chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; CHILLS; GRADUALLY INCREASING FEVER; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, high blood pressure (controlled), high cholesterol (controlled), non alcohol user, and non smoker. The patient 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, and batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, 1 total administered to left arm on 11-AUG-2021 09:00AM for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, 12 hours after vaccination at 09:00pm, the patient experienced a gradually increasing fever and at 10:00pm it was at 102.5 degrees Fahrenheit. The patient took Tylenol which did not work till 2:00 am but after that the temperature went down. The patient also experienced chills but had no headache or aches. On 01-OCT-2021. the patient had an antibody test (serology test) through his allergist and it was a SARS-CoV2 IgG (severe acute respiratory syndrome coronavirus 2 immunoglobulin G) Nucleocap and IgM (Immunoglobulin M) Spike QL. The results were ready in 24 hours and showed antibody IgG negative and antibody IgM negative (confirmed immunological vaccine failure). The patient was concerned that he may not be protected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and gradually increasing fever on 12-AUG-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a Product Quality Complaint.; Sender's Comments: V0: 20211018382-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 antibody 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 57 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: 1820095, expiry: 02-OCT-2021) dose was not reported, 1 total administered to left arm on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient tested positive for covid-19 infection using rapid SARS covid antigen test (suspected covid-19 infection, suspected clinical vaccination failure). On OCT-2021, in between the time, the patient was tested and the time he tested positive for covid, he did undergo some blood work for which the results were not reported. The patient contracted covid-19 greater than 28 days post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000196859.; Sender's Comments: V0 20211018511-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: INCORRECT ROUTE OF DRUG ADMINISTRATION (VACCINE WAS GIVEN SUBCUTANEOUS AND NOT INTRAMUSCULAR); OFF LABEL USE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced incorrect route of drug administration (vaccine was given subcutaneous and not intramuscular). On 08-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect route of drug administration (vaccine was given subcutaneous and not intramuscular) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018346.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Laboratory test, Neck pain
Clinical narrative: FUNNY CHEST PAIN; PAIN ON NECK VEINS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported expiry: 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 funny chest pain, and pain on neck veins. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and pain on neck veins. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: MUSCLES FEEL LIKE JOINT PAIN; MILD HEADACHE; MUSCLE ACHES/SORENESS AT THE CALVES, QUADS AND RIGHT ELBOW (INTERMITTENTLY); EXTREME FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: radical cystectomy, and hysterectomy, and concurrent conditions included: non-alcohol user, non-smoker, penicillin allergy, sulfa allergy, and high grade bladder cancer, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-OCT-2021, the patient experienced muscles feel like joint pain, mild headache, muscle aches/soreness at the calves, quads and right elbow (intermittently), and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue on 04-OCT-2021, and had not recovered from mild headache, muscle aches/soreness at the calves, quads and right elbow (intermittently), and muscles feel like joint pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT (POSITIVE EFFECT OF NOT EXPERIENCING HAY FEVER ALLERGY SYMPTOMS, NO ITCHY WATER EYES, ITCHY THROAT, NOSE STUFFINESS); VERY LATE ONSET OF SNEEZING (DELAYED AND MILD); This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use occasionally, non-smoker, and ragweed allergy (suffers hay fever symptoms of stuffy nose, itchy watery eyes, sore throat, sneezing yearly), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient was previously treated with chlorphenamine maleate for ragweed allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced very late onset of sneezing (delayed and mild). On an unspecified date, the patient experienced unexpected therapeutic benefit (positive effect of not experiencing hay fever allergy symptoms, no itchy water eyes, itchy throat, nose stuffiness). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very late onset of sneezing (delayed and mild), and the outcome of unexpected therapeutic benefit (positive effect of not experiencing hay fever allergy symptoms, no itchy water eyes, itchy throat, nose stuffiness) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED DOSE; This spontaneous report received from a health care professional concerned a 46 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, intramuscular, batch number: 204A21A, and expiry: 21-09-2021) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administered expired dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018746, 20211018754, 20211019478 and 20211006668.
