chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEELING OF BEING DRUNK; This spontaneous report received from a consumer (husband of 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-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 patient had some mild symptoms and some strong symptoms but nothing awful as of yet. The patient experienced headaches, fatigue (suspected clinical vaccination failure and suspected covid-19 infection) and almost a feeling of being drunk. The patient was not consulted to any healthcare professional. The action taken with covid-19 vaccine was not applicable. The outcome of the feeling of being drunk, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210913267.; Sender's Comments: V0: 20210913259- covid-19 vaccine -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN ON THE SHOULDER (WHERE TOOK VACCINE); 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: Unk) 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 joint pain on the shoulder (where took vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain on the shoulder (where took vaccine) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling drunk, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: FEELING OF BEING DRUNK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes, and smoker. 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 09-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 patient had some mild symptoms and some strong symptoms but nothing awful as of yet. The patient experienced headaches, fatigue and almost a feeling of being drunk. He also felt tightness in chest and some shortness of breath. On 01-SEP-2021, the patient tested COVID-19 virus test which resulted positive (suspected clinical vaccination failure and suspected covid-19 infection). He was not consulted to any healthcare professional. He started taking unspecified flu and cold medication and ibuprofen as treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and feeling of being drunk was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210913259.; Sender's Comments: V0: 20210913267-COVID-19 VACCINE AD26.COV2.S - Suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: RETARDED; 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 retarded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of retarded was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: SAW BLACK SPOTS ALL AROUND; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: drinking wine. 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 saw black spots all around. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of saw black spots all around was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913090 and 20210912958.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: INCREASED NEED TO URINATE (CONDITION AGGRAVATED); This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: increased urination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 18-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced increased need to urinate (condition aggravated). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of increased need to urinate (condition aggravated) was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and 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: 041A21A, and expiry: 09-JAN-2023) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced covid-19 test positive. Laboratory data 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. This report was associated with product quality complaint 90000192454.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE WITH COVID; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 tested positive with covid. 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 tested positive with covid was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Contusion, Muscle twitching, Nodule
Clinical narrative: BURNING SENSATION IN LEFT LEG; ITCHING IN LEFT LEG; BRUISING IN LEFT LEG; TENDER TO THE TOUCH IN LEFT LEG; KNOT IN LEFT LEG; SELF DIAGNOSED BLOOD CLOT IN HER LEFT LEG BEHIND THE KNEE; SUSPECTED COVID-19 INFECTION; SWELLING IN BOTH LEGS; MUSCLE TWITCHES; CHILLS; TINY LITTLE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included: blood clots prior to getting the vaccine, and concurrent conditions included: marijuana smoker, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no medical history and none medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-AUG-2021 at 16:00 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced chills, tiny little fever, muscle twitches for two days and then patient was fine. On 03-SEP-2021, the patient experienced shortness of breathe, coughing, sore throat, extremely tired as symptoms of COVID-19 (suspected COVID-19 infection) and swelling in both legs. The patient has not had a COVID-19 test performed to clinically confirm the diagnosis.  On 06-SEP-2021, the patient noticed self diagnosed blood clot in her left leg behind the knee. The patient described it as burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg, and knot in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitches, chills, and tiny little fever on 15-AUG-2021, and had not recovered from suspected COVID-19 infection, swelling in both legs, self diagnosed blood clot in her left leg behind the knee, burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg and knot in left leg. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210830488.; Sender's Comments: V0:20210913595- covid-19 vaccine ad26.cov2.s-self diagnosed blood clot in her left leg behind the knee.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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Suspected COVID-19, Tenderness
