chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
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 patient of unspecified age and sex. Initial information was processed along with the additional information received on 29-JUN-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: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The patient experienced confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184327.; Sender's Comments: V0:20210663851-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of reporting. 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, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  As of end of MAY-2021, the patient was tested for antibodies and no detectable antibodies to the spike protein present in the body which was reported as inadequate immune response (coded as confirmed immunological vaccine failure). Patient reported that ,she didn't experience any symptoms after the vaccination (no arm pain, fever, chills, etc.), so she was worried that she received an expired or inadequate product per the pharmacist. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) No detectable antibodies to the spike protein. 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: 20210663889- 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: SEVERE CHILLS; FEVER; MUSCLE PAIN; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's weight was not reported and height was 64 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced severe chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscle pain. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, fever, muscle pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210664040.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Underdose
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; PATIENT RECEIVED 0.15ML DOSE OF VACCINE (INCOMPLETE DOSE); OFF LABEL USE; This spontaneous report received from a physician concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) .15 ml, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 28-JUN-2021, the subject experienced subject received 0.15ml dose of vaccine (incomplete dose). On 28-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration, off label use and patient received 0.15ml dose of vaccine (incomplete dose) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female.  The patient's weight was not reported and height was 66 inches. 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female.  The patient's weight was not reported and height was 66 inches. 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the 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. This case, from the same reporter is linked to 20210664038.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac imaging procedure, Chest pain, Computerised tomogram head, Dizziness
Clinical narrative: FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate, Heart rate increased, Hypersensitivity
Clinical narrative: FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Magnetic resonance imaging, Malaise, Palpitations, Syncope
Clinical narrative: FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF IMPROPERLY STORED VACCINE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced administration of improperly stored vaccine. On 01-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of improperly stored vaccine and out of specification product use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE OUTSIDE EXCURSION REQUIREMENTS; VACCINE OUTSIDE EXCURSION TEMPERATURE 51F FOR 15 HOURS; This spontaneous report received from a health care professional 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, and batch number: 1821286 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administration of vaccine outside excursion requirements, and vaccine outside excursion temperature 51f for 15 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine outside excursion requirements and vaccine outside excursion temperature 51f for 15 hours was not reported. This report was non-serious. This report was associated with product quality complaint: 90000184262. The suspected product quality complaint has been confirmed to be voided (no PQC identified) based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: LACK OF EFFECTIVENESS; This spontaneous report received from a physician 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) 1 total, 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 lack of effectiveness with vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effectiveness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  20210664590-COVID-19 VACCINE AD26.COV2.S- lack of effectiveness. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: SLEEPING LOT; JOINT ACHES; CHILLS; HIVES; FEVER; EXTREME TIREDNESS; HEADACHE; MUSCLE ACHES; PAIN AT INJECTION SITE; ELEVATED HEART RATE; TIGHTNESS IN CHEST; TIGHTNESS IN JAW/TIGHTNESS IN BACK; 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 past medical history included thyroid issue, and chemical exposure, and concurrent conditions included no alcohol use, non smoker, penicillin allergy, and codeine allergy. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUN-2021, the subject experienced elevated heart rate. On 24-JUN-2021, the subject experienced tightness in chest. On 24-JUN-2021, the subject experienced tightness in jaw/tightness in back. On 24-JUN-2021, the subject experienced joint aches. On 24-JUN-2021, the subject experienced chills. On 24-JUN-2021, the subject experienced hives. On 24-JUN-2021, the subject experienced fever. On 24-JUN-2021, the subject experienced extreme tiredness. On 24-JUN-2021, the subject experienced headache. On 24-JUN-2021, the subject experienced muscle aches. On 24-JUN-2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced sleeping lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, headache, and muscle aches on 26-JUN-2021, had not recovered from elevated heart rate, extreme tiredness, tightness in chest, and tightness in jaw/tightness in back, and the outcome of pain at injection site, fever, chills, hives and sleeping lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersomnia, Injection site pain, Muscle tightness, Myalgia