Sex: U
Vaccine: COVID19
Symptoms: Petechiae, Vascular rupture
Clinical narrative: 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, 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 petechiae all over body, and blood vessels popping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the petechiae all over body and blood vessels popping was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Retching
Clinical narrative: NAUSEA; DIZZINESS; GAGING; SORE ARM AT INJECTION SITE FOR 5 DAYS; HEADACHE; This spontaneous report received from a consumer concerned a 49 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: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced gaging. On OCT-2021, the patient experienced sore arm at injection site for 5 days. On OCT-2021, the patient experienced headache. On 01-OCT-2021, the patient experienced dizziness. On 02-OCT-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site for 5 days on OCT-2021, was recovering from dizziness, had not recovered from nausea, and the outcome of headache and gaging was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Injection site swelling, Pyrexia
Clinical narrative: BACK PAINS; CHILLS; HIGH TEMPERATURE; SWELLING AT THE INJECTION SITE; 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, 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 back pains, chills, high temperature, and swelling at the injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) HIGH. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pains, chills, high temperature and swelling at the injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 19 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, intramuscular, batch number: 204A21A, and expiry: 21-SEP-2021) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668, 20211006371, 20211018789 and 20211009653.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; LOOKS TERRIBLE; This spontaneous report received from a patient via a company representative concerned a male of an unspecified age and origin,. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known medical history. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on an unspecified date of SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, reporter stated that the patient was tested positive for Covid-19 polymerase chain reaction (PCR) (confirmed covid-19 infection), and she was unaware of his symptoms (suspected clinical vaccination failure) however she said that patient was not feeling well and looks terrible. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, looks terrible and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196854.; Sender's Comments: V0:20211018993-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
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: CONGESTION; RUNNY NOSE; COUGH; BODY ACHES; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 130 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included carbamazepine for bipolar, and quetiapine fumarate for bipolar.  On an unspecified date, the patient experienced congestion, runny nose, cough, body aches, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, congestion, runny nose, cough, fatigue and body aches was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: CONGESTION; RUNNY NOSE; COUGH; BODY ACHES; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 130 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included carbamazepine for bipolar, and quetiapine fumarate for bipolar.  On an unspecified date, the patient experienced congestion, runny nose, cough, body aches, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, congestion, runny nose, cough, fatigue and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disturbance in attention, Facial pain, Feeling abnormal, Fibrin D dimer
Clinical narrative: FACIAL PRESSURE; LOSS OF APPETITE; COULD NOT FOCUS; LUMP AT INJECTION SITE; SIGNIFICANT MOOD CHANGE; DOES NOT FEEL LIKE HER SELF / POKING FEELING ALL OVER BODY AT DIFFERENT TIMES; PAIN IN LEG; TINGLING FEELING; REDNESS AT INJECTION SITE; SEVERE MUSCLE PAIN; LOOKS LIKE TOO MUCH LIQUID IN THE SYRINGE MORE THAN 0.5 ML; This spontaneous report received from a patient concerned a 38 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: 1808982, expiry: 21-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 looks like too much liquid in the syringe more than 0.5 ml. On SEP-2021, the patient experienced facial pressure, loss of appetite, could not focus, lump at injection site, significant mood change, does not feel like her self / poking feeling all over body at different times, pain in leg, tingling feeling, redness at injection site, and severe muscle pain. Laboratory data included: Fibrin D dimer (NR: not provided) level was okay and not found clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial pressure, significant mood change, and does not feel like her self / poking feeling all over body at different times, and the outcome of loss of appetite, severe muscle pain, tingling feeling, pain in leg, could not focus, lump at injection site, redness at injection site and looks like too much liquid in the syringe more than 0.5 ml was not reported. This report was non-serious. This report is associated with product quality complaint: 90000196873.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site erythema, Injection site mass, Mood altered, Myalgia
