the patient experienced feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint, hip, knee, ankle, shoulder elbow are achy, wrist/hand sore to touch, tired, feverish, and sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a 3 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, 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 patient experienced covid-19 test positive after vaccination. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive after vaccination was not reported. This report was non-serious. This report was associated with a product quality complaint 90000189095.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient did not have any medical conditions and did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced body aches. On 09-AUG-2021, the patient experienced chills. On 09-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 10-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100.7 F, 99 F. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of body aches and chills was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Drug monitoring procedure incorrectly performed, Fatigue, Injection site haematoma, Myalgia
Clinical narrative: HEMATOMA BELOW INJECTION SITE; SORE ARM; VIAL WAS SHAKEN BY VACCINE PROVIDER; LOWER BACK PAIN; FATIGUE; MUSCULAR PAIN; This spontaneous report received from a patient concerned a 49 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced lower back pain. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced muscular pain. On 06-AUG-2021, the patient experienced vial was shaken by vaccine provider. On 06-AUG-2021, the patient experienced sore arm. On 10-AUG-2021, the patient experienced hematoma below injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was shaken by vaccine provider, fatigue, lower back pain, muscular pain, hematoma below injection site and sore arm was not reported. This report was non-serious.