chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Injection site rash, Oral discomfort, Oropharyngeal discomfort
Clinical narrative: Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline.  1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms.  No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath.  1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine.  1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation.  At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit.  1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal swelling, Rash, Rash pruritic, Swollen tongue
Clinical narrative: Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline.  1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms.  No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath.  1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine.  1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation.  At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit.  1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Headache, Hypertension, Nausea
Clinical narrative: Pt has h/o HTN (not on medication) and occasional asthma(no hospitalizations), and allergies to Penicillin (tongue swelling), tree nuts (throat swelling), and Bees (local swelling); Pt notes she only takes benadryl for these reactions; she has never been prescribed or used epinephrine. Pt denies heart disease, strokes, diabetes, increased bleeding tendency. No early heart disease in family. LMP in the last week. Pt notes she was supposed to see allergist in past, but has not. Pt was feeling well this morning before she came to COVID vaccine clinic. Pt had received first Moderna Vaccine shortly before 0918am here. At 0938 Pt noted feeling "heaviness" in head and "lump in throat." Pt denied itching/swelling to mouth, itching/hives to body, dyspnea, chest pain, nausea. No lightheadedness/dizziness. Pt walked to stretcher. BP at right forearm was 223/151 and then 221/132 on repeat. Heartrate in 90s. Sao2 on RA 100%. RR 18. Pt notes having high BPs at times, but not often as high here. Pt speaking is slightly hoarse voice. No strider. Pt speaking in full sentences. No oropharyngeal edema. No urticaria. No tachypnea or wheeze. HRT RRR. 2+ left rad pulse.  A/P: given Pt's h/o severe allergies and now new Globus sensation and change to voice I discussed with Pt that she was likely having allergic reaction. Given involvement of airway I recommended epi administration to neutralize reaction and transfer to ED for observation. I advised Pt that epi would increase heartrate and blood pressure. I determined benefit of treating anaphylaxis outweighed risk of elevating BP, even though she has hypertensive urgency BP values. Pt has some headache; she could be bordering on hypertensive emergency. I asked pharmacist to call 911 indicating early anaphylaxis and request of paramedic.  ~5 minutes after Epi (given at 0942) Pt notes lump sensation and voice improved. I had RN place IV to left AC and gave verbal order for benadryl 25mg IV. Pt notes some nausea and dizziness. Lump sensation continues to improve. EMS arrived ~0950. I gave report to paramedic.  I discussed with Pt that I would place referral to Allergy and Immunology; they will determine if and when Pt could receive second moderna vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: Pt has h/o HTN (not on medication) and occasional asthma(no hospitalizations), and allergies to Penicillin (tongue swelling), tree nuts (throat swelling), and Bees (local swelling); Pt notes she only takes benadryl for these reactions; she has never been prescribed or used epinephrine. Pt denies heart disease, strokes, diabetes, increased bleeding tendency. No early heart disease in family. LMP in the last week. Pt notes she was supposed to see allergist in past, but has not. Pt was feeling well this morning before she came to COVID vaccine clinic. Pt had received first Moderna Vaccine shortly before 0918am here. At 0938 Pt noted feeling "heaviness" in head and "lump in throat." Pt denied itching/swelling to mouth, itching/hives to body, dyspnea, chest pain, nausea. No lightheadedness/dizziness. Pt walked to stretcher. BP at right forearm was 223/151 and then 221/132 on repeat. Heartrate in 90s. Sao2 on RA 100%. RR 18. Pt notes having high BPs at times, but not often as high here. Pt speaking is slightly hoarse voice. No strider. Pt speaking in full sentences. No oropharyngeal edema. No urticaria. No tachypnea or wheeze. HRT RRR. 2+ left rad pulse.  