chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vision blurred, Vomiting
Clinical narrative: BLURRY VISION; JOINT ISSUES; SORE THROAT; BREAKING OUT IN COLD SWEAT (MOSTLY HER HEAD); CHILLS; LOW GRADE FEVER; FEET HURT; SHORTNESS OF BREATH; HIGH HEART RATE; FELT LIKE GOING TO FAINT; MUSCLE ACHE; BAD HEADACHE; VOMITING; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 67 inches. The patient's past medical history included: flu, and concurrent conditions included: hashimoto's disease, sjogren's disease, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced vomiting. On MAR-2021, the patient experienced muscle ache. On MAR-2021, the patient experienced bad headache. On 17-AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced high heart rate. On 17-AUG-2021, the patient experienced felt like going to faint. Laboratory data included: Heart rate (NR: not provided) 117 {beats}/min, 83 {beats}/min, leveled off. On an unspecified date, the patient experienced blurry vision, joint issues, sore throat, breaking out in cold sweat (mostly her head), chills, low grade fever, and feet hurt. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 180, Titer 640, Blood test (NR: not provided) Something was low but not sure what it was, COVID-19 virus test (NR: not provided) Negative, Negative, and Hepatic enzyme (NR: not provided) Have been different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart rate on 17-AUG-2021, and vomiting, had not recovered from bad headache, muscle ache, joint issues, breaking out in cold sweat (mostly her head), and feet hurt, and the outcome of blurry vision, chills, sore throat, low grade fever, shortness of breath and felt like going to faint was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART ISSUE; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Ear discomfort, Impaired work ability, Tinnitus
Clinical narrative: HEARING LOSS/CAN NOT HEAR VERY WELL; DIZZINESS; TOSSING IN EAR / PULSING IN EAR; MAKE IT VERY HARD TO DO THINGS; TINNITUS; This spontaneous report received from a consumer concerned a 27 year old male of unspecified 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, and batch number: 202A21A expiry: unknown) dose was not reported,1 total, administered on 11-APR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient started experiencing hearing loss/could not hear very well, and also got worse, dizziness, tossing in ear/pulsing in ear and tinnitus. The reporter further stated that the symptom was patient experienced not for all days but mostly when the patient woke up. It was very hard for him to do things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, dizziness, hearing loss/can not hear very well, tossing in ear/pulsing in ear, make it very hard to do things. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210835348.; Sender's Comments: V0:20210835136-Covid-19 vaccine ad26.cov2.s-Hearing loss/could not hear very well. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Death, Headache, Palpitations
Clinical narrative: DIED; HEART RACING; HEADACHE; This spontaneous report received from a consumer via a company representative via social media 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, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient complained of heart racing and headache and the patient died two weeks later. The cause of death was unknown. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause of death on an unspecified date, and the outcome of heart racing and headache was not reported. This report was serious (Death).; Sender's Comments: V0 20210835168-COVID-19 VACCINE AD26.COV2.S-died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE PERSISTENT (ON  BACK OF THE SKULL AND FOREHEAD); This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: social alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-AUG-2021, the patient experienced body aches. On 12-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced fever. On 12-AUG-2021, the patient experienced headache persistent (on back of the skull and forehead). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on AUG-2021, and had not recovered from headache persistent (on back of the skull and forehead). This report was non-serious.
