chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Night sweats, Pyrexia
Clinical narrative: Headache, Fever, NauseaVomiting, chills, night sweats Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, chills, night sweats Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema multiforme, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Erythemia Multiform & UrticariaPruritus Adverse Event Description 12/30 soreness, swelling and tenderness to injection site. 12/31 light-head until 1/7. 1/6 redness, sore, itchiness, hard lump at injection site and 1 in. below injection, took loratadine at bedtime. 1/8  redness spreading but lump is not as hard
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Erythemia Multiform & UrticariaPruritus Adverse Event Description 12/30 soreness, swelling and tenderness to injection site. 12/31 light-head until 1/7. 1/6 redness, sore, itchiness, hard lump at injection site and 1 in. below injection, took loratadine at bedtime. 1/8  redness spreading but lump is not as hard
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea Fatigue Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Headache, NauseaVomiting,  fatigue Narrative:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site discomfort, Injection site erythema, Myalgia
Clinical narrative: Myalgia discomfort/redness at injection site, chills, fatigue Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Headache, Diarrhea,  chills, fatigue, neck soreness, shoulder stiffness Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Headache, Diarrhea,  chills, fatigue, neck soreness, shoulder stiffness Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Myalgia chills, fatigue Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased interest, Disorientation, Fatigue, Headache
Clinical narrative: Headache  fatigue, disorientation, loss of interest  Narrative:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache & NauseaVomiting Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: pain, discomfort, redness at injection site Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus, none Narrative:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypertension, Scan with contrast, Tachycardia
Clinical narrative: HYPERtension & Tachycardia Narrative:  went to the emergency room when he started to feel tachycardia and his BP was 160's over 100's. Employee has a history of AAA and was observed, CT scan with contrast and released. no medicine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Apraxia, Eye swelling, Rash, Swelling face
Clinical narrative: Rash Rash on face and facial swelling  Narrative:  Developed a rash the day of the vaccine and then woke up with eye and facial swelling the following day. States he took Benadryl which helped the rash go away, but some of the swelling remains today. States it was difficult to open his eye lids first thing in the morning.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Palpitations, Paraesthesia
Clinical narrative: Dizziness, Headache, Tachycardia,  tingling Narrative:  Patient remained in clinic after her inoculation for 30 minutes. She felt fine, after home she started feeling like her heart was racing, sob, and tingling. Sent to ER. States they observed her only and asked if she had anxiety (which she does not).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Dizziness, Headache, Tachycardia,  tingling Narrative:  Patient remained in clinic after her inoculation for 30 minutes. She felt fine, after home she started feeling like her heart was racing, sob, and tingling. Sent to ER. States they observed her only and asked if she had anxiety (which she does not).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash swelling, redness at injection site Narrative:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Flushing, Headache
Clinical narrative: Headache, Arthralgia, flushing, fatigue lasting 4 days Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Narrative:
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Cannot move it; Left arm was very sore; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890719-1), reported by other health professional and concerned a 73-year-old male patient.  The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies (NKDA).  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was 279817.  On the same day, after receiving Fluad Quadrivalent, the patient's left arm was very sore, and he could not move it.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 73-year-old, female was administered Fluad Quadrivalent vaccine in the left arm. On the same day, after receiving Fluad Quadrivalent, the patient's left arm was very sore, and he could not move it. Causality is assessed as possibly related injected limb mobility decreased and pain in extremity.; Sender's Comments: A 73-year-old, female was administered Fluad Quadrivalent vaccine in the left arm. On the same day, after receiving Fluad Quadrivalent, the patient's left arm was very sore, and he could not move it. Causality is assessed as possibly related injected limb mobility decreased and pain in extremity.
