chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fever and nausea to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient for herself. The age at vaccination was not reported. The patient received Fluarix vaccine about a year ago and developed fever and nausea. The patient had nothing else to report. The reporter refused to provide additional information because she already reported adverse event to her doctor last year.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, 1 total, 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. 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: 20211104021-Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Neurological examination
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a maleof an 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: 211A21A expiry: 14-DEC-2021) dose was not reported, 1 total, administered at right arm on 23-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-OCT-2021, the patient experienced general off feeling, headache and weakness were reported. On 25-OCT-2021, the patient started to feel partial paralysis in the right hand and leg and he went to work for a few hours and was sent home by employer. On 26-OCT-2021, the patient visited emergency room due to persistence of symptoms and he underwent through laboratory tests included blood tests, assessments for strength and motor skills and CAT (computerized axial tomography) scan performed results were not reported and he was admitted to the hospital along with this an MRI (magnetic resonance imaging) was performed. The next day, 27-OCT-2021, he got confirmation of a stroke had occurred. On 30-OCT-2021, the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered stroke.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211106356-COVID-19 VACCINE AD26.COV2.S-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Adrenal insufficiency, Chest pain, Computerised tomogram, Laboratory test, Lung disorder
Clinical narrative: SCAR TISSUE IN LUNGS; ADRENAL GLAND INSUFFICIENCY; SUSPECTED LUNG DISEASE; CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose and 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.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 in 2021, the patient had scar tissue in lungs and suspected lung disease. The patient underwent computed tomography (CAT) scan which was found to be abnormal and showed scar tissue in the lungs with lung disease suspected.  On an unspecified date, the patient had multiple symptoms of fatigue, nausea, chest pain and difficulty breathing. She had done multiple test and it revealed adrenal gland insufficiency due to steroid usage. She had started an oral medication for treatment of condition and felt like she was noticing improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from adrenal gland insufficiency, and chest pain, and the outcome of scar tissue in lungs and suspected lung disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20211108588 covid-19 vaccine ad26.cov2.s-scar tissue in lungs. 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). 20211108588 covid-19 vaccine ad26.cov2.s- adrenal gland insufficiency .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: CONMEDS-OTHER SUSPECT DRUGS
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary fibrosis
Clinical narrative: SCAR TISSUE IN LUNGS; ADRENAL GLAND INSUFFICIENCY; SUSPECTED LUNG DISEASE; CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose and 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.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 in 2021, the patient had scar tissue in lungs and suspected lung disease. The patient underwent computed tomography (CAT) scan which was found to be abnormal and showed scar tissue in the lungs with lung disease suspected.  On an unspecified date, the patient had multiple symptoms of fatigue, nausea, chest pain and difficulty breathing. She had done multiple test and it revealed adrenal gland insufficiency due to steroid usage. She had started an oral medication for treatment of condition and felt like she was noticing improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from adrenal gland insufficiency, and chest pain, and the outcome of scar tissue in lungs and suspected lung disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20211108588 covid-19 vaccine ad26.cov2.s-scar tissue in lungs. 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). 20211108588 covid-19 vaccine ad26.cov2.s- adrenal gland insufficiency .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: CONMEDS-OTHER SUSPECT DRUGS
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Cardiac valve disease, Cardiac valve vegetation, Cardiovascular evaluation, Death