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 multiple patients of unknown race and ethnicity.   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 and start therapy date were not reported, 1 total, administered 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 diagnosed with suspected covid-19 infection (Suspected clinical vaccination failure). 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: V0:20210835200-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Injection site pain, Lip swelling, Swelling face
Clinical narrative: SWELLING IN LEFT HALF OF THE UPPER AND BOTTOM LIP WHILE SLEEPING; LEFT EYE SWELLING WHILE SLEEPING; SWELLING OF LEFT SIDE OF FACE WHILE SLEEPING; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. Patient had no current medication usage, and no previous known medical conditions. The patient was previously treated with tetanus vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 04-MAY-2021, the patient experienced sore arm at injection site. On JUN-2021, the patient experienced swelling in left half of the upper and bottom lip while sleeping. On JUN-2021, the patient experienced left eye swelling while sleeping. On JUN-2021, the patient experienced swelling of left side of face while sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in left half of the upper and bottom lip while sleeping, left eye swelling while sleeping, and swelling of left side of face while sleeping, and the outcome of sore arm at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: ALTERED TASTE/FOOD NOT TASTING SAME; ALTERED SMELL/CONSTANT SMELL OF SCENT; This spontaneous report received from a patient via a company representative concerned a 50 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 01-APR-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 altered taste/food not tasting same. On APR-2021, the patient experienced altered smell/constant smell of scent. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from altered taste/food not tasting same, and altered smell/constant smell of scent.  This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES WITH ITCHING; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: latex allergy, bees allergy, shellfish allergy, non smoker, and alcoholic, and other pre-existing medical conditions included: Patient did not 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced hives with itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives with itching. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Deafness, Dizziness, Hypoacusis, Pyrexia
Clinical narrative: HEARING LOSS; HEARING PROBLEM/MAKES IT HARD TO HEAR; DIZZINESS; TINNITUS/TOSSING IN MY EARS/PULSING IN EAR; FEVER; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient did not have any health conditions. Patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, after the vaccine administration, patient experienced fever for a day, then it went away and she was doing ok. Laboratory data included: Body temperature (NR: not provided) 104 F. On 15-JUN-2021, (in the middle of June), patient started experiencing hearing problem. Patient experienced hearing loss, tossing in ears, made it hard to hear, tinnitus, not for all day but mostly when she woke up. Symptoms were getting worse, pulsing in their ears but not all day, made it very hard to do things, could not hear very well, dizziness. Patient did not perform any lab test, investigation, or diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 11-MAR-2021, and had not recovered from dizziness, hearing problem/makes it hard to hear, tinnitus/tossing in my ears/pulsing in ear, and hearing loss. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210835136.; Sender's Comments: V0: 20210835348-Covid-19 vaccine ad26.cov2.s-Hearing loss. 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: HEARING LOSS; HEARING PROBLEM/MAKES IT HARD TO HEAR; DIZZINESS; TINNITUS/TOSSING IN MY EARS/PULSING IN EAR; FEVER; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient did not have any health conditions. Patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, after the vaccine administration, patient experienced fever for a day, then it went away and she was doing ok. Laboratory data included: Body temperature (NR: not provided) 104 F. On 15-JUN-2021, (in the middle of June), patient started experiencing hearing problem. Patient experienced hearing loss, tossing in ears, made it hard to hear, tinnitus, not for all day but mostly when she woke up. Symptoms were getting worse, pulsing in their ears but not all day, made it very hard to do things, could not hear very well, dizziness. Patient did not perform any lab test, investigation, or diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 11-MAR-2021, and had not recovered from dizziness, hearing problem/makes it hard to hear, tinnitus/tossing in my ears/pulsing in ear, and hearing loss. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210835136.; Sender's Comments: V0: 20210835348-Covid-19 vaccine ad26.cov2.s-Hearing loss. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash pruritic
Clinical narrative: PAIN FEELS LIKE BURN-LIKE A CHEMICAL BURN OR SUN BURN; RED ITCHY RASH ALL OVER THE BODY; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 125 pounds, and height was 66 inches. 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. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, the patient experienced pain feels like burn-like a chemical burn or sun burn. On 11-AUG-2021, the patient experienced red itchy rash all over the body. On 11-AUG-2021 13:00, treatment medications included: diphenhydramine hydrochloride. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red itchy rash all over the body, and pain feels like burn-like a chemical burn or sun burn. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: BELOW 18 YEARS OLD GOT VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced below 18 years old got vaccine. On 15-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and below 18 years old got vaccine was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oropharyngeal pain, Paraesthesia
Clinical narrative: SLIGHT SORE THROAT; SLIGHT ARM NUMBNESS; TINGLY ARM, FELT LIKE ARM IS ASLEEP; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bells palsy, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: 06-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-AUG-2021, the patient experienced slight sore throat. On 16-AUG-2021, the patient experienced slight arm numbness. On 16-AUG-2021, the patient experienced tingly arm, felt like arm is asleep. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore throat on AUG-2021, was recovering from slight arm numbness, and the outcome of tingly arm, felt like arm is asleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Medication error
Clinical narrative: Stroke; MEDICATION ERROR (RECEIVED PFIZER COVID19 VACCINE FOLLOWED BY JANSSEN COVID 19 VACCINE); This spontaneous report received from a consumer concerned a male of unspecified age, 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, and batch number were not reported) dose was not reported, frequency 1 total, administered in JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included BNT 162 for prophylactic vaccination On an unspecified date, the patient experienced stroke, after receiving covid-19 vaccine ad26.cov2.s as second dose. The patient was informed that it does not matter if the first dose was of BNT 162 (medication error). The patient was hospitalized for stroke on unspecified date for unknown days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and medication error (received pfizer covid19 vaccine followed by janssen covid 19 vaccine) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210835451-Covid-19 vaccine ad26.cov2.s- Stroke This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Off label use
Clinical narrative: RECEIVED OTHER COVID-19 VACCINATIONS AS BOOSTERS AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; 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, 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. Concomitant medications included covid-19 vaccine for prophylactic vaccination. On an unspecified date, the patient experienced off label use, and received other covid-19 vaccinations as boosters after receiving the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and received other covid-19 vaccinations as boosters after receiving the janssen covid-19 vaccine was not reported. This report was non-serious.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED DOSES TO PATIENT BEYOND THE 2 HOUR RECOMMENDED STORAGE WINDOW; This spontaneous report received from a pharmacist concerned a 23 year old of unspecified sex. 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. The patient have no history of 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced administered doses to patient beyond the 2 hour recommended storage window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered doses to patient beyond the 2 hour recommended storage window was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram
Clinical narrative: STROKE; This spontaneous report received from a consumer (husband of patient) concerned a 64 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 no known allergies, no medical history and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, administered in last week of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021 at 7.00 am, daughter of patient found that the patient was on the floor and staring at ceiling. The patient was taken to the Emergency Room (ER). The physician of emergency room said that patient had a stroke. On the same day patient was transferred to the hospital where computed tomography (CT Scan) was done and a stroke was confirmed (patient would see the back physician in OCT-2021) did not have any specific information or the test results. The patient was completely healthy with no medical condition. The patient was under the care of physician. The date of admission and discharge from hospital were not reported. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210835603- covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Palpitations, Pyrexia
