chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
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 patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinusitis, high blood pressure, prediabetes, allergy to almonds, abstains alcohol, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient tested positive to covid-19 (suspected clinical vaccination failure and suspected covid-19 infection) after receiving the vaccine. She stated that she walked in to a walk-in clinic thinking it as sinus and received some sinus treatment then the test came back as positive to Covid-19. Her symptoms were stuffy nose and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191510.; Sender's Comments: V0: 20210860158-COVID-19 VACCINE AD26.COV2.S - Suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAK THROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; 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, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced break through infection, and tested positive for covid-19. She also had suspected clinical vaccination failure on 08-AUG-2021. On 28-AUG-2021, the patient tested negative for covid-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection on 28-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000191521. This case is a duplicate of 20210860224.; Sender's Comments: V0 2021086210-COVID-19 VACCINE AD26.COV2.S-breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  2021086210-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.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: This spontaneous report received from a consumer which she heard on the news (social media) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, 1 total, 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 consumer reported that "she heard on the news that there were break through infections in 2 officials who received the Janssen covid-19 vaccine and one was hospitalized". The date of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infections was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210860115. This report was associated with product quality complaint: 90000191561.; Sender's Comments: V0: 20210860259-: Covid-19 Vaccine Ad26.Cov2.S -Breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eye irritation, Eye pruritus, Hypotension, Lacrimation increased
Clinical narrative: FAINTING AT NIGHT; LOW BLOOD PRESSURE AFTER VACCINATION; LIGHT SENSITIVITY; BLISTER LIKE LESIONS ON HER ARMS AND LEGS; INCREASED THIRST; ITCHY EYES; BURNING EYES; WATERY EYES; This solicited report received from a patient via PPSIMM000648: SPP Fee For Service Sponsored Communication- Humana concerned an elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient was treated with Tremfya (guselkumab) (solution for infusion in pre-filled syringe, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthropathy.  The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported frequency time 1 total prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case Concomitant medications included betamethasone, citalopram, (Dicyclomine) dicycloverine ,fenofibrate, folic acid, hydrochlorothiazide, methotrexate, nystatin, olmesartan medoxomil ,propranolol, and simvastatin for unknown indication. On an unspecified date, the patient experienced fainting at night, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy, burning and watery eyes and low blood pressure after vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The patient had not recovered from low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, fainting at night, itchy eyes, burning eyes, and watery eyes. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related; and between guselkumab, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860397-COVID-19 VACCINE AD26.COV2.S-FAINTING AT NIGHT. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210860397- GUSELKUMAB-FAINTING AT NIGHT. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Syncope, Thirst
Clinical narrative: FAINTING AT NIGHT; LOW BLOOD PRESSURE AFTER VACCINATION; LIGHT SENSITIVITY; BLISTER LIKE LESIONS ON HER ARMS AND LEGS; INCREASED THIRST; ITCHY EYES; BURNING EYES; WATERY EYES; This solicited report received from a patient via PPSIMM000648: SPP Fee For Service Sponsored Communication- Humana concerned an elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient was treated with Tremfya (guselkumab) (solution for infusion in pre-filled syringe, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthropathy.  The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported frequency time 1 total prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case Concomitant medications included betamethasone, citalopram, (Dicyclomine) dicycloverine ,fenofibrate, folic acid, hydrochlorothiazide, methotrexate, nystatin, olmesartan medoxomil ,propranolol, and simvastatin for unknown indication. On an unspecified date, the patient experienced fainting at night, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy, burning and watery eyes and low blood pressure after vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The patient had not recovered from low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, fainting at night, itchy eyes, burning eyes, and watery eyes. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related; and between guselkumab, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860397-COVID-19 VACCINE AD26.COV2.S-FAINTING AT NIGHT. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210860397- GUSELKUMAB-FAINTING AT NIGHT. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer survivor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, 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, patient had done an antibody test and it was negative test (suspected immunological vaccine failure) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860781 and 20210860500. This report was associated with product quality complaint.; Sender's Comments: V0: 20210860607- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; 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) 1 in Total dose were not reported, 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 had negative antibodies test (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860607 and 20210860500.; Sender's Comments: V0: 20210860781-COVID-19 VACCINE AD26.COV2.S- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: BILATERAL LEG SWELLING; FEELING HOT; SWEATY; RANDOM CHEST PAIN; BILATERAL LEG PAIN; WEAKNESS; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-AUG-2021, the patient experienced bilateral leg swelling. On 29-AUG-2021, the patient experienced feeling hot. On 29-AUG-2021, the patient experienced sweaty. On 29-AUG-2021, the patient experienced random chest pain. On 29-AUG-2021, the patient experienced bilateral leg pain. On 29-AUG-2021, the patient experienced weakness. On 29-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bilateral leg pain, bilateral leg swelling, feeling hot, sweaty, nausea, weakness, and random chest pain. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: BILATERAL LEG SWELLING; FEELING HOT; SWEATY; RANDOM CHEST PAIN; BILATERAL LEG PAIN; WEAKNESS; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-AUG-2021, the patient experienced bilateral leg swelling. On 29-AUG-2021, the patient experienced feeling hot. On 29-AUG-2021, the patient experienced sweaty. On 29-AUG-2021, the patient experienced random chest pain. On 29-AUG-2021, the patient experienced bilateral leg pain. On 29-AUG-2021, the patient experienced weakness. On 29-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bilateral leg pain, bilateral leg swelling, feeling hot, sweaty, nausea, weakness, and random chest pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: BOTH ARMS WERE TURNING BROWN AND BLOTCHY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 both arms were turning brown and blotchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both arms were turning brown and blotchy. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This spontaneous report received from a 34 year old African American, not Hispanic or Latino female patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: unknown) dose was not reported, administered, 1 total, to left deltoid on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, 5-10 minutes after receiving the injection patient fainted and was rushed to the ER (Emergency room) by paramedics. Laboratory data included: Blood test (NR: not provided) normal, EKG (Electrocardiogram) (NR: not provided) normal, and Urine analysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 17-AUG-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210900241-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).
Sex: U
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; 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: not reported) dose was not reported, 1 total, 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 received the Janssen covid-19 vaccine and had no antibodies/negative antibody test (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative (No antibodies). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210900383. ; Sender's Comments: V0:20210900277-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: This spontaneous report received from a health care professional (Nurse) concerned a 59 year old white and unknown ethnicity of male. The patient's weight was 290 pounds, and height was 75 inches. The patient's concurrent conditions included: non alcohol user, non smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included allopurinol 300 mg, enalapril 20mg, hydrochlorothiazide 25mg, and levothyroxine100mcg once a day. On 26-AUG-2021, the patient's blood sample was collected. 30-AUG-2021, the laboratory test results received for SARS-CoV-2 IgG antibody test (SARs Covid - IgG spike test (does not give numerical results) -semi QN test) was found to be negative (units unspecified) which was concluded as confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191666.; Sender's Comments: V0:20210900292-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hypotension
Clinical narrative: ANXIETY; HYPOTENSION; DIZZINESS AND LIGHT HEADED; This spontaneous report received from a health care professional concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 anxiety, hypotension, and dizziness and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety, hypotension and dizziness and light headed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; 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. 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 bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad reaction. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Body temperature, Chills, Disturbance in attention
Clinical narrative: SLIGHTLY ESCALATED HEART RATE; ESCALATED BLOOD PRESSURE; SLIGHT LIGHTHEADEDNESS; CHANGE IN FINGER NAILS COLOR (DARK PINK/PURPLE); CHANGE IN FINGER COLOR (PALE); BLOOD SHOT EYES; TOUGH TO FOCUS; BACK PAIN; CHILLS; 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 pre-existing medical conditions included: The patient does not smoke weed. 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 slightly escalated heart rate, escalated blood pressure, slight lightheadedness, change in finger nails color (dark pink/purple), change in finger color (pale), blood shot eyes, tough to focus, back pain, and chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8, 98.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly escalated heart rate, and slight lightheadedness, had not recovered from tough to focus, and chills, and the outcome of blood shot eyes, change in finger color (pale), change in finger nails color (dark pink/purple), back pain and escalated blood pressure was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Nail discolouration, Ocular hyperaemia, Pallor