Clinical narrative: SUCCUMBING; MYOCARDITIS; VEGETATION ON PULMONIC VALVE; VALVE DESTROYED; FLUID PERMEATED LUNGS; PERICARDIAL CENTESIS; DISSEMINATED INTRAVASCULAR COAGULATION; 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. The patient's pre-existing medical conditions included: The patient never had any health problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, 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, 10 days post vaccination patient experienced chest pain and performed cardiac workup which result came negative, a week later patient had same symptoms and performed cardiac workup which showed vegetation on pulmonic valve. On an unspecified date patient had surgery and valve was cultured with result negative for bacteria. It was reported that valve completely destroyed after one week and developed myocarditis, fluid permeated lungs and performed chest tubes, pericardial centesis (1.8 Liter), and thoracotomy. On an unspecified date, patient had disseminated intravascular coagulation (DIC). The patient went through four weeks of torture before succumbing. On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of succumbing on an unspecified date, had not recovered from vegetation on pulmonic valve, and valve destroyed, and the outcome of myocarditis, disseminated intravascular coagulation, pericardial centesis and fluid permeated lungs was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211104021.; Sender's Comments: V0: 20211110984-covid-19 vaccine ad26.cov2.s-myocarditis, succumbing, vegetation on pulmonic valve, valve destroyed, fluid permeated lungs, pericardial centesis, disseminated intravascular coagulation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Disseminated intravascular coagulation, Myocarditis, Pericardial effusion, Pleural effusion
Clinical narrative: SUCCUMBING; MYOCARDITIS; VEGETATION ON PULMONIC VALVE; VALVE DESTROYED; FLUID PERMEATED LUNGS; PERICARDIAL CENTESIS; DISSEMINATED INTRAVASCULAR COAGULATION; 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. The patient's pre-existing medical conditions included: The patient never had any health problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, 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, 10 days post vaccination patient experienced chest pain and performed cardiac workup which result came negative, a week later patient had same symptoms and performed cardiac workup which showed vegetation on pulmonic valve. On an unspecified date patient had surgery and valve was cultured with result negative for bacteria. It was reported that valve completely destroyed after one week and developed myocarditis, fluid permeated lungs and performed chest tubes, pericardial centesis (1.8 Liter), and thoracotomy. On an unspecified date, patient had disseminated intravascular coagulation (DIC). The patient went through four weeks of torture before succumbing. On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of succumbing on an unspecified date, had not recovered from vegetation on pulmonic valve, and valve destroyed, and the outcome of myocarditis, disseminated intravascular coagulation, pericardial centesis and fluid permeated lungs was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211104021.; Sender's Comments: V0: 20211110984-covid-19 vaccine ad26.cov2.s-myocarditis, succumbing, vegetation on pulmonic valve, valve destroyed, fluid permeated lungs, pericardial centesis, disseminated intravascular coagulation. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Deafness, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: FELT LIKE RUN OVER BY TRUCK; UNSTEADY; COMPLETELY LOST HEARING IN LEFT EAR; VERTIGO/SPINS; FELT SICK; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. The patient's past medical history included: low vitamin D, and concurrent conditions included: hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A and expiry: 19-SEP-2021) dose was not reported, 1 total administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient had completely lost hearing in left ear (hearing issue began in beginning of September), Woke up and couldn't hear well and had vertigo and had spins, unsteady (gave medicine for vertigo and spinning). Hearing is still gone. The hearing loss happened all of a sudden, woke up one day and hearing was gone. On 08-APR-2021, the patient experienced felt sick, low grade fever. On an unspecified date, the patient experienced felt like run over by truck. Laboratory data (dates unspecified) included: Vitamin D low. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo/spins, unsteady, felt sick and low grade fever on 11-APR-2021, had not recovered from completely lost hearing in left ear and the outcome of felt like run over by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114640-COVID-19 VACCINE AD26.COV2.S- completely lost hearing in left ear. This event is considered unassessable. The event 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vitamin D