Clinical narrative: SLEEPING LOT; JOINT ACHES; CHILLS; HIVES; FEVER; EXTREME TIREDNESS; HEADACHE; MUSCLE ACHES; PAIN AT INJECTION SITE; ELEVATED HEART RATE; TIGHTNESS IN CHEST; TIGHTNESS IN JAW/TIGHTNESS IN BACK; 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 past medical history included thyroid issue, and chemical exposure, and concurrent conditions included no alcohol use, non smoker, penicillin allergy, and codeine allergy. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUN-2021, the subject experienced elevated heart rate. On 24-JUN-2021, the subject experienced tightness in chest. On 24-JUN-2021, the subject experienced tightness in jaw/tightness in back. On 24-JUN-2021, the subject experienced joint aches. On 24-JUN-2021, the subject experienced chills. On 24-JUN-2021, the subject experienced hives. On 24-JUN-2021, the subject experienced fever. On 24-JUN-2021, the subject experienced extreme tiredness. On 24-JUN-2021, the subject experienced headache. On 24-JUN-2021, the subject experienced muscle aches. On 24-JUN-2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced sleeping lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, headache, and muscle aches on 26-JUN-2021, had not recovered from elevated heart rate, extreme tiredness, tightness in chest, and tightness in jaw/tightness in back, and the outcome of pain at injection site, fever, chills, hives and sleeping lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: SLEEPING LOT; JOINT ACHES; CHILLS; HIVES; FEVER; EXTREME TIREDNESS; HEADACHE; MUSCLE ACHES; PAIN AT INJECTION SITE; ELEVATED HEART RATE; TIGHTNESS IN CHEST; TIGHTNESS IN JAW/TIGHTNESS IN BACK; 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 past medical history included thyroid issue, and chemical exposure, and concurrent conditions included no alcohol use, non smoker, penicillin allergy, and codeine allergy. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUN-2021, the subject experienced elevated heart rate. On 24-JUN-2021, the subject experienced tightness in chest. On 24-JUN-2021, the subject experienced tightness in jaw/tightness in back. On 24-JUN-2021, the subject experienced joint aches. On 24-JUN-2021, the subject experienced chills. On 24-JUN-2021, the subject experienced hives. On 24-JUN-2021, the subject experienced fever. On 24-JUN-2021, the subject experienced extreme tiredness. On 24-JUN-2021, the subject experienced headache. On 24-JUN-2021, the subject experienced muscle aches. On 24-JUN-2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced sleeping lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, headache, and muscle aches on 26-JUN-2021, had not recovered from elevated heart rate, extreme tiredness, tightness in chest, and tightness in jaw/tightness in back, and the outcome of pain at injection site, fever, chills, hives and sleeping lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Dizziness, Headache, Nasopharyngitis
Clinical narrative: BRUISING TO RIGHT ARM; LIGHT HEADEDNESS; COLD; GETS REALLY SLEEPY; RIGHT SIDE OF BACK HURTING; SLIGHT PAIN TO RIGHT ARM; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and the patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced bruising to right arm. On 28-JUN-2021, the subject experienced light headedness. On 28-JUN-2021, the subject experienced cold. On 28-JUN-2021, the subject experienced gets really sleepy. On 28-JUN-2021, the subject experienced right side of back hurting. On 28-JUN-2021, the subject experienced slight pain to right arm. On 28-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, cold, gets really sleepy, and headache on 28-JUN-2021, and had not recovered from bruising to right arm, right side of back hurting, and slight pain to right arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: BRUISING TO RIGHT ARM; LIGHT HEADEDNESS; COLD; GETS REALLY SLEEPY; RIGHT SIDE OF BACK HURTING; SLIGHT PAIN TO RIGHT ARM; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and the patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced bruising to right arm. On 28-JUN-2021, the subject experienced light headedness. On 28-JUN-2021, the subject experienced cold. On 28-JUN-2021, the subject experienced gets really sleepy. On 28-JUN-2021, the subject experienced right side of back hurting. On 28-JUN-2021, the subject experienced slight pain to right arm. On 28-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, cold, gets really sleepy, and headache on 28-JUN-2021, and had not recovered from bruising to right arm, right side of back hurting, and slight pain to right arm. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Echocardiogram, Electrocardiogram normal, Troponin increased
Clinical narrative: Chest pain and weakness on evening of 7/1/21 after working for 8 hours and while taking a bath. Chest pain worsened and went to ER.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myoclonus, Tachycardia
Clinical narrative: Mycolonus and elevated heart rate/tachycardia 8-weeks following vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-JUN-2021, the patient did an antibody test and was found to have no antibodies (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality control number 90000184461.  Initial information was received on 28-JUN-2021, with additional information received from Complaint Organization on 29-JUN-2021. The following information was updated and incorporated into the case narrative: The PQC (Product quality complaint) identification number added and updated in the narrative.; Sender's Comments: V0: 20210665173-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: DEVELOPED PSORIASIS PATCHES ALL OVER BODY, MOSTLY ON LEGS AND BACK SHORTLY AFTER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis vulgaris. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. Non-company suspect drugs included: risankizumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) 75 mg, frequency was not reported, from 17-MAR-2021 for psoriasis vulgaris. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included hydrochlorothiazide/losartan potassium, lovastatin, tadalafil, and vitamin d nos. On APR-2021, the subject experienced developed psoriasis patches all over body, mostly on legs and back shortly after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from developed psoriasis patches all over body, mostly on legs and back shortly after on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Sneezing
