chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Dizziness, Eye swelling
Clinical narrative: loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; diarrhea; nausea; dizzy; joint pain; migraine; throat swelling; nose swelling; eyes swelling; This is a spontaneous report received a contactable consumer, the patient. A 33-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot ER8729 and expiry information not reported) in the right arm via unspecified route on 06Apr2021 at 09:45 (at 33 years-old) for COVID-19 immunisation. Relevant medical history included asthma, allergies, penicillin and adhesive tape allergies, and high blood pressure. Concomitant medications included lisinopril. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER7531) in the right arm on 16Mar2021 at 09:45 (at 32-years-old). The patient previously received treatment for an unspecified indication with hydrocodone bitartrate/paracetamol (NORCO) and experienced an allergy. The denied being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 06Apr2021 at 20:00 the patient experienced fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms. The patient reported as a result of the events the patient sought care with a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for COVID-19 since the vaccine with nasal swab test on 07Apr2021 and was negative. Treatment for the events received in the emergency room (ER) included diphenhydramine HCl (BENADRYL), ibuprofen, and acetaminophen (TYLENOL). The outcome of the events, fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms, was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Migraine, Nasal oedema, Nausea, Paralysis
Clinical narrative: loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; diarrhea; nausea; dizzy; joint pain; migraine; throat swelling; nose swelling; eyes swelling; This is a spontaneous report received a contactable consumer, the patient. A 33-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot ER8729 and expiry information not reported) in the right arm via unspecified route on 06Apr2021 at 09:45 (at 33 years-old) for COVID-19 immunisation. Relevant medical history included asthma, allergies, penicillin and adhesive tape allergies, and high blood pressure. Concomitant medications included lisinopril. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER7531) in the right arm on 16Mar2021 at 09:45 (at 32-years-old). The patient previously received treatment for an unspecified indication with hydrocodone bitartrate/paracetamol (NORCO) and experienced an allergy. The denied being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 06Apr2021 at 20:00 the patient experienced fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms. The patient reported as a result of the events the patient sought care with a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for COVID-19 since the vaccine with nasal swab test on 07Apr2021 and was negative. Treatment for the events received in the emergency room (ER) included diphenhydramine HCl (BENADRYL), ibuprofen, and acetaminophen (TYLENOL). The outcome of the events, fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms, was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; diarrhea; nausea; dizzy; joint pain; migraine; throat swelling; nose swelling; eyes swelling; This is a spontaneous report received a contactable consumer, the patient. A 33-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot ER8729 and expiry information not reported) in the right arm via unspecified route on 06Apr2021 at 09:45 (at 33 years-old) for COVID-19 immunisation. Relevant medical history included asthma, allergies, penicillin and adhesive tape allergies, and high blood pressure. Concomitant medications included lisinopril. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER7531) in the right arm on 16Mar2021 at 09:45 (at 32-years-old). The patient previously received treatment for an unspecified indication with hydrocodone bitartrate/paracetamol (NORCO) and experienced an allergy. The denied being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 06Apr2021 at 20:00 the patient experienced fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms. The patient reported as a result of the events the patient sought care with a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for COVID-19 since the vaccine with nasal swab test on 07Apr2021 and was negative. Treatment for the events received in the emergency room (ER) included diphenhydramine HCl (BENADRYL), ibuprofen, and acetaminophen (TYLENOL). The outcome of the events, fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms, was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Death, Feeling of body temperature change, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: [Moderna Covid vaccine] use for COVID-19 under Emergency Use Authorization (EUA):This is the case of a 69 year old who lives with her husband of 47 years. She was diagnosed with Stage 1B pancreatitis last summer, and underwent a Whipple procedure at Hospital on Dec. 14th, and has been receiving chemo treatments every 2 weeks with Dr. her physician urged her to get the Covid vaccine, and schedule it between her Chemo treatments. She has been doing well with no recent complaints until today, when she developed symptoms of cold hands, shaking. bilateral arm stiffness and numbness. her physician was contacted, and they were told symptoms were likely due to the vaccine. When symptoms worsened, with trouble speaking progressing to complete aphasia and a blank stare, falling to the ground, her husband called 911. She was able to follow commands, and he noted no visual difficulty, He thought she was having a stroke. Upon arrival of EMS, they found her in cardiac arrest with equal pupils, began CPR and ACLS protocol to no avail. CodE was called at 2248 hours, with death declared at that time. I contacted Dr.'s office with the above information, and there was agreement as to covid vaccine contributing to cause of death. I obtained pericardial blood for nucleocapsid antibodies assay which was sent to Lab for testing on 4/8/21. Vaccination history as follows: 2/27/2021 Moderna 012A21A exp 08/17/2021; 4/1/2021 Moderna 003B21A exp 09/09/2021. VAERS report has been made. FDA Report filed. Unable to run test due to no serum in sample, only red cells
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Staring, Tremor
Clinical narrative: [Moderna Covid vaccine] use for COVID-19 under Emergency Use Authorization (EUA):This is the case of a 69 year old who lives with her husband of 47 years. She was diagnosed with Stage 1B pancreatitis last summer, and underwent a Whipple procedure at Hospital on Dec. 14th, and has been receiving chemo treatments every 2 weeks with Dr. her physician urged her to get the Covid vaccine, and schedule it between her Chemo treatments. She has been doing well with no recent complaints until today, when she developed symptoms of cold hands, shaking. bilateral arm stiffness and numbness. her physician was contacted, and they were told symptoms were likely due to the vaccine. When symptoms worsened, with trouble speaking progressing to complete aphasia and a blank stare, falling to the ground, her husband called 911. She was able to follow commands, and he noted no visual difficulty, He thought she was having a stroke. Upon arrival of EMS, they found her in cardiac arrest with equal pupils, began CPR and ACLS protocol to no avail. CodE was called at 2248 hours, with death declared at that time. I contacted Dr.'s office with the above information, and there was agreement as to covid vaccine contributing to cause of death. I obtained pericardial blood for nucleocapsid antibodies assay which was sent to Lab for testing on 4/8/21. Vaccination history as follows: 2/27/2021 Moderna 012A21A exp 08/17/2021; 4/1/2021 Moderna 003B21A exp 09/09/2021. VAERS report has been made. FDA Report filed. Unable to run test due to no serum in sample, only red cells
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cardiac arrest, Cardio-respiratory arrest, Death, Fall
Clinical narrative: [Moderna Covid vaccine] use for COVID-19 under Emergency Use Authorization (EUA):This is the case of a 69 year old who lives with her husband of 47 years. She was diagnosed with Stage 1B pancreatitis last summer, and underwent a Whipple procedure at Hospital on Dec. 14th, and has been receiving chemo treatments every 2 weeks with Dr. her physician urged her to get the Covid vaccine, and schedule it between her Chemo treatments. She has been doing well with no recent complaints until today, when she developed symptoms of cold hands, shaking. bilateral arm stiffness and numbness. her physician was contacted, and they were told symptoms were likely due to the vaccine. When symptoms worsened, with trouble speaking progressing to complete aphasia and a blank stare, falling to the ground, her husband called 911. She was able to follow commands, and he noted no visual difficulty, He thought she was having a stroke. Upon arrival of EMS, they found her in cardiac arrest with equal pupils, began CPR and ACLS protocol to no avail. CodE was called at 2248 hours, with death declared at that time. I contacted Dr.'s office with the above information, and there was agreement as to covid vaccine contributing to cause of death. I obtained pericardial blood for nucleocapsid antibodies assay which was sent to Lab for testing on 4/8/21. Vaccination history as follows: 2/27/2021 Moderna 012A21A exp 08/17/2021; 4/1/2021 Moderna 003B21A exp 09/09/2021. VAERS report has been made. FDA Report filed. Unable to run test due to no serum in sample, only red cells
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Pericardial drainage test, Peripheral coldness, Resuscitation
Clinical narrative: [Moderna Covid vaccine] use for COVID-19 under Emergency Use Authorization (EUA):This is the case of a 69 year old who lives with her husband of 47 years. She was diagnosed with Stage 1B pancreatitis last summer, and underwent a Whipple procedure at Hospital on Dec. 14th, and has been receiving chemo treatments every 2 weeks with Dr. her physician urged her to get the Covid vaccine, and schedule it between her Chemo treatments. She has been doing well with no recent complaints until today, when she developed symptoms of cold hands, shaking. bilateral arm stiffness and numbness. her physician was contacted, and they were told symptoms were likely due to the vaccine. When symptoms worsened, with trouble speaking progressing to complete aphasia and a blank stare, falling to the ground, her husband called 911. She was able to follow commands, and he noted no visual difficulty, He thought she was having a stroke. Upon arrival of EMS, they found her in cardiac arrest with equal pupils, began CPR and ACLS protocol to no avail. CodE was called at 2248 hours, with death declared at that time. I contacted Dr.'s office with the above information, and there was agreement as to covid vaccine contributing to cause of death. I obtained pericardial blood for nucleocapsid antibodies assay which was sent to Lab for testing on 4/8/21. Vaccination history as follows: 2/27/2021 Moderna 012A21A exp 08/17/2021; 4/1/2021 Moderna 003B21A exp 09/09/2021. VAERS report has been made. FDA Report filed. Unable to run test due to no serum in sample, only red cells
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Staring, Tremor, Vaccination complication
Clinical narrative: [Moderna Covid vaccine] use for COVID-19 under Emergency Use Authorization (EUA):This is the case of a 69 year old who lives with her husband of 47 years. She was diagnosed with Stage 1B pancreatitis last summer, and underwent a Whipple procedure at Hospital on Dec. 14th, and has been receiving chemo treatments every 2 weeks with Dr. her physician urged her to get the Covid vaccine, and schedule it between her Chemo treatments. She has been doing well with no recent complaints until today, when she developed symptoms of cold hands, shaking. bilateral arm stiffness and numbness. her physician was contacted, and they were told symptoms were likely due to the vaccine. When symptoms worsened, with trouble speaking progressing to complete aphasia and a blank stare, falling to the ground, her husband called 911. She was able to follow commands, and he noted no visual difficulty, He thought she was having a stroke. Upon arrival of EMS, they found her in cardiac arrest with equal pupils, began CPR and ACLS protocol to no avail. CodE was called at 2248 hours, with death declared at that time. I contacted Dr.'s office with the above information, and there was agreement as to covid vaccine contributing to cause of death. I obtained pericardial blood for nucleocapsid antibodies assay which was sent to Lab for testing on 4/8/21. Vaccination history as follows: 2/27/2021 Moderna 012A21A exp 08/17/2021; 4/1/2021 Moderna 003B21A exp 09/09/2021. VAERS report has been made. FDA Report filed. Unable to run test due to no serum in sample, only red cells
Age: 87.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: I experienced the clotting; This is a spontaneous report. A contactable 87-year-old consumer (patient) of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 (at the age of 87-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported to have experienced the clotting (as reported) in Feb2021. The patient had to spend 4 days in the hospital and was on oxygen and Eliquis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulopathy
Clinical narrative: I experienced the clotting; This is a spontaneous report. A contactable 87-year-old consumer (patient) of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 (at the age of 87-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported to have experienced the clotting (as reported) in Feb2021. The patient had to spend 4 days in the hospital and was on oxygen and Eliquis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: I experienced the clotting; This is a spontaneous report. A contactable 87-year-old consumer (patient) of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 (at the age of 87-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported to have experienced the clotting (as reported) in Feb2021. The patient had to spend 4 days in the hospital and was on oxygen and Eliquis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aldolase, Back pain, Blood creatine phosphokinase normal, Blood folate normal, Epstein-Barr virus test negative
Clinical narrative: Severe muscle pain and fatigue, decreased strength (unable to walk unsupported)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count normal, Gait disturbance, Limb discomfort, Magnetic resonance imaging head normal
Clinical narrative: Severe muscle pain and fatigue, decreased strength (unable to walk unsupported)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal normal, Metabolic function test normal, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe muscle pain and fatigue, decreased strength (unable to walk unsupported)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Thyroid function test normal, Vitamin B12 normal, Walking aid user
Clinical narrative: Severe muscle pain and fatigue, decreased strength (unable to walk unsupported)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Gait inability, Laboratory test, Lumbar puncture
Clinical narrative: Severe muscle pain and fatigue, decreased strength (unable to walk unsupported)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myalgia
Clinical narrative: Severe muscle pain and fatigue, decreased strength (unable to walk unsupported)
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Eye movement disorder, Loss of consciousness