Clinical narrative: FELT LIKE RUN OVER BY TRUCK; UNSTEADY; COMPLETELY LOST HEARING IN LEFT EAR; VERTIGO/SPINS; FELT SICK; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. The patient's past medical history included: low vitamin D, and concurrent conditions included: hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A and expiry: 19-SEP-2021) dose was not reported, 1 total administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient had completely lost hearing in left ear (hearing issue began in beginning of September), Woke up and couldn't hear well and had vertigo and had spins, unsteady (gave medicine for vertigo and spinning). Hearing is still gone. The hearing loss happened all of a sudden, woke up one day and hearing was gone. On 08-APR-2021, the patient experienced felt sick, low grade fever. On an unspecified date, the patient experienced felt like run over by truck. Laboratory data (dates unspecified) included: Vitamin D low. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo/spins, unsteady, felt sick and low grade fever on 11-APR-2021, had not recovered from completely lost hearing in left ear and the outcome of felt like run over by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114640-COVID-19 VACCINE AD26.COV2.S- completely lost hearing in left ear. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This spontaneous report received from a patient via a company representative through social media  concerned a patient of unspecified age, sex, race and ethnic origin.. 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 administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 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 stated that experienced pericarditis after got the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114655- COVID-19 VACCINE AD26.COV2.S- Pericarditis. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Femur fracture, Syncope
Clinical narrative: BROKE HER FEMUR; FAINTED; This spontaneous report received from a consumer via a company representative concerned a female patient of an unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient got vaccine and she fainted because of it and broke her femur. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted and broke her femur was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211115201.; Sender's Comments: V0: 20211114927-covid-19 vaccine ad26.cov2.s-broke her femur,  fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Injection site hypoaesthesia, Radiculitis brachial
Clinical narrative: VACCINE INDUCED BRACHIAL NEURITIS; NUMBNESS INJECTION SIDE FOREARM/PINKY/ IN DELTOID INJECTION SITE; 90 PERCENT STRENGTH LOSS HAND/ FINGERS/THUMB/LEFT ARM/ WRIST HAND DIGITS; 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. 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 vaccine induced brachial neuritis, numbness injection side forearm/pinky/ in deltoid injection site, and 90 percent strength loss hand/ fingers/thumb/left arm/ wrist hand digits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness injection side forearm/pinky/ in deltoid injection site, 90 percent strength loss hand/ fingers/thumb/left arm/ wrist hand digits, and vaccine induced brachial neuritis. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE FOR MONTHS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced migraine for months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine for months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211114927.; Sender's Comments: V0:  Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: POSSIBLE BLOOD CLOT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. 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, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter stated that on an unspecified date, the patient experienced possible blood clot but unsure if that was before or after the vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211115081, 20211115400 and 20211115414.; Sender's Comments: V0: 20211115315-covid-19 vaccine ad26.cov2.s-possible blood clot. This event(s) is considered unassessable. 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).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiovascular disorder, Dizziness, Paraesthesia, Physiotherapy
Clinical narrative: DIZZINESS; CIRCULATION PROBLEMS WITH FEET, HANDS AND KNEES; INCREASING NEED FOR PHYSIOTHERAPY; JOINT PAINS; FINGERS TINGLING; FAINTED ON THE INJECTION DAY; This spontaneous report received from a patient concerned a 62 year old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A expiry: unknown) dose was not reported, 01 total administered in left arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient fainted on the injection day. On an unspecified date, the patient had dizziness, circulation problems with feet, hands and knees, increasing need for physiotherapy, joint pains, and fingers tingling. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, circulation problems with feet, hands and knees, fingers tingling, joint pains, increasing need for physiotherapy and fainted on the injection day was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211116539-COVID-19 VACCINE AD26.COV2.S-fainted on the injection day. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: DIZZINESS; CIRCULATION PROBLEMS WITH FEET, HANDS AND KNEES; INCREASING NEED FOR PHYSIOTHERAPY; JOINT PAINS; FINGERS TINGLING; FAINTED ON THE INJECTION DAY; This spontaneous report received from a patient concerned a 62 year old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A expiry: unknown) dose was not reported, 01 total administered in left arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient fainted on the injection day. On an unspecified date, the patient had dizziness, circulation problems with feet, hands and knees, increasing need for physiotherapy, joint pains, and fingers tingling. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, circulation problems with feet, hands and knees, fingers tingling, joint pains, increasing need for physiotherapy and fainted on the injection day was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211116539-COVID-19 VACCINE AD26.COV2.S-fainted on the injection day. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: HEART ATTACK; HUGE BLOOD CLOTS; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, start therapy date were not reported, 01 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.  Consumer reported that on an unspecified date, the patient got the shot and shortly he was dead from a heart attack caused by huge blood clots of the size of a tennis ball. It was unknown if an autopsy was performed.    The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of heart attack and huge blood clots on an unspecified date. This report was serious (Death).; Sender's Comments: V0 20211116646-COVID-19 VACCINE AD26.COV2.S- Heart attack, huge blood clots. 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: HEART ATTACK; HUGE BLOOD CLOTS
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chest pain, Dysuria, Ear pain
Clinical narrative: COULD NOT WALK; PAIN IN EAR; PAIN IN ABDOMEN; PAIN IN NECK; DIFFICULTY URINATING; PAIN IN GROIN AREA; PINCHING SENSATION; PAIN IN CHEST; PAIN IN UPPER BACK; BURNING SENSATION WHEN URINATING; HEAVY LEFT SHOULDER; TINGLING SENSATION; THROBBING HEADACHE/ HEADACHE THAT DID NOT GO AWAY; 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 27-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 27-OCT-2021, the patient experienced could not walk. On 27-OCT-2021, the patient experienced pain in ear. On 27-OCT-2021, the patient experienced pain in abdomen. On 27-OCT-2021, the patient experienced pain in neck. On 27-OCT-2021, the patient experienced difficulty urinating. On 27-OCT-2021, the patient experienced pain in groin area. On 27-OCT-2021, the patient experienced pinching sensation. On 27-OCT-2021, the patient experienced pain in chest. On 27-OCT-2021, the patient experienced pain in upper back. On 27-OCT-2021, the patient experienced burning sensation when urinating. On 27-OCT-2021, the patient experienced heavy left shoulder. On 27-OCT-2021, the patient experienced tingling sensation. On 27-OCT-2021, the patient experienced throbbing headache/ headache that did not go away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation, could not walk, pain in ear, pain in abdomen, pain in neck, difficulty urinating, pain in groin area, pinching sensation, pain in chest, pain in upper back, burning sensation when urinating, throbbing headache/ headache that did not go away, and heavy left shoulder. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Groin pain, Headache, Limb discomfort, Neck pain
Clinical narrative: COULD NOT WALK; PAIN IN EAR; PAIN IN ABDOMEN; PAIN IN NECK; DIFFICULTY URINATING; PAIN IN GROIN AREA; PINCHING SENSATION; PAIN IN CHEST; PAIN IN UPPER BACK; BURNING SENSATION WHEN URINATING; HEAVY LEFT SHOULDER; TINGLING SENSATION; THROBBING HEADACHE/ HEADACHE THAT DID NOT GO AWAY; 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 27-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 27-OCT-2021, the patient experienced could not walk. On 27-OCT-2021, the patient experienced pain in ear. On 27-OCT-2021, the patient experienced pain in abdomen. On 27-OCT-2021, the patient experienced pain in neck. On 27-OCT-2021, the patient experienced difficulty urinating. On 27-OCT-2021, the patient experienced pain in groin area. On 27-OCT-2021, the patient experienced pinching sensation. On 27-OCT-2021, the patient experienced pain in chest. On 27-OCT-2021, the patient experienced pain in upper back. On 27-OCT-2021, the patient experienced burning sensation when urinating. On 27-OCT-2021, the patient experienced heavy left shoulder. On 27-OCT-2021, the patient experienced tingling sensation. On 27-OCT-2021, the patient experienced throbbing headache/ headache that did not go away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation, could not walk, pain in ear, pain in abdomen, pain in neck, difficulty urinating, pain in groin area, pinching sensation, pain in chest, pain in upper back, burning sensation when urinating, throbbing headache/ headache that did not go away, and heavy left shoulder. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: COULD NOT WALK; PAIN IN EAR; PAIN IN ABDOMEN; PAIN IN NECK; DIFFICULTY URINATING; PAIN IN GROIN AREA; PINCHING SENSATION; PAIN IN CHEST; PAIN IN UPPER BACK; BURNING SENSATION WHEN URINATING; HEAVY LEFT SHOULDER; TINGLING SENSATION; THROBBING HEADACHE/ HEADACHE THAT DID NOT GO AWAY; 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 27-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 27-OCT-2021, the patient experienced could not walk. On 27-OCT-2021, the patient experienced pain in ear. On 27-OCT-2021, the patient experienced pain in abdomen. On 27-OCT-2021, the patient experienced pain in neck. On 27-OCT-2021, the patient experienced difficulty urinating. On 27-OCT-2021, the patient experienced pain in groin area. On 27-OCT-2021, the patient experienced pinching sensation. On 27-OCT-2021, the patient experienced pain in chest. On 27-OCT-2021, the patient experienced pain in upper back. On 27-OCT-2021, the patient experienced burning sensation when urinating. On 27-OCT-2021, the patient experienced heavy left shoulder. On 27-OCT-2021, the patient experienced tingling sensation. On 27-OCT-2021, the patient experienced throbbing headache/ headache that did not go away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation, could not walk, pain in ear, pain in abdomen, pain in neck, difficulty urinating, pain in groin area, pinching sensation, pain in chest, pain in upper back, burning sensation when urinating, throbbing headache/ headache that did not go away, and heavy left shoulder. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous report received from a health care professional 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, and batch number were not reported) dose was not reported, administered on 01-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 21-SEP-2021, the patient experienced covid-19. 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 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Faeces discoloured, Malaise
Clinical narrative: LIGHT HEADED; DARK BLACK COLOR STOOL; FELT LIKE SICK; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-NOV-2021, the patient experienced dark black color stool. On 06-NOV-2021, the patient experienced light headed. On 06-NOV-2021, the patient experienced felt like sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headed, and the outcome of dark black color stool and felt like sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: BAD ADVERSE REACTION; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced bad adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad adverse reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Contusion, Fatigue
Clinical narrative: BRUISING ON FINGERS/ BRUISE MORE EASILY; VERY TIRED; STRANGE BLOOD VESSELS IN FINGERS; This spontaneous report received from a patient concerned a 70 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) 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 strange blood vessels in fingers, bruising on fingers/ bruise more easily, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very tired, and the outcome of bruising on fingers/ bruise more easily and strange blood vessels in fingers was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Retinal vascular thrombosis
Clinical narrative: BLOOD CLOT IN ONE EYE; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the patient experienced blood clot in one eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in one eye on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash erythematous
Clinical narrative: FEEL LIKE STIR FRIED CRUD TODAY; HUGE RED SPOT ON THE TOP OF HIS FOOT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-NOV-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 07-NOV-2021, the patient experienced feel like stir fried crud today. On 07-NOV-2021, the patient experienced huge red spot on the top of his foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like stir fried crud today and huge red spot on the top of his foot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POTENTIAL ADMINISTRATION ISSUE OF AN EXPIRED PUNCTURED JANSSEN COVID-19 VACCINE; 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, 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. No concomitant medications were reported. On an unspecified date, the patient experienced potential administration issue of an expired punctured janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration issue of an expired punctured janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Gait disturbance
Clinical narrative: RARE REACTION; LEARNING TO WALK AGAIN; This spontaneous report received from a consumer via a company representative concerned an 18 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 experienced rare reaction, and learning to walk again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rare reaction and learning to walk again was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received doses from vial after 30-day Use By Date.; Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from vial after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from vial after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from vial after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No adverse events reported for the patient.  On follow-up reporter stated that,The vaccines administered September 1 - October 12, 2021 from lot number 046C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccines administered October 13 - October 19, 2021 from lot number 046C21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration; however, some vaccine may have activity below the level studied in our clinical trials. The vaccines administered on or after October 20, 2021 from lot number 046C21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Information provided by reporter added in I-narrative. On 04-Nov-2021: Follow-up contains no new information.