chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia, Thrombosis
Clinical narrative: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA; This spontaneous report was received from literature with VITT following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. Blood advances. 29-SEP-2021. This report concerned multiple patients (3) of unspecified age, sex, race and ethnic origin. The objective of this literature was to describe vaccine-induced immune thrombotic thrombocytopenia (VITT) following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. No past medical history or concurrent conditions were reported. The patients (over 8.7 million) 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, 01 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 3 patients (11 percent) experienced vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia following vaccination. On an unspecified date, unfortunately the patients died. It was not specified whether patients autopsy were performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia on an unspecified date. The author commented that this literature highlighted the critical importance of knowing Covid-19 vaccine history. The author emphasized as on timely recognition that would be essential to prevent catastrophic complications and would require knowing the patient's vaccine history. This report was serious (Death). This case, from same literature article was linked to 20211004121 and 20211006771.; Sender's Comments: V0: 20211011609- COVID-19 VACCINE AD26.COV2.S- Vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eye swelling, Lip swelling, Mouth swelling, Swelling face
Clinical narrative: BELL'S PALSY; SWOLLEN LIPS; SWELLING INSIDE MOUTH; SWOLLEN FACE AND JAW; SWOLLEN LEFT AND RIGHT EYE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had allergies. 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 at left arm on15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-SEP-2021, the patient experienced her whole face and left eye was swollen and described it as total distortion. Her face was huge. she went to the doctor but doctor did not know what it was and thought it was allergic reaction so patient did some research and On an unspecified date, she thought she was having bell's palsy from the vaccine. They gave her shot and put her on steroids patient was fine after 24 to 36 hours. On 05-OCT-2021, patient experienced her face started to swell up again and also her right eyes was swollen. On 06-OCT-2021, the patient experienced swelling came down to her jaw, lips and inside of the mouth. swollen lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen face and jaw, swollen left and right eye, swollen lips, and swelling inside mouth, and the outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211011928-COVID-19 VACCINE AD26.COV2.S-bell's palsy, swollen face and jaw, swollen left and right eye. 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: Cerebral haemorrhage, Thrombosis
Clinical narrative: BLOOD CLOT; HEMORRHAGE IN BRAIN; 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 and expiry: Unknown) 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 was admitted to the hospital and on 22-SEP-2021, she was found to have a blood clot with hemorrhage in the brain. The reporter stated that the patient remained sedated by in stable condition but had at least three surgeries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and hemorrhage in brain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211014208-COVID-19 VACCINE AD26.COV2.S-blood clot, hemorrhage in brain. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; LITTLE ACHE-Y; LITTLE BIT OF A SORETHROAT; TIRED; This spontaneous report received from a patient concerned a 56 year old female of an unspecified ethnic origin. The patient's weight was 215 pounds, and height was 62 inches. The patient's past medical history included: heart attack, and transient ischaemic attack (TIA), and concurrent conditions included: non alcoholic, non smoker, and hypertension (HTN). The patient had no drug abuse or illicit usage. The patient experienced drug allergy when treated with acetylsalicylic acid (ASA) used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1437217 or 143A21A, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included statins and Plavix (clopidogrel bisulfate) for heart attack, and blood pressure medications for hypertension. On 07-APR-2021, the patient was tired, little ache-y and had a little bit of sore throat for about a week. On 08-SEP-2021, patient started feeling sick (tired, achy, sore throat)- covid-19 infection. On 12-SEP-2021, patient underwent a nasal swab test (COVID-19 virus test) which came positive and patient was clinically confirmed with COVID-19 diagnosis (suspected clinical vaccination failure). All of these symptoms had resolved but a little tiredness was persistent.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little ache-y, little bit of a sore throat and tired on APR-2021, was recovering from covid-19 infection- feeling sick (tired, achy, sore throat), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Sender's Comments: V0:20211014275-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; LITTLE ACHE-Y; LITTLE BIT OF A SORETHROAT; TIRED; This spontaneous report received from a patient concerned a 56 year old female of an unspecified ethnic origin. The patient's weight was 215 pounds, and height was 62 inches. The patient's past medical history included: heart attack, and transient ischaemic attack (TIA), and concurrent conditions included: non alcoholic, non smoker, and hypertension (HTN). The patient had no drug abuse or illicit usage. The patient experienced drug allergy when treated with acetylsalicylic acid (ASA) used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1437217 or 143A21A, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included statins and Plavix (clopidogrel bisulfate) for heart attack, and blood pressure medications for hypertension. On 07-APR-2021, the patient was tired, little ache-y and had a little bit of sore throat for about a week. On 08-SEP-2021, patient started feeling sick (tired, achy, sore throat)- covid-19 infection. On 12-SEP-2021, patient underwent a nasal swab test (COVID-19 virus test) which came positive and patient was clinically confirmed with COVID-19 diagnosis (suspected clinical vaccination failure). All of these symptoms had resolved but a little tiredness was persistent.