Clinical narrative: FACIAL PRESSURE; LOSS OF APPETITE; COULD NOT FOCUS; LUMP AT INJECTION SITE; SIGNIFICANT MOOD CHANGE; DOES NOT FEEL LIKE HER SELF / POKING FEELING ALL OVER BODY AT DIFFERENT TIMES; PAIN IN LEG; TINGLING FEELING; REDNESS AT INJECTION SITE; SEVERE MUSCLE PAIN; LOOKS LIKE TOO MUCH LIQUID IN THE SYRINGE MORE THAN 0.5 ML; This spontaneous report received from a patient concerned a 38 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: 1808982, expiry: 21-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 looks like too much liquid in the syringe more than 0.5 ml. On SEP-2021, the patient experienced facial pressure, loss of appetite, could not focus, lump at injection site, significant mood change, does not feel like her self / poking feeling all over body at different times, pain in leg, tingling feeling, redness at injection site, and severe muscle pain. Laboratory data included: Fibrin D dimer (NR: not provided) level was okay and not found clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial pressure, significant mood change, and does not feel like her self / poking feeling all over body at different times, and the outcome of loss of appetite, severe muscle pain, tingling feeling, pain in leg, could not focus, lump at injection site, redness at injection site and looks like too much liquid in the syringe more than 0.5 ml was not reported. This report was non-serious. This report is associated with product quality complaint: 90000196873.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: FACIAL PRESSURE; LOSS OF APPETITE; COULD NOT FOCUS; LUMP AT INJECTION SITE; SIGNIFICANT MOOD CHANGE; DOES NOT FEEL LIKE HER SELF / POKING FEELING ALL OVER BODY AT DIFFERENT TIMES; PAIN IN LEG; TINGLING FEELING; REDNESS AT INJECTION SITE; SEVERE MUSCLE PAIN; LOOKS LIKE TOO MUCH LIQUID IN THE SYRINGE MORE THAN 0.5 ML; This spontaneous report received from a patient concerned a 38 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: 1808982, expiry: 21-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 looks like too much liquid in the syringe more than 0.5 ml. On SEP-2021, the patient experienced facial pressure, loss of appetite, could not focus, lump at injection site, significant mood change, does not feel like her self / poking feeling all over body at different times, pain in leg, tingling feeling, redness at injection site, and severe muscle pain. Laboratory data included: Fibrin D dimer (NR: not provided) level was okay and not found clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial pressure, significant mood change, and does not feel like her self / poking feeling all over body at different times, and the outcome of loss of appetite, severe muscle pain, tingling feeling, pain in leg, could not focus, lump at injection site, redness at injection site and looks like too much liquid in the syringe more than 0.5 ml was not reported. This report was non-serious. This report is associated with product quality complaint: 90000196873.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. 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 outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS FLARE-UP; This spontaneous report received from a patient via a company representative concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. 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. Concomitant medications included ustekinumab for psoriasis. On 15-SEP-2021, the patient experienced psoriasis flare-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of psoriasis flare-up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: METALLIC TASTE; SLIGHT HEADACHE; This spontaneous report received from a parent via a company representative concerned a 3 decade 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. 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 metallic taste, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, and slight headache. This report was non-serious. This case, from the same reporter is linked to 20211017006.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Dizziness, Fatigue
Clinical narrative: INCREASED BLOOD PRESSURE; CHEST PAIN; TUNNEL VISION; FAINTNESS; SHOOTING PAINS UNDER LEFT NIPPLE; HEAD IN THE CLOUDS; NOT MENTALLY CLEAR; TINGLING OF FINGERS; FATIGUE; HEADACHE; TINNITUS; HEAD RUSH; DIZZINESS; This spontaneous report received from a patient concerned a 51 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: egg allergy. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 29-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced dizziness, head rush, tinnitus and headache. On 30-SEP-2021, the patient experienced tunnel vision, faintness, chest pain, shooting pains under left nipple, head in the clouds, not mentally clear, tingling of fingers and fatigue. On 04-OCT-2021, the patient experienced increased blood pressure. The patient stated that he was seen at multiple urgent care facilities looking for steroids for tinnitus but was denied steroid prescription due to elevated blood pressure. Patient also stated that he found article on the internet that suggested steroid treatment for persistent tinnitus. The patient also attempted to self medicate with tylenol and OTC antihistamine but with no success. Laboratory data included: Blood pressure (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision, chest pain, shooting pains under left nipple, and tingling of fingers on 01-OCT-2021, and had not recovered from tinnitus, dizziness, headache, increased blood pressure, fatigue, head rush, head in the clouds, not mentally clear, and faintness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211020198-covid-19 vaccine ad26.cov2.-Tunnel vision, Faintness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache, Nipple pain, Paraesthesia
