chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Headache, Injection site pain
Clinical narrative: FEELING COLD; NAUSEA; HEADACHE; FATIGUE; INJECTION SITE SORENESS; TIRED; FEVER; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced injection site soreness. On 06-APR-2021, the subject experienced tired. On 06-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced nausea, and feeling cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, tired, nausea, headache, and feeling cold, fever on 07-APR-2021, and fatigue on 09-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: FEELING COLD; NAUSEA; HEADACHE; FATIGUE; INJECTION SITE SORENESS; TIRED; FEVER; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced injection site soreness. On 06-APR-2021, the subject experienced tired. On 06-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced nausea, and feeling cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, tired, nausea, headache, and feeling cold, fever on 07-APR-2021, and fatigue on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Medication error
Clinical narrative: MEDICATION ERROR; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 subject experienced medication error, and expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Platelet count decreased, Polymerase chain reaction, Respiratory viral panel
Clinical narrative: PLATELET COUNT WAS VERY LOW 20K; BRUISES; This spontaneous report received from a patient via a company representative 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, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 25-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 APR-2021, 3 weeks after the vaccine the patient experienced bruises. On 26-APR-2021, the patient experienced platelet count was very low 20k and was immediately advised to go to the hospital emergency room . She was given steroids at first and was tested covid positive in respiratory panel test so steroids were stopped. The patient had no other symptom. On 24-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. Laboratory data included: Blood test (NR: not provided) Platelet count very low 20k. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Has antibodies for covid, COVID-19 antigen test (NR: not provided) Negative, PCR (NR: not provided) Negative, and Respiratory viral panel (NR: not provided) Covid positive. Hematologist sent the patient home with low dose steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises and platelet count was very low 20k was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210457211-COVID-19 VACCINE AD26.COV2.S -platelet count very low. This event(s) is considered un assessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: PLATELET COUNT WAS VERY LOW 20K; BRUISES; This spontaneous report received from a patient via a company representative 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, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 25-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 APR-2021, 3 weeks after the vaccine the patient experienced bruises. On 26-APR-2021, the patient experienced platelet count was very low 20k and was immediately advised to go to the hospital emergency room . She was given steroids at first and was tested covid positive in respiratory panel test so steroids were stopped. The patient had no other symptom. On 24-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. Laboratory data included: Blood test (NR: not provided) Platelet count very low 20k. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Has antibodies for covid, COVID-19 antigen test (NR: not provided) Negative, PCR (NR: not provided) Negative, and Respiratory viral panel (NR: not provided) Covid positive. Hematologist sent the patient home with low dose steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises and platelet count was very low 20k was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210457211-COVID-19 VACCINE AD26.COV2.S -platelet count very low. This event(s) is considered un assessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN; This spontaneous report received from a consumer via an unspecified company representative concerned a male 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, 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 subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Gait disturbance, Headache, Muscle fatigue
Clinical narrative: LEGS ARE VERY TIRED; WEAKNESS IN BOTH LEG; PAIN IN BOTH LEG, BUT WORSE IN LEFT; HARDLY WALK; CHEST PAIN DURING NIGHT; HEADACHE; SOMETIMES DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sometimes difficulty breathing. On 08-APR-2021, the subject experienced chest pain during night. On 08-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced hardly walk. On 12-APR-2021, the subject experienced legs are very tired. On 12-APR-2021, the subject experienced weakness in both leg. On 12-APR-2021, the subject experienced pain in both leg, but worse in left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sometimes difficulty breathing on 09-APR-2021, and chest pain during night on 08-APR-2021, and had not recovered from headache, hardly walk, pain in both leg, but worse in left, legs are very tired, and weakness in both leg. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: LEGS ARE VERY TIRED; WEAKNESS IN BOTH LEG; PAIN IN BOTH LEG, BUT WORSE IN LEFT; HARDLY WALK; CHEST PAIN DURING NIGHT; HEADACHE; SOMETIMES DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sometimes difficulty breathing. On 08-APR-2021, the subject experienced chest pain during night. On 08-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced hardly walk. On 12-APR-2021, the subject experienced legs are very tired. On 12-APR-2021, the subject experienced weakness in both leg. On 12-APR-2021, the subject experienced pain in both leg, but worse in left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sometimes difficulty breathing on 09-APR-2021, and chest pain during night on 08-APR-2021, and had not recovered from headache, hardly walk, pain in both leg, but worse in left, legs are very tired, and weakness in both leg. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: PAIN; MUSCLE ACHE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced pain, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache and pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PAIN IN SHOULDER; ARM/DELTOID PAIN; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced arm/deltoid pain. On an unspecified date, the subject experienced pain in shoulder. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm/deltoid pain, and pain in shoulder. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a physician concerned a male 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, route of administration not reported, batch number: Unknown) frequency one total, 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.  The physician reported that on an unspecified date, the patient experienced clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210456400.; Sender's Comments: V0.20210457363-COVID-19 VACCINE AD26.COV2.S -Thrombosis. 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: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This spontaneous report received from a patient via an unspecified company representative concerned a male 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, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Tremor
Clinical narrative: SHAKING; SHIVERING; LINGERING MUSCLE ACHES; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced shaking. On 27-APR-2021, the subject experienced shivering. On 27-APR-2021, the subject experienced lingering muscle aches. On 27-APR-2021, the subject experienced tiredness. On 27-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, shivering, and headache on 27-APR-2021, and was recovering from lingering muscle aches, and tiredness. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: INCREASED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, and rheumatoid arthritis. 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 23-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced increased blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 190 unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased blood pressure. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Trismus
Clinical narrative: PAINFUL FACIAL SWELLING ON LEFT SIDE OF FACE; DIFFICULT TO OPEN MOUTH; SWELLING IS UNDERNEATH THE EAR LOBE, ON THE NECK AND JAWBONE; This spontaneous report received from a patient concerned a 78-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and phenobarbital and ciprofloxacin allergy. 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 28-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the subject experienced painful facial swelling on left side of face. On 28-APR-2021, the subject experienced difficult to open mouth. On 28-APR-2021, the subject experienced swelling is underneath the ear lobe, on the neck and jawbone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful facial swelling on left side of face, difficult to open mouth, and swelling is underneath the ear lobe, on the neck and jawbone. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product storage error was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: RAPID HEART RATE; HEADACHE; MUSCLE ACHE; FEVER; 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 non smoker, allergy to polyethylene glycol (peg), and thermerisol allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. 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: 206A21A, and batch number: 206A21A expiry: 06-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced rapid heart rate. On 28-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced muscle ache. On 28-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heart rate, headache, muscle ache, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: HIV test, Immune system disorder, Liver function test, Malaise, Platelet count
Clinical narrative: WHITE BLOOD CELL COUNT DECREASED; PLATELETS INCREASED; T-CELL COUNT DECREASED; SEVERE LOWER EXTREMITY RASH (PURPURA IN NATURE/NOT PRURITIC)ALL OVER HIS LOWER LEGS; SEVERE MALAISE; SOME TYPE OF IMMUNE EFFECT; This spontaneous report received from a physician concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive, and other pre-existing medical conditions included the patient was on antiviral therapy. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced some type of immune effect. On APR-2021, the subject experienced severe lower extremity rash (purpura in nature/not pruritic) all over his lower legs. On APR-2021, the subject experienced severe malaise. On 09-APR-2021, the subject experienced white blood cell count decreased. On 09-APR-2021, the subject experienced platelets increased. On 09-APR-2021, the subject experienced t-cell count decreased. Laboratory data included: Liver function test (NR: not provided) stable, no change, Platelet count (NR: not provided) baseline was 85, 000 which increased to 140, 000., T-lymphocyte count (NR: not provided) baseline was 600 and it decreased to 140, Urine analysis (NR: not provided) normal, Viral test (NR: not provided) viral load remains undetectable, and White blood cell count (NR: not provided) dropped by 50% - baseline was 3000 which decreased to 1500. Laboratory data (dates unspecified) included: HIV test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe lower extremity rash (purpura in nature/not pruritic)all over his lower legs, and the outcome of white blood cell count decreased, platelets increased, severe malaise, t-cell count decreased and some type of immune effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count increased, Purpura, T-lymphocyte count, T-lymphocyte count decreased, Urine analysis
