chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: REAL COUGH; CONGESTION/NASAL CONGESTION; FEELING ACHY, BODY ACHES; COULD NOT THINK RIGHT NOW; FEELING ILL; NAUSEA; HEADACHE; FEVER; THREW UP; FEELING FOG,FEELING ALL CLOUDY; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (reporting on herself) concerned a 50 year old white female. The patient's weight was 200 pounds and height was 68 inches. The patient's concurrent conditions included: alcohol user (every once and a while) and non-smoker. The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient was not pregnant at time of reporting. The patient mentioned that she had no other known medical conditions. The patient also stated that she had covid twice once on Aug-2020 (pre-vaccination).The patient stated that she was told by her doctors that she had covid-19 on AUG-2020 but she had not tested positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported,1 total administered on 31-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that on JUL-2021, the patient became symptomatic and tested positive for covid-19 and she experienced symptoms as nausea, body aches, headaches, congestion, nasal congestion but she did not had fever and real cough and stated that she threw up (coded as suspected covid-19 infection, suspected clinical vaccination failure).The patient also stated that the symptoms from her infection with covid-19 in JUL-2021 was resolved in early AUG-2021 and she was feeling ill again at the time reporting. On 21-SEP-2021, the patient experienced achy and suspected that she had covid-19 and was awaiting for the test results that she performed on 21-SEP-2021. Later patient experienced foggy feeling and mentioned that this 'COVID business' makes all cloudy. She also stated that she could not think at the time of reporting. The patient recovered from suspected covid-19 infection on AUG-2021, had not recovered from feeling fog,feeling all cloudy, nausea, feeling achy, body aches, headaches, congestion/nasal congestion, feeling ill, fever, real cough, threw up, and could not think right now, and the outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product complaint (PQC): 90000194338.; Sender's Comments: V0: 20210944635-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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal, Vaccination failure, Vomiting
Clinical narrative: REAL COUGH; CONGESTION/NASAL CONGESTION; FEELING ACHY, BODY ACHES; COULD NOT THINK RIGHT NOW; FEELING ILL; NAUSEA; HEADACHE; FEVER; THREW UP; FEELING FOG,FEELING ALL CLOUDY; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (reporting on herself) concerned a 50 year old white female. The patient's weight was 200 pounds and height was 68 inches. The patient's concurrent conditions included: alcohol user (every once and a while) and non-smoker. The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient was not pregnant at time of reporting. The patient mentioned that she had no other known medical conditions. The patient also stated that she had covid twice once on Aug-2020 (pre-vaccination).The patient stated that she was told by her doctors that she had covid-19 on AUG-2020 but she had not tested positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported,1 total administered on 31-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that on JUL-2021, the patient became symptomatic and tested positive for covid-19 and she experienced symptoms as nausea, body aches, headaches, congestion, nasal congestion but she did not had fever and real cough and stated that she threw up (coded as suspected covid-19 infection, suspected clinical vaccination failure).The patient also stated that the symptoms from her infection with covid-19 in JUL-2021 was resolved in early AUG-2021 and she was feeling ill again at the time reporting. On 21-SEP-2021, the patient experienced achy and suspected that she had covid-19 and was awaiting for the test results that she performed on 21-SEP-2021. Later patient experienced foggy feeling and mentioned that this 'COVID business' makes all cloudy. She also stated that she could not think at the time of reporting. The patient recovered from suspected covid-19 infection on AUG-2021, had not recovered from feeling fog,feeling all cloudy, nausea, feeling achy, body aches, headaches, congestion/nasal congestion, feeling ill, fever, real cough, threw up, and could not think right now, and the outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product complaint (PQC): 90000194338.; Sender's Comments: V0: 20210944635-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: Adverse drug reaction
Clinical narrative: LITTLE EFFECT; 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: 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 little effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20210947115.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 57 year old male. The patient's weight was 235 pounds, and height was 71 inches. The patient's concurrent conditions included: gastroesophageal reflux disease, high blood pressure, rare alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies or any 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: unknown) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pantoprazole sodium sesquihydrate for gastroesophageal reflux disease, and bisoprolol fumarate/hydrochlorothiazide for high blood pressure.  On 23-SEP-2021, the patient experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000194500. The suspected product quality complaint has been confirmed to be voided based on the reported events and timelines, there was insufficient time for the patient to achieve immunity, therefore this report does not meet the definition of a product quality complaint or explicitly allege a potency issue. this record will be voided. based on the PQC evaluation/investigation performed. This case is a duplicate of 20210946647.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, 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 21-MAY-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 43 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: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949808, 20210949322, 20210950004, 20210950006 and 20210950120.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Illness, Malaise, Nausea
Clinical narrative: SALIVA IS CONSTANTLY COMING UP, JUST ACCUMULATING IN BACK OF THROAT; NOT FEELING SO GREAT; HIGH FEVER; WANTED TO PUKE/ FEEL LIKE THROWING UP; FEVER BLISTERS; SO SICK; PERSISTENT ABDOMINAL PAIN; HEAD THROBBING; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no difficulty in walking after vaccination. 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 20-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-SEP-2021, the patient experienced head throbbing. On 21-SEP-2021, the patient experienced so sick. On 21-SEP-2021, the patient experienced persistent abdominal pain. On 21-SEP-2021, the patient experienced fever blisters. On 21-SEP-2021, the patient experienced high fever. On 21-SEP-2021, the patient experienced wanted to puke/ feel like throwing up. On 22-SEP-2021, the patient experienced saliva is constantly coming up, just accumulating in back of throat. On 22-SEP-2021, the patient experienced not feeling so great. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head throbbing, persistent abdominal pain, saliva is constantly coming up, just accumulating in back of throat, and wanted to puke/ feel like throwing up, and the outcome of high fever, not feeling so great, fever blisters and so sick was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia, Salivary hypersecretion
Clinical narrative: SALIVA IS CONSTANTLY COMING UP, JUST ACCUMULATING IN BACK OF THROAT; NOT FEELING SO GREAT; HIGH FEVER; WANTED TO PUKE/ FEEL LIKE THROWING UP; FEVER BLISTERS; SO SICK; PERSISTENT ABDOMINAL PAIN; HEAD THROBBING; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no difficulty in walking after vaccination. 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 20-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-SEP-2021, the patient experienced head throbbing. On 21-SEP-2021, the patient experienced so sick. On 21-SEP-2021, the patient experienced persistent abdominal pain. On 21-SEP-2021, the patient experienced fever blisters. On 21-SEP-2021, the patient experienced high fever. On 21-SEP-2021, the patient experienced wanted to puke/ feel like throwing up. On 22-SEP-2021, the patient experienced saliva is constantly coming up, just accumulating in back of throat. On 22-SEP-2021, the patient experienced not feeling so great. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head throbbing, persistent abdominal pain, saliva is constantly coming up, just accumulating in back of throat, and wanted to puke/ feel like throwing up, and the outcome of high fever, not feeling so great, fever blisters and so sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ankle brachial index, Blood test, Formication, Oedema, Pain in extremity
Clinical narrative: RASH VERY ITCHY AND THERE ARE LITTLE RED DOTS LIKE A VEIN PROBLEM AROUND IT; LEG HURT LIKE THERE IS A PRESSURE INSIDE; LITTLE EDEMA WHERE SHE HAS A RASH; WEIRD CRAWLING SENSATION IN SKIN ON RASH AREA; RASH ON LEFT LEG BETWEEN ANKLE AND KNEE; STRANGE FEELING OF TINGLY SENSATION OF THE WHOLE LEG; This spontaneous report received from a patient concerned a 73 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: Z05A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the patient experienced rash on left leg between ankle and knee. On 22-JUN-2021, the patient experienced strange feeling of tingly sensation of the whole leg. On 20-JUL-2021, Laboratory data included: Venous Doppler (NR: not provided) The blood test ruled out a blood clot. On 03-AUG-2021, Laboratory data included: Ankle brachial index (NR: not provided) Negative for claudication. On an unspecified date, the patient experienced weird crawling sensation in skin on rash area, rash very itchy and there are little red dots like a vein problem around it, leg hurt like there is a pressure inside, and little edema where she has a rash. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Ruled out having cellulitis or diabetes. Treatment medications (dates unspecified) included: mupirocin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left leg between ankle and knee, and rash very itchy and there are little red dots like a vein problem around it, and the outcome of strange feeling of tingly sensation of the whole leg, weird crawling sensation in skin on rash area, leg hurt like there is a pressure inside and little edema where she has a rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Rash pruritic, Ultrasound Doppler
Clinical narrative: RASH VERY ITCHY AND THERE ARE LITTLE RED DOTS LIKE A VEIN PROBLEM AROUND IT; LEG HURT LIKE THERE IS A PRESSURE INSIDE; LITTLE EDEMA WHERE SHE HAS A RASH; WEIRD CRAWLING SENSATION IN SKIN ON RASH AREA; RASH ON LEFT LEG BETWEEN ANKLE AND KNEE; STRANGE FEELING OF TINGLY SENSATION OF THE WHOLE LEG; This spontaneous report received from a patient concerned a 73 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: Z05A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the patient experienced rash on left leg between ankle and knee. On 22-JUN-2021, the patient experienced strange feeling of tingly sensation of the whole leg. On 20-JUL-2021, Laboratory data included: Venous Doppler (NR: not provided) The blood test ruled out a blood clot. On 03-AUG-2021, Laboratory data included: Ankle brachial index (NR: not provided) Negative for claudication. On an unspecified date, the patient experienced weird crawling sensation in skin on rash area, rash very itchy and there are little red dots like a vein problem around it, leg hurt like there is a pressure inside, and little edema where she has a rash. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Ruled out having cellulitis or diabetes. Treatment medications (dates unspecified) included: mupirocin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left leg between ankle and knee, and rash very itchy and there are little red dots like a vein problem around it, and the outcome of strange feeling of tingly sensation of the whole leg, weird crawling sensation in skin on rash area, leg hurt like there is a pressure inside and little edema where she has a rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN RIGHT HAND; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the patient experienced pain in right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right hand. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 37 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949974, 20210950004, 20210950006, 20210949322 and 20210949808.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuropathy peripheral, Sensory disturbance
Clinical narrative: NEUROPATHY; MUSCLE STIFFNESS IN THE LEGS; FELT LIKE FALLING IN ANY MINUTE; This spontaneous report received from a patient concerned a female of unspecified age.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-AUG-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced lost sensation in her left hand, muscle stiffness in the legs, which further caused muscle weakness in both legs under the knees involving both feet. The patient was unable to walk or move normally and felt that she can fall any minute. On 13-AUG-2021, the patient also experienced loss of muscle in both legs, and felt like her nerves were damaged. The symptoms of lost sensation in left hand and muscle stiffness in legs were started about 15 minutes after vaccination. The patient also stated that she was diagnosed with neuropathy a couple of weeks ago by an unspecified physician. On 22-SEP-2021, the patient began feeling pain on her left foot as if someone was stabbing the foot with a needle. The patient does not want to provide any personal details about herself and did not want to be identified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle stiffness in the legs, had not recovered from neuropathy, and the outcome of felt like falling in any minute was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210950131- JANSSEN COVID-19 VACCINE Ad26.COV2.S-  neuropathy- 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: Anxiety, Bedridden, Body temperature, Chills, Cough