Clinical narrative: BURNING SENSATION IN LEFT LEG; ITCHING IN LEFT LEG; BRUISING IN LEFT LEG; TENDER TO THE TOUCH IN LEFT LEG; KNOT IN LEFT LEG; SELF DIAGNOSED BLOOD CLOT IN HER LEFT LEG BEHIND THE KNEE; SUSPECTED COVID-19 INFECTION; SWELLING IN BOTH LEGS; MUSCLE TWITCHES; CHILLS; TINY LITTLE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included: blood clots prior to getting the vaccine, and concurrent conditions included: marijuana smoker, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no medical history and none medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-AUG-2021 at 16:00 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced chills, tiny little fever, muscle twitches for two days and then patient was fine. On 03-SEP-2021, the patient experienced shortness of breathe, coughing, sore throat, extremely tired as symptoms of COVID-19 (suspected COVID-19 infection) and swelling in both legs. The patient has not had a COVID-19 test performed to clinically confirm the diagnosis.  On 06-SEP-2021, the patient noticed self diagnosed blood clot in her left leg behind the knee. The patient described it as burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg, and knot in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitches, chills, and tiny little fever on 15-AUG-2021, and had not recovered from suspected COVID-19 infection, swelling in both legs, self diagnosed blood clot in her left leg behind the knee, burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg and knot in left leg. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210830488.; Sender's Comments: V0:20210913595- covid-19 vaccine ad26.cov2.s-self diagnosed blood clot in her left leg behind the knee.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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BURNING SENSATION IN LEFT LEG; ITCHING IN LEFT LEG; BRUISING IN LEFT LEG; TENDER TO THE TOUCH IN LEFT LEG; KNOT IN LEFT LEG; SELF DIAGNOSED BLOOD CLOT IN HER LEFT LEG BEHIND THE KNEE; SUSPECTED COVID-19 INFECTION; SWELLING IN BOTH LEGS; MUSCLE TWITCHES; CHILLS; TINY LITTLE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included: blood clots prior to getting the vaccine, and concurrent conditions included: marijuana smoker, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no medical history and none medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-AUG-2021 at 16:00 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced chills, tiny little fever, muscle twitches for two days and then patient was fine. On 03-SEP-2021, the patient experienced shortness of breathe, coughing, sore throat, extremely tired as symptoms of COVID-19 (suspected COVID-19 infection) and swelling in both legs. The patient has not had a COVID-19 test performed to clinically confirm the diagnosis.  On 06-SEP-2021, the patient noticed self diagnosed blood clot in her left leg behind the knee. The patient described it as burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg, and knot in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitches, chills, and tiny little fever on 15-AUG-2021, and had not recovered from suspected COVID-19 infection, swelling in both legs, self diagnosed blood clot in her left leg behind the knee, burning sensation in left leg, itching in left leg, bruising in left leg, tender to the touch in left leg and knot in left leg. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210830488.; Sender's Comments: V0:20210913595- covid-19 vaccine ad26.cov2.s-self diagnosed blood clot in her left leg behind the knee.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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 39 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, and batch number were not reported) 1 total, dose was not reported approximately 4 months ago from date of report for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patient was diagnosed with COVID-19 through rapid antigen test and this was a breakthrough infection (suspected clinical vaccination failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000192472.; Sender's Comments: V0. 20210913849-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccine failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH DUE TO THE VACCINE; This spontaneous report received from a consumer concerned a 32 year old of unspecified 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 died due to the Johnson and Johnson vaccine. It was unknown 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: 20210914084-Covid-19 vaccine ad26.cov2.s-Death due to the  vaccine. 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
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Back pain, Chest discomfort, Dyspnoea, Electrocardiogram
