chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gout, Hypokinesia, Insomnia, Loss of personal independence in daily activities
Clinical narrative: CANNOT PERFORM DAILY ACTIVITIES AND AFFECTS QUALITY OF LIFE; CANNOT STAY IN BED; FEELS WEAK; CANNOT MOVE KNEE; GOUT; SWELLING IN RIGHT ARM ,LEFT LEG SWOLLEN FROM GROIN DOWN, HAS BEEN GOING ON FOR 5 MONTHS; This spontaneous report received from a patient concerned a 75 year old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hip replacement, and concurrent conditions included: high blood pressure, latex allergy (latex rash), social alcohol drinker (glass of wine with meals occasionally), and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 at about 10:54 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, a week later after vaccination, the patient had a swelling on right arm and 2 weeks later on MAR-2021, the patient had a swelling in right toe, and went to doctor twice. On MAR-2021, patient was diagnosed with gout and was provided with cortisone shots. On MAR-2021, the patient also experienced swelling in left leg, from groin down which had been going on for 5 months. The patient had been visiting the doctor since 12-MAR-2021. The patient had been visiting the doctor's office almost every week. The patient believed that his primary care physician was not providing him the proper care. On 24-AUG-2021, the patient's left leg was swollen and was unable to move his knee. The patient was unable to stay in bed. 3-4 days ago, the doctors provided antibiotics to the patient. On unspecified date, the patient felt weak and was unable to perform daily activities which had affected his quality of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felts weak, swelling in right arm ,left leg swollen from groin down, has been going on for 5 months, gout (swelling in right toe), cannot perform daily activities and affects quality of life, and cannot move knee, and the outcome of cannot stay in bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210848967-Covid-19 vaccine ad26.cov2.s- Gout- 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).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: CANNOT PERFORM DAILY ACTIVITIES AND AFFECTS QUALITY OF LIFE; CANNOT STAY IN BED; FEELS WEAK; CANNOT MOVE KNEE; GOUT; SWELLING IN RIGHT ARM ,LEFT LEG SWOLLEN FROM GROIN DOWN, HAS BEEN GOING ON FOR 5 MONTHS; This spontaneous report received from a patient concerned a 75 year old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hip replacement, and concurrent conditions included: high blood pressure, latex allergy (latex rash), social alcohol drinker (glass of wine with meals occasionally), and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 at about 10:54 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, a week later after vaccination, the patient had a swelling on right arm and 2 weeks later on MAR-2021, the patient had a swelling in right toe, and went to doctor twice. On MAR-2021, patient was diagnosed with gout and was provided with cortisone shots. On MAR-2021, the patient also experienced swelling in left leg, from groin down which had been going on for 5 months. The patient had been visiting the doctor since 12-MAR-2021. The patient had been visiting the doctor's office almost every week. The patient believed that his primary care physician was not providing him the proper care. On 24-AUG-2021, the patient's left leg was swollen and was unable to move his knee. The patient was unable to stay in bed. 3-4 days ago, the doctors provided antibiotics to the patient. On unspecified date, the patient felt weak and was unable to perform daily activities which had affected his quality of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felts weak, swelling in right arm ,left leg swollen from groin down, has been going on for 5 months, gout (swelling in right toe), cannot perform daily activities and affects quality of life, and cannot move knee, and the outcome of cannot stay in bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210848967-Covid-19 vaccine ad26.cov2.s- Gout- 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).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Suspected COVID-19
Clinical narrative: SUSPECTED COVID 19 INFECTION; TIGHTNESS IN CHEST (FELT LIKE A 10-POUND DUMBBELL WAS ON HIS CHEST); This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced suspected covid 19 infection. On 22-AUG-2021, the patient experienced tightness in chest (felt like a 10-pound dumbbell was on his chest). Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and tightness in chest (felt like a 10-pound dumbbell was on his chest) was not reported. This report was non-serious. This report was associated with product quality complaint: 90000190988.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED A DOSE OF THE VACCINE 46 MINUTES AFTER THE 6 HOUR TIME FOR HOLDING.; This spontaneous report received from a pharmacist 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: 1808980 expiry: 18-SEP-2021) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced administered a dose of the vaccine 46 minutes after the 6 hour time for holding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered a dose of the vaccine 46 minutes after the 6 hour time for holding. was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media (Facebook) and concerned a patient of unspecified age, sex, race and ethnicity. 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) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had covid-19 symptoms (suspected clinical vaccine failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190742.; Sender's Comments: V0:20210849222-Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; This spontaneous report received from a patient concerned a 53 year old male of unknown race and ethnicity. The patient's weight was 100 kilograms, and height was not reported. The patient's concurrent conditions included: secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered on 02-AUG-2021 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 tadalafil. On 17-AUG-2021, the patient fainted after taking the dog outside which might have been heat related. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fainted was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to A-NJ2020-205487.; Sender's Comments: V0:20210849338-COVID-19 VACCINE AD26.COV2.S-Fainted. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Eczema, Fatigue, Hypersensitivity
Clinical narrative: WAKE UP FEELING BURNING ALL OVER THE BODY; HAD NOT SLEPT IN WEEKS DUE TO ITCHINESS; EXHAUSTION; ALLERGIC REACTION; SEVERE SUDDEN RASH ALL OVER THE BODY (BOTH ARMS, BOTH LEGS, TORSO, BACK AND SHOULDERS BUT MOSTLY ON THE UPPER BODY) WHICH THE DOCTOR WAS REFERRING TO IT AS AN ALLERGIC REACTION WITH ECZEMA,; OLD POLIO VACCINE SCAR ON THE LEFT SHOULDER HAS BLOWN UP AND BLISTERED; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with polio vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the patient experienced severe sudden rash all over the body (both arms, both legs, torso, back and shoulders but mostly on the upper body) which the doctor was referring to it as an allergic reaction with eczema. On 07-JUL-2021, the patient experienced old polio vaccine scar on the left shoulder has blown up and blistered. On 07-JUL-2021, the patient experienced allergic reaction. On 10-JUL-2021, the patient experienced had not slept in weeks due to itchiness. On 10-JUL-2021, the patient experienced exhaustion. On 14-JUL-2021, the patient experienced wake up feeling burning all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from old polio vaccine scar on the left shoulder has blown up and blistered, exhaustion, wake up feeling burning all over the body, severe sudden rash all over the body (both arms, both legs, torso, back and shoulders but mostly on the upper body) which the doctor was referring to it as an allergic reaction with eczema, had not slept in weeks due to itchiness, and allergic reaction. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: WAKE UP FEELING BURNING ALL OVER THE BODY; HAD NOT SLEPT IN WEEKS DUE TO ITCHINESS; EXHAUSTION; ALLERGIC REACTION; SEVERE SUDDEN RASH ALL OVER THE BODY (BOTH ARMS, BOTH LEGS, TORSO, BACK AND SHOULDERS BUT MOSTLY ON THE UPPER BODY) WHICH THE DOCTOR WAS REFERRING TO IT AS AN ALLERGIC REACTION WITH ECZEMA,; OLD POLIO VACCINE SCAR ON THE LEFT SHOULDER HAS BLOWN UP AND BLISTERED; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with polio vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the patient experienced severe sudden rash all over the body (both arms, both legs, torso, back and shoulders but mostly on the upper body) which the doctor was referring to it as an allergic reaction with eczema. On 07-JUL-2021, the patient experienced old polio vaccine scar on the left shoulder has blown up and blistered. On 07-JUL-2021, the patient experienced allergic reaction. On 10-JUL-2021, the patient experienced had not slept in weeks due to itchiness. On 10-JUL-2021, the patient experienced exhaustion. On 14-JUL-2021, the patient experienced wake up feeling burning all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from old polio vaccine scar on the left shoulder has blown up and blistered, exhaustion, wake up feeling burning all over the body, severe sudden rash all over the body (both arms, both legs, torso, back and shoulders but mostly on the upper body) which the doctor was referring to it as an allergic reaction with eczema, had not slept in weeks due to itchiness, and allergic reaction. 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.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Dyspnoea, Fatigue, Hypersomnia
Clinical narrative: DEHYDRATED; NUMBNESS IN FINGERTIPS; FELT TINGLING; BEGAN TO FEEL DIZZY; SLEPT THE REST OF THAT FRIDAY AND ALL DAY SATURDAY; SHORTNESS OF BREATH; EXHAUSTION/FATIGUE; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, cigarette smoker, cats allergy, and latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included escitalopram oxalate. On 20-AUG-2021, the patient experienced shortness of breath. On 20-AUG-2021, the patient experienced exhaustion/fatigue. On 20-AUG-2021, the patient experienced slept the rest of that friday and all day saturday. On 22-AUG-2021, the patient experienced began to feel dizzy. On 24-AUG-2021, the patient experienced dehydrated. On 24-AUG-2021, the patient experienced numbness in fingertips. On 24-AUG-2021, the patient experienced felt tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in fingertips, shortness of breath, and exhaustion/fatigue, and the outcome of began to feel dizzy, dehydrated, felt tingling and slept the rest of that friday and all day saturday was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: DEHYDRATED; NUMBNESS IN FINGERTIPS; FELT TINGLING; BEGAN TO FEEL DIZZY; SLEPT THE REST OF THAT FRIDAY AND ALL DAY SATURDAY; SHORTNESS OF BREATH; EXHAUSTION/FATIGUE; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, cigarette smoker, cats allergy, and latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included escitalopram oxalate. On 20-AUG-2021, the patient experienced shortness of breath. On 20-AUG-2021, the patient experienced exhaustion/fatigue. On 20-AUG-2021, the patient experienced slept the rest of that friday and all day saturday. On 22-AUG-2021, the patient experienced began to feel dizzy. On 24-AUG-2021, the patient experienced dehydrated. On 24-AUG-2021, the patient experienced numbness in fingertips. On 24-AUG-2021, the patient experienced felt tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in fingertips, shortness of breath, and exhaustion/fatigue, and the outcome of began to feel dizzy, dehydrated, felt tingling and slept the rest of that friday and all day saturday was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Injection site pain, Insomnia, Panic reaction
