chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Circulatory collapse, Diarrhoea, Dizziness
Clinical narrative: then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Fatigue, Feeling abnormal, Hyperhidrosis, Limb injury
Clinical narrative: then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Tinnitus, Tremor
Clinical narrative: then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Epigastric discomfort, Fall, Feeling abnormal, Hyperhidrosis
Clinical narrative: then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Tinnitus
Clinical narrative: then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood bicarbonate decreased, Blood calcium normal, Blood chloride normal
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood glucose increased, Blood magnesium increased, Blood pH decreased, Blood potassium normal
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood sodium normal, Blood urea increased, Carbon dioxide decreased, Cardiac arrest, Chest X-ray abnormal
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Continuous positive airway pressure, Death, Dyspnoea, Endotracheal intubation, Foaming at mouth
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haemoptysis, PCO2 increased, PO2 decreased
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count increased, Pneumothorax, Protein total normal, Pulmonary oedema, Respiratory distress
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, White blood cell count normal
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute pulmonary oedema, Cardiac arrest, Condition aggravated, Death
Clinical narrative: Pt presented to the ED within an hour of receiving her first Moderna Covid 19 vaccine. She was in Acute Pulmonary Edema and Cardiac Arrest. Passed away shortly after.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Periarthritis, Swelling
Clinical narrative: Patient came into clinic for second dose of Moderna. Patient stated she was nervous because last vaccine had caused her to have mobility problems with her right arm and decided to get seen by a doctor about 5 days after vaccine was given because symptoms would not improve. She stated that she went to a shoulder specialist and was told she had SIRVA. Per patient, she has had prednisone shots to her right shoulder and physical therapy sessions to help regain the movement of her right joint, her right shoulder is still not back to full ROM.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mobility decreased
Clinical narrative: Patient came into clinic for second dose of Moderna. Patient stated she was nervous because last vaccine had caused her to have mobility problems with her right arm and decided to get seen by a doctor about 5 days after vaccine was given because symptoms would not improve. She stated that she went to a shoulder specialist and was told she had SIRVA. Per patient, she has had prednisone shots to her right shoulder and physical therapy sessions to help regain the movement of her right joint, her right shoulder is still not back to full ROM.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient came into clinic for second dose of Moderna. Patient stated she was nervous because last vaccine had caused her to have mobility problems with her right arm and decided to get seen by a doctor about 5 days after vaccine was given because symptoms would not improve. She stated that she went to a shoulder specialist and was told she had SIRVA. Per patient, she has had prednisone shots to her right shoulder and physical therapy sessions to help regain the movement of her right joint, her right shoulder is still not back to full ROM.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Muscle tightness, Pain in jaw
Clinical narrative: slight Bell's Palsy
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: slight Bell's Palsy
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test abnormal, Chest pain, Computerised tomogram abnormal, Electrocardiogram abnormal, Prinzmetal angina
Clinical narrative: 5 days after I started to have chest pain. It was variable and now I have been diagnosed with Prinzmetal angina; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) via an unspecified route of administration, administered on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included high BP that was under control and allergy: glue on tape used in hospitals. Concomitant medications included losartan, levothyroxine and hydrochlorothiazide. On 23Jan2021 02:00 PM (5 days after), the patient started to have chest pain. It was variable and now I have been diagnosed with Prinzmetal angina. Treatment was received for the events. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is in the process of stabilizing the angina. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event Prinzmetal angina 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Ultrasound scan normal
Clinical narrative: 5 days after I started to have chest pain. It was variable and now I have been diagnosed with Prinzmetal angina; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) via an unspecified route of administration, administered on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included high BP that was under control and allergy: glue on tape used in hospitals. Concomitant medications included losartan, levothyroxine and hydrochlorothiazide. On 23Jan2021 02:00 PM (5 days after), the patient started to have chest pain. It was variable and now I have been diagnosed with Prinzmetal angina. Treatment was received for the events. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is in the process of stabilizing the angina. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event Prinzmetal angina 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Prinzmetal angina
Clinical narrative: 5 days after I started to have chest pain. It was variable and now I have been diagnosed with Prinzmetal angina; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) via an unspecified route of administration, administered on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included high BP that was under control and allergy: glue on tape used in hospitals. Concomitant medications included losartan, levothyroxine and hydrochlorothiazide. On 23Jan2021 02:00 PM (5 days after), the patient started to have chest pain. It was variable and now I have been diagnosed with Prinzmetal angina. Treatment was received for the events. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is in the process of stabilizing the angina. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event Prinzmetal angina 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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Dyspnoea, Erythema, Hyperhidrosis
Clinical narrative: Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Paraesthesia, Respiratory disorder, Respiratory distress
Clinical narrative: Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat tightness, Tongue disorder
Clinical narrative: Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Audiogram abnormal, Deafness neurosensory, Hypoacusis, Injection site pain
Clinical narrative: developed coryzal sxs of nasal stuffiness; developed coryzal sxs of nasal stuffiness; ear fullness; decreased hearing L ear; unilateral hearing loss without dizziness or pain; sensorineural dysfunction; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), intramuscular, administered in left arm on 17Feb2021 09:15 as single dose for covid-19 immunisation at a hospital. Medical history included allergies to sulfa-urticaria, hypertension (HNT), hyperlipidemia, hypothyroidism, GERD, osteoarthritis, and coronary artery calcification per cardiac CT scan. Concomitant medications included levothyroxine sodium (SYNTHROID), atorvastatin, metformin hydrochloride (METFORMIN ER), hctz, famotidine, ergocalciferol (VIT D), and melatonin. The patient had no other vaccine in four weeks. The patient previously took fenofibrate and experienced allergies: photosensitivity. The patient received IM injection on 17Feb2021 with no sequelae initially. On or about 03Mar2021 at 13:00, the patient developed coryzal sxs of nasal stuffiness and ear fullness. The patient used Flonase and Z pack and Afrin. The patient also developed decreased hearing L ear confirmed yesterday by ENT doc. This was unilateral hearing loss without dizziness or pain. Hearing has improved but is still abnormal. Tympanograms are normal. Exam was consistent with sensorineural dysfunction. The patient was reluctant to receive the second dose scheduled for Wednesday, 17Mar2021. The events were assessed as serious due to disability or permanent damage and resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for Covid post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Nasal congestion, Rhinitis
Clinical narrative: developed coryzal sxs of nasal stuffiness; developed coryzal sxs of nasal stuffiness; ear fullness; decreased hearing L ear; unilateral hearing loss without dizziness or pain; sensorineural dysfunction; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), intramuscular, administered in left arm on 17Feb2021 09:15 as single dose for covid-19 immunisation at a hospital. Medical history included allergies to sulfa-urticaria, hypertension (HNT), hyperlipidemia, hypothyroidism, GERD, osteoarthritis, and coronary artery calcification per cardiac CT scan. Concomitant medications included levothyroxine sodium (SYNTHROID), atorvastatin, metformin hydrochloride (METFORMIN ER), hctz, famotidine, ergocalciferol (VIT D), and melatonin. The patient had no other vaccine in four weeks. The patient previously took fenofibrate and experienced allergies: photosensitivity. The patient received IM injection on 17Feb2021 with no sequelae initially. On or about 03Mar2021 at 13:00, the patient developed coryzal sxs of nasal stuffiness and ear fullness. The patient used Flonase and Z pack and Afrin. The patient also developed decreased hearing L ear confirmed yesterday by ENT doc. This was unilateral hearing loss without dizziness or pain. Hearing has improved but is still abnormal. Tympanograms are normal. Exