chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mouth injury, Pain in extremity, Speech disorder
Clinical narrative: CAN NOT TALK WELL; CAN NOT EAT WELL; CAN HARDLY CARE FOR HERSELF; BROKE MOUTH; FELT SICK; STROKE ON LEFT SIDE WITH A 2ND STROKE IN A WEEK; FELT WEAK; SORE LEFT ARM; This spontaneous report received from a patient concerned a 54 year old female. Initial information was processed along with additional information on 21-SEP-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, 1 total, administered on 28-JUL-2021 at left arm for prophylactic vaccination. No concomitant medication was reported.  On unspecified date in JUL-2021, after receiving vaccine, patient experienced side effects which included sore left arm and felt weak. Four days later on 01-AUG-2021, patient was sick and had a stoke on left side which effected whole left side. Patient went to a hospital and it was informed that she had a stroke. Patient was hospitalized on unspecified date for 5 days. Patient experienced second stroke in a week and was again hospitalized on an unspecified date, patient broke her mouth and could not talk and eat well and could hardly care for herself. Patient stated that it really affected her life. Patient did not go to work for the past 48 days. Patient said those 47 days have stopped her life and she could not even enjoy with her grandkids. Patient felt bad and cried a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke on left side with a 2nd stroke in a week, sore left arm, felt sick, felt weak, can not talk well, can not eat well, can hardly care for herself and broke mouth was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938360-covid-19 vaccine ad26.cov2.s-stroke on left side/ a 2nd stroke, can barely talk, can barely eat, can barely take care of herself, broke mouth. 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).  20210938360-covid-19 vaccine ad26.cov2.s- sore left arm, felt sick, felt weak. This event(s) is labeled per RSI and is therefore considered potentially related
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dehydration
Clinical narrative: blacked out; throwing up to point of severe dehydration; Shortness of breathe caused asthma to flare up; Shortness of breathe caused asthma to flare up; throwing up to point of severe dehydration; chest pain; rash on arm of injection; diarrhea; affected menstrual cycle; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 19-years-old via an unspecified route of administration, administered in Arm Left on 31Aug2021 11:15 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and bronchial asthma from unknown dates. The patient has no known allergies. Concomitant medication included ethinylestradiol, norgestrel (LOW-OGESTREL-28) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021 12:45, the patient experienced Shortness of breathe caused asthma to flare up, blacked out, throwing up to point of severe dehydration, chest pain, rash on arm of injection, diarrhea, affected menstrual cycle and severe headache. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as a result of the events which included IV fluid for dehydration and rescue inhaler. The patient recovered with sequel from the events on an unspecified date.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Electrocardiogram, Headache, Loss of consciousness
Clinical narrative: blacked out; throwing up to point of severe dehydration; Shortness of breathe caused asthma to flare up; Shortness of breathe caused asthma to flare up; throwing up to point of severe dehydration; chest pain; rash on arm of injection; diarrhea; affected menstrual cycle; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 19-years-old via an unspecified route of administration, administered in Arm Left on 31Aug2021 11:15 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and bronchial asthma from unknown dates. The patient has no known allergies. Concomitant medication included ethinylestradiol, norgestrel (LOW-OGESTREL-28) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021 12:45, the patient experienced Shortness of breathe caused asthma to flare up, blacked out, throwing up to point of severe dehydration, chest pain, rash on arm of injection, diarrhea, affected menstrual cycle and severe headache. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as a result of the events which included IV fluid for dehydration and rescue inhaler. The patient recovered with sequel from the events on an unspecified date.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Rash, SARS-CoV-2 test, Vomiting
Clinical narrative: blacked out; throwing up to point of severe dehydration; Shortness of breathe caused asthma to flare up; Shortness of breathe caused asthma to flare up; throwing up to point of severe dehydration; chest pain; rash on arm of injection; diarrhea; affected menstrual cycle; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 19-years-old via an unspecified route of administration, administered in Arm Left on 31Aug2021 11:15 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and bronchial asthma from unknown dates. The patient has no known allergies. Concomitant medication included ethinylestradiol, norgestrel (LOW-OGESTREL-28) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021 12:45, the patient experienced Shortness of breathe caused asthma to flare up, blacked out, throwing up to point of severe dehydration, chest pain, rash on arm of injection, diarrhea, affected menstrual cycle and severe headache. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as a result of the events which included IV fluid for dehydration and rescue inhaler. The patient recovered with sequel from the events on an unspecified date.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chest pain, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: blacked out; throwing up to point of severe dehydration; Shortness of breathe caused asthma to flare up; Shortness of breathe caused asthma to flare up; throwing up to point of severe dehydration; chest pain; rash on arm of injection; diarrhea; affected menstrual cycle; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 19-years-old via an unspecified route of administration, administered in Arm Left on 31Aug2021 11:15 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and bronchial asthma from unknown dates. The patient has no known allergies. Concomitant medication included ethinylestradiol, norgestrel (LOW-OGESTREL-28) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021 12:45, the patient experienced Shortness of breathe caused asthma to flare up, blacked out, throwing up to point of severe dehydration, chest pain, rash on arm of injection, diarrhea, affected menstrual cycle and severe headache. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as a result of the events which included IV fluid for dehydration and rescue inhaler. The patient recovered with sequel from the events on an unspecified date.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of consciousness, Menstrual disorder, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: blacked out; throwing up to point of severe dehydration; Shortness of breathe caused asthma to flare up; Shortness of breathe caused asthma to flare up; throwing up to point of severe dehydration; chest pain; rash on arm of injection; diarrhea; affected menstrual cycle; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 19-years-old via an unspecified route of administration, administered in Arm Left on 31Aug2021 11:15 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and bronchial asthma from unknown dates. The patient has no known allergies. Concomitant medication included ethinylestradiol, norgestrel (LOW-OGESTREL-28) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021 12:45, the patient experienced Shortness of breathe caused asthma to flare up, blacked out, throwing up to point of severe dehydration, chest pain, rash on arm of injection, diarrhea, affected menstrual cycle and severe headache. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as a result of the events which included IV fluid for dehydration and rescue inhaler. The patient recovered with sequel from the events on an unspecified date.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: blacked out; throwing up to point of severe dehydration; Shortness of breathe caused asthma to flare up; Shortness of breathe caused asthma to flare up; throwing up to point of severe dehydration; chest pain; rash on arm of injection; diarrhea; affected menstrual cycle; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 19-years-old via an unspecified route of administration, administered in Arm Left on 31Aug2021 11:15 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and bronchial asthma from unknown dates. The patient has no known allergies. Concomitant medication included ethinylestradiol, norgestrel (LOW-OGESTREL-28) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021 12:45, the patient experienced Shortness of breathe caused asthma to flare up, blacked out, throwing up to point of severe dehydration, chest pain, rash on arm of injection, diarrhea, affected menstrual cycle and severe headache. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as a result of the events which included IV fluid for dehydration and rescue inhaler. The patient recovered with sequel from the events on an unspecified date.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Delusion, Full blood count normal, Hallucination, auditory, Hallucination, visual, Metabolic function test
Clinical narrative: auditory and visual hallucination; paranoid delusion; This is a spontaneous report from a contactable physician. A 16-year-old non-significant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route on 05Aug2021 at patient age of 16-year-old, as single dose (Lot Number: EW0173) for COVID-19 immunisation. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had known allergies to fruit orange caused mild rash on her hand. None other medical history. The patient concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced auditory and visual hallucination, paranoid delusion on 08Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received medication (risperidone) as treatment. It was unknown if the patient has been tested for COVID-19. The events was reported as non-serious. The outcome of the events was recovering.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between adverse event Auditory and visual hallucinations and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toxicologic test normal, Urine analysis normal