Clinical narrative: SLIGHTLY ESCALATED HEART RATE; ESCALATED BLOOD PRESSURE; SLIGHT LIGHTHEADEDNESS; CHANGE IN FINGER NAILS COLOR (DARK PINK/PURPLE); CHANGE IN FINGER COLOR (PALE); BLOOD SHOT EYES; TOUGH TO FOCUS; BACK PAIN; CHILLS; 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 pre-existing medical conditions included: The patient does not smoke weed. 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 slightly escalated heart rate, escalated blood pressure, slight lightheadedness, change in finger nails color (dark pink/purple), change in finger color (pale), blood shot eyes, tough to focus, back pain, and chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8, 98.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly escalated heart rate, and slight lightheadedness, had not recovered from tough to focus, and chills, and the outcome of blood shot eyes, change in finger color (pale), change in finger nails color (dark pink/purple), back pain and escalated blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102 FEVER; This spontaneous report received from a consumer 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 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 102 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 102 fever. This report was non-serious. This case, from the same reporter is linked to 20210900975.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; THE VACCINE WAS OUT AND THEN PUT IN THE FRIDGE AND THEN OUT AGAIN "BEYOND THE 2 HOUR MARK" / INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced poor quality drug administered. On 30-AUG-2021, the patient experienced the vaccine was out and then put in the fridge and then out again "beyond the 2 hour mark" / incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality drug administered and the vaccine was out and then put in the fridge and then out again "beyond the 2 hour mark" / incorrect storage of drug was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USAGE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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: 043A21A, expiry: 19/SEP/2021) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-AUG-2021, the patient experienced out of specification product usage. On 31-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product usage and incorrect product storage was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Discomfort, Hypoaesthesia, Somnolence
Clinical narrative: LEFT SIDED FACE TO NECK NUMBNESS; FELT SLEEPY; LEFT SIDE OF FACE FELT HEAVY; FELT HEAVINESS ON LEFT EYE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: nut allergy, alcohol user, non smoker, and cortisone allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting, had no medical history and she was not taking any medication on a daily basis (that was prescribed by her doctor). The patient stated earlier that she had history of getting botox, had a really bad reaction to dissolvable stitches and allergic to Isothiazoline especially in the following surgical glue; any kind of adhesives, had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207N21N, expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included botulinum toxin type a. On AUG-2021, the patient experienced felt sleepy. On AUG-2021, the patient experienced left side of face felt heavy. On AUG-2021, the patient experienced felt heaviness on left eye. Treatment medications included: cyanocobalamin. On 20-AUG-2021, the patient experienced left sided face to neck numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sleepy, had not recovered from left sided face to neck numbness, and the outcome of left side of face felt heavy and felt heaviness on left eye was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Renal pain, Somnolence
Clinical narrative: GOT SLEEPY AND THEN FELL ASLEEP; HEART PALPITATIONS; KIDNEY PAIN; 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 30-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for kidney pain.  On 30-AUG-2021, the patient experienced got sleepy and then fell asleep. On 30-AUG-2021, the patient experienced heart palpitations. On 30-AUG-2021, the patient experienced kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got sleepy and then fell asleep, heart palpitations and kidney pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: FLARE OF POISON IVY RASH, ABOUT 2 WEEKS AFTER VACCINATION; This spontaneous report received from a health care professional concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's past medical history included: pituitary tumor, and concurrent conditions included: poison ivy rash. The patient was previously treated with methylprednisolone for poison ivy rash.  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 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-AUG-2021, the patient experienced flare of poison ivy rash, about 2 weeks after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare of poison ivy rash, about 2 weeks after vaccination. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Incorrect route of product administration, Injection site mass, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: PATIENT EXPERIENCED SOME COVID-19 SYMPTOMS BUT THE CALLER WAS NOT SURE WHAT THE SYMPTOMS WERE SPECIFICALLY; A HUGE BUBBLE FORMED AND WENT DOWN ON THE AREA ADMINISTERED ON THE LEFT LOWER FOREARM DESCRIBED AS ON THE TOPSIDE WITH THE PALM FACING UP DUE TO BEING ADMINISTERED INTRADERMALLY; ACCIDENTAL ADMINISTRATION OF THE JANSSEN COVID-19 VACCINE INTRADERMALLY; IMMEDIATE PAIN SORENESS AT THE INJECTION SITE AND COMPLAINED THAT THE NEEDLE HURT WHEN IT WAS INSERTED INTRADERMALLY; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intradermal, batch number: Unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUL-2019, Laboratory data included: COVID-19 antigen test (NR: not provided) positive. On 09-JUL-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative.  