chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish; Chills; Warm body; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 11:00 at single dose for covid-19 immunization. Medical history included asthma. Concomitant medication included salbutamol sulfate (PROVENTIL) for asthma. Patient previously took first dose of bnt162b2 on 30Dec2020 at single dose for covid-19 immunization. Patient got second vaccination on 18Jan2021 and may be around about 11 O'clock on same day patient felt to have a body ache all over which patient knew it was normal. However, it was getting worse throughout the day. And patient couldn't even get up and went to work. Also have very bad headache and patient blood pressure was 140/100. For about 3 hours patient did had left leg swell and caused severe pain in toes, that just subsided. Patient didn't have a fever but patient feel feverish, chills, warm body. Patient had been taking Ibuprofen on and off as treatment. Outcome of events left leg swell and caused severe pain in toes were recovering, and outcome of other events was unknown.    Information about Lot/Batch number is requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: lymph nodes swelled, swelling went away 1/26. Pain behind ears and facial numbness continues.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Hypoaesthesia, Lymphadenopathy
Clinical narrative: lymph nodes swelled, swelling went away 1/26. Pain behind ears and facial numbness continues.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Nausea, Throat tightness
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphasia, Arthralgia, Chest pain, Chills
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Diarrhoea, Differential white blood cell count, Dyspnoea, Electrocardiogram
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Full blood count, Loss of consciousness, Metabolic function test, Migraine
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pharyngeal swelling, Pyrexia
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Vomiting
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphasia, Apparent life threatening event, Arthralgia, Chest discomfort
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypotension, Injection site pain, Injection site swelling, Loss of consciousness
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased, Nausea, Pain
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pyrexia, Speech disorder
Clinical narrative: Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional.  A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies.  On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Myalgia, Rash maculo-papular
Clinical narrative: Hives or rash from topof head to bottom of feet very hot to touch very itchy.low grade temp
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: Hives or rash from topof head to bottom of feet very hot to touch very itchy.low grade temp
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Oral discomfort, Rash
Clinical narrative: Vaccinated at 1:20 PM on 1/26/2021. Approximately 15 min later I was in the waiting area, the nurse had been pre-notified to watch me for allergic reaction . In 15 minutes my symptoms were fast heart rate, lips burning, dark red facial flushing, ears flushing, and anterior neck flush, body tremors, a rapid response team notified to evaluate me. I was administered a 25 mg  Benadryl tablet per mouth.  I felt stabilized and chose to go to the ER within the building for further evaluation.  Remaining stabilized, had a 4 hour wait until I was seen by emergency staff. My treatment was Solumedrol IV, Pepcid IV and Benadryl 25 mg po. I was placed on a heart monitor and a pulse oximeter to check my oxygen levels the entire time I was in the ER. 4 hours prior to being seen by the ER doctors I had a CBC, a BMP blood work, and an EKG. After medications were administered I was observed approximately 1.5-2 hours. I was discharged with a 5 day medicine regimen to follow. Prednisone 40 mg per day; Pepcid 40 mg per day; Benadryl 25 mg every 6 hours. On 1/27 I chose to take the Benadryl 25 mg only because I had received the Pepcid and Prednisone the previous night late. On the 28th I took the medicine as prescribed but only took Benadryl every 12 hours. I felt Benadryl 4 times a day would not be handled well with my body. On 1/30 I was able to take the Pepcid and Prednisone but had to discontinue the Benadryl due to waking up with a spinning sensation upon opening eyes and a loss of equilibrium upon walking. I completed my medicine regimen on 2/1. Today 2/2 I woke up with symptoms of watery eyes, flushed face, mild facial itching, after drinking one cup of full caffeine coffee developed an increased heart rate and nervousness, was medicated with Benadryl 25 mg po at 10:00 AM along with my blood pressure medicine and potassium. Also at that time my blood pressure was 150/80. Three hours later my blood pressure had come down to 130s/60s but felt extreme weakness and felt the need to lay down and rest with legs elevated.  I continue with my day with increased heart rate with activity, so I have remained inactive for the rest of the day.   Also on 6:00 AM on 1/27 I was awakened with a heart rate In the 160s, I called 911, paramedics came 5 minutes later. On arrival my heart rate had instantly went down to the  112-120 range. The paramedics explained they have been treating COVID patients and have seen this a lot, we discussed going to the hospital but I felt I was stabilized and didn't need further treatment.   Also upon discharge from ER visit they had me get 2 epi-pens and I now have 2 epi-pens available at home.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Ear discomfort, Electrocardiogram, Flushing