Clinical narrative: INCREASED BLOOD PRESSURE; CHEST PAIN; TUNNEL VISION; FAINTNESS; SHOOTING PAINS UNDER LEFT NIPPLE; HEAD IN THE CLOUDS; NOT MENTALLY CLEAR; TINGLING OF FINGERS; FATIGUE; HEADACHE; TINNITUS; HEAD RUSH; DIZZINESS; This spontaneous report received from a patient concerned a 51 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: egg allergy. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 29-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced dizziness, head rush, tinnitus and headache. On 30-SEP-2021, the patient experienced tunnel vision, faintness, chest pain, shooting pains under left nipple, head in the clouds, not mentally clear, tingling of fingers and fatigue. On 04-OCT-2021, the patient experienced increased blood pressure. The patient stated that he was seen at multiple urgent care facilities looking for steroids for tinnitus but was denied steroid prescription due to elevated blood pressure. Patient also stated that he found article on the internet that suggested steroid treatment for persistent tinnitus. The patient also attempted to self medicate with tylenol and OTC antihistamine but with no success. Laboratory data included: Blood pressure (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision, chest pain, shooting pains under left nipple, and tingling of fingers on 01-OCT-2021, and had not recovered from tinnitus, dizziness, headache, increased blood pressure, fatigue, head rush, head in the clouds, not mentally clear, and faintness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211020198-covid-19 vaccine ad26.cov2.-Tunnel vision, Faintness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Thinking abnormal, Tinnitus, Tunnel vision
Clinical narrative: INCREASED BLOOD PRESSURE; CHEST PAIN; TUNNEL VISION; FAINTNESS; SHOOTING PAINS UNDER LEFT NIPPLE; HEAD IN THE CLOUDS; NOT MENTALLY CLEAR; TINGLING OF FINGERS; FATIGUE; HEADACHE; TINNITUS; HEAD RUSH; DIZZINESS; This spontaneous report received from a patient concerned a 51 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: egg allergy. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 29-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced dizziness, head rush, tinnitus and headache. On 30-SEP-2021, the patient experienced tunnel vision, faintness, chest pain, shooting pains under left nipple, head in the clouds, not mentally clear, tingling of fingers and fatigue. On 04-OCT-2021, the patient experienced increased blood pressure. The patient stated that he was seen at multiple urgent care facilities looking for steroids for tinnitus but was denied steroid prescription due to elevated blood pressure. Patient also stated that he found article on the internet that suggested steroid treatment for persistent tinnitus. The patient also attempted to self medicate with tylenol and OTC antihistamine but with no success. Laboratory data included: Blood pressure (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision, chest pain, shooting pains under left nipple, and tingling of fingers on 01-OCT-2021, and had not recovered from tinnitus, dizziness, headache, increased blood pressure, fatigue, head rush, head in the clouds, not mentally clear, and faintness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211020198-covid-19 vaccine ad26.cov2.-Tunnel vision, Faintness. 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: Chest discomfort, Facial pain, Throat tightness
Clinical narrative: LEFT SIDE OF FACE STARTED HURTING; THROAT TIGHTENING; CHEST HAVING CONSTRICTION; 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 SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced left side of face started hurting. On SEP-2021, the patient experienced throat tightening. On SEP-2021, the patient experienced chest having constriction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left side of face started hurting, throat tightening and chest having constriction was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Stress