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; HEART PALPITATION; THROBBING; RINGING OF EARS; TERRIBLE HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker. The patient had no known allergies, no history of drug abuse or illicit drug use and she did not had any medical history nor she was taking any medications prescribed by a physician/doctor. Patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the same day after vaccination the patient had fever of 101.8 degree fahrenheit and terrible headache which was throbbing and because of which patient was unable to stand up. The patient also experienced ringing of ears and throbbing. The patient said that she did not felt any symptoms until 11-AUG-2021 when the patient again reported having fever of 102.9 degree fahrenheit, chills, body aches, heart palpitations, and headache which was ponding, all of which lasted for 4 days. The patient also experienced cough, congested, and was extremely tired. The patient said that she could not do much whenever she tried to get active. On 12-AUG-2021 the patient took BinaxNow Covid-19 Antigen Swab Test which came negative. On 16-AUG-2021 the patient experienced loss of taste and smell and again took BinaxNow Covid-19 Antigen Swab Test which came out to be positive(suspected covid-19 infection and suspected clinical vaccine failure).     The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation on 14-AUG-2021, and terrible headache, and fever on 24-MAR-2021, had not recovered from ringing of ears, and throbbing, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210835629- covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Tinnitus, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; HEART PALPITATION; THROBBING; RINGING OF EARS; TERRIBLE HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker. The patient had no known allergies, no history of drug abuse or illicit drug use and she did not had any medical history nor she was taking any medications prescribed by a physician/doctor. Patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the same day after vaccination the patient had fever of 101.8 degree fahrenheit and terrible headache which was throbbing and because of which patient was unable to stand up. The patient also experienced ringing of ears and throbbing. The patient said that she did not felt any symptoms until 11-AUG-2021 when the patient again reported having fever of 102.9 degree fahrenheit, chills, body aches, heart palpitations, and headache which was ponding, all of which lasted for 4 days. The patient also experienced cough, congested, and was extremely tired. The patient said that she could not do much whenever she tried to get active. On 12-AUG-2021 the patient took BinaxNow Covid-19 Antigen Swab Test which came negative. On 16-AUG-2021 the patient experienced loss of taste and smell and again took BinaxNow Covid-19 Antigen Swab Test which came out to be positive(suspected covid-19 infection and suspected clinical vaccine failure).     The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation on 14-AUG-2021, and terrible headache, and fever on 24-MAR-2021, had not recovered from ringing of ears, and throbbing, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210835629- covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Deep vein thrombosis, Fall, Loss of consciousness, Pulmonary embolism
Clinical narrative: LOST CONSCIOUSNESS; RHABDOMYOLISIS; TRAUMATIC FALL; PULMONARY EMBOLISM; ACUTE KIDNEY INJURY; DEEP VEIN THROMBOSIS IN RIGHT LOWER LEG; This spontaneous report received from a physician concerned a 38-year-old Male, race and ethnicity unknown. The patient's weight was 96 kilograms, and height was 183 centimeters. The patient's past medical history included panic attacks, prehypertension, syphilis, oropharyngeal gonorrhea, mild gynecomastia, and amphetamine use disorder. The patient was not on any medication at the time of event. 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, frequency 1 total, administered on 10-Apr-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-Jul-2021, the patient lost consciousness at home and was transported by ambulance to the local emergency Room. The patient was hospitalized on an unspecified date. The patient was found to have deep vein thrombosis in right lower leg and extensive pulmonary emboli. The reporter stated that no predisposing factors developed DVT (deep vein thrombosis) such as long time in stationary position or trauma to leg. The Patient was taken to the operating room for embolectomy and was started on anticoagulants. The patient experienced rhabdomyolysis due to traumatic fall and acute kidney injury during hospitalization. On 16-Jul-2021, the patient was discharged from hospital, with oral anticoagulant therapy (Apixaban 5 mg).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, acute kidney injury, and rhabdomyolisis, and the outcome of deep vein thrombosis in right lower leg, lost consciousness and traumatic fall was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20210820514.; Sender's Comments: V0: 20210835633-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pulmonary embolism, Acute kidney injury, Deep vein thrombosis, Lost consciousness, Rhabdomyolysis, Traumatic fall. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: LOST CONSCIOUSNESS; RHABDOMYOLISIS; TRAUMATIC FALL; PULMONARY EMBOLISM; ACUTE KIDNEY INJURY; DEEP VEIN THROMBOSIS IN RIGHT LOWER LEG; This spontaneous report received from a physician concerned a 38-year-old Male, race and ethnicity unknown. The patient's weight was 96 kilograms, and height was 183 centimeters. The patient's past medical history included panic attacks, prehypertension, syphilis, oropharyngeal gonorrhea, mild gynecomastia, and amphetamine use disorder. The patient was not on any medication at the time of event. 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, frequency 1 total, administered on 10-Apr-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-Jul-2021, the patient lost consciousness at home and was transported by ambulance to the local emergency Room. The patient was hospitalized on an unspecified date. The patient was found to have deep vein thrombosis in right lower leg and extensive pulmonary emboli. The reporter stated that no predisposing factors developed DVT (deep vein thrombosis) such as long time in stationary position or trauma to leg. The Patient was taken to the operating room for embolectomy and was started on anticoagulants. The patient experienced rhabdomyolysis due to traumatic fall and acute kidney injury during hospitalization. On 16-Jul-2021, the patient was discharged from hospital, with oral anticoagulant therapy (Apixaban 5 mg).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, acute kidney injury, and rhabdomyolisis, and the outcome of deep vein thrombosis in right lower leg, lost consciousness and traumatic fall was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20210820514.; Sender's Comments: V0: 20210835633-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pulmonary embolism, Acute kidney injury, Deep vein thrombosis, Lost consciousness, Rhabdomyolysis, Traumatic fall. 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: F
Vaccine: COVID19
Symptoms: Burning sensation, Confusional state, Dizziness, Feeling abnormal, Headache
Clinical narrative: FELT LIKE CRAP; UNABLE TO MOVE AND GET UP FOR WORK; NAUSEOUS; TERRIBLE HEADACHE; ACHE IN LEFT ARM WHERE VACCINE WAS GIVEN; DIZZY; CONFUSED; HARD TIME GETTING WORDS OUT; RAPID HEARTBEAT; ITCHING ON LEFT ARM AT VACCINATION SITE; ITCHING IN SCALP SHOULDER AREA AND WHOLE BACK; WHOLE BACK BURNING; This spontaneous report received from a patient concerned a 47 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, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced dizzy. On 16-AUG-2021, the patient experienced confused. On 16-AUG-2021, the patient experienced hard time getting words out. On 16-AUG-2021, the patient experienced rapid heartbeat. On 16-AUG-2021, the patient experienced itching on left arm at vaccination site. On 16-AUG-2021, the patient experienced itching in scalp shoulder area and whole back. On 16-AUG-2021, the patient experienced whole back burning. On 16-AUG-2021, the patient experienced nauseous. On 16-AUG-2021, the patient experienced terrible headache. On 16-AUG-2021, the patient experienced ache in left arm where vaccine was given. On 18-AUG-2021, the patient experienced felt like crap. On 18-AUG-2021, the patient experienced unable to move and get up for work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nauseous, dizzy, confused, hard time getting words out, rapid heartbeat, terrible headache, ache in left arm where vaccine was given, itching on left arm at vaccination site, itching in scalp shoulder area and whole back, whole back burning, felt like crap and unable to move and get up for work was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pruritus, Movement disorder, Nausea, Pruritus
Clinical narrative: FELT LIKE CRAP; UNABLE TO MOVE AND GET UP FOR WORK; NAUSEOUS; TERRIBLE HEADACHE; ACHE IN LEFT ARM WHERE VACCINE WAS GIVEN; DIZZY; CONFUSED; HARD TIME GETTING WORDS OUT; RAPID HEARTBEAT; ITCHING ON LEFT ARM AT VACCINATION SITE; ITCHING IN SCALP SHOULDER AREA AND WHOLE BACK; WHOLE BACK BURNING; This spontaneous report received from a patient concerned a 47 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, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced dizzy. On 16-AUG-2021, the patient experienced confused. On 16-AUG-2021, the patient experienced hard time getting words out. On 16-AUG-2021, the patient experienced rapid heartbeat. On 16-AUG-2021, the patient experienced itching on left arm at vaccination site. On 16-AUG-2021, the patient experienced itching in scalp shoulder area and whole back. On 16-AUG-2021, the patient experienced whole back burning. On 16-AUG-2021, the patient experienced nauseous. On 16-AUG-2021, the patient experienced terrible headache. On 16-AUG-2021, the patient experienced ache in left arm where vaccine was given. On 18-AUG-2021, the patient experienced felt like crap. On 18-AUG-2021, the patient experienced unable to move and get up for work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nauseous, dizzy, confused, hard time getting words out, rapid heartbeat, terrible headache, ache in left arm where vaccine was given, itching on left arm at vaccination site, itching in scalp shoulder area and whole back, whole back burning, felt like crap and unable to move and get up for work was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Vaccination site pain