Clinical narrative: Vaccinated at 1:20 PM on 1/26/2021. Approximately 15 min later I was in the waiting area, the nurse had been pre-notified to watch me for allergic reaction . In 15 minutes my symptoms were fast heart rate, lips burning, dark red facial flushing, ears flushing, and anterior neck flush, body tremors, a rapid response team notified to evaluate me. I was administered a 25 mg  Benadryl tablet per mouth.  I felt stabilized and chose to go to the ER within the building for further evaluation.  Remaining stabilized, had a 4 hour wait until I was seen by emergency staff. My treatment was Solumedrol IV, Pepcid IV and Benadryl 25 mg po. I was placed on a heart monitor and a pulse oximeter to check my oxygen levels the entire time I was in the ER. 4 hours prior to being seen by the ER doctors I had a CBC, a BMP blood work, and an EKG. After medications were administered I was observed approximately 1.5-2 hours. I was discharged with a 5 day medicine regimen to follow. Prednisone 40 mg per day; Pepcid 40 mg per day; Benadryl 25 mg every 6 hours. On 1/27 I chose to take the Benadryl 25 mg only because I had received the Pepcid and Prednisone the previous night late. On the 28th I took the medicine as prescribed but only took Benadryl every 12 hours. I felt Benadryl 4 times a day would not be handled well with my body. On 1/30 I was able to take the Pepcid and Prednisone but had to discontinue the Benadryl due to waking up with a spinning sensation upon opening eyes and a loss of equilibrium upon walking. I completed my medicine regimen on 2/1. Today 2/2 I woke up with symptoms of watery eyes, flushed face, mild facial itching, after drinking one cup of full caffeine coffee developed an increased heart rate and nervousness, was medicated with Benadryl 25 mg po at 10:00 AM along with my blood pressure medicine and potassium. Also at that time my blood pressure was 150/80. Three hours later my blood pressure had come down to 130s/60s but felt extreme weakness and felt the need to lay down and rest with legs elevated.  I continue with my day with increased heart rate with activity, so I have remained inactive for the rest of the day.   Also on 6:00 AM on 1/27 I was awakened with a heart rate In the 160s, I called 911, paramedics came 5 minutes later. On arrival my heart rate had instantly went down to the  112-120 range. The paramedics explained they have been treating COVID patients and have seen this a lot, we discussed going to the hospital but I felt I was stabilized and didn't need further treatment.   Also upon discharge from ER visit they had me get 2 epi-pens and I now have 2 epi-pens available at home.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Heart rate increased, Laboratory test, Lacrimation increased, Nervousness
Clinical narrative: Vaccinated at 1:20 PM on 1/26/2021. Approximately 15 min later I was in the waiting area, the nurse had been pre-notified to watch me for allergic reaction . In 15 minutes my symptoms were fast heart rate, lips burning, dark red facial flushing, ears flushing, and anterior neck flush, body tremors, a rapid response team notified to evaluate me. I was administered a 25 mg  Benadryl tablet per mouth.  I felt stabilized and chose to go to the ER within the building for further evaluation.  Remaining stabilized, had a 4 hour wait until I was seen by emergency staff. My treatment was Solumedrol IV, Pepcid IV and Benadryl 25 mg po. I was placed on a heart monitor and a pulse oximeter to check my oxygen levels the entire time I was in the ER. 4 hours prior to being seen by the ER doctors I had a CBC, a BMP blood work, and an EKG. After medications were administered I was observed approximately 1.5-2 hours. I was discharged with a 5 day medicine regimen to follow. Prednisone 40 mg per day; Pepcid 40 mg per day; Benadryl 25 mg every 6 hours. On 1/27 I chose to take the Benadryl 25 mg only because I had received the Pepcid and Prednisone the previous night late. On the 28th I took the medicine as prescribed but only took Benadryl every 12 hours. I felt Benadryl 4 times a day would not be handled well with my body. On 1/30 I was able to take the Pepcid and Prednisone but had to discontinue the Benadryl due to waking up with a spinning sensation upon opening eyes and a loss of equilibrium upon walking. I completed my medicine regimen on 2/1. Today 2/2 I woke up with symptoms of watery eyes, flushed face, mild facial itching, after drinking one cup of full caffeine coffee developed an increased heart rate and nervousness, was medicated with Benadryl 25 mg po at 10:00 AM along with my blood pressure medicine and potassium. Also at that time my blood pressure was 150/80. Three hours later my blood pressure had come down to 130s/60s but felt extreme weakness and felt the need to lay down and rest with legs elevated.  I continue with my day with increased heart rate with activity, so I have remained inactive for the rest of the day.   Also on 6:00 AM on 1/27 I was awakened with a heart rate In the 160s, I called 911, paramedics came 5 minutes later. On arrival my heart rate had instantly went down to the  112-120 range. The paramedics explained they have been treating COVID patients and have seen this a lot, we discussed going to the hospital but I felt I was stabilized and didn't need further treatment.   Also upon discharge from ER visit they had me get 2 epi-pens and I now have 2 epi-pens available at home.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral discomfort, Palpitations, Pruritus, Tremor, Vertigo