Clinical narrative: PALENESS; SWEATING; HEART RATE FLUCTUATION; FELT SICK; SEVERE LEG PAIN; NAUSEA; CHILLS; DIARRHEA; VOMITING; BODY ACHES; FLUTTERING EYES; BLOOD PRESSURE WENT UP; CHEST PAIN; TIREDNESS; ANAPHYLACTIC REACTION; BRUISES IN UPPER LEG; This spontaneous report received from a consumer concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  The consumer stated that her daughter had an anaphylactic reaction to the vaccine on 12-APR-2021 and was calling to inquire if she should take her to the hospital again due to her severe leg pain. The consumer stated that on 12-APR-2021 10:30, her daughter had numbness, redness and tingling in her right cheek and her eyes were fluttering and couldn't breathe as her throat was closing up. The consumer and patient went to health system where patient received epinephrine and Benadryl and discharged within 2 hours. The consumer stated her blood pressure went up due to the epinephrine. After coming home the daughter had chest pain and was tired and kept taking Benadryl. On 13-APR-2021, consumer reported that her daughter was vomiting and had diarrhea, chills and aches all over her body. On 16-APR-2021, all symptoms were gone. On 17-APR-2021, she felt sick again and had nausea and her heart rate has been fluctuating as her apple watch reading was showing readings of 49 to 159 and she was having leg pain that felt like blood vessels are bursting in her leg. On 18-APR-2021 consumer reported that her daughter was able to have breakfast and she went to work. While on the phone the daughter texted consumer that she was experiencing nausea, paleness and sweating that comes and goes along the leg pain. Consumer also reported that her daughter has bruises in her upper leg that she doesn't remember how she got it (not sure which leg). The consumer stated the daughter doesn't have an HCP but will seek medical help for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, fluttering eyes, blood pressure went up, diarrhea, vomiting, body aches, chest pain, chills, and tiredness on 16-APR-2021, had not recovered from severe leg pain, nausea, paleness, and sweating, and the outcome of felt sick, bruises in upper leg and heart rate fluctuation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436182-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per Agency and is therefore considered potentially related.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: PALENESS; SWEATING; HEART RATE FLUCTUATION; FELT SICK; SEVERE LEG PAIN; NAUSEA; CHILLS; DIARRHEA; VOMITING; BODY ACHES; FLUTTERING EYES; BLOOD PRESSURE WENT UP; CHEST PAIN; TIREDNESS; ANAPHYLACTIC REACTION; BRUISES IN UPPER LEG; This spontaneous report received from a consumer concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  The consumer stated that her daughter had an anaphylactic reaction to the vaccine on 12-APR-2021 and was calling to inquire if she should take her to the hospital again due to her severe leg pain. The consumer stated that on 12-APR-2021 10:30, her daughter had numbness, redness and tingling in her right cheek and her eyes were fluttering and couldn't breathe as her throat was closing up. The consumer and patient went to health system where patient received epinephrine and Benadryl and discharged within 2 hours. The consumer stated her blood pressure went up due to the epinephrine. After coming home the daughter had chest pain and was tired and kept taking Benadryl. On 13-APR-2021, consumer reported that her daughter was vomiting and had diarrhea, chills and aches all over her body. On 16-APR-2021, all symptoms were gone. On 17-APR-2021, she felt sick again and had nausea and her heart rate has been fluctuating as her apple watch reading was showing readings of 49 to 159 and she was having leg pain that felt like blood vessels are bursting in her leg. On 18-APR-2021 consumer reported that her daughter was able to have breakfast and she went to work. While on the phone the daughter texted consumer that she was experiencing nausea, paleness and sweating that comes and goes along the leg pain. Consumer also reported that her daughter has bruises in her upper leg that she doesn't remember how she got it (not sure which leg). The consumer stated the daughter doesn't have an HCP but will seek medical help for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, fluttering eyes, blood pressure went up, diarrhea, vomiting, body aches, chest pain, chills, and tiredness on 16-APR-2021, had not recovered from severe leg pain, nausea, paleness, and sweating, and the outcome of felt sick, bruises in upper leg and heart rate fluctuation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436182-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per Agency and is therefore considered potentially related.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Chest pain, Chills, Contusion
Clinical narrative: PALENESS; SWEATING; HEART RATE FLUCTUATION; FELT SICK; SEVERE LEG PAIN; NAUSEA; CHILLS; DIARRHEA; VOMITING; BODY ACHES; FLUTTERING EYES; BLOOD PRESSURE WENT UP; CHEST PAIN; TIREDNESS; ANAPHYLACTIC REACTION; BRUISES IN UPPER LEG; This spontaneous report received from a consumer concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  The consumer stated that her daughter had an anaphylactic reaction to the vaccine on 12-APR-2021 and was calling to inquire if she should take her to the hospital again due to her severe leg pain. The consumer stated that on 12-APR-2021 10:30, her daughter had numbness, redness and tingling in her right cheek and her eyes were fluttering and couldn't breathe as her throat was closing up. The consumer and patient went to health system where patient received epinephrine and Benadryl and discharged within 2 hours. The consumer stated her blood pressure went up due to the epinephrine. After coming home the daughter had