Clinical narrative: FELT LIKE CRAP; UNABLE TO MOVE AND GET UP FOR WORK; NAUSEOUS; TERRIBLE HEADACHE; ACHE IN LEFT ARM WHERE VACCINE WAS GIVEN; DIZZY; CONFUSED; HARD TIME GETTING WORDS OUT; RAPID HEARTBEAT; ITCHING ON LEFT ARM AT VACCINATION SITE; ITCHING IN SCALP SHOULDER AREA AND WHOLE BACK; WHOLE BACK BURNING; This spontaneous report received from a patient concerned a 47 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, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced dizzy. On 16-AUG-2021, the patient experienced confused. On 16-AUG-2021, the patient experienced hard time getting words out. On 16-AUG-2021, the patient experienced rapid heartbeat. On 16-AUG-2021, the patient experienced itching on left arm at vaccination site. On 16-AUG-2021, the patient experienced itching in scalp shoulder area and whole back. On 16-AUG-2021, the patient experienced whole back burning. On 16-AUG-2021, the patient experienced nauseous. On 16-AUG-2021, the patient experienced terrible headache. On 16-AUG-2021, the patient experienced ache in left arm where vaccine was given. On 18-AUG-2021, the patient experienced felt like crap. On 18-AUG-2021, the patient experienced unable to move and get up for work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nauseous, dizzy, confused, hard time getting words out, rapid heartbeat, terrible headache, ache in left arm where vaccine was given, itching on left arm at vaccination site, itching in scalp shoulder area and whole back, whole back burning, felt like crap and unable to move and get up for work was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: ASYMPTOMATIC ATRIAL FIBRILLATION; This spontaneous report received from a consumer concerned a 57 year old white, not Hispanic or Latino male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, frequency one total, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination.  No concomitant medications were reported.  On 29-JUL-2021, the patient went for a well check up and the EKG (Electrocardiography) showed atrial fibrillation, the patient visited to emergency room, as the patient experienced asymptomatic atrial fibrillation, was hospitalized and treated with some type of medication (beta blocker) and was fine.  Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (Electrocardiography) (NR: not provided) Atrial Fibrillation, Echocardiogram (NR: not provided) Normal, and Venogram (NR: not provided) Normal.  The number of days hospitalized was not reported. Patient was on medication to keep to his heart in check and had an appointment on the 2nd week of September with the cardiologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asymptomatic atrial fibrillation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210835730-Covid-19 vaccine ad26.cov2.s-asymptomatic atrial fibrillation. 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Venogram
Clinical narrative: ASYMPTOMATIC ATRIAL FIBRILLATION; This spontaneous report received from a consumer concerned a 57 year old white, not Hispanic or Latino male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, frequency one total, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination.  No concomitant medications were reported.  On 29-JUL-2021, the patient went for a well check up and the EKG (Electrocardiography) showed atrial fibrillation, the patient visited to emergency room, as the patient experienced asymptomatic atrial fibrillation, was hospitalized and treated with some type of medication (beta blocker) and was fine.  Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (Electrocardiography) (NR: not provided) Atrial Fibrillation, Echocardiogram (NR: not provided) Normal, and Venogram (NR: not provided) Normal.  The number of days hospitalized was not reported. Patient was on medication to keep to his heart in check and had an appointment on the 2nd week of September with the cardiologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asymptomatic atrial fibrillation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210835730-Covid-19 vaccine ad26.cov2.s-asymptomatic atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Myalgia
Clinical narrative: LOSS OF APPETITE; SLIGHT CHILLS; TENDERNESS AT THE SITE; FATIGUE; SEVERE MUSCLE ACHE; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the patient experienced loss of appetite. On JUL-2021, the patient experienced slight chills. On JUL-2021, the patient experienced tenderness at the site. On JUL-2021, the patient experienced fatigue. On JUL-2021, the patient experienced severe muscle ache. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from loss of appetite, fatigue, slight chills, and severe muscle ache, and had not recovered from tenderness at the site. This report was non-serious.