Clinical narrative: Vaccinated at 1:20 PM on 1/26/2021. Approximately 15 min later I was in the waiting area, the nurse had been pre-notified to watch me for allergic reaction . In 15 minutes my symptoms were fast heart rate, lips burning, dark red facial flushing, ears flushing, and anterior neck flush, body tremors, a rapid response team notified to evaluate me. I was administered a 25 mg  Benadryl tablet per mouth.  I felt stabilized and chose to go to the ER within the building for further evaluation.  Remaining stabilized, had a 4 hour wait until I was seen by emergency staff. My treatment was Solumedrol IV, Pepcid IV and Benadryl 25 mg po. I was placed on a heart monitor and a pulse oximeter to check my oxygen levels the entire time I was in the ER. 4 hours prior to being seen by the ER doctors I had a CBC, a BMP blood work, and an EKG. After medications were administered I was observed approximately 1.5-2 hours. I was discharged with a 5 day medicine regimen to follow. Prednisone 40 mg per day; Pepcid 40 mg per day; Benadryl 25 mg every 6 hours. On 1/27 I chose to take the Benadryl 25 mg only because I had received the Pepcid and Prednisone the previous night late. On the 28th I took the medicine as prescribed but only took Benadryl every 12 hours. I felt Benadryl 4 times a day would not be handled well with my body. On 1/30 I was able to take the Pepcid and Prednisone but had to discontinue the Benadryl due to waking up with a spinning sensation upon opening eyes and a loss of equilibrium upon walking. I completed my medicine regimen on 2/1. Today 2/2 I woke up with symptoms of watery eyes, flushed face, mild facial itching, after drinking one cup of full caffeine coffee developed an increased heart rate and nervousness, was medicated with Benadryl 25 mg po at 10:00 AM along with my blood pressure medicine and potassium. Also at that time my blood pressure was 150/80. Three hours later my blood pressure had come down to 130s/60s but felt extreme weakness and felt the need to lay down and rest with legs elevated.  I continue with my day with increased heart rate with activity, so I have remained inactive for the rest of the day.   Also on 6:00 AM on 1/27 I was awakened with a heart rate In the 160s, I called 911, paramedics came 5 minutes later. On arrival my heart rate had instantly went down to the  112-120 range. The paramedics explained they have been treating COVID patients and have seen this a lot, we discussed going to the hospital but I felt I was stabilized and didn't need further treatment.   Also upon discharge from ER visit they had me get 2 epi-pens and I now have 2 epi-pens available at home.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, COVID-19 pneumonia, Cardiomyopathy, Cardioversion, Central venous catheterisation
Clinical narrative: cardiac arrest; turned blue became unresponsive; V-fib; bradycardia; difficulty breathing; junctional rhythm; This is a spontaneous report from a contactable physician. A 65-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EL3302) intramuscular on the left arm on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included CABG 3 years before, gastric bypass, HTN and HLP. Cobcomitant medications were not reported. The patient received vaccine on 18Jan2021 in morning. Reported difficulty breathing while in bed to his wife later that night, turned blue became unresponsive. 911 called, received CPR w/ multiple defibrillation for V-fib; between ER and CMS had 9 rounds of epi, amiodarone 150 and 300 mg before becoming stable with bradycardia/junctional rhythm. On 18Jan2021, EKG did not show STEMI; cardiac enzymes nml; echo: severe cardiomyopathy w/ LVEF 20%; CTA chest: no Pulmonary embolism; B extensive airspace consolidation, cannot exclude pneumonia; CXR: Extensive opacity R upper lobe and diffuse opacities throughout L hemithorax, are nonspecific. Patient went into terminal VFib arrest and pronounced dead 01:53 of 19Jan2021. No autopsy was performed. Cause of death was cardiac arrest. Junctional rhythm and bradycardia recovered in Jan2021. Outcome of difficulty breathing and V-fib was unknown.; Reported Cause(s) of Death: cardiac arrest
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Conduction disorder, Cyanosis, Death, Dyspnoea
Clinical narrative: cardiac arrest; turned blue became unresponsive; V-fib; bradycardia; difficulty breathing; junctional rhythm; This is a spontaneous report from a contactable physician. A 65-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EL3302) intramuscular on the left arm on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included CABG 3 years before, gastric bypass, HTN and HLP. Cobcomitant medications were not reported. The patient received vaccine on 18Jan2021 in morning. Reported difficulty breathing while in bed to his wife later that night, turned blue became unresponsive. 911 called, received CPR w/ multiple defibrillation for V-fib; between ER and CMS had 9 rounds of epi, amiodarone 150 and 300 mg before becoming stable with bradycardia/junctional rhythm. On 18Jan2021, EKG did not show STEMI; cardiac enzymes nml; echo: severe cardiomyopathy w/ LVEF 20%; CTA chest: no Pulmonary embolism; B extensive airspace consolidation, cannot exclude pneumonia; CXR: Extensive opacity R upper lobe and diffuse opacities throughout L hemithorax, are nonspecific. Patient went into terminal VFib arrest and pronounced dead 01:53 of 19Jan2021. No autopsy was performed. Cause of death was cardiac arrest. Junctional rhythm and bradycardia recovered in Jan2021. Outcome of difficulty breathing and V-fib was unknown.; Reported Cause(s) of Death: cardiac arrest