Clinical narrative: WHITE BLOOD CELL COUNT DECREASED; PLATELETS INCREASED; T-CELL COUNT DECREASED; SEVERE LOWER EXTREMITY RASH (PURPURA IN NATURE/NOT PRURITIC)ALL OVER HIS LOWER LEGS; SEVERE MALAISE; SOME TYPE OF IMMUNE EFFECT; This spontaneous report received from a physician concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive, and other pre-existing medical conditions included the patient was on antiviral therapy. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced some type of immune effect. On APR-2021, the subject experienced severe lower extremity rash (purpura in nature/not pruritic) all over his lower legs. On APR-2021, the subject experienced severe malaise. On 09-APR-2021, the subject experienced white blood cell count decreased. On 09-APR-2021, the subject experienced platelets increased. On 09-APR-2021, the subject experienced t-cell count decreased. Laboratory data included: Liver function test (NR: not provided) stable, no change, Platelet count (NR: not provided) baseline was 85, 000 which increased to 140, 000., T-lymphocyte count (NR: not provided) baseline was 600 and it decreased to 140, Urine analysis (NR: not provided) normal, Viral test (NR: not provided) viral load remains undetectable, and White blood cell count (NR: not provided) dropped by 50% - baseline was 3000 which decreased to 1500. Laboratory data (dates unspecified) included: HIV test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe lower extremity rash (purpura in nature/not pruritic)all over his lower legs, and the outcome of white blood cell count decreased, platelets increased, severe malaise, t-cell count decreased and some type of immune effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Viral test, White blood cell count, White blood cell count decreased
Clinical narrative: WHITE BLOOD CELL COUNT DECREASED; PLATELETS INCREASED; T-CELL COUNT DECREASED; SEVERE LOWER EXTREMITY RASH (PURPURA IN NATURE/NOT PRURITIC)ALL OVER HIS LOWER LEGS; SEVERE MALAISE; SOME TYPE OF IMMUNE EFFECT; This spontaneous report received from a physician concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive, and other pre-existing medical conditions included the patient was on antiviral therapy. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced some type of immune effect. On APR-2021, the subject experienced severe lower extremity rash (purpura in nature/not pruritic) all over his lower legs. On APR-2021, the subject experienced severe malaise. On 09-APR-2021, the subject experienced white blood cell count decreased. On 09-APR-2021, the subject experienced platelets increased. On 09-APR-2021, the subject experienced t-cell count decreased. Laboratory data included: Liver function test (NR: not provided) stable, no change, Platelet count (NR: not provided) baseline was 85, 000 which increased to 140, 000., T-lymphocyte count (NR: not provided) baseline was 600 and it decreased to 140, Urine analysis (NR: not provided) normal, Viral test (NR: not provided) viral load remains undetectable, and White blood cell count (NR: not provided) dropped by 50% - baseline was 3000 which decreased to 1500. Laboratory data (dates unspecified) included: HIV test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe lower extremity rash (purpura in nature/not pruritic)all over his lower legs, and the outcome of white blood cell count decreased, platelets increased, severe malaise, t-cell count decreased and some type of immune effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Off label use
Clinical narrative: ADMINISTERED 1 HOUR PAST THE ALLOWED 6 HOURS STORAGE POST FIRST PUNCTURE; OFF LABEL USE; POTENTIALLY EXPIRED DRUG ADMINISTERED; This spontaneous report received from a pharmacist 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, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced administered 1 hour past the allowed 6 hours storage post first puncture. On 28-APR-2021, the subject experienced off label use. On 28-APR-2021, the subject experienced potentially expired drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 1 hour past the allowed 6 hours storage post first puncture, off label use and potentially expired drug administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 04-APR-2021. This report was non-serious. This case, from the same reporter is linked to
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pyrexia
Clinical narrative: REAL BACK PAIN; FEVER; This spontaneous report received from a consumer 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, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced real back pain. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and real back pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421426.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Antibody test
Clinical narrative: MILD REACTION TO VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, 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 subject experienced mild reaction to vaccine. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) antibodies from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild reaction to vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Pyrexia, Vomiting
Clinical narrative: VOMITING; UPSET STOMACH; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 28-APR-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 APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 104. On 29-APR-2021, the subject experienced vomiting. On 29-APR-2021, the subject experienced upset stomach. On 29-APR-2021, the subject experienced chills. Laboratory data included: Fever (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, vomiting and upset stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the subject experienced suspected immunological vaccine failure. Laboratory data included: Antibody test (NR: not provided) nonreactive result for 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 non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LITTLE LIGHTHEADED; This spontaneous report received from a patient via a company representative concerned an 83 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-APR-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 29-APR-2021, the subject experienced little lightheaded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little lightheaded. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE FOR A FEW DAYS/ LESS ENERGY THAN USUAL; This spontaneous report received from a consumer concerned a male 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue for a few days/ less energy than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue for a few days/ less energy than usual was not reported. This report was non-serious. This case, from the same reporter is linked to 20210458955.