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain Barre syndrome; This spontaneous case was retrieved on 22-Dec-2020, (reference number: 897370-1) reported by other health professional with additional information (being processed together) received on 28-Dec-2020 and concerned an 82-year-old male patient.  The patient's medical history included sinus polyps. The patient's concomitant medications included prednisone for unreported indication.  On 06-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 282541.  On 14-Nov-2020, eight days after receiving Fluad Quadrivalent, the patient experienced symptoms of Guillain Barre syndrome.  On an unspecified date in Nov-2020, the patient was hospitalized due to the event. Spinal tap was ordered by a neurologist and confirmed the diagnosis.  On 18-Nov-2020, the patient called pharmacy to report that he was diagnosed with Guillain Barre syndrome.  At the time of initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The event of Guillain Barre syndrome was considered to be serious due to the seriousness criteria of hospitalization and medical significance.  Company comment: A 82-years old male patient experienced Guillain-Barre syndrome 8 days after administration of Fluad Quadrivalent. The patient's medical history included sinus polyps, while concomitant medications included prednisone for unreported indication. Spinal tap was ordered by a neurologist and confirmed the diagnosis. Causality is assessed as possibly related due to chronological and biological plausibility. Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.; Sender's Comments: A 82-years old male patient experienced Guillain-Barre syndrome 8 days after administration of Fluad Quadrivalent. The patient's medical history included sinus polyps, while concomitant medications included prednisone for unreported indication. Spinal tap was ordered by a neurologist and confirmed the diagnosis. Causality is assessed as possibly related due to chronological and biological plausibility. Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) reported by other health professional and concerned a 69-year-old, female patient.  The patient's concurrent condition included allergy to Vasotec (enalapril). The patient's concomitant medications were not reported.   On 03-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported). The batch number reported was 279794.  On an unspecified day in Sep-2020, three weeks after receiving Fluad Quadrivalent, the patient developed symptoms and her doctor thought that she possibly had got Guillain-Barre syndrome. The patient was hospitalized due to event. However, no further details were not reported.   It was not reported whether the patient discharged from hospital.  The outcome of the event was unknown.   The reporter did not provide a causality assessment.  The event of Guillain-Barre syndrome was assessed as serious due to seriousness criteria of hospitalization and medical significance.  Company comment: A 69-year-old female patient developed Guillain-Barre syndrome three weeks after vaccination with the suspect product, Fluad Quadrivalent. More information regarding the underlying medical history is needed. Information regarding the diagnostic findings have not been provided. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes). Due to limited information, Brighton Collaboration criteria for Guillain-Barre syndrome could not be assessed.; Sender's Comments: A 69-year-old female patient developed Guillain-Barre syndrome three weeks after vaccination with the suspect product, Fluad Quadrivalent. More information regarding the underlying medical history is needed. Information regarding the diagnostic findings have not been provided. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes). Due to limited information, Brighton Collaboration criteria for Guillain-Barre syndrome could not be assessed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Nausea
Clinical narrative: Erytema with facial  flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Fatigue, Headache, Pyrexia
Clinical narrative: About 15 minutes after vaccine,  hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: About 15 minutes after vaccine,  hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Immune thrombocytopenia, Platelet count
Clinical narrative: Death; This is a spontaneous report from a contactable Physician. An elderly male patient received BNT162B2 (COVID vaccine), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced death in Jan2021. It was unknown if an autopsy was performed. It was unknown if any treatment was received for the event. It was unknown if the patient was diagnosed with COVID prior vaccination or if the patient had been tested for COVID post vaccination. Seriousness criteria for the event was reported as death and hospitalization.  Pfizer is a marketing authorization holder of [COVID vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.; Sender's Comments: Current information is very limited for full assessment.  Further information such medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.  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.; Reported Cause(s) of Death: Death
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a contactable Physician. An elderly male patient received BNT162B2 (COVID vaccine), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced death in Jan2021. It was unknown if an autopsy was performed. It was unknown if any treatment was received for the event. It was unknown if the patient was diagnosed with COVID prior vaccination or if the patient had been tested for COVID post vaccination. Seriousness criteria for the event was reported as death and hospitalization.  Pfizer is a marketing authorization holder of [COVID vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.; Sender's Comments: Current information is very limited for full assessment.  Further information such medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.  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.; Reported Cause(s) of Death: Death
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Muscular weakness, Neurological symptom, Paraesthesia, Peroneal nerve palsy
Clinical narrative: Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; Flu like symptoms first 3 days; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ek5730) at left arm, via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes, migraines, Eosinophilic granulomatosis with polyangiitis (EGPA) remission. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 21Dec2020, the patient experienced flu like symptoms first 3 days. Followed by neurological symptoms staring day 4, parasthesias of both upper extremity with progression to muscle weakness of all four extremities. Leading to 2 ER visits and hospital admission. Evaluation by internal medicine, neurology and rheumatology. Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The treatment for events included High dose steroid. Covid test included Nasal Swab: negative on 19Dec2020. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events influenza like illness, neurological symptom, paraesthesia, muscular weakness and peroneal nerve palsy  cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; Flu like symptoms first 3 days; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ek5730) at left arm, via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes, migraines, Eosinophilic granulomatosis with polyangiitis (EGPA) remission. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 21Dec2020, the patient experienced flu like symptoms first 3 days. Followed by neurological symptoms staring day 4, parasthesias of both upper extremity with progression to muscle weakness of all four extremities. Leading to 2 ER visits and hospital admission. Evaluation by internal medicine, neurology and rheumatology. Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The treatment for events included High dose steroid. Covid test included Nasal Swab: negative on 19Dec2020. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events influenza like illness, neurological symptom, paraesthesia, muscular weakness and peroneal nerve palsy  cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Lip pruritus, Pruritus, Swollen tongue
Clinical narrative: Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw.  Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring.  Received 4 days of Prednisone and Pepcid PO.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Oedema mucosal, Oxygen saturation decreased
Clinical narrative: 5pm injection, felt fine. 505pm hr 150s, chest tight, winded, no rash- BP 140s/70s and sat upper 90s.   515 HR 120s-140s and felt slightly better.  520pm HR back up to 150s w chest tighness so pt taken to local ER.  In wait room FR 140s plus, sat dropped to mid 80s and mucosal sweeling (tongue/oral mucosa) Sat in ER wait room 5 more min then taken back, tx w steroid injection, benadryl iv  then medrol dose pack at dc     observed in ER a few hours
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: 5pm injection, felt fine. 505pm hr 150s, chest tight, winded, no rash- BP 140s/70s and sat upper 90s.   515 HR 120s-140s and felt slightly better.  520pm HR back up to 150s w chest tighness so pt taken to local ER.  In wait room FR 140s plus, sat dropped to mid 80s and mucosal sweeling (tongue/oral mucosa) Sat in ER wait room 5 more min then taken back, tx w steroid injection, benadryl iv  then medrol dose pack at dc     observed in ER a few hours
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Urgent care. 36 hours after vaccination I have fever of 102.8. Horrible headache, chills, extreme fatigue.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Paraesthesia, Pyrexia
Clinical narrative: Tingling up and down spine 24 hrs later next day mild tingling a change in sensation like cold up down spine resolved  by the next day  28,  December 2020. Felt body chills and feverish and fatigue . By 12/29/2020 felt fine.  Last week had a lot of fatigue, and  sleepiness varius. ER on Sunday, 12/27/2020  not concern though it to be a immune response.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Tingling up and down spine 24 hrs later next day mild tingling a change in sensation like cold up down spine resolved  by the next day  28,  December 2020. Felt body chills and feverish and fatigue . By 12/29/2020 felt fine.  Last week had a lot of fatigue, and  sleepiness varius. ER on Sunday, 12/27/2020  not concern though it to be a immune response.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Sudden and rapid onset of generalized Urticaria accompanied by dyspnea; sudden and rapid onset of generalized uritcaria accompanied by dyspnea; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular on 30Dec2020 11:00 at single dose at right arm for covid-19 immunization. Medical history included Grave's dse, psoriasis, bronchial asthma. Concomitant medication in two weeks included propranolol, methimazole, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), colecalciferol (VITAMIN D). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took adalimumab and experienced drug allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. 9hrs post-vaccine, patient developed sudden and rapid onset of generalized uritcaria accompanied by dyspnea on 30Dec2020 20:00 with outcome of recovered with sequelae. Adverse events resulted in emergency room/department or urgent care. Patient received intramuscular epinephrine, intravenous solumedrol & benadryl, and oral prednisone x5 for events. This report is considered as non-serious.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events urticaria and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Face oedema, Flushing, Pruritus
Clinical narrative: Sudden and rapid onset of generalized Urticaria accompanied by dyspnea; sudden and rapid onset of generalized uritcaria accompanied by dyspnea; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular on 30Dec2020 11:00 at single dose at right arm for covid-19 immunization. Medical history included Grave's dse, psoriasis, bronchial asthma. Concomitant medication in two weeks included propranolol, methimazole, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), colecalciferol (VITAMIN D). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took adalimumab and experienced drug allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. 9hrs post-vaccine, patient developed sudden and rapid onset of generalized uritcaria accompanied by dyspnea on 30Dec2020 20:00 with outcome of recovered with sequelae. Adverse events resulted in emergency room/department or urgent care. Patient received intramuscular epinephrine, intravenous solumedrol & benadryl, and oral prednisone x5 for events. This report is considered as non-serious.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events urticaria and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Sudden and rapid onset of generalized Urticaria accompanied by dyspnea; sudden and rapid onset of generalized uritcaria accompanied by dyspnea; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular on 30Dec2020 11:00 at single dose at right arm for covid-19 immunization. Medical history included Grave's dse, psoriasis, bronchial asthma. Concomitant medication in two weeks included propranolol, methimazole, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), colecalciferol (VITAMIN D). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took adalimumab and experienced drug allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. 9hrs post-vaccine, patient developed sudden and rapid onset of generalized uritcaria accompanied by dyspnea on 30Dec2020 20:00 with outcome of recovered with sequelae. Adverse events resulted in emergency room/department or urgent care. Patient received intramuscular epinephrine, intravenous solumedrol & benadryl, and oral prednisone x5 for events. This report is considered as non-serious.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events urticaria and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Hot flush, Pruritus, Throat irritation