Clinical narrative: COUGH; CHILLS ON AND OFF; HEADACHE; HIGHEST FEVER 102.4 ON AND OFF; ARM SORE FOR A WHILE; BODY ACHE ON AND OFF; GOOSE EGG ON ARM; STAYED IN BED OR ON THE COUCH FOR TWO DAYS; ELEVATED HEART RATE FOR ABOUT 4 HOURS; ANXIETY; 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, and batch number were not reported) dose was not reported, administered on 20-SEP-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 SEP-2021, the patient experienced body ache on and off. On SEP-2021, the patient experienced goose egg on arm. On SEP-2021, the patient experienced stayed in bed or on the couch for two days. On SEP-2021, the patient experienced elevated heart rate for about 4hours. On SEP-2021, the patient experienced anxiety. On SEP-2021, the patient experienced arm sore for a while. Laboratory data included: Heart rate (NR: not provided) Elevated. On 20-SEP-2021, the patient experienced cough. On 20-SEP-2021, the patient experienced chills on and off. On 20-SEP-2021, the patient experienced headache. On 20-SEP-2021, the patient experienced highest fever 102.4 on and off. Laboratory data included: Body temperature (NR: not provided) 102.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from goose egg on arm, stayed in bed or on the couch for two days, elevated heart rate for about 4hours, and arm sore for a while on SEP-2021, and highest fever 102.4 on and off on 22-SEP-2021, and the outcome of chills on and off, cough, headache, body ache on and off and anxiety was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Pain, Pain in extremity
Clinical narrative: COUGH; CHILLS ON AND OFF; HEADACHE; HIGHEST FEVER 102.4 ON AND OFF; ARM SORE FOR A WHILE; BODY ACHE ON AND OFF; GOOSE EGG ON ARM; STAYED IN BED OR ON THE COUCH FOR TWO DAYS; ELEVATED HEART RATE FOR ABOUT 4 HOURS; ANXIETY; 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, and batch number were not reported) dose was not reported, administered on 20-SEP-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 SEP-2021, the patient experienced body ache on and off. On SEP-2021, the patient experienced goose egg on arm. On SEP-2021, the patient experienced stayed in bed or on the couch for two days. On SEP-2021, the patient experienced elevated heart rate for about 4hours. On SEP-2021, the patient experienced anxiety. On SEP-2021, the patient experienced arm sore for a while. Laboratory data included: Heart rate (NR: not provided) Elevated. On 20-SEP-2021, the patient experienced cough. On 20-SEP-2021, the patient experienced chills on and off. On 20-SEP-2021, the patient experienced headache. On 20-SEP-2021, the patient experienced highest fever 102.4 on and off. Laboratory data included: Body temperature (NR: not provided) 102.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from goose egg on arm, stayed in bed or on the couch for two days, elevated heart rate for about 4hours, and arm sore for a while on SEP-2021, and highest fever 102.4 on and off on 22-SEP-2021, and the outcome of chills on and off, cough, headache, body ache on and off and anxiety was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: COUGH; CHILLS ON AND OFF; HEADACHE; HIGHEST FEVER 102.4 ON AND OFF; ARM SORE FOR A WHILE; BODY ACHE ON AND OFF; GOOSE EGG ON ARM; STAYED IN BED OR ON THE COUCH FOR TWO DAYS; ELEVATED HEART RATE FOR ABOUT 4 HOURS; ANXIETY; 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, and batch number were not reported) dose was not reported, administered on 20-SEP-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 SEP-2021, the patient experienced body ache on and off. On SEP-2021, the patient experienced goose egg on arm. On SEP-2021, the patient experienced stayed in bed or on the couch for two days. On SEP-2021, the patient experienced elevated heart rate for about 4hours. On SEP-2021, the patient experienced anxiety. On SEP-2021, the patient experienced arm sore for a while. Laboratory data included: Heart rate (NR: not provided) Elevated. On 20-SEP-2021, the patient experienced cough. On 20-SEP-2021, the patient experienced chills on and off. On 20-SEP-2021, the patient experienced headache. On 20-SEP-2021, the patient experienced highest fever 102.4 on and off. Laboratory data included: Body temperature (NR: not provided) 102.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from goose egg on arm, stayed in bed or on the couch for two days, elevated heart rate for about 4hours, and arm sore for a while on SEP-2021, and highest fever 102.4 on and off on 22-SEP-2021, and the outcome of chills on and off, cough, headache, body ache on and off and anxiety was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, 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 experienced covid (COVID-19) and suspected clinical vaccination failure. On an unspecified date, the patient died from covid (COVID-19). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint number. This case, from the same reporter is linked to 20210950686, 20210950658 and 20210950479.; Sender's Comments: V0: 20210950539-Covid-19 vaccine ad26.cov2.s - Covid. 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). V0: 20210950539-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; Reported Cause(s) of Death: COVID
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ALMOST DIED; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-SEP-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 25-SEP-2021, the patient experienced almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was non-serious.  .