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: UNPLEASANT BUT NOT TOO BAD; PERSISTENT HEADACHE; SEVERE ACHE; SEVERE FEVER; This spontaneous report received from a patient concerned a male 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 28-APR-2021, the subject experienced severe ache. On 28-APR-2021, the subject experienced severe fever. On 29-APR-2021, the subject experienced unpleasant but not too bad. On 29-APR-2021, the subject experienced persistent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe ache, and severe fever on 29-APR-2021, had not recovered from persistent headache, and the outcome of unpleasant but not too bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: SORENESS; BACK ACHE; FEVER; 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 concurrent conditions included weed smoker. 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 requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced soreness, back ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, back ache, and fever. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: SEVERE MIGRAINE HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraines. On 29-APR-2021, the subject experienced severe migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe migraine headache was not reported. This report was non-serious.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS (FEVER, BODY ACHE, CHILLS); This spontaneous report received from a patient via a company representative concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease. 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu like symptoms (fever, body ache, chills). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms (fever, body ache, chills) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nodule, Pain in extremity
Clinical narrative: KNOT UNDER LEFT ARM; PAIN IN LEFT ARM; PAIN IN SHOULDER; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a male 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, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 15-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 15-MAR-2021, the subject experienced knot under left arm. On 15-MAR-2021, the subject experienced pain in left arm. On 15-MAR-2021, the subject experienced pain in shoulder. On 15-MAR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in left arm, terrible headache, pain in shoulder and knot under left arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Blood test, Chest pain, Dizziness
Clinical narrative: STOMACH ACHE; FEELS DISTORTED; DIZZINESS; BODY SWAYS; ACHES IN  BILATERAL THIGHS AND FRONT/BACK OF CALVES; MUSCLE ACHES; HEADACHES; TIRED; CHEST PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthy and not using any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced chest pain. On 28-APR-2021, the subject experienced stomach ache. On 28-APR-2021, the subject experienced feels distorted. On 28-APR-2021, the subject experienced dizziness. On 28-APR-2021, the subject experienced body sways. On 28-APR-2021, the subject experienced aches in bilateral thighs and front/back of calves. On 28-APR-2021, the subject experienced muscle aches. On 28-APR-2021, the subject experienced headaches. On 28-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets and d-dimer were normal, and ECG (NR: not provided) unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 17-APR-2021, had not recovered from muscle aches, headaches, feels distorted, body sways, and stomach ache, and the outcome of tired, aches in bilateral thighs and front/back of calves and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: STOMACH ACHE; FEELS DISTORTED; DIZZINESS; BODY SWAYS; ACHES IN  BILATERAL THIGHS AND FRONT/BACK OF CALVES; MUSCLE ACHES; HEADACHES; TIRED; CHEST PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthy and not using any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced chest pain. On 28-APR-2021, the subject experienced stomach ache. On 28-APR-2021, the subject experienced feels distorted. On 28-APR-2021, the subject experienced dizziness. On 28-APR-2021, the subject experienced body sways. On 28-APR-2021, the subject experienced aches in bilateral thighs and front/back of calves. On 28-APR-2021, the subject experienced muscle aches. On 28-APR-2021, the subject experienced headaches. On 28-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets and d-dimer were normal, and ECG (NR: not provided) unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 17-APR-2021, had not recovered from muscle aches, headaches, feels distorted, body sways, and stomach ache, and the outcome of tired, aches in bilateral thighs and front/back of calves and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: STOMACH ACHE; FEELS DISTORTED; DIZZINESS; BODY SWAYS; ACHES IN  BILATERAL THIGHS AND FRONT/BACK OF CALVES; MUSCLE ACHES; HEADACHES; TIRED; CHEST PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthy and not using any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced chest pain. On 28-APR-2021, the subject experienced stomach ache. On 28-APR-2021, the subject experienced feels distorted. On 28-APR-2021, the subject experienced dizziness. On 28-APR-2021, the subject experienced body sways. On 28-APR-2021, the subject experienced aches in bilateral thighs and front/back of calves. On 28-APR-2021, the subject experienced muscle aches. On 28-APR-2021, the subject experienced headaches. On 28-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets and d-dimer were normal, and ECG (NR: not provided) unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 17-APR-2021, had not recovered from muscle aches, headaches, feels distorted, body sways, and stomach ache, and the outcome of tired, aches in bilateral thighs and front/back of calves and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Malaise
Clinical narrative: DIZZINESS; TROUBLE WALKING; RUN DOWN; This spontaneous report received from a consumer 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced trouble walking. On APR-2021, the subject experienced run down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and trouble walking, and the outcome of run down was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Fatigue
Clinical narrative: SORE; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from sore, and tired on APR-2021. This report was non-serious.