A/P: given Pt's h/o severe allergies and now new Globus sensation and change to voice I discussed with Pt that she was likely having allergic reaction. Given involvement of airway I recommended epi administration to neutralize reaction and transfer to ED for observation. I advised Pt that epi would increase heartrate and blood pressure. I determined benefit of treating anaphylaxis outweighed risk of elevating BP, even though she has hypertensive urgency BP values. Pt has some headache; she could be bordering on hypertensive emergency. I asked pharmacist to call 911 indicating early anaphylaxis and request of paramedic.  ~5 minutes after Epi (given at 0942) Pt notes lump sensation and voice improved. I had RN place IV to left AC and gave verbal order for benadryl 25mg IV. Pt notes some nausea and dizziness. Lump sensation continues to improve. EMS arrived ~0950. I gave report to paramedic.  I discussed with Pt that I would place referral to Allergy and Immunology; they will determine if and when Pt could receive second moderna vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphonia, Head discomfort, Headache
Clinical narrative: Pt has h/o HTN (not on medication) and occasional asthma(no hospitalizations), and allergies to Penicillin (tongue swelling), tree nuts (throat swelling), and Bees (local swelling); Pt notes she only takes benadryl for these reactions; she has never been prescribed or used epinephrine. Pt denies heart disease, strokes, diabetes, increased bleeding tendency. No early heart disease in family. LMP in the last week. Pt notes she was supposed to see allergist in past, but has not. Pt was feeling well this morning before she came to COVID vaccine clinic. Pt had received first Moderna Vaccine shortly before 0918am here. At 0938 Pt noted feeling "heaviness" in head and "lump in throat." Pt denied itching/swelling to mouth, itching/hives to body, dyspnea, chest pain, nausea. No lightheadedness/dizziness. Pt walked to stretcher. BP at right forearm was 223/151 and then 221/132 on repeat. Heartrate in 90s. Sao2 on RA 100%. RR 18. Pt notes having high BPs at times, but not often as high here. Pt speaking is slightly hoarse voice. No strider. Pt speaking in full sentences. No oropharyngeal edema. No urticaria. No tachypnea or wheeze. HRT RRR. 2+ left rad pulse.  A/P: given Pt's h/o severe allergies and now new Globus sensation and change to voice I discussed with Pt that she was likely having allergic reaction. Given involvement of airway I recommended epi administration to neutralize reaction and transfer to ED for observation. I advised Pt that epi would increase heartrate and blood pressure. I determined benefit of treating anaphylaxis outweighed risk of elevating BP, even though she has hypertensive urgency BP values. Pt has some headache; she could be bordering on hypertensive emergency. I asked pharmacist to call 911 indicating early anaphylaxis and request of paramedic.  ~5 minutes after Epi (given at 0942) Pt notes lump sensation and voice improved. I had RN place IV to left AC and gave verbal order for benadryl 25mg IV. Pt notes some nausea and dizziness. Lump sensation continues to improve. EMS arrived ~0950. I gave report to paramedic.  I discussed with Pt that I would place referral to Allergy and Immunology; they will determine if and when Pt could receive second moderna vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Sensation of foreign body
Clinical narrative: Pt has h/o HTN (not on medication) and occasional asthma(no hospitalizations), and allergies to Penicillin (tongue swelling), tree nuts (throat swelling), and Bees (local swelling); Pt notes she only takes benadryl for these reactions; she has never been prescribed or used epinephrine. Pt denies heart disease, strokes, diabetes, increased bleeding tendency. No early heart disease in family. LMP in the last week. Pt notes she was supposed to see allergist in past, but has not. Pt was feeling well this morning before she came to COVID vaccine clinic. Pt had received first Moderna Vaccine shortly before 0918am here. At 0938 Pt noted feeling "heaviness" in head and "lump in throat." Pt denied itching/swelling to mouth, itching/hives to body, dyspnea, chest pain, nausea. No lightheadedness/dizziness. Pt walked to stretcher. BP at right forearm was 223/151 and then 221/132 on repeat. Heartrate in 90s. Sao2 on RA 100%. RR 18. Pt notes having high BPs at times, but not often as high here. Pt speaking is slightly hoarse voice. No strider. Pt speaking in full sentences. No oropharyngeal edema. No urticaria. No tachypnea or wheeze. HRT RRR. 2+ left rad pulse.  A/P: given Pt's h/o severe allergies and now new Globus sensation and change to voice I discussed with Pt that she was likely having allergic reaction. Given involvement of airway I recommended epi administration to neutralize reaction and transfer to ED for observation. I advised Pt that epi would increase heartrate and blood pressure. I determined benefit of treating anaphylaxis outweighed risk of elevating BP, even though she has hypertensive urgency BP values. Pt has some headache; she could be bordering on hypertensive emergency. I asked pharmacist to call 911 indicating early anaphylaxis and request of paramedic.  ~5 minutes after Epi (given at 0942) Pt notes lump sensation and voice improved. I had RN place IV to left AC and gave verbal order for benadryl 25mg IV. Pt notes some nausea and dizziness. Lump sensation continues to improve. EMS arrived ~0950. I gave report to paramedic.  I discussed with Pt that I would place referral to Allergy and Immunology; they will determine if and when Pt could receive second moderna vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Numbness and tingling (parathesia) in both legs from hips to balls of heels which started 32 hours after vaccine, Pfizer Covid vaccine #2.    12 hours after vaccine hip/groin pain, but resolved prior to parathesia.  No more hip pain.  Parathesia lasted 2 full weeks, but now is current intermittent in occurance, worse at 2 AM while skeeping.  Parathesia currently from knees to balls of heels, mainly in back of knees.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood thyroid stimulating hormone decreased, C-reactive protein increased, Full blood count normal, Groin pain
Clinical narrative: Numbness and tingling (parathesia) in both legs from hips to balls of heels which started 32 hours after vaccine, Pfizer Covid vaccine #2.    12 hours after vaccine hip/groin pain, but resolved prior to parathesia.  No more hip pain.  Parathesia lasted 2 full weeks, but now is current intermittent in occurance, worse at 2 AM while skeeping.  Parathesia currently from knees to balls of heels, mainly in back of knees.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Numbness and tingling (parathesia) in both legs from hips to balls of heels which started 32 hours after vaccine, Pfizer Covid vaccine #2.    12 hours after vaccine hip/groin pain, but resolved prior to parathesia.  No more hip pain.  Parathesia lasted 2 full weeks, but now is current intermittent in occurance, worse at 2 AM while skeeping.  Parathesia currently from knees to balls of heels, mainly in back of knees.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: 12/30 vaccination 1/7 1:20 The injections site was very red, swollen, firm to touch, hurting. Radiated to shoulder. That night and next day, I was very lethargic, nausea.  1/8 Saw Dr. I was taking Benadryl. I did have HA. Prescribed prednisone but didn't take.  1 1/2" oval redness wide, 3" long
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Musculoskeletal stiffness, Nausea
Clinical narrative: 12/30 vaccination 1/7 1:20 The injections site was very red, swollen, firm to touch, hurting. Radiated to shoulder. That night and next day, I was very lethargic, nausea.  1/8 Saw Dr. I was taking Benadryl. I did have HA. Prescribed prednisone but didn't take.  1 1/2" oval redness wide, 3" long
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 12/30 vaccination 1/7 1:20 The injections site was very red, swollen, firm to touch, hurting. Radiated to shoulder. That night and next day, I was very lethargic, nausea.  1/8 Saw Dr. I was taking Benadryl. I did have HA. Prescribed prednisone but didn't take.  1 1/2" oval redness wide, 3" long
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Lethargy, Nausea, Pain
Clinical narrative: 12/30 vaccination 1/7 1:20 The injections site was very red, swollen, firm to touch, hurting. Radiated to shoulder. That night and next day, I was very lethargic, nausea.  1/8 Saw Dr. I was taking Benadryl. I did have HA. Prescribed prednisone but didn't take.  1 1/2" oval redness wide, 3" long
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Tunnel vision, Urinary incontinence, Vomiting
Clinical narrative: Syncope; Passed out within minutes of second dose.; Urination and emesis upon waking up; Urination and emesis upon waking up; This is a spontaneous report from a contactable Pharmacist (patient). A 26-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 26-year-old) on 17Jan2021 at 09:30 AM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 at 09:30 AM via an unspecified route of administration in Left arm (at age of 26-year-old) for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 17Jan2021 at 09:45 AM patient experienced syncope. Passed out within minutes of second dose. Urination and emesis upon waking up. Brought to hospital, given 1L nacl and 1 dose of ondansetron (ZOFRAN). Events considered serious due to hospitalization. Events resulted in Emergency room/ department or urgent care. Patient was treated with fluids and ondansetron (ZOFRAN). Patient was not tested for Covid post vaccination. Patient recovered from the events on unknown date.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Micturition disorder, Syncope, Vomiting
Clinical narrative: Syncope; Passed out within minutes of second dose.; Urination and emesis upon waking up; Urination and emesis upon waking up; This is a spontaneous report from a contactable Pharmacist (patient). A 26-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 26-year-old) on 17Jan2021 at 09:30 AM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 at 09:30 AM via an unspecified route of administration in Left arm (at age of 26-year-old) for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 17Jan2021 at 09:45 AM patient experienced syncope. Passed out within minutes of second dose. Urination and emesis upon waking up. Brought to hospital, given 1L nacl and 1 dose of ondansetron (ZOFRAN). Events considered serious due to hospitalization. Events resulted in Emergency room/ department or urgent care. Patient was treated with fluids and ondansetron (ZOFRAN). Patient was not tested for Covid post vaccination. Patient recovered from the events on unknown date.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Disseminated intravascular coagulation, Electrocardiogram, Feeling hot, Motion sickness
Clinical narrative: 37 YEAR OLD FEMALE STARTED EXPERIENCING GENERALIZED ANXIETY. ONSITE EMS WAS REQESTED.  BP 124/80 HR 71  100%O2 ON ROOM AIR. SHE WAS EVALUATED BY EMS AND ONSITE PHYSICIAN AND TRANSPORTED TO A LOCAL HOSPITAL.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Palpitations, Throat tightness
Clinical narrative: 37 YEAR OLD FEMALE STARTED EXPERIENCING GENERALIZED ANXIETY. ONSITE EMS WAS REQESTED.  BP 124/80 HR 71  100%O2 ON ROOM AIR. SHE WAS EVALUATED BY EMS AND ONSITE PHYSICIAN AND TRANSPORTED TO A LOCAL HOSPITAL.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety
Clinical narrative: 37 YEAR OLD FEMALE STARTED EXPERIENCING GENERALIZED ANXIETY. ONSITE EMS WAS REQESTED.  BP 124/80 HR 71  100%O2 ON ROOM AIR. SHE WAS EVALUATED BY EMS AND ONSITE PHYSICIAN AND TRANSPORTED TO A LOCAL HOSPITAL.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Laboratory test, Lethargy, Oral discomfort
Clinical narrative: Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Confusional state, Electrocardiogram, Fatigue
Clinical narrative: Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 4 hours after shot, patient's underarm lymph node swell. He is continuing to see his doctor regarding the lymph node. The lymph node is still swollen with not much improvement per patient.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Pharyngeal swelling, Rash, Swelling face
Clinical narrative: UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trunk and extremities, anxiety; received famotidine, NS, ativan, diphenhydramine, solumedrol
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Lip swelling, Pharyngeal swelling, Rash erythematous
Clinical narrative: UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trunk and extremities, anxiety; received famotidine, NS, ativan, diphenhydramine, solumedrol
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Aphasia, Blood test, Cerebrovascular accident, Computerised tomogram thorax normal
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Echocardiogram, Hemiparesis, Intensive care, Magnetic resonance imaging abnormal
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test, Speech disorder, Thrombosis, Venogram
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Deep vein thrombosis, SARS-CoV-2 test
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood pressure diastolic, Blood pressure systolic, Body mass index, Body temperature
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiovascular examination, Computerised tomogram, Deep vein thrombosis, Echocardiogram, Gastrointestinal examination
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Ischaemic stroke, Magnetic resonance imaging, Ophthalmological examination, Oxygen saturation
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis, Respiratory rate, Skin test, Thermometry, Ultrasound joint
Clinical narrative: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: During the 15 minute observation period, patient began to not feel well complaining of difficulty walking and a strange feeling in her legs. When she did not improve and continued to have difficulty walking, she was transported to the ER for continued monitoring and evaluation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Gait disturbance, Malaise, Sensory disturbance
Clinical narrative: During the 15 minute observation period, patient began to not feel well complaining of difficulty walking and a strange feeling in her legs. When she did not improve and continued to have difficulty walking, she was transported to the ER for continued monitoring and evaluation.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Airway secretion clearance therapy, Breath sounds abnormal, Cardiac arrest, Cardioversion, Death