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little ache-y, little bit of a sore throat and tired on APR-2021, was recovering from covid-19 infection- feeling sick (tired, achy, sore throat), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Sender's Comments: V0:20211014275-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, SARS-CoV-2 antibody test
Clinical narrative: LOW ANTIBODIES AGAINST COVID VIRUS; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 23-AUG-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced low antibodies against covid virus. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) 1.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation, Skin fissures, Skin haemorrhage, Skin reaction
Clinical narrative: HANDS PEELING; SALT WATER POOL CAUSED HANDS TO BLEED; HAD A PRETTY TERRIBLE EXPERIENCE WITH A BAD SKIN REACTION; HANDS CRACKING; RASH ON HANDS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not mention any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 185029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced hands peeling. On MAR-2021, the patient experienced salt water pool caused hands to bleed. On MAR-2021, the patient experienced had a pretty terrible experience with a bad skin reaction. On MAR-2021, the patient experienced hands cracking. On MAR-2021, the patient experienced rash on hands. Treatment medications (dates unspecified) included: mineral oil light/paraffin/petrolatum/wool alcohols. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a pretty terrible experience with a bad skin reaction, rash on hands, hands cracking, hands peeling and salt water pool caused hands to bleed was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thinking abnormal, Thrombosis
Clinical narrative: STROKE; BLOOD CLOT; OUT OF HIS GOURD; This spontaneous report received from a consumer concerned a 7 decade old male of an unspecified 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, batch number: unknown, expiry: unknown) dose were not reported, 1 total administered, 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 stroke, blood clot. As per reporter, patient was out of his gourd, but at the time of reporting patient was some what normal but patient would never be normal and also stated that the Janssen COVID-19 vaccine was 2 doses of mRNA. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot, stroke, and out of his gourd. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211014628 and 20211014552.; Sender's Comments: V0: 20211014652-covid-19 vaccine ad26.cov2.s-stroke, blood clot. 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: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 84 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart surgery. 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, 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.  On an unspecified date, the patient experienced suspected covid-19 infection (breakthrough infection), and suspected clinical vaccination failure, and was hospitalized (date and days unspecified). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The day before reporting the patient's lungs were clear and had no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product ra: 90000196454.; Sender's Comments: V0: 20211014653-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection. 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. 20211014653-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: RIGHT SIDE SWELLING BY RIB CAGE; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 1 right side swelling by rib cage (PT: swelling). The event occurred unknown days after COVID-19 vaccine  Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovering.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with 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.   On 20-JUL-2021, the subject experienced right side swelling by rib cage.   The outcome of erythema was recovering.  Investigator's causality assessment:  The event of swelling was not related to the study vaccine.  Company causality assessment: The event of swelling was not related to the study vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Concussion, Expired product administered, Head injury, Seizure