Clinical narrative: auditory and visual hallucination; paranoid delusion; This is a spontaneous report from a contactable physician. A 16-year-old non-significant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route on 05Aug2021 at patient age of 16-year-old, as single dose (Lot Number: EW0173) for COVID-19 immunisation. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had known allergies to fruit orange caused mild rash on her hand. None other medical history. The patient concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced auditory and visual hallucination, paranoid delusion on 08Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received medication (risperidone) as treatment. It was unknown if the patient has been tested for COVID-19. The events was reported as non-serious. The outcome of the events was recovering.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between adverse event Auditory and visual hallucinations and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Delusion, Hallucinations, mixed
Clinical narrative: auditory and visual hallucination; paranoid delusion; This is a spontaneous report from a contactable physician. A 16-year-old non-significant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route on 05Aug2021 at patient age of 16-year-old, as single dose (Lot Number: EW0173) for COVID-19 immunisation. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had known allergies to fruit orange caused mild rash on her hand. None other medical history. The patient concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced auditory and visual hallucination, paranoid delusion on 08Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received medication (risperidone) as treatment. It was unknown if the patient has been tested for COVID-19. The events was reported as non-serious. The outcome of the events was recovering.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between adverse event Auditory and visual hallucinations and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient complains of left arm numbness, shortness of breath with exertion and at rest, and chills after 2nd dose of Pfizer vaccine.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient complains of left arm numbness, shortness of breath with exertion and at rest, and chills after 2nd dose of Pfizer vaccine.
Age: 0.33
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hyperhidrosis, Nausea
Clinical narrative: 1 week after vaccination I became weak, faint, had episodes of increased blood pressure then sudden drops. Also abdominal pressure and pain left flank. Weakness and periods of extreme fatigue have continued.
Age: 0.33
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood glucose, Blood pressure fluctuation, Blood test, Chest X-ray
Clinical narrative: 1 week after vaccination I became weak, faint, had episodes of increased blood pressure then sudden drops. Also abdominal pressure and pain left flank. Weakness and periods of extreme fatigue have continued.
Age: 0.33
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Discomfort, Electrocardiogram, Fatigue, Flank pain
Clinical narrative: 1 week after vaccination I became weak, faint, had episodes of increased blood pressure then sudden drops. Also abdominal pressure and pain left flank. Weakness and periods of extreme fatigue have continued.
Age: 0.33
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Syncope, Urine analysis
Clinical narrative: 1 week after vaccination I became weak, faint, had episodes of increased blood pressure then sudden drops. Also abdominal pressure and pain left flank. Weakness and periods of extreme fatigue have continued.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Chest X-ray abnormal, Confusional state, Lung opacity
Clinical narrative: Pt received both doses of the Pfizer COVID-19 vaccine, on 1/22/2021 and 2/12/2021 respectively.  Pt tested positive for COVID on 9/6/2021, presented to ED same day and was admitted for stroke-like symptoms.  Over the course of her hospitalization,  she developed symptoms of severe COVID, with pneumonia and acute hypoxic respiratory failure.  She was discharged back to her ALF on 9/15/2021.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Pt received both doses of the Pfizer COVID-19 vaccine, on 1/22/2021 and 2/12/2021 respectively.  Pt tested positive for COVID on 9/6/2021, presented to ED same day and was admitted for stroke-like symptoms.  Over the course of her hospitalization,  she developed symptoms of severe COVID, with pneumonia and acute hypoxic respiratory failure.  She was discharged back to her ALF on 9/15/2021.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Neurological symptom, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Pt received both doses of the Pfizer COVID-19 vaccine, on 1/22/2021 and 2/12/2021 respectively.  Pt tested positive for COVID on 9/6/2021, presented to ED same day and was admitted for stroke-like symptoms.  Over the course of her hospitalization,  she developed symptoms of severe COVID, with pneumonia and acute hypoxic respiratory failure.  She was discharged back to her ALF on 9/15/2021.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris
Clinical narrative: Heart pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 57-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FF2587) via an unspecified route of administration in left arm on 17Sep2021 11:30 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient medical history included known allergies to Penicillun. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not received any other medications within 2 weeks of vaccination. On 18Sep2021 02:00, the patient experienced heart pain, sudden semi sharp pain in his heart that lasted for about 5 seconds and returned sometimes in a minute or two. The reported seriousness of the case was non-serious. Patient did not receive any treatment for the adverse events. The outcome of the event was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: He received the vaccine and and started feeling light headed not long after.  Around 2:00 I came home and he looked odd.  Like staring in to blank space.  I talked to him but he just talked a little.  I walked to screened in porch and noticed a little water on a table.  Asked if he had seen it.  He came out there and walked inside.  My grandson was talking to him he wasn't responding he was just staring.  I then his eyes rolled back and he went out like a light.  It took around 4 minutes to get him to open his eyes.  You could tell he was breathing but he was out like someone had KO'd him.  When he came to He couldn't remember anything about the day or the prior day.  He had no idea what happened.  I  waited on my son to arrive to get my grandchild and took him to the ER.  He was starting to come around (make sense) and went to the restroom in the ER.   I felt like it had been to long for him to be gone then I heard a nurse say are you lost.  And he couldn't remember where he was, it appeared as if he was completely lost.  They admitted him to the hospital and started running all types of tests.  They have found nothing except some elevated blood pressure.  he is on blood pressure medicine now since leaving the hospital.  They asked that he wear a heart monitor for 30 days so he has that now.  I believe that the healthcare system is doing all they can to not admit the vaccine caused him to pass out.  There is no doubt in my mind whatsoever that is the very reason he passed out.   I don't believe the press and government should be applying so much pressure to Americans to get the vaccine when it is not FDA approved nor has it been on the market long enough to truly understand the side effects and long term effects on Humans.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Amnesia, Blood pressure increased, Blood test, Computerised tomogram
Clinical narrative: He received the vaccine and and started feeling light headed not long after.  Around 2:00 I came home and he looked odd.  Like staring in to blank space.  I talked to him but he just talked a little.  I walked to screened in porch and noticed a little water on a table.  Asked if he had seen it.  He came out there and walked inside.  My grandson was talking to him he wasn't responding he was just staring.  I then his eyes rolled back and he went out like a light.  It took around 4 minutes to get him to open his eyes.  You could tell he was breathing but he was out like someone had KO'd him.  When he came to He couldn't remember anything about the day or the prior day.  He had no idea what happened.  I  waited on my son to arrive to get my grandchild and took him to the ER.  He was starting to come around (make sense) and went to the restroom in the ER.   I felt like it had been to long for him to be gone then I heard a nurse say are you lost.  And he couldn't remember where he was, it appeared as if he was completely lost.  They admitted him to the hospital and started running all types of tests.  They have found nothing except some elevated blood pressure.  he is on blood pressure medicine now since leaving the hospital.  They asked that he wear a heart monitor for 30 days so he has that now.  I believe that the healthcare system is doing all they can to not admit the vaccine caused him to pass out.  There is no doubt in my mind whatsoever that is the very reason he passed out.   I don't believe the press and government should be applying so much pressure to Americans to get the vaccine when it is not FDA approved nor has it been on the market long enough to truly understand the side effects and long term effects on Humans.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram ambulatory, Eye movement disorder, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: He received the vaccine and and started feeling light headed not long after.  Around 2:00 I came home and he looked odd.  Like staring in to blank space.  I talked to him but he just talked a little.  I walked to screened in porch and noticed a little water on a table.  Asked if he had seen it.  He came out there and walked inside.  My grandson was talking to him he wasn't responding he was just staring.  I then his eyes rolled back and he went out like a light.  It took around 4 minutes to get him to open his eyes.  You could tell he was breathing but he was out like someone had KO'd him.  When he came to He couldn't remember anything about the day or the prior day.  He had no idea what happened.  I  waited on my son to arrive to get my grandchild and took him to the ER.  He was starting to come around (make sense) and went to the restroom in the ER.   I felt like it had been to long for him to be gone then I heard a nurse say are you lost.  And he couldn't remember where he was, it appeared as if he was completely lost.  They admitted him to the hospital and started running all types of tests.  They have found nothing except some elevated blood pressure.  he is on blood pressure medicine now since leaving the hospital.  They asked that he wear a heart monitor for 30 days so he has that now.  I believe that the healthcare system is doing all they can to not admit the vaccine caused him to pass out.  There is no doubt in my mind whatsoever that is the very reason he passed out.   I don't believe the press and government should be applying so much pressure to Americans to get the vaccine when it is not FDA approved nor has it been on the market long enough to truly understand the side effects and long term effects on Humans.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Ultrasound scan, X-ray
Clinical narrative: He received the vaccine and and started feeling light headed not long after.  Around 2:00 I came home and he looked odd.  Like staring in to blank space.  I talked to him but he just talked a little.  I walked to screened in porch and noticed a little water on a table.  Asked if he had seen it.  He came out there and walked inside.  My grandson was talking to him he wasn't responding he was just staring.  I then his eyes rolled back and he went out like a light.  It took around 4 minutes to get him to open his eyes.  You could tell he was breathing but he was out like someone had KO'd him.  When he came to He couldn't remember anything about the day or the prior day.  He had no idea what happened.  I  waited on my son to arrive to get my grandchild and took him to the ER.  He was starting to come around (make sense) and went to the restroom in the ER.   I felt like it had been to long for him to be gone then I heard a nurse say are you lost.  And he couldn't remember where he was, it appeared as if he was completely lost.  They admitted him to the hospital and started running all types of tests.  They have found nothing except some elevated blood pressure.  he is on blood pressure medicine now since leaving the hospital.  They asked that he wear a heart monitor for 30 days so he has that now.  I believe that the healthcare system is doing all they can to not admit the vaccine caused him to pass out.  There is no doubt in my mind whatsoever that is the very reason he passed out.   I don't believe the press and government should be applying so much pressure to Americans to get the vaccine when it is not FDA approved nor has it been on the market long enough to truly understand the side effects and long term effects on Humans.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Erythema
Clinical narrative: PATIENT STATES THAT AFTER HER SECOND MODERNA COVID VACCINE DOSE, SHE DEVELOPED A BIG, RED SPOT AT THE AREA OF INJECTION. THE PATIENT WAS DIAGNOSED WITH CELLULITIS.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: PATIENT STATES THAT AFTER HER SECOND MODERNA COVID VACCINE DOSE, SHE DEVELOPED A BIG, RED SPOT AT THE AREA OF INJECTION. THE PATIENT WAS DIAGNOSED WITH CELLULITIS.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Nausea, Swollen tongue
Clinical narrative: Swollen throat; Numbness in "my" lips and tongue and gums; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183), via an unspecified route of administration in the left arm on 20Sep2021 at 17:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included sleep apnea and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN); both for unknown indication from unknown date and unknown if ongoing. On 20Sep2021 at 17:45, the patient experienced swollen throat, numbness in lips, tongue and gums, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen throat, numbness in lips and tongue and gums, headache and nausea was not resolved at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia oral, Nausea, Pharyngeal swelling
Clinical narrative: Swollen throat; Numbness in "my" lips and tongue and gums; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183), via an unspecified route of administration in the left arm on 20Sep2021 at 17:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included sleep apnea and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN); both for unknown indication from unknown date and unknown if ongoing. On 20Sep2021 at 17:45, the patient experienced swollen throat, numbness in lips, tongue and gums, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen throat, numbness in lips and tongue and gums, headache and nausea was not resolved at the time of this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Electrocardiogram, Fatigue, Laboratory test
Clinical narrative: tachycardia; heart palpitations; diarrhea; ocular migraine to right eye; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was experienced tachycardia, heart palpitations, and diarrhea for 8 days. Also complaining of a ocular migraine to right eye that was till present at the time of reporting. The patient was asking should she take the next dose, since she had the severe allergic reaction to the first dose in 2021. Outcome of the events tachycardia, heart palpitations, and diarrhea was recovered in 2021; for event ocular migraine to right eye was not recovered and other event of severe allergic reaction was unknown.  The U.S. Centres for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine during the EUA. These interim clinical considerations from ACIP note the following: If the second dose is given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There are only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Migraine, Palpitations, Pollakiuria, SARS-CoV-2 test negative