Clinical narrative: Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100.  Taken to the ER, received epinephrine breathing treatment and Benadryl  Observed for 2 hours then discharged.  Slept most of the following day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Oral pruritus, Oropharyngeal pain, Pruritus, Somnolence
Clinical narrative: Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100.  Taken to the ER, received epinephrine breathing treatment and Benadryl  Observed for 2 hours then discharged.  Slept most of the following day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Wheezing
Clinical narrative: Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100.  Taken to the ER, received epinephrine breathing treatment and Benadryl  Observed for 2 hours then discharged.  Slept most of the following day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: The lip starting ripping and the face started itching; The lip starting ripping and the face started itching; It started spreading from the ear to the neck, it started itching bad and getting hive in that area; having trouble in breathing because it was swelling up; having trouble in breathing because it was swelling up; The lip was swelled to red and then it started to going up the jaw; The lip was swelled to red and then it started to going up the jaw; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1686, expiration date: Mar2021) via an unspecified route of administration on the arm right in Dec2020 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high.  Concomitant medication included lisinopril taken for blood pressure high. The patient had the BNT162B2 on Thursday morning (Dec2020) and Thursday evening the patient had a reaction to that, the lip was swelled to red and then it started to going up the jaw. So the next day it was in the jaw and in the lip and then the lip starting ripping and the face started itching and that's didn't go away and then yesterday it started spreading from the ear to the neck, it started itching bad and getting hive in that area. The patient went to the emergency room, consumer stated that she had nurse practitioner that called her on a steroid (treatment). The consumer stated, "the thing she called her also in an Epi Pen in case she has started having trouble in breathing because it was swelling up. The patient didn't have to end up using that but she just has to use in case she has". Treatment was received for the events. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chapped lips, Erythema, Lip erythema, Lip swelling, Pruritus
Clinical narrative: The lip starting ripping and the face started itching; The lip starting ripping and the face started itching; It started spreading from the ear to the neck, it started itching bad and getting hive in that area; having trouble in breathing because it was swelling up; having trouble in breathing because it was swelling up; The lip was swelled to red and then it started to going up the jaw; The lip was swelled to red and then it started to going up the jaw; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1686, expiration date: Mar2021) via an unspecified route of administration on the arm right in Dec2020 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high.  Concomitant medication included lisinopril taken for blood pressure high. The patient had the BNT162B2 on Thursday morning (Dec2020) and Thursday evening the patient had a reaction to that, the lip was swelled to red and then it started to going up the jaw. So the next day it was in the jaw and in the lip and then the lip starting ripping and the face started itching and that's didn't go away and then yesterday it started spreading from the ear to the neck, it started itching bad and getting hive in that area. The patient went to the emergency room, consumer stated that she had nurse practitioner that called her on a steroid (treatment). The consumer stated, "the thing she called her also in an Epi Pen in case she has started having trouble in breathing because it was swelling up. The patient didn't have to end up using that but she just has to use in case she has". Treatment was received for the events. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: The lip starting ripping and the face started itching; The lip starting ripping and the face started itching; It started spreading from the ear to the neck, it started itching bad and getting hive in that area; having trouble in breathing because it was swelling up; having trouble in breathing because it was swelling up; The lip was swelled to red and then it started to going up the jaw; The lip was swelled to red and then it started to going up the jaw; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1686, expiration date: Mar2021) via an unspecified route of administration on the arm right in Dec2020 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high.  Concomitant medication included lisinopril taken for blood pressure high. The patient had the BNT162B2 on Thursday morning (Dec2020) and Thursday evening the patient had a reaction to that, the lip was swelled to red and then it started to going up the jaw. So the next day it was in the jaw and in the lip and then the lip starting ripping and the face started itching and that's didn't go away and then yesterday it started spreading from the ear to the neck, it started itching bad and getting hive in that area. The patient went to the emergency room, consumer stated that she had nurse practitioner that called her on a steroid (treatment). The consumer stated, "the thing she called her also in an Epi Pen in case she has started having trouble in breathing because it was swelling up. The patient didn't have to end up using that but she just has to use in case she has". Treatment was received for the events. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Dizziness, Flushing
Clinical narrative: chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included asthma and  gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough.  The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Presyncope, Pruritus
Clinical narrative: chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included asthma and  gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough.  The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Cough, Dizziness, Electrocardiogram normal
Clinical narrative: chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included asthma and  gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough.  The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.