On 24-AUG-2021, the patient experienced a huge bubble formed and went down on the area administered on the left lower forearm described as on the topside with the palm facing up due to being administered intradermally. On 24-AUG-2021, the patient experienced accidental administration of the janssen covid-19 vaccine intradermally. On 24-AUG-2021, the patient experienced immediate pain soreness at the injection site and complained that the needle hurt when it was inserted intradermally. On 25-AUG-2021, the patient experienced patient experienced some covid-19 symptoms but the caller was not sure what the symptoms were specifically. Laboratory data included: COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a huge bubble formed and went down on the area administered on the left lower forearm described as on the topside with the palm facing up due to being administered intradermally on 24-AUG-2021, had not recovered from immediate pain soreness at the injection site and complained that the needle hurt when it was inserted intradermally, and the outcome of accidental administration of the janssen covid-19 vaccine intradermally and patient experienced some covid-19 symptoms but the caller was not sure what the symptoms were specifically was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: ASYMPTOMATIC COVID-19; 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 not reported) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 31-AUG-2021, the patient experienced asymptomatic covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Dehydration, Hypokinesia
Clinical narrative: LOW BLOOD PRESSURE (USUALLY 120/80 WAS AT 90/60); WEAKNESS; DEHYDRATION; COULD NOT GET OFF THE FLOOR; SO SICK; VOMITING SO BAD; NAUSEA; FEVER; This spontaneous report received from a parent concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure (NR: not provided) 90/60 (units unspecified), 120/80 (units unspecified), and COVID-19 virus test (NR: not provided) Not reported. On 07-APR-2021, the patient experienced dehydration. On 07-APR-2021, the patient experienced could not get off the floor. On 07-APR-2021, the patient experienced so sick. On 07-APR-2021, the patient experienced vomiting so bad. On 07-APR-2021, the patient experienced nausea. On 07-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On an unspecified date, the patient experienced low blood pressure (usually 120/80 was at 90/60), and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration on MAY-2021, could not get off the floor, and vomiting so bad on 10-APR-2021, and so sick, nausea, fever, and weakness, and had not recovered from low blood pressure (usually 120/80 was at 90/60). This report was non-serious. This case, from the same reporter is linked to 20210901129 and 20210900297.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Malaise, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: LOW BLOOD PRESSURE (USUALLY 120/80 WAS AT 90/60); WEAKNESS; DEHYDRATION; COULD NOT GET OFF THE FLOOR; SO SICK; VOMITING SO BAD; NAUSEA; FEVER; This spontaneous report received from a parent concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure (NR: not provided) 90/60 (units unspecified), 120/80 (units unspecified), and COVID-19 virus test (NR: not provided) Not reported. On 07-APR-2021, the patient experienced dehydration. On 07-APR-2021, the patient experienced could not get off the floor. On 07-APR-2021, the patient experienced so sick. On 07-APR-2021, the patient experienced vomiting so bad. On 07-APR-2021, the patient experienced nausea. On 07-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On an unspecified date, the patient experienced low blood pressure (usually 120/80 was at 90/60), and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration on MAY-2021, could not get off the floor, and vomiting so bad on 10-APR-2021, and so sick, nausea, fever, and weakness, and had not recovered from low blood pressure (usually 120/80 was at 90/60). This report was non-serious. This case, from the same reporter is linked to 20210901129 and 20210900297.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: LOW BLOOD PRESSURE (USUALLY 120/80 WAS AT 90/60); WEAKNESS; DEHYDRATION; COULD NOT GET OFF THE FLOOR; SO SICK; VOMITING SO BAD; NAUSEA; FEVER; This spontaneous report received from a parent concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure (NR: not provided) 90/60 (units unspecified), 120/80 (units unspecified), and COVID-19 virus test (NR: not provided) Not reported. On 07-APR-2021, the patient experienced dehydration. On 07-APR-2021, the patient experienced could not get off the floor. On 07-APR-2021, the patient experienced so sick. On 07-APR-2021, the patient experienced vomiting so bad. On 07-APR-2021, the patient experienced nausea. On 07-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On an unspecified date, the patient experienced low blood pressure (usually 120/80 was at 90/60), and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration on MAY-2021, could not get off the floor, and vomiting so bad on 10-APR-2021, and so sick, nausea, fever, and weakness, and had not recovered from low blood pressure (usually 120/80 was at 90/60). This report was non-serious. This case, from the same reporter is linked to 20210901129 and 20210900297.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: LEFT ARM MAGNETIC; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced left arm magnetic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left arm magnetic was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SLIGHT TENDERNESS IN ARM LIKE ANY SHOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 slight tenderness in arm like any shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight tenderness in arm like any shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210900481.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Hypersomnia, Lethargy
Clinical narrative: SLEPT SO MUCH; CHILLS; HOT FLASHES; REALLY LETHARGIC; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20UB21A, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-AUG-2021, the patient experienced hot flashes. On 28-AUG-2021, the patient experienced really lethargic. On 28-AUG-2021, the patient experienced chills. On 30-AUG-2021, the patient experienced slept so much. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, really lethargic, slept so much, and chills on 31-AUG-2021. This report was non-serious.