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date was 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 suspected covid-19 infection and suspected clinical vaccination failure. On an unspecified date, the patient died from suspected covid-19 infection. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).  This case, from the same reporter is linked to 20210950539, 20210950479 and 20210950658.; Sender's Comments: V0: 20210950686- COVID-19 VACCINE AD26.COV2.S- suspected covid-19 infection. 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). 20210950686-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Swelling
Clinical narrative: MORE SWELLING; PAIN IN ALL JOINTS SPECIALLY IN HANDS AND THE LEFT SIDE UNDER SCAPULA (LOTS OF PAIN THAT COMES AND GOES); PAIN IN HANDS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bee stings allergy, arthritis, egg yoke allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUL-2021, the patient experienced more swelling. On 25-JUL-2021, the patient experienced pain in all joints specially in hands and the left side under scapula (lots of pain that comes and goes). On 25-JUL-2021, the patient experienced pain in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in all joints specially in hands and the left side under scapula (lots of pain that comes and goes), more swelling, and pain in hands. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: BODY PAIN AND ACHES; PAIN IN THE ARM; FEELING ILL; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and smoker, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient had no health conditions. Patient had taken some vitamins for treatment. 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 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced body pain and aches. On 24-SEP-2021, the patient experienced pain in the arm. On 24-SEP-2021, the patient experienced feeling ill. On 24-SEP-2021, the patient experienced headache. On 24-SEP-2021, the patient experienced feeling tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in the arm, body pain and aches, headache, feeling tired, and feeling ill. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN FACE, HANDS, AREA TOWARDS EARS, THROAT AND FINGERS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: latex allergy, certain food allergy, abstain from alcohol, non smoker, high cholesterol, and irregular heart beat, and other pre-existing medical conditions included: Since childhood patient gets scared when everything gets dark and she was unable to breathe. The patient had not 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: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total administered on 24-SEP-2021 in left arm for prophylactic vaccination. Concomitant medications included atenolol/hydrochlorothiazide, and simvastatin.  On 24-SEP-2021, around 3 PM she felt the sensation in fingers and hands. The tingling started in lower face on the right side then moved to the left. It started right under her chin area towards ears and moved down to throat(Paraesthesia).Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in face, hands, area towards ears, throat and fingers. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210951778-covid-19 vaccine ad26.cov2.s - tingling in face, hands, area towards ears, throat and fingers.This event(s) is labeled per Safety Information and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING SENSATIONS IN ARM AND FEET; NUMBNESS IN BOTH FEET; This spontaneous report received from a patient concerned a 56 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: 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 SEP-2021, the patient experienced tingling sensations in arm and feet. On SEP-2021, the patient experienced numbness in both feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensations in arm and feet, and numbness in both feet. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Fall, Glycosylated haemoglobin, Lipids, Metabolic function test
Clinical narrative: TINGLING SENSATIONS IN ARM AND FEET; NUMBNESS IN BOTH FEET; This spontaneous report received from a patient concerned a 56 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: 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 SEP-2021, the patient experienced tingling sensations in arm and feet. On SEP-2021, the patient experienced numbness in both feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensations in arm and feet, and numbness in both feet. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sensory loss, Subacute inflammatory demyelinating polyneuropathy, Thermal burn
Clinical narrative: TINGLING SENSATIONS IN ARM AND FEET; NUMBNESS IN BOTH FEET; This spontaneous report received from a patient concerned a 56 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: 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 SEP-2021, the patient experienced tingling sensations in arm and feet. On SEP-2021, the patient experienced numbness in both feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensations in arm and feet, and numbness in both feet. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 41 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953012 and 20210953327.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT AGED 12 YEARS; This spontaneous report received from a health care professional concerned a 12 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-SEP-2021, the patient experienced off-label use. On 27-SEP-2021, the patient experienced vaccine administered to patient aged 12 years. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient aged 12 years was not reported. This report was non-serious.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned an 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). On an unspecified date in 2021, the patient died from covid-19. It was unspecified, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000194804.; Sender's Comments: V0:20210952702-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection. 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). 20210952702-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; Reported Cause(s) of Death: COVID-19
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 79 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: 230A21A, and batch number: 230A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952911.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.