chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: TWO BLOOD CLOTS BEHIND SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethic 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 (Janssen, dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient got the vaccine shot and experienced two blood clots behind them. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two blood clots behind shot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211229802-covid-19 vaccine ad26.cov2.s- thrombosis, deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media 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, and batch number were not reported) 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "the patient died within 24 hours of the shot". It was unknown if an autopsy was performed.  On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211229952 -covid-19 vaccine ad26.cov2.s- Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 got covid. The action taken with covid-19 vaccine was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint 90000206891. Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Infection susceptibility increased, Pilonidal cyst, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: ULCERATIVE COLITIS SYMPTOMS WORSENED OR FLARE UP; SUSPECTED CLINICAL VACCINATION FAILURE; DRUG EFFECT DECREASED; INCREASED TENDENCY FOR INFECTION; SUSPECTED COVID-19 INFECTION; PILONIDAL CYST RECURRING; This spontaneous report received from a patient via a company representative concerned a 19 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pilonidal cyst. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown. expiry: Unknown) dose was not reported, 1 total, administered on 30-SEP-2021 for prophylactic vaccination. (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  The patient had pilonidal cysts before initial treatment of Humira. on 03-Dec-2021, patient had pilonidal cyst removal, this was a recurring cyst that had previously had a removal due to this patient thought he had a ulcerative colitis flare up, but Humira was no longer working well. The patient was on pain killers for relief, patient was more prone to these infections being on Humira, but, symptoms have just worsened. Patient had Covid positive diagnosis after receiving first vaccine. (Suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected clinical vaccination failure, and suspected covid-19 infection, was recovering from drug effect decreased, and ulcerative colitis symptoms worsened or flare up, had not recovered from increased tendency for infection, and the outcome of pilonidal cyst recurring was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207067.; Sender's Comments: V0.20211230093-covid-19 vaccine ad26.cov2.s -Ulcerative colitis symptoms worsened  or flare up. 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).  20211230093-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: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased, Vaccination failure
Clinical narrative: ULCERATIVE COLITIS SYMPTOMS WORSENED OR FLARE UP; SUSPECTED CLINICAL VACCINATION FAILURE; DRUG EFFECT DECREASED; INCREASED TENDENCY FOR INFECTION; SUSPECTED COVID-19 INFECTION; PILONIDAL CYST RECURRING; This spontaneous report received from a patient via a company representative concerned a 19 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pilonidal cyst. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown. expiry: Unknown) dose was not reported, 1 total, administered on 30-SEP-2021 for prophylactic vaccination. (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  The patient had pilonidal cysts before initial treatment of Humira. on 03-Dec-2021, patient had pilonidal cyst removal, this was a recurring cyst that had previously had a removal due to this patient thought he had a ulcerative colitis flare up, but Humira was no longer working well. The patient was on pain killers for relief, patient was more prone to these infections being on Humira, but, symptoms have just worsened. Patient had Covid positive diagnosis after receiving first vaccine. (Suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected clinical vaccination failure, and suspected covid-19 infection, was recovering from drug effect decreased, and ulcerative colitis symptoms worsened or flare up, had not recovered from increased tendency for infection, and the outcome of pilonidal cyst recurring was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207067.; Sender's Comments: V0.20211230093-covid-19 vaccine ad26.cov2.s -Ulcerative colitis symptoms worsened  or flare up. 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).  20211230093-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: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Therapeutic response unexpected
Clinical narrative: SLEEPY; UNEXPECTED BENEFIT (SHOT HELPED, MADE HIM CALM, MADE HIM FEEL SAFE IN HIS BODY, FELT GREAT, NOW TALKING IN COMPLETE  SENTENCES AND NO GRAND MAL AND NO DROP SEIZURES); TIRED; This spontaneous report received from a parent concerned a 4 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: landau-klefner seizures, autism, hyperactive, celiac disease, non-smoker, non-alcoholic, and peanut allergy, and other pre-existing medical conditions included: Patient was allergic to lots of stuff and had epipen. Patient had no drug abuse or illicit drug usage. The patient was previously treated with measles vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 19-SEP-2021) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On an unspecified date, the patient experienced sleepy, unexpected benefit (shot helped, made him calm, made him feel safe in his body, felt great, now talking in complete sentences and no grand mal and no drop seizures), and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, and tired, and the outcome of unexpected benefit (shot helped, made him calm, made him feel safe in his body, felt great, now talking in complete sentences and no grand mal and no drop seizures) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: RETINA VEIN OCCLUSION; This spontaneous report received from a patient via social media via a company representative 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, and batch number were not reported) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. (Dose number in series 1). 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 JUN-2021, the patient stated that, "I took the J&J shot back in April days before they pulled it off for the issues. Two months later I had a blood vein in my eye bust. Condition called retina vein occlusion. No more shots of any kind for me. I believe the shot caused it. My eye Dr. has been able to improve my sight with 4 needle medicine shots in my eye." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from retina vein occlusion. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211230354- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Retina vein occlusion. 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: Burning sensation, Decreased appetite, Gait disturbance, Heart rate increased, Hypoaesthesia
Clinical narrative: HEART PALPITATIONS; ELEVATED HEART RATE; LOSE OF APPETITE; LOSS OF SLEEP; BURNING  SENSATION IN SHOULDER; LOSS OF ABILITY TO WALK; TINGLING IN ARMS AND HAND; HANDS WENT NUMB; 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, and batch number were 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 heart palpitations, elevated heart rate, lose of appetite, loss of sleep, burning sensation in shoulder, loss of ability to walk, tingling in arms and hand, and hands went numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, elevated heart rate, lose of appetite, loss of sleep, burning sensation in shoulder, hands went numb, loss of ability to walk and tingling in arms and hand was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, Paraesthesia
Clinical narrative: HEART PALPITATIONS; ELEVATED HEART RATE; LOSE OF APPETITE; LOSS OF SLEEP; BURNING  SENSATION IN SHOULDER; LOSS OF ABILITY TO WALK; TINGLING IN ARMS AND HAND; HANDS WENT NUMB; 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, and batch number were 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 heart palpitations, elevated heart rate, lose of appetite, loss of sleep, burning sensation in shoulder, loss of ability to walk, tingling in arms and hand, and hands went numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, elevated heart rate, lose of appetite, loss of sleep, burning sensation in shoulder, hands went numb, loss of ability to walk and tingling in arms and hand was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pain, Sinus congestion
Clinical narrative: BODY ACHES; CONGESTION; COVID-19; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 01-DEC-2021, the patient experienced covid-19. On an unspecified date, the patient experienced body aches, and congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from covid-19, and congestion, and the outcome of body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: get winded much more easily; blood oxygen numbers were below 95; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and loss of smell, and other pre-existing medical conditions included: Patient did not have a history of lung issues, allergies, or known comorbidities outlined in the patient or prescriber package inserts. Patient was a healthy and athletic person whose blood oxygen numbers hovered in the 97-100 range prior to received the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced blood oxygen numbers were below 95. Laboratory data included: Oxygen saturation (NR: not provided) 94 %, 93 %, 83 %, 75 %. On an unspecified date, the patient experienced get winded much more easily. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 94 %, 78 %. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood oxygen numbers were below 95 and get winded much more easily was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Radiculitis brachial
Clinical narrative: BRACHIAL NEURITIS; 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, and batch number were 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 brachial neuritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brachial neuritis was not reported. This report was non-serious. This case, from the same reporter is linked to 20211043237 and 20211155195.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Cough, Fatigue
Clinical narrative: RUNNY NOSE; SNEEZING; COUGH; SLEPT A LOT; STOMACH CRAMPS; JOINT PAIN (SPECIALLY THE RIGHT WRIST, FEELS ARTHRITIC OR DISLOCATED, ALL JOINT ARE SORE); FEVER; HEADACHE; FATIGUE (REALLY TIRED); This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema, and oyster shell allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 034A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-DEC-2021, the patient experienced runny nose. On 11-DEC-2021, the patient experienced sneezing. On 11-DEC-2021, the patient experienced cough. On 11-DEC-2021, the patient experienced slept a lot. On 11-DEC-2021, the patient experienced stomach cramps. On 11-DEC-2021, the patient experienced joint pain (specially the right wrist, feels arthritic or dislocated, all joint are sore). On 11-DEC-2021, the patient experienced fever. On 11-DEC-2021, the patient experienced headache. On 11-DEC-2021, the patient experienced fatigue (really tired). Laboratory data included: Body temperature (NR: not provided) above 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, runny nose, and headache, had not recovered from joint pain (specially the right wrist, feels arthritic or dislocated, all joint are sore), and fatigue (really tired), and the outcome of sneezing, cough, slept a lot and stomach cramps was not reported. This report was non-serious. This case, from the same reporter is linked to 20211229762 and 20211230837.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: RUNNY NOSE; SNEEZING; COUGH; SLEPT A LOT; STOMACH CRAMPS; JOINT PAIN (SPECIALLY THE RIGHT WRIST, FEELS ARTHRITIC OR DISLOCATED, ALL JOINT ARE SORE); FEVER; HEADACHE; FATIGUE (REALLY TIRED); This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema, and oyster shell allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 034A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-DEC-2021, the patient experienced runny nose. On 11-DEC-2021, the patient experienced sneezing. On 11-DEC-2021, the patient experienced cough. On 11-DEC-2021, the patient experienced slept a lot. On 11-DEC-2021, the patient experienced stomach cramps. On 11-DEC-2021, the patient experienced joint pain (specially the right wrist, feels arthritic or dislocated, all joint are sore). On 11-DEC-2021, the patient experienced fever. On 11-DEC-2021, the patient experienced headache. On 11-DEC-2021, the patient experienced fatigue (really tired). Laboratory data included: Body temperature (NR: not provided) above 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, runny nose, and headache, had not recovered from joint pain (specially the right wrist, feels arthritic or dislocated, all joint are sore), and fatigue (really tired), and the outcome of sneezing, cough, slept a lot and stomach cramps was not reported. This report was non-serious. This case, from the same reporter is linked to 20211229762 and 20211230837.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: SEVERAL BOUTS OF NUMBNESS (RADIATED ON ONE SIDE OF BODY, WENT FROM SHOULDER DOWN THROUGH LEG, EACH EPISODE LASTED ABOUT 10 MINUTES); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced several bouts of numbness radiated on one side of body, went from shoulder down through leg, each episode lasted about 10 minutes. Treatment medications included acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from several bouts of numbness radiated on one side of body, went from shoulder down through leg, each episode lasted about 10 minutes. This report was non-serious. This case, from the same reporter is linked to 20211232860.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: LOST MOST OF HAIR DUE TO THE JANSSEN VACCINE; 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, and batch number were 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 lost most of hair due to the janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost most of hair due to the janssen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211127938.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: LOTS OF PAIN CAUSED BY NEEDLE AND NOT THE VACCINE AT INJECTION SITE; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-DEC-2021, the patient experienced lots of pain caused by needle and not the vaccine at injection site. The action taken with covid-19 vaccine was not applicable. The outcome of lots of pain caused by needle and not the vaccine at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS DOWN THE ONE SIDE OF HIS BODY; This spontaneous report received from a patient via a company representative 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, 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 numbness down the one side of his body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness down the one side of his body was not reported. This report was non-serious. This case, from the same reporter is linked to 20211232675.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Gait disturbance, Mumps, Unevaluable event