Clinical narrative: SNEEZING; DRY COUGHING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not been infected with Covid in the past. 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 sneezing, and dry coughing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing, and dry coughing. This report was non-serious. This case, from the same reporter is linked to 20210661153.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: VOMITING; SEVERE FEVER; MYALGIA; This solicited report received from a physician concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient's initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported and expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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's experienced vomiting, severe fever, and myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe fever, vomiting and myalgia was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and vomiting, severe fever, and myalgia as related. Company causality between covid-19 vaccine ad26.cov2.s, and vomiting was not related and related for severe fever and myalgia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210666118-COVID-19 VACCINE AD26.COV2.S- vomiting. This event(s) is considered not related. 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). 20210666118-COVID-19 VACCINE AD26.COV2.S-severe fever, and myalgia. This event(s) is labeled and is therefore considered potentially related.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Neck pain, Pain, Rhinorrhoea
Clinical narrative: ACHINESS ALL OVER THE BODY LIKE FLU; RUNNY NOSE; NECK PAIN; BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 65 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, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced achiness all over the body like flu. On 29-JUN-2021, the subject experienced runny nose. On 29-JUN-2021, the subject experienced neck pain. On 29-JUN-2021, the subject experienced back pain. On 29-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from achiness all over the body like flu, runny nose, neck pain, and back pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; SICK; LOW GRADE FEVER; HEADACHES; SHOT HURT LIKE HELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 subject experienced body aches, sick, low grade fever, headaches, and shot hurt bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sick, low grade fever, headaches, and shot hurt bad. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a Business partner (Pfizer Inc.) on 25-JUN-2021 concerned three patients of unspecified age and gender. 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 date: unknown) dose was not reported, 1 total, start therapy date was 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, three patients were developed blood clot after vaccination. The patient died from blood clots on an unspecified date. 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: V0:20210666397-Covid-19 vaccine ad26.cov2.s -Blood clots. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Ear discomfort, Head discomfort
Clinical narrative: PRESSURE IN HEAD; PRESSURE AND RINGING IN EARS; LOWER BACK PAIN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-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 MAR-2021, the subject experienced pressure and ringing in ears. On MAR-2021, the subject experienced lower back pain. On 29-MAR-2021, the subject experienced pressure in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in head, pressure and ringing in ears, and lower back pain. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Drainage, Dry throat, Hot flush
Clinical narrative: CHEST PAIN; DRAINAGE; COTTON BALL FEELING IN THROAT; HOT FLASHES; NECK PAIN; BACK PAIN; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no any relevant medical history, concurrent medical condition, no allergies to medications, food, or other products, patient was not previously diagnosed with covid-19, had not received any vaccines within 4 weeks prior to the covid vaccine and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EP7533, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 09:30 for prophylactic vaccination. Concomitant medications included bifidobacterium lactis, cyanocobalamin, and ergocalciferol.  On 06-APR-2021, the subject experienced chest pain. On 06-APR-2021, the subject experienced drainage. On 06-APR-2021, the subject experienced cotton ball feeling in throat. On 06-APR-2021, the subject experienced hot flashes. On 06-APR-2021, the subject experienced neck pain. On 06-APR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain, drainage, cotton ball feeling in throat, hot flashes, neck pain, and back pain. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: CHEST PAIN; DRAINAGE; COTTON BALL FEELING IN THROAT; HOT FLASHES; NECK PAIN; BACK PAIN; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no any relevant medical history, concurrent medical condition, no allergies to medications, food, or other products, patient was not previously diagnosed with covid-19, had not received any vaccines within 4 weeks prior to the covid vaccine and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EP7533, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 09:30 for prophylactic vaccination. Concomitant medications included bifidobacterium lactis, cyanocobalamin, and ergocalciferol.  On 06-APR-2021, the subject experienced chest pain. On 06-APR-2021, the subject experienced drainage. On 06-APR-2021, the subject experienced cotton ball feeling in throat. On 06-APR-2021, the subject experienced hot flashes. On 06-APR-2021, the subject experienced neck pain. On 06-APR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain, drainage, cotton ball feeling in throat, hot flashes, neck pain, and back pain. This report was non-serious.