Clinical narrative: PERIPHERAL NEUROPATHY (MAINLY TINGLING AND SLIGHT LOSS OF SENSATION) IN BOTH FEET; VERY STRESSED; 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 pre-existing medical conditions included: The patient was not diabetic and never had diabetic. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 212A21A expiry: unknown) dose was not reported, administered 01 total to right arm on 24-SEP-2021 at 08:00 hours for prophylactic vaccination. No concomitant medications were reported. Patient reported that after 7 days of vaccination, on 30-SEP-2021, it appeared to her that she experienced peripheral neuropathy (mainly tingling and slight loss of sensation) in both feet. The onset was sudden at the 7 day mark after receiving the vaccine and the side effects continue, they were not getting any better. The patient stated that her podiatrist was the one that suspects peripheral neuropathy and referred her to the neurologist, the appointment to see the Neurologist was on 29-OCT-2021. The patient also stated that she had never experienced anything like this before. On an unspecified date in SEP-2021, the patient reported that she was very stressed. The patient also visited to physician office for the event peripheral neuropathy (mainly tingling and slight loss of sensation) in both feet. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peripheral neuropathy (mainly tingling and slight loss of sensation) in both feet, and the outcome of very stressed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211020241-covid-19 vaccine ad26.cov2.s -peripheral neuropathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH OF WOMAN IN MIDDLE AGE WITH CERTAIN BLOOD TYPE AFTER THE VACCINATION; This spontaneous report received from a consumer concerned a female of middle age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had the certain blood type. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death in her middle age with certain blood type after the vaccination. As per the reporter, "I only heard about one woman in her middle age with a certain blood type which resulted in death after receiving the Janssen Covid-19 vaccine." On an unspecified date, the patient died from unknown cause of death. Date of death were not reported. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211020266-covid-19 vaccine ad26.cov2.-Death of women in the middle age with certain blood type after the vaccination. 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: U
Vaccine: COVID19
Symptoms: Adverse event, Pain, Pain in extremity
Clinical narrative: BODY PAIN FOR LONG TIME AFTER SHOT; OTHER SYMPTOMS; FEEL SLIGHT PAIN ON RIGHT CALF AND CONSTANT PAIN ON LEFT CALF; 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 JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the patient experienced body pain for long time after shot. On JUN-2021, the patient experienced other symptoms. On JUN-2021, the patient experienced feel slight pain on right calf and constant pain on left calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel slight pain on right calf and constant pain on left calf, and the outcome of other symptoms and body pain for long time after shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fear, Heart rate irregular, Nervousness
Clinical narrative: HEART PAIN; RANDOM ERRATIC HEARTBEATS; EPISODES OF FEELING FAINT; WRECK; SCARED; HIVES EVERYWHERE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 08-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart pain. On OCT-2021, the patient experienced random erratic heartbeats. On OCT-2021, the patient experienced episodes of feeling faint. On OCT-2021, the patient experienced wreck. On OCT-2021, the patient experienced scared. On OCT-2021, the patient experienced hives everywhere. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives everywhere, heart pain, random erratic heartbeats, episodes of feeling faint, wreck and scared was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HEART PAIN; RANDOM ERRATIC HEARTBEATS; EPISODES OF FEELING FAINT; WRECK; SCARED; HIVES EVERYWHERE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 08-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart pain. On OCT-2021, the patient experienced random erratic heartbeats. On OCT-2021, the patient experienced episodes of feeling faint. On OCT-2021, the patient experienced wreck. On OCT-2021, the patient experienced scared. On OCT-2021, the patient experienced hives everywhere. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives everywhere, heart pain, random erratic heartbeats, episodes of feeling faint, wreck and scared was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: DEATH; MASSIVE HEART ATTACK; This spontaneous report received from a consumer via social media concerned a 5 decade old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was fit and active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. 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 (one week after vaccination), the patient experienced massive heart attack and died from an unknown cause. The consumer reported that "I have an employee whose dad a week after the J&J shot had a massive heart attack and died, he was late 40s and was fit and active". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0- 20211020424-covid-19 vaccine ad26.cov2.s-Death, Massive heart attack. 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SORE SHOULDER FOR ABOUT A WEEK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-MAR-2021, the patient experienced sore shoulder for about a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore shoulder for about a week on 15-MAR-2021. This report was non-serious.