Clinical narrative: TERRIBLE REACTION; COULD BARELY WALK; BED BOUND FOR FOUR DAYS; BODY BROKE OUT IN MUMPS LOOKING BUMPS, FROM HEAD TO TOE; BODY WAS WEAK; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had sea moss, diet, water and rest. 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 terrible reaction, could barely walk, bed bound for four days, body broke out in mumps looking bumps, from head to toe, and body was weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible reaction, could barely walk, bed bound for four days, body broke out in mumps looking bumps, from head to toe, and body was weak. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE ACHES; This spontaneous report received from a pharmacist 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, and batch number were not reported) dose was not reported, administered on 21-MAY-2021 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 muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20211233321.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: GIVEN A DOSE OF THE JANSSEN COVID-19 VACCINE THAT WAS EXPOSED TO TEMPERATURES BELOW AND ABOVE THE RECOMMENDED STORAGE TEMPERATURE/TEMPERATURE EXCURSION; INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a health care professional concerned multiple patients. 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: 211D21A expiry: 11-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 18-NOV-2021, the patient experienced given a dose of the janssen covid-19 vaccine that was exposed to temperatures below and above the recommended storage temperature/temperature excursion. On 18-NOV-2021, the patient experienced incorrectly stored vaccine administered. On 18-NOV-2021, the patient experienced vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrectly stored vaccine administered, given a dose of the janssen covid-19 vaccine that was exposed to temperatures below and above the recommended storage temperature/temperature excursion and vaccine stored outside of the acceptable limits was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore arm. This report was non-serious. This case, from the same reporter is linked to 20211232396.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Autonomic nervous system imbalance, Central nervous system lesion, Cognitive disorder, Connective tissue disorder
Clinical narrative: hives; memory loss; difficulty concentrating; brain fog; 2 small lesions on her brain; mast cell cognition problem; connective tissue disorder; dysautonomia; rashes; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog) and CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Idiopathic urticaria, Memory loss, Intelligence decreased, Concentration ability impaired, Connective tissue disorder and Dysautonomia.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog), CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain), COGNITIVE DISORDER (mast cell cognition problem), CONNECTIVE TISSUE DISORDER (connective tissue disorder), AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia) and RASH (rashes). At the time of the report, URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog), CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain), COGNITIVE DISORDER (mast cell cognition problem), CONNECTIVE TISSUE DISORDER (connective tissue disorder), AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia) and RASH (rashes) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Eosinophil count: elevated (High) elevated. On an unknown date, Monocyte count: elevated (High) elevated. On an unknown date, Platelet count: low (Low) low. On an unknown date, Tryptase: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history of the patient was not reported. Current condition of the patient also included hereditary alpha tryptasemia.  Concomitant medication of the patient was not reported.  The patient also experienced gene triplication.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Eosinophil count, Feeling abnormal, Monocyte count, Platelet count
Clinical narrative: hives; memory loss; difficulty concentrating; brain fog; 2 small lesions on her brain; mast cell cognition problem; connective tissue disorder; dysautonomia; rashes; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog) and CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Idiopathic urticaria, Memory loss, Intelligence decreased, Concentration ability impaired, Connective tissue disorder and Dysautonomia.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog), CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain), COGNITIVE DISORDER (mast cell cognition problem), CONNECTIVE TISSUE DISORDER (connective tissue disorder), AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia) and RASH (rashes). At the time of the report, URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog), CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain), COGNITIVE DISORDER (mast cell cognition problem), CONNECTIVE TISSUE DISORDER (connective tissue disorder), AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia) and RASH (rashes) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Eosinophil count: elevated (High) elevated. On an unknown date, Monocyte count: elevated (High) elevated. On an unknown date, Platelet count: low (Low) low. On an unknown date, Tryptase: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history of the patient was not reported. Current condition of the patient also included hereditary alpha tryptasemia.  Concomitant medication of the patient was not reported.  The patient also experienced gene triplication.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tryptase, Urticaria