Clinical narrative: POSSIBLE CONCUSSION; EXPIRED VACCINE ADMINISTERED; SEIZURE; HIT HEAD REQUIRING STAPLES; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 22-MAR-2021) dose was not reported, 1 total, administered on 06-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, after vaccination, patient went to wait the 15 minutes in his car but came back into the pharmacy. The patient did not look good according to the technician who approached patient. Patient was began to speak then went down (passed out) and hit his head and did not seem to be breathing and one of the pharmacists went to give cardiopulmonary resuscitation (CPR) when patient gasped for air. Patient had labored breathing and had a seizure at that time for which he was taken to emergency room. It was stated that the patient was fine when he first came into the pharmacy to get the vaccine. On the same day, as per reporter, the patient and his mom came into the pharmacy and at that time patient did have some staples put into his head because he hit his head when he went down. Patient received expired vaccine on same day. On 07-OCT-2021, patient had a headache, nauseous and was resting. As per reporter, patient might have a concussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hit head requiring staples, and seizure, had not recovered from possible concussion, and the outcome of expired vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211015018-COVID-19 VACCINE AD26.COV2.S-Seizure. 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: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Seizure
Clinical narrative: POSSIBLE CONCUSSION; EXPIRED VACCINE ADMINISTERED; SEIZURE; HIT HEAD REQUIRING STAPLES; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 22-MAR-2021) dose was not reported, 1 total, administered on 06-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, after vaccination, patient went to wait the 15 minutes in his car but came back into the pharmacy. The patient did not look good according to the technician who approached patient. Patient was began to speak then went down (passed out) and hit his head and did not seem to be breathing and one of the pharmacists went to give cardiopulmonary resuscitation (CPR) when patient gasped for air. Patient had labored breathing and had a seizure at that time for which he was taken to emergency room. It was stated that the patient was fine when he first came into the pharmacy to get the vaccine. On the same day, as per reporter, the patient and his mom came into the pharmacy and at that time patient did have some staples put into his head because he hit his head when he went down. Patient received expired vaccine on same day. On 07-OCT-2021, patient had a headache, nauseous and was resting. As per reporter, patient might have a concussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hit head requiring staples, and seizure, had not recovered from possible concussion, and the outcome of expired vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211015018-COVID-19 VACCINE AD26.COV2.S-Seizure. 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: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Concussion, Expired product administered, Head injury, Seizure
Clinical narrative: HEADACHE; SEIZURES; BREATHING ISSUES; This spontaneous report received from a parent concerned a 23 year old white male of unknown ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: partial seizures, and concurrent conditions included: alcohol user, and smoker, and other pre-existing medical conditions included: No known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported,1 total administered on 06-OCT-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced seizures. The symptoms started within 5 minutes of receiving the vaccine. The patient fell backwards and it required 6 staples in his head and was non responsive for 3 minutes with his eyes open. He had headaches. The patient still has the staples and he pretty much stayed in bed through 07-OCT-2021. He finally got to rinse his head on 11-OCT-2021. He is back to normal as it appears. He had some breathing issue and was taken to the Emergency room (ER) and Doctor told that this happens when people were nervous (faint) and made it sound like it's an anxiety related reaction.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures, and breathing issues on 06-OCT-2021, and the outcome of headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211023292-covid-19 vaccine ad26.cov2.s -Seizures. 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: MEDICAL HISTORY
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Seizure
Clinical narrative: HEADACHE; SEIZURES; BREATHING ISSUES; This spontaneous report received from a parent concerned a 23 year old white male of unknown ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: partial seizures, and concurrent conditions included: alcohol user, and smoker, and other pre-existing medical conditions included: No known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported,1 total administered on 06-OCT-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced seizures. The symptoms started within 5 minutes of receiving the vaccine. The patient fell backwards and it required 6 staples in his head and was non responsive for 3 minutes with his eyes open. He had headaches. The patient still has the staples and he pretty much stayed in bed through 07-OCT-2021. He finally got to rinse his head on 11-OCT-2021. He is back to normal as it appears. He had some breathing issue and was taken to the Emergency room (ER) and Doctor told that this happens when people were nervous (faint) and made it sound like it's an anxiety related reaction.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures, and breathing issues on 06-OCT-2021, and the outcome of headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211023292-covid-19 vaccine ad26.cov2.s -Seizures. 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: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: HAVING UNDERLYING PNEUMONIA; This spontaneous report received from a health care professional concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: pulmonary arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, Expiry: Unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. Concomitant medications included Macitentan for pulmonary arterial hypertension. The batch number was not reported and has been requested. The patient was hospitalized (date unspecified) and having underlying pneumonia. She was unaware that having underlying pneumonia. She stated that had no side effects from the medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having underlying pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211015035-covid-19 vaccine ad26.cov2.s-having underlying pneumonia. 