chest pain and was tired and kept taking Benadryl. On 13-APR-2021, consumer reported that her daughter was vomiting and had diarrhea, chills and aches all over her body. On 16-APR-2021, all symptoms were gone. On 17-APR-2021, she felt sick again and had nausea and her heart rate has been fluctuating as her apple watch reading was showing readings of 49 to 159 and she was having leg pain that felt like blood vessels are bursting in her leg. On 18-APR-2021 consumer reported that her daughter was able to have breakfast and she went to work. While on the phone the daughter texted consumer that she was experiencing nausea, paleness and sweating that comes and goes along the leg pain. Consumer also reported that her daughter has bruises in her upper leg that she doesn't remember how she got it (not sure which leg). The consumer stated the daughter doesn't have an HCP but will seek medical help for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, fluttering eyes, blood pressure went up, diarrhea, vomiting, body aches, chest pain, chills, and tiredness on 16-APR-2021, had not recovered from severe leg pain, nausea, paleness, and sweating, and the outcome of felt sick, bruises in upper leg and heart rate fluctuation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436182-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per Agency and is therefore considered potentially related.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Eye movement disorder, Fatigue, Heart rate, Heart rate abnormal
Clinical narrative: PALENESS; SWEATING; HEART RATE FLUCTUATION; FELT SICK; SEVERE LEG PAIN; NAUSEA; CHILLS; DIARRHEA; VOMITING; BODY ACHES; FLUTTERING EYES; BLOOD PRESSURE WENT UP; CHEST PAIN; TIREDNESS; ANAPHYLACTIC REACTION; BRUISES IN UPPER LEG; This spontaneous report received from a consumer concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  The consumer stated that her daughter had an anaphylactic reaction to the vaccine on 12-APR-2021 and was calling to inquire if she should take her to the hospital again due to her severe leg pain. The consumer stated that on 12-APR-2021 10:30, her daughter had numbness, redness and tingling in her right cheek and her eyes were fluttering and couldn't breathe as her throat was closing up. The consumer and patient went to health system where patient received epinephrine and Benadryl and discharged within 2 hours. The consumer stated her blood pressure went up due to the epinephrine. After coming home the daughter had chest pain and was tired and kept taking Benadryl. On 13-APR-2021, consumer reported that her daughter was vomiting and had diarrhea, chills and aches all over her body. On 16-APR-2021, all symptoms were gone. On 17-APR-2021, she felt sick again and had nausea and her heart rate has been fluctuating as her apple watch reading was showing readings of 49 to 159 and she was having leg pain that felt like blood vessels are bursting in her leg. On 18-APR-2021 consumer reported that her daughter was able to have breakfast and she went to work. While on the phone the daughter texted consumer that she was experiencing nausea, paleness and sweating that comes and goes along the leg pain. Consumer also reported that her daughter has bruises in her upper leg that she doesn't remember how she got it (not sure which leg). The consumer stated the daughter doesn't have an HCP but will seek medical help for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, fluttering eyes, blood pressure went up, diarrhea, vomiting, body aches, chest pain, chills, and tiredness on 16-APR-2021, had not recovered from severe leg pain, nausea, paleness, and sweating, and the outcome of felt sick, bruises in upper leg and heart rate fluctuation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436182-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per Agency and is therefore considered potentially related.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: PALENESS; SWEATING; HEART RATE FLUCTUATION; FELT SICK; SEVERE LEG PAIN; NAUSEA; CHILLS; DIARRHEA; VOMITING; BODY ACHES; FLUTTERING EYES; BLOOD PRESSURE WENT UP; CHEST PAIN; TIREDNESS; ANAPHYLACTIC REACTION; BRUISES IN UPPER LEG; This spontaneous report received from a consumer concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  The consumer stated that her daughter had an anaphylactic reaction to the vaccine on 12-APR-2021 and was calling to inquire if she should take her to the hospital again due to her severe leg pain. The consumer stated that on 12-APR-2021 10:30, her daughter had numbness, redness and tingling in her right cheek and her eyes were fluttering and couldn't breathe as her throat was closing up. The consumer and patient went to health system where patient received epinephrine and Benadryl and discharged within 2 hours. The consumer stated her blood pressure went up due to the epinephrine. After coming home the daughter had chest pain and was tired and kept taking Benadryl. On 13-APR-2021, consumer reported that her daughter was vomiting and had diarrhea, chills and aches all over her body. On 16-APR-2021, all symptoms were gone. On 17-APR-2021, she felt sick again and had nausea and her heart rate has been fluctuating as her apple watch reading was showing readings of 49 to 159 and she was having leg pain that felt like blood vessels are bursting in her leg. On 18-APR-2021 consumer reported that her daughter