Clinical narrative: FEVER OF 99.2 F; BREATHLESSNESS; COULD NOT SLEEP; FELT PANIC; FELT RESTLESS; TINGLING SENSATION ALL OVER BODY; LEFT ARM PAIN AT THE SITE OF INJECTION; This spontaneous report received from a pharmacist concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sleep disorder, and concurrent conditions included: asthma, seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient did not have history of drug abuse or illicit drug usage. The patient was previously treated with diphenhydramine hydrochloride/paracetamol for sleep. 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 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, treatment medications included: budesonide/formoterol fumarate. On 23-AUG-2021, the patient experienced breathlessness. On 23-AUG-2021, the patient experienced could not sleep. On 23-AUG-2021, the patient experienced felt panic. On 23-AUG-2021, the patient experienced felt restless. On 23-AUG-2021, the patient experienced tingling sensation all over body. On 23-AUG-2021, the patient experienced left arm pain at the site of injection. On 24-AUG-2021, the patient experienced fever of 99.2 f. Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation all over body, fever of 99.2 F, and left arm pain at the site of injection, and the outcome of could not sleep, felt panic, breathlessness and felt restless was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Restlessness
Clinical narrative: FEVER OF 99.2 F; BREATHLESSNESS; COULD NOT SLEEP; FELT PANIC; FELT RESTLESS; TINGLING SENSATION ALL OVER BODY; LEFT ARM PAIN AT THE SITE OF INJECTION; This spontaneous report received from a pharmacist concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sleep disorder, and concurrent conditions included: asthma, seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient did not have history of drug abuse or illicit drug usage. The patient was previously treated with diphenhydramine hydrochloride/paracetamol for sleep. 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 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, treatment medications included: budesonide/formoterol fumarate. On 23-AUG-2021, the patient experienced breathlessness. On 23-AUG-2021, the patient experienced could not sleep. On 23-AUG-2021, the patient experienced felt panic. On 23-AUG-2021, the patient experienced felt restless. On 23-AUG-2021, the patient experienced tingling sensation all over body. On 23-AUG-2021, the patient experienced left arm pain at the site of injection. On 24-AUG-2021, the patient experienced fever of 99.2 f. Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation all over body, fever of 99.2 F, and left arm pain at the site of injection, and the outcome of could not sleep, felt panic, breathlessness and felt restless was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a physician 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 was not reported, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, several months prior to this report the patient recently had a breakthrough Covid-19 infection after receiving the Janssen vaccine. The patient further stated that he just had congestion and aches as symptoms (Suspected clinical vaccination failure and Suspected COVID-19- infection). 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: 20210849843 -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: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Chest pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHEST PAIN; A LOT OF THINGS; WEAKNESS; FEVER; This spontaneous report received from a parent 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: Unk) dose was not reported, administered on AUG-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 AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced chest pain. On AUG-2021, the patient experienced a lot of things. On AUG-2021, the patient experienced weakness. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, weakness, body aches, chest pain and a lot of things was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NEGATIVE EFFECTS OF VACCINE BUT DID  NOT SPECIFY WHAT THOSE EFFECTS WERE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 negative effects of vaccine but did not specify what those effects were. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative effects of vaccine but did not specify what those effects were was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 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, few months after receiving vaccine, the patient was diagnosed with Covid-19 (suspected clinical vaccination failure, and suspected covid-19 infection), lab test date and name unspecified.  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: 20210850450-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: DIDN'T FEEL TOO WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-AUG-2021, the patient experienced didn't feel too well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of didn't feel too well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210845308.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: LOW PLATELETS/PLATELETS OF 50; 3/4TH OF BODY COVERED IN BRUISES/BRUISES ARE GETTING WORSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 205 pounds, and height was 61 inches. The patient's past medical history included: surgery, and concurrent conditions included: type-2 diabetes mellitus, hypertension, sulfa allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: Platelet count (NR: not provided) high/above average at that point. On 13-MAR-2021, the patient experienced 3/4th of body covered in bruises/bruises are getting worse. On 15-JUN-2021, the patient experienced low platelets/platelets of 50. Laboratory data included: Platelet count (NR: not provided) LOW. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 50. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 3/4th of body covered in bruises/bruises are getting worse, and the outcome of low platelets/platelets of 50 was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: SLUGGISHNESS; FEVERISH; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced sluggishness. On APR-2021, the patient experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, and feverish. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: WEIGHT LOSS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 weight loss. Laboratory data (dates unspecified) included: Weight loss (NR: not provided) 5-8 lbs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weight loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829077.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: BODY ACHES; MY ARM HURT THE REST OF THE DAY AND NIGHT; HEADACHE; FATIGUE; LOW FEVER (99-100); 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99-100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; MY ARM HURT THE REST OF THE DAY AND NIGHT; HEADACHE; FATIGUE; LOW FEVER (99-100); 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99-100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: SORENESS AND ACHINESS; HIGH FEVER; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced soreness and achiness. On 25-AUG-2021, the patient experienced high fever. On 25-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, soreness and achiness and headaches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: INJECTIONS STARTED TO COMING OUT FROM NECK AND IF DID NOT RECEIVED VACCINE WOULD BE DEAD; 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. The patient's concurrent conditions included: numbness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced injections started to coming out from neck and if did not received vaccine would be dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injections started to coming out from neck and if did not received vaccine would be dead was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSE BLEED; 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. 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 nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleed. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered 1 in total on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications were not reported.  The patient commented that she recently experienced a breakthrough case of COVID (dates not specified) (coded to suspected covid-19 infection and suspected clinical vaccination failure). As per this report, the patient was recommended to receive the booster shot of vaccine in eight months. 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). This report associated with Product Quality compliant and PQC number has been requested.; Sender's Comments: V0: 20210851625-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: F
Vaccine: COVID19
Symptoms: Injection site pain, Thrombosis
Clinical narrative: LITTLE BLOOD CLOT ON LEFT LEG NEAR KNEE THE SIZE OF PENNY; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 26 year old female with unspecified ethnicity. 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: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 06-AUG-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient experienced arm soreness initially for 3 or 4 days at the injection site. On 25-AUG-2021, the patient experienced little blood clot on left leg near knee the size of a penny. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness at the injection site on 10-AUG-2021, and the outcome of little blood clot on left leg near knee the size of penny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851662- Covid-19 vaccine ad26.cov2.s- Little blood clot on left leg near knee the size of penny. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: TIRED; HEADACHE; This spontaneous report received from a patient concerned a 72 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: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the patient experienced tired. On 30-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) keep going up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and headache on 30-MAR-2021. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 YEAR OLD); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 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: 1820095, expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced drug administered to patient of inappropriate age (17 year old). On 25-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 drug administered to patient of inappropriate age (17 year old) and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: ADMINISTERED THE JANSSEN  COVID-19 VACCINE TO A FEMALE  PATIENT AND GAVE HER THE ENTIRE  VIAL; OFF LABEL USE; This spontaneous report received from a health care professional concerned an adult 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, intramuscular, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced administered the janssen covid-19 vaccine to a female patient and gave her the entire vial. On 25-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 administered the janssen covid-19 vaccine to a female patient and gave her the entire vial and off label use was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE CRUSHING HEADACHE, ON AND OFF HEADACHES OF MILD NATURE AND SLEPT MOST OF THE TIME BECAUSE IT WAS DEBILITATING; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included: cigarette smoker, and concurrent conditions included: alcohol user, and non allergy nasal issues, and other pre-existing medical conditions included: The patient had no known allergies, and no history of drug abuse or illicit dug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. Concomitant medications included alendronate sodium for non allergy nasal issues, azelastine for non allergy nasal issues, and fluticasone propionate for non allergy nasal issues.  On 20-JUL-2021, the patient experienced severe crushing headache, on and off headaches of mild nature and slept most of the time because it was debilitating. Treatment medications (dates unspecified) included: paracetamol, and acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe crushing headache, on and off headaches of mild nature and slept most of the time because it was debilitating. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: IN BED ALL WEEK; This spontaneous report received from a patient concerned a 38 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 (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 in bed all week. The action taken with covid-19 vaccine was not applicable. The patient recovered from in bed all week. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSE BLEED; 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. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose bleed was not reported. This report was non-serious.