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous potential legal report received from a patient concerned a 53 year old white male of unspecified ethnic origin. 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 drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient felt very sick and went to a drive to get tested for COVID 19 test and results came back positive. The patient stated that he had horrific symptoms such as 105 Fahrenheit (F) fever for five days. The patient stated he was about to go to the hospital and his oxygen levels went down to 90 percent (confirmed covid-19 infection and confirmed clinical vaccination failure). As per the report, the patient had clinically confirmed COVID 19 infection more than 28 days post vaccination. Treatment medications included: Aleve (naproxen sodium).  As per the report, the patient felt little better however still was coughing. The patient was very upset and stated that the vaccine did not help him at all but made things worse for him. The patient mentioned that his friend who was not vaccinated was having less severe symptoms with COVID 19 than him. The patient was questioning about vaccine and said was it just water because it did not work at all. The patient stated as his physician was aware of his symptoms and was disturbed and told to the patient that he (physician) had been hearing lot of similar cases. The patient stated he was otherwise healthy,  and no health conditions, had no flu in 20 years. As per the report the patient stated that he did not want to give any additional information now until he speaks with his attorney. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number was requested.; Sender's Comments: V0:  20211015070-Covid-19 vaccine - confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: VACCINE EXPOSURE VIA BREAST FEEDING; This spontaneous report received from a parent via a (VAERS- Vaccine Adverse Event Reporting System) (VAERS ID: 1714945) concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 22-MAY-2021, the patient experienced vaccine exposure via breast feeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast feeding was not reported. This report was non-serious. This parent/child case is linked to 20211009578.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a 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 Guillain barre syndrome (previously had experienced when she was 19 and 40 years old). Patient was with a group of 14 whom all tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-SEP-2021, patient experienced sore throat. On 06-OCT-2021, she lost her taste and smell and received the regeneron monoclonal antibody (IV treatment). On an unspecified date, she tested positive for covid-19 infection (coded to suspected covid-19 infection) and also experienced suspected clinical vaccination failure but was not hospitalised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196465.; Sender's Comments: V0: 20211015230-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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 20211015230-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. This event(s) is considered not related. The event(s) has an unknown/unclear 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: INSOMNIA; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 2 insomnia. The event occurred unknown days after COVID-19 vaccine  Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovered.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with 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.   On 20-JUL-2021, the subject experienced insomnia.  On 24-JUL-2021, the subject recovered from insomnia.  Investigator's causality assessment:  The event of insomnia was possible to the study vaccine.  Company causality assessment: The event of insomnia was possible to the study vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: LOWER BACK PAIN; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 1 lower back pain. The event occurred unknown days after COVID-19 vaccine  Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovering.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with 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.   On 24-JUL-2021, the subject experienced lower back pain due to an exercise related injury.   The subject was recovering from lower back pain.  Investigator's causality assessment:  The event of back pain was not related to the study vaccine.  Company causality assessment: The event of back pain was not related to the study vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Right axillary swelling and soreness; This report received from a business partner via clinical trial 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines, (subject number and site number were not reported). The subject's weight, height, and medical history were not reported. The subject initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, the subject experienced right axillary swelling and soreness.  The dose of covid-19 vaccine ad26.cov2.s was not changed. The subject was recovering from right axillary swelling and soreness. The investigator assessed the severity of right axillary swelling and soreness as grade 1 mild adverse event. The investigator considered the causality between covid-19 vaccine ad26.cov2.s and right axillary swelling and soreness as possible.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This report received from a business partner via clinical trial 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines, (subject number and site number were not reported). The subject's weight, height, and medical history were not reported. The subject initiated treatment with 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. No concomitant medications were reported.  On 22-JUL-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The subject recovered from dizziness on 23-JUL-2021. The investigator assessed the severity of dizziness as grade 2 moderate adverse event. The investigator considered the causality between covid-19 vaccine ad26.cov2.s and dizziness as possible.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Medication error, Pyrexia
Clinical narrative: NEARLY DIED; MEDICATION ERROR; FEVER OF 104; 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, 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 number. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced nearly died, medication error, and fever of 104. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 104, and the outcome of nearly died and medication error was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Immunosuppression, Palpitations
Clinical narrative: IMMUNE COMPROMISED ISSUES; DIFFICULTY BREATHING; LIGHT HEADED ALMOST PASSED OUT (DIZZINESS); HEART RACING; THROAT FELT LIKE IT WAS GOING TO CLOSE UP; DYING; WEAKNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: seizures, and concurrent conditions included: coconut allergy, and immune compromised, and other pre-existing medical conditions included: Patient had many illness and she was on end stage and dying. 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,1 total, administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was dying and had all kinds of immune compromised issues and one day after vaccination, at around 21:00, she was in the back of the bathroom and felt like she was going to pass out (light headed, dizziness), she hollard for her husband and he got her to the chair (weakness). She stated that she ended up with all serious side effects except all over rash. Her heart was racing, her throat felt like it was going to close up like it did when she had coconut. She had difficulty breathing and went to the Emergency room (ER) and was discharged the same night. Her husband put her in bed and watched her overnight to make sure she was ok. She was abused, raped, had seizures, been institutionalized for speaking about God and was going paralyzed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, light headed almost passed out (dizziness), heart racing, weakness, and throat felt like it was going to close up, and the outcome of immune compromised issues and dying was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20211016208-covid-19 vaccine ad26.cov2.s- Immune compromised issues. This event(s) is considered not related. The event(s) has a unknown/unclear 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: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Throat tightness
Clinical narrative: IMMUNE COMPROMISED ISSUES; DIFFICULTY BREATHING; LIGHT HEADED ALMOST PASSED OUT (DIZZINESS); HEART RACING; THROAT FELT LIKE IT WAS GOING TO CLOSE UP; DYING; WEAKNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: seizures, and concurrent conditions included: coconut allergy, and immune compromised, and other pre-existing medical conditions included: Patient had many illness and she was on end stage and dying. 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,1 total, administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was dying and had all kinds of immune compromised issues and one day after vaccination, at around 21:00, she was in the back of the bathroom and felt like she was going to pass out (light headed, dizziness), she hollard for her husband and he got her to the chair (weakness). She stated that she ended up with all serious side effects except all over rash. Her heart was racing, her throat felt like it was going to close up like it did when she had coconut. She had difficulty breathing and went to the Emergency room (ER) and was discharged the same night. Her husband put her in bed and watched her overnight to make sure she was ok. She was abused, raped, had seizures, been institutionalized for speaking about God and was going paralyzed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, light headed almost passed out (dizziness), heart racing, weakness, and throat felt like it was going to close up, and the outcome of immune compromised issues and dying was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20211016208-covid-19 vaccine ad26.cov2.s- Immune compromised issues. This event(s) is considered not related. The event(s) has a unknown/unclear 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: POSITIVE COVID-19 TEST AFTER VACCINATION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-OCT-2021, the patient experienced positive covid-19 test after vaccination. 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 positive covid-19 test after vaccination was not reported. This report was non-serious. This case is a duplicate of 20211016096.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS/INCREASE AND PERSISTENT RINGING IN THE EARS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: tinnitus, and supraventricular tachycardia. 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, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced tinnitus/increase and persistent ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus/increase and persistent ringing in the ears. This report was non-serious.