Clinical narrative: flash pulmonary edema; anaphylaxis; vomiting; shortness of breath; This is a spontaneous report from contactable consumers (one consumer is the patient daughter) and physician. This report was received via a sales representative a from a Pfizer-sponsored program and from internet news. A 58-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot # EL9263), via an unspecified route of administration on 30Jan2021 17:00 at single dose at left arm for Covid-19 immunisation. Medical history included obesity, type 2 diabetes, known allergies_Penicillin, sleep apnoea, hypertension. The patient's concomitant medications included cholesterol lowering medication, blood pressure regulation medicine, medication for blood glucose, but oral, not insulin. The patient while back to home, couldn't breathe and started vomiting. They did administer an EpiPen, CPR and oxygen as well. They tried to remove fluid from her lungs. They called it flash pulmonary edema, and it can be caused by anaphylaxis, patient was taken to a hospital where she was diagnosed. Patient died within an hour of receiving the COVID-19 Pfizer vaccine on 30Jan2021 from pulmonary edema. Her reaction was shortness of breath occurred within 30 minutes after receiving the vaccine dose, also had anaphylaxis (life-threatening), flash pulmonary edema, vomiting and couldn't breathe. Outcome of events shortness of breath and vomiting were unknown, outcome of events flash pulmonary edema and anaphylaxis was fatal. Patient was probably around 5 feet 2 inches and probably over 300 pounds. Cause of death were reported as pending. Toxicology tests were requested as the law has other tests. But they did not do a full autopsy. They only did blood work. Reporter confirmed that autopsy was not performed. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up (04Feb2021): This is a follow-up report combining information from duplicate reports 2021117416, 2021130543, 2021141606 and 2021116417. The current and all subsequent information will be reported under manufacturer report number 2021116417. The new information reported included new event (shortness of breath), seriousness, and clinical course.; Reported Cause(s) of Death: flash pulmonary edema; anaphylaxis
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Mobility decreased, Pulseless electrical activity, Unresponsive to stimuli
Clinical narrative: flash pulmonary edema; anaphylaxis; vomiting; shortness of breath; This is a spontaneous report from contactable consumers (one consumer is the patient daughter) and physician. This report was received via a sales representative a from a Pfizer-sponsored program and from internet news. A 58-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot # EL9263), via an unspecified route of administration on 30Jan2021 17:00 at single dose at left arm for Covid-19 immunisation. Medical history included obesity, type 2 diabetes, known allergies_Penicillin, sleep apnoea, hypertension. The patient's concomitant medications included cholesterol lowering medication, blood pressure regulation medicine, medication for blood glucose, but oral, not insulin. The patient while back to home, couldn't breathe and started vomiting. They did administer an EpiPen, CPR and oxygen as well. They tried to remove fluid from her lungs. They called it flash pulmonary edema, and it can be caused by anaphylaxis, patient was taken to a hospital where she was diagnosed. Patient died within an hour of receiving the COVID-19 Pfizer vaccine on 30Jan2021 from pulmonary edema. Her reaction was shortness of breath occurred within 30 minutes after receiving the vaccine dose, also had anaphylaxis (life-threatening), flash pulmonary edema, vomiting and couldn't breathe. Outcome of events shortness of breath and vomiting were unknown, outcome of events flash pulmonary edema and anaphylaxis was fatal. Patient was probably around 5 feet 2 inches and probably over 300 pounds. Cause of death were reported as pending. Toxicology tests were requested as the law has other tests. But they did not do a full autopsy. They only did blood work. Reporter confirmed that autopsy was not performed. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up (04Feb2021): This is a follow-up report combining information from duplicate reports 2021117416, 2021130543, 2021141606 and 2021116417. The current and all subsequent information will be reported under manufacturer report number 2021116417. The new information reported included new event (shortness of breath), seriousness, and clinical course.; Reported Cause(s) of Death: flash pulmonary edema; anaphylaxis