Clinical narrative: CHEST TIGHTNESS; SHARP PAIN IN THE BACK BETWEEN HER SHOULDER BLADES; DIFFICULTY BREATHING; RAPID HEART BEAT; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa (hives) allergy, alcohol user (infrequently and just socially), and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced severe headache. On 30-AUG-2021, the patient experienced nausea. On 01-SEP-2021, the patient experienced chest tightness. On 01-SEP-2021, the patient experienced sharp pain in the back between her shoulder blades. On 01-SEP-2021, the patient experienced difficulty breathing. On 01-SEP-2021, the patient experienced rapid heart beat. On 04-SEP-2021, Laboratory data included: CT angiography (NR: not provided) no sign of heart attack or pulmonary embolism, Electrocardiogram (NR: not provided) no sign of heart attack or pulmonary embolism, and Laboratory test (NR: not provided) normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and nausea on 01-SEP-2021, and had not recovered from chest tightness, sharp pain in the back between her shoulder blades, difficulty breathing, and rapid heart beat. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Laboratory test, Nausea
Clinical narrative: CHEST TIGHTNESS; SHARP PAIN IN THE BACK BETWEEN HER SHOULDER BLADES; DIFFICULTY BREATHING; RAPID HEART BEAT; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa (hives) allergy, alcohol user (infrequently and just socially), and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced severe headache. On 30-AUG-2021, the patient experienced nausea. On 01-SEP-2021, the patient experienced chest tightness. On 01-SEP-2021, the patient experienced sharp pain in the back between her shoulder blades. On 01-SEP-2021, the patient experienced difficulty breathing. On 01-SEP-2021, the patient experienced rapid heart beat. On 04-SEP-2021, Laboratory data included: CT angiography (NR: not provided) no sign of heart attack or pulmonary embolism, Electrocardiogram (NR: not provided) no sign of heart attack or pulmonary embolism, and Laboratory test (NR: not provided) normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and nausea on 01-SEP-2021, and had not recovered from chest tightness, sharp pain in the back between her shoulder blades, difficulty breathing, and rapid heart beat. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Back pain, Blood test normal, Chest discomfort, Dyspnoea
Clinical narrative: CHEST TIGHTNESS; SHARP PAIN IN THE BACK BETWEEN HER SHOULDER BLADES; DIFFICULTY BREATHING; RAPID HEART BEAT; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa (hives) allergy, alcohol user (infrequently and just socially), and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced severe headache. On 30-AUG-2021, the patient experienced nausea. On 01-SEP-2021, the patient experienced chest tightness. On 01-SEP-2021, the patient experienced sharp pain in the back between her shoulder blades. On 01-SEP-2021, the patient experienced difficulty breathing. On 01-SEP-2021, the patient experienced rapid heart beat. On 04-SEP-2021, Laboratory data included: CT angiography (NR: not provided) no sign of heart attack or pulmonary embolism, Electrocardiogram (NR: not provided) no sign of heart attack or pulmonary embolism, and Laboratory test (NR: not provided) normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and nausea on 01-SEP-2021, and had not recovered from chest tightness, sharp pain in the back between her shoulder blades, difficulty breathing, and rapid heart beat. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Headache, Nausea, SARS-CoV-2 antibody test negative, Tachycardia
Clinical narrative: CHEST TIGHTNESS; SHARP PAIN IN THE BACK BETWEEN HER SHOULDER BLADES; DIFFICULTY BREATHING; RAPID HEART BEAT; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa (hives) allergy, alcohol user (infrequently and just socially), and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced severe headache. On 30-AUG-2021, the patient experienced nausea. On 01-SEP-2021, the patient experienced chest tightness. On 01-SEP-2021, the patient experienced sharp pain in the back between her shoulder blades. On 01-SEP-2021, the patient experienced difficulty breathing. On 01-SEP-2021, the patient experienced rapid heart beat. On 04-SEP-2021, Laboratory data included: CT angiography (NR: not provided) no sign of heart attack or pulmonary embolism, Electrocardiogram (NR: not provided) no sign of heart attack or pulmonary embolism, and Laboratory test (NR: not provided) normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and nausea on 01-SEP-2021, and had not recovered from chest tightness, sharp pain in the back between her shoulder blades, difficulty breathing, and rapid heart beat. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: FEELING WEAK; This spontaneous report received from a patient concerned a 68 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: 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 in AUG-2021, patient felt good but was hospitalized for feeling week. Patient mentioned that hospitalization was after receiving vaccine and it was due to being out in the sun. The number of days hospitalized was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling weak was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210915360-Covid-19 vaccine ad26.cov2.s-Feeling weak. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year old male of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, cholesterol, hepatitis c ( non transferable), non smoker, non alcohol user. Patient had allergies had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) 1 total, dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included Allegra M (fexofenadine hydrochloride/montelukast sodium) for allergy. On 25-AUG-2021, patient had antibody testing. The antibody tests he received were SARS COVID 2 antibody immunoglobulin M (IgM) and SARS COVID 2 antibody immunoglobulin G (IgG). His results came back 0 percent showing no antibodies present (Negative) (coded to confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210915503 - JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Paraesthesia, Pruritus
Clinical narrative: ITCHINESS OVER THE ENTIRE BODY; CHEST PAIN FELT LIKE PINS AND NEEDLES; PINS AND NEEDLES FEELING OVER THE LEFT SIDE OF THE BODY; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 08-SEP-2021 08:50 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced itchiness over the entire body. On 08-SEP-2021, the patient experienced chest pain felt like pins and needles. On 08-SEP-2021, the patient experienced pins and needles feeling over the left side of the body. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchiness over the entire body, pins and needles feeling over the left side of the body, and chest pain felt like pins and needles. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Speech disorder
Clinical narrative: SHORTNESS OF BREATH; CHEST TIGHTNESS; DIFFICULTY TO TALK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy, athletic and anti-vaxxer. 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-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ceftazidime for drug used for unknown indication.  On SEP-2021, the patient experienced shortness of breath. On SEP-2021, the patient experienced chest tightness. On SEP-2021, the patient experienced difficulty to talk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chest tightness, and difficulty to talk. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature decreased, Fatigue, Headache
Clinical narrative: TEMPERATURE LITTLE ON THE LOW SIDE; HEADACHE; FATIGUE; MUSCLE ACHES; This spontaneous report received from a consumer concerned an 80 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's past medical history included: infectious hepatitis as a child/teenager, and concurrent conditions included: non alcoholic, non smoker, hives with exposure to mosquito bites or certain foods (rarely), exposure to mosquito bites, and hives with exposure to certain foods (rarely), and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with acetylsalicylic acid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A /205AZ1A expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced fatigue/feeling very tired. On JUL-2021, the patient experienced muscle ache. On an unspecified date, the patient experienced temperature little on the low side, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Between 60 to 70 bpm, Body temperature (NR: not provided) Normal or a little on the low side, and Oxygen saturation (NR: not provided) 98 %. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fatigue, muscle aches, and headache, and the outcome of temperature little on the low side was not reported. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oxygen saturation
Clinical narrative: TEMPERATURE LITTLE ON THE LOW SIDE; HEADACHE; FATIGUE; MUSCLE ACHES; This spontaneous report received from a consumer concerned an 80 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's past medical history included: infectious hepatitis as a child/teenager, and concurrent conditions included: non alcoholic, non smoker, hives with exposure to mosquito bites or certain foods (rarely), exposure to mosquito bites, and hives with exposure to certain foods (rarely), and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with acetylsalicylic acid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A /205AZ1A expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced fatigue/feeling very tired. On JUL-2021, the patient experienced muscle ache. On an unspecified date, the patient experienced temperature little on the low side, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Between 60 to 70 bpm, Body temperature (NR: not provided) Normal or a little on the low side, and Oxygen saturation (NR: not provided) 98 %. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fatigue, muscle aches, and headache, and the outcome of temperature little on the low side was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED JANSSEN COVID 19 VACCINE DUE TO TEMPERATURE EXCURSTION; This spontaneous report received from a pharmacist concerned a 21 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: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the patient experienced administration of expired janssen covid 19 vaccine due to temperature excurstion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administration of expired janssen covid 19 vaccine due to temperature excurstion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915852, 20210915731, 20210916228, 20210916312, 20210916300, 20210916455, 20210916553, 20210916520, 20210916697, 20210916658, 20210915719, 20210915661, 20210916965, 20210917160, 20210915748, 20210916849, 20210916910, 20210916959, 20210915646, 20210916907, 20210916965, 20210916808, 20210916129, 20210916401, 20210916415, 20210916715, 20210916768, 20210916498, 20210916811, 20210917074, 20210917163, 20210917603, 20210916584, 20210917515, 20210917226, 20210917500, 20210913164 and 20210916465.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Organic erectile dysfunction