Clinical narrative: hives; memory loss; difficulty concentrating; brain fog; 2 small lesions on her brain; mast cell cognition problem; connective tissue disorder; dysautonomia; rashes; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog) and CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Idiopathic urticaria, Memory loss, Intelligence decreased, Concentration ability impaired, Connective tissue disorder and Dysautonomia.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog), CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain), COGNITIVE DISORDER (mast cell cognition problem), CONNECTIVE TISSUE DISORDER (connective tissue disorder), AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia) and RASH (rashes). At the time of the report, URTICARIA (hives), AMNESIA (memory loss), DISTURBANCE IN ATTENTION (difficulty concentrating), FEELING ABNORMAL (brain fog), CENTRAL NERVOUS SYSTEM LESION (2 small lesions on her brain), COGNITIVE DISORDER (mast cell cognition problem), CONNECTIVE TISSUE DISORDER (connective tissue disorder), AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia) and RASH (rashes) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Eosinophil count: elevated (High) elevated. On an unknown date, Monocyte count: elevated (High) elevated. On an unknown date, Platelet count: low (Low) low. On an unknown date, Tryptase: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history of the patient was not reported. Current condition of the patient also included hereditary alpha tryptasemia.  Concomitant medication of the patient was not reported.  The patient also experienced gene triplication.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vial was punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: full blown Covid symptoms for 2 days after her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown Covid symptoms for 2 days after her 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown Covid symptoms for 2 days after her 1st dose). At the time of the report, SUSPECTED COVID-19 (full blown Covid symptoms for 2 days after her 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not provided by the reporter. Patient states that his wife had full blown Covid symptoms for 2 days after her 1st dose of the Moderna Covid-19 Vaccine & for 1 day after her 2nd dose. Treatment information was not provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of Suspected COVID without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred after the first and had a duration of 2 days. The patient experienced COVID symptoms, which were not further specified. SARS-CoV-2 test was not performed. COVID symptoms were also reported after the second dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395682 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of Suspected COVID without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred after the first and had a duration of 2 days. The patient experienced COVID symptoms, which were not further specified. SARS-CoV-2 test was not performed. COVID symptoms were also reported after the second dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: full blown Covid symptoms for 1 day after her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown Covid symptoms for 1 day after her 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown Covid symptoms for 1 day after her 2nd dose). At the time of the report, SUSPECTED COVID-19 (full blown Covid symptoms for 1 day after her 2nd dose) outcome was unknown.            Concomitant medication of the patient was not reported. Patient states that she had full blown Covid symptoms for 2 days after her 1st dose of the Moderna Covid-19 Vaccine & for 1 day after her 2nd dose. No treatment information was provided by the reporter.  This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of Suspected COVID without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred after the second dose of mRNA- 1273 Moderna vaccine and had a duration of 1 day. The patient experienced COVID symptoms, which were not further specified. It is unknown if SARS-CoV-2 test was performed. COVID symptoms were also reported after the first dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395649 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.  Reported that a family got a COVID-19 vaccine (possible Moderna, but uncertain) and had COVID-19 4 months after. Reporter had very limited information and did not know who many patients were involved. Only gave initials of one patient who is on theirs 50s (age unknown).  Company comment: This is a spontaneous case concerning a  male patient of an unknown age with no medical history reported, who experienced unexpected events of COVID 19. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. It was reported that a family got a COVID-19 vaccine (possible Moderna, but uncertain) and had COVID-19 4 months after. Reporter had very limited information and did not know who many patients were involved. Only gave initials of one patient who is on theirs 50s (age unknown). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  male patient of an unknown age with no medical history reported, who experienced unexpected events of COVID 19 (AESI). The event occurred on an unknown date after a dose of mRNA-1273 vaccine. It was reported that a family got a COVID-19 vaccine (possible Moderna, but uncertain) and had COVID-19 4 months after. Reporter had very limited information and did not know who many patients were involved. Only gave initials of one patient who is on theirs 50s (age unknown). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.