was able to have breakfast and she went to work. While on the phone the daughter texted consumer that she was experiencing nausea, paleness and sweating that comes and goes along the leg pain. Consumer also reported that her daughter has bruises in her upper leg that she doesn't remember how she got it (not sure which leg). The consumer stated the daughter doesn't have an HCP but will seek medical help for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, fluttering eyes, blood pressure went up, diarrhea, vomiting, body aches, chest pain, chills, and tiredness on 16-APR-2021, had not recovered from severe leg pain, nausea, paleness, and sweating, and the outcome of felt sick, bruises in upper leg and heart rate fluctuation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436182-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per Agency and is therefore considered potentially related.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Vomiting
Clinical narrative: PALENESS; SWEATING; HEART RATE FLUCTUATION; FELT SICK; SEVERE LEG PAIN; NAUSEA; CHILLS; DIARRHEA; VOMITING; BODY ACHES; FLUTTERING EYES; BLOOD PRESSURE WENT UP; CHEST PAIN; TIREDNESS; ANAPHYLACTIC REACTION; BRUISES IN UPPER LEG; This spontaneous report received from a consumer concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  The consumer stated that her daughter had an anaphylactic reaction to the vaccine on 12-APR-2021 and was calling to inquire if she should take her to the hospital again due to her severe leg pain. The consumer stated that on 12-APR-2021 10:30, her daughter had numbness, redness and tingling in her right cheek and her eyes were fluttering and couldn't breathe as her throat was closing up. The consumer and patient went to health system where patient received epinephrine and Benadryl and discharged within 2 hours. The consumer stated her blood pressure went up due to the epinephrine. After coming home the daughter had chest pain and was tired and kept taking Benadryl. On 13-APR-2021, consumer reported that her daughter was vomiting and had diarrhea, chills and aches all over her body. On 16-APR-2021, all symptoms were gone. On 17-APR-2021, she felt sick again and had nausea and her heart rate has been fluctuating as her apple watch reading was showing readings of 49 to 159 and she was having leg pain that felt like blood vessels are bursting in her leg. On 18-APR-2021 consumer reported that her daughter was able to have breakfast and she went to work. While on the phone the daughter texted consumer that she was experiencing nausea, paleness and sweating that comes and goes along the leg pain. Consumer also reported that her daughter has bruises in her upper leg that she doesn't remember how she got it (not sure which leg). The consumer stated the daughter doesn't have an HCP but will seek medical help for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, fluttering eyes, blood pressure went up, diarrhea, vomiting, body aches, chest pain, chills, and tiredness on 16-APR-2021, had not recovered from severe leg pain, nausea, paleness, and sweating, and the outcome of felt sick, bruises in upper leg and heart rate fluctuation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436182-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per Agency and is therefore considered potentially related.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation.  Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blindness, Blood pressure increased, Blood pressure measurement, Body temperature
Clinical narrative: This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation.  Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature decreased, Cardiovascular disorder, Chest discomfort, Cyanosis, Dysphagia
Clinical narrative: This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation.  Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Hyperhidrosis, Intracranial pressure increased, Mydriasis, Pulmonary function test
Clinical narrative: This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation.  Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus rhythm
Clinical narrative: This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation.  Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation.  Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Deafness bilateral, Ear pain, Feeling abnormal
Clinical narrative: Hearing loss in the right ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the second COVID-19 shot and had developed hearing loss in the right ear on an unspecified date. The patient was trying to get information on this effect. The patient asked if the company had any data on hearing loss, duration, remedy, etc. The patient also advised to feel free to contact him/her to help the patient and/or use him/her to help others. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Otitis media, Pyrexia
Clinical narrative: Hearing loss in the right ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the second COVID-19 shot and had developed hearing loss in the right ear on an unspecified date. The patient was trying to get information on this effect. The patient asked if the company had any data on hearing loss, duration, remedy, etc. The patient also advised to feel free to contact him/her to help the patient and/or use him/her to help others. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.