Clinical narrative: TIGHTNESS IN CHEST; SHORTNESS OF BREATH; DIZZINESS; SEVERE DECREASE IN SEXUAL PERFORMANCE; LACK OF MORNING ERECTIONS; FATIGUE; 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced shortness of breath. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced severe decrease in sexual performance. On AUG-2021, the patient experienced lack of morning erections. On AUG-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, tightness in chest, shortness of breath, dizziness, severe decrease in sexual performance and lack of morning erections was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sexual dysfunction
Clinical narrative: TIGHTNESS IN CHEST; SHORTNESS OF BREATH; DIZZINESS; SEVERE DECREASE IN SEXUAL PERFORMANCE; LACK OF MORNING ERECTIONS; FATIGUE; 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced shortness of breath. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced severe decrease in sexual performance. On AUG-2021, the patient experienced lack of morning erections. On AUG-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, tightness in chest, shortness of breath, dizziness, severe decrease in sexual performance and lack of morning erections was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED VACCINE DUE TO TEMPERATURE EXCURSTION; This spontaneous report received from a pharmacist concerned a 52 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: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 02-JUN-2021, the patient experienced administration of expired vaccine due to temperature excurstion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine due to temperature excurstion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915852, 20210915731, 20210916228, 20210916312, 20210916300, 20210916455, 20210916553, 20210916697, 20210915748, 20210916401, 20210916849, 20210916811, 20210915661, 20210916965, 20210916498, 20210916465, 20210916415, 20210916129, 20210916910, 20210915719, 20210917074, 20210916520, 20210916907, 20210916658, 20210916584, 20210916959, 20210917226, 20210916768, 20210917163, 20210915623, 20210913164, 20210917160, 20210917515, 20210917500, 20210917515 and 20210917603.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 61 year old male with unspecified race and ethnicity. Initial information was processed along with the additional information received on 06-SEP-2021. 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, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-AUG-2021, it was reported that the patient was tested positive for covid (suspected clinical vaccination failure and suspected covid-19 infection). The patient had sore throat, fever, body aches and chills for nearly a week. 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 product quality complaint: 90000192658.; Sender's Comments: V0: -20210915647 - covid-19 vaccine ad26.cov2 - 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Gait inability, Headache, Muscle spasms
Clinical narrative: TRAVELLED TO CHEST/CHEST SYMPTOMS/DIFFICULTY BREATHING (COULDN'T GET A DEEP BREATH); SEVERE HEADACHE (RESIDUAL HEADACHE STILL ONGOING); FEVER; OVERWHELMING BODY ACHES; COULD NOT WALK DUE TO EXCRUCIATING PAIN; WOKE UP EVERY 2 HOURS; CRAMPING IN LEFT FOOT(FELT LIKE A CHARLIE HORSE IN THE ARCH OF THE FOOT); PAIN IN LEFT FOOT(FELT LIKE A CHARLIE HORSE IN THE ARCH OF THE FOOT); This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 129 pounds, and height was 62 inches. The patient's concurrent conditions included: alcohol user, non-smoker, and antibiotic induced colitis, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient was previously treated with ergocalciferol for drug used for unknown indication; and experienced bad reaction to vaccine (gets the flu) when treated with influenza vaccine for prophylactic vaccination, and joints hurt/upper shoulder hurt when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, Z06AZ1A, expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 31-AUG-2021, the patient experienced overwhelming body aches. On 31-AUG-2021, the patient experienced could not walk due to excruciating pain. On 31-AUG-2021, the patient experienced woke up every 2 hours. On 31-AUG-2021, the patient experienced cramping in left foot (felt like a charlie horse in the arch of the foot). On 31-AUG-2021, the patient experienced pain in left foot (felt like a charlie horse in the arch of the foot). On SEP-2021, treatment medications included: paracetamol. On 01-SEP-2021, the patient experienced severe headache (residual headache still ongoing). On 01-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-SEP-2021, the patient experienced travelled to chest/chest symptoms/difficulty breathing (couldn't get a deep breath). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from overwhelming body aches, and could not walk due to excruciating pain, travelled to chest/chest symptoms/difficulty breathing (couldn't get a deep breath) on 07-SEP-2021, and fever on 03-SEP-2021, was recovering from pain in left foot(felt like a charlie horse in the arch of the foot), severe headache (residual headache still ongoing), and cramping in left foot(felt like a charlie horse in the arch of the foot), and the outcome of woke up every 2 hours was not reported. This report was non-serious.