Clinical narrative: tachycardia; heart palpitations; diarrhea; ocular migraine to right eye; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was experienced tachycardia, heart palpitations, and diarrhea for 8 days. Also complaining of a ocular migraine to right eye that was till present at the time of reporting. The patient was asking should she take the next dose, since she had the severe allergic reaction to the first dose in 2021. Outcome of the events tachycardia, heart palpitations, and diarrhea was recovered in 2021; for event ocular migraine to right eye was not recovered and other event of severe allergic reaction was unknown.  The U.S. Centres for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine during the EUA. These interim clinical considerations from ACIP note the following: If the second dose is given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There are only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Urine analysis
Clinical narrative: tachycardia; heart palpitations; diarrhea; ocular migraine to right eye; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was experienced tachycardia, heart palpitations, and diarrhea for 8 days. Also complaining of a ocular migraine to right eye that was till present at the time of reporting. The patient was asking should she take the next dose, since she had the severe allergic reaction to the first dose in 2021. Outcome of the events tachycardia, heart palpitations, and diarrhea was recovered in 2021; for event ocular migraine to right eye was not recovered and other event of severe allergic reaction was unknown.  The U.S. Centres for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine during the EUA. These interim clinical considerations from ACIP note the following: If the second dose is given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There are only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Hypersensitivity, Ophthalmic migraine, Palpitations, Tachycardia
Clinical narrative: tachycardia; heart palpitations; diarrhea; ocular migraine to right eye; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was experienced tachycardia, heart palpitations, and diarrhea for 8 days. Also complaining of a ocular migraine to right eye that was till present at the time of reporting. The patient was asking should she take the next dose, since she had the severe allergic reaction to the first dose in 2021. Outcome of the events tachycardia, heart palpitations, and diarrhea was recovered in 2021; for event ocular migraine to right eye was not recovered and other event of severe allergic reaction was unknown.  The U.S. Centres for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine during the EUA. These interim clinical considerations from ACIP note the following: If the second dose is given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There are only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menstruation irregular, Pain in extremity
Clinical narrative: Pain in right underarm; Period cycle changed; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the right arm on 17Sep2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 26Aug2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 01:00, after the second dose, the patient experienced pain in right underarm and her period cycle had changed as well. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain in right underarm and period cycle changed were recovering at the time of this report.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Menstrual disorder
Clinical narrative: Pain in right underarm; Period cycle changed; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the right arm on 17Sep2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 26Aug2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 01:00, after the second dose, the patient experienced pain in right underarm and her period cycle had changed as well. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain in right underarm and period cycle changed were recovering at the time of this report.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed Shingles; This is a spontaneous report from a contactable pharmacist reported. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via intramuscular, administered in arm right on 25Mar2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via intramuscular, administered in arm right on 02Mar2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. On 19Sep2021, the patient was diagnosed shingles and treated with valganciclovir. The adverse event result in Doctor or other healthcare professional office/clinic visit. No Serious criteria was provided. Outcome of the event was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ADMINISTRATION ERROR; THE PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR 6.5-7 HOURS PRIOR TO ADMINISTRATION; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced administration error. On 21-SEP-2021, the patient experienced the punctured vial stored in the refrigerator for 6.5-7 hours prior to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the punctured vial stored in the refrigerator for 6.5-7 hours prior to administration and administration error was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR; THE PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR 6.5-7 HOURS PRIOR TO ADMINISTRATION; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced administration error. On 21-SEP-2021, the patient experienced the punctured vial stored in the refrigerator for 6.5-7 hours prior to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the punctured vial stored in the refrigerator for 6.5-7 hours prior to administration and administration error was not reported. This report was non-serious.