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: flash pulmonary edema; anaphylaxis; vomiting; shortness of breath; This is a spontaneous report from contactable consumers (one consumer is the patient daughter) and physician. This report was received via a sales representative a from a Pfizer-sponsored program and from internet news. A 58-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot # EL9263), via an unspecified route of administration on 30Jan2021 17:00 at single dose at left arm for Covid-19 immunisation. Medical history included obesity, type 2 diabetes, known allergies_Penicillin, sleep apnoea, hypertension. The patient's concomitant medications included cholesterol lowering medication, blood pressure regulation medicine, medication for blood glucose, but oral, not insulin. The patient while back to home, couldn't breathe and started vomiting. They did administer an EpiPen, CPR and oxygen as well. They tried to remove fluid from her lungs. They called it flash pulmonary edema, and it can be caused by anaphylaxis, patient was taken to a hospital where she was diagnosed. Patient died within an hour of receiving the COVID-19 Pfizer vaccine on 30Jan2021 from pulmonary edema. Her reaction was shortness of breath occurred within 30 minutes after receiving the vaccine dose, also had anaphylaxis (life-threatening), flash pulmonary edema, vomiting and couldn't breathe. Outcome of events shortness of breath and vomiting were unknown, outcome of events flash pulmonary edema and anaphylaxis was fatal. Patient was probably around 5 feet 2 inches and probably over 300 pounds. Cause of death were reported as pending. Toxicology tests were requested as the law has other tests. But they did not do a full autopsy. They only did blood work. Reporter confirmed that autopsy was not performed. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up (04Feb2021): This is a follow-up report combining information from duplicate reports 2021117416, 2021130543, 2021141606 and 2021116417. The current and all subsequent information will be reported under manufacturer report number 2021116417. The new information reported included new event (shortness of breath), seriousness, and clinical course.; Reported Cause(s) of Death: flash pulmonary edema; anaphylaxis
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute pulmonary oedema, Anaphylactic reaction, Body height, Dyspnoea, Investigation
Clinical narrative: flash pulmonary edema; anaphylaxis; vomiting; shortness of breath; This is a spontaneous report from contactable consumers (one consumer is the patient daughter) and physician. This report was received via a sales representative a from a Pfizer-sponsored program and from internet news. A 58-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot # EL9263), via an unspecified route of administration on 30Jan2021 17:00 at single dose at left arm for Covid-19 immunisation. Medical history included obesity, type 2 diabetes, known allergies_Penicillin, sleep apnoea, hypertension. The patient's concomitant medications included cholesterol lowering medication, blood pressure regulation medicine, medication for blood glucose, but oral, not insulin. The patient while back to home, couldn't breathe and started vomiting. They did administer an EpiPen, CPR and oxygen as well. They tried to remove fluid from her lungs. They called it flash pulmonary edema, and it can be caused by anaphylaxis, patient was taken to a hospital where she was diagnosed. Patient died within an hour of receiving the COVID-19 Pfizer vaccine on 30Jan2021 from pulmonary edema. Her reaction was shortness of breath occurred within 30 minutes after receiving the vaccine dose, also had anaphylaxis (life-threatening), flash pulmonary edema, vomiting and couldn't breathe. Outcome of events shortness of breath and vomiting were unknown, outcome of events flash pulmonary edema and anaphylaxis was fatal. Patient was probably around 5 feet 2 inches and probably over 300 pounds. Cause of death were reported as pending. Toxicology tests were requested as the law has other tests. But they did not do a full autopsy. They only did blood work. Reporter confirmed that autopsy was not performed. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up (04Feb2021): This is a follow-up report combining information from duplicate reports 2021117416, 2021130543, 2021141606 and 2021116417. The current and all subsequent information will be reported under manufacturer report number 2021116417. The new information reported included new event (shortness of breath), seriousness, and clinical course.; Reported Cause(s) of Death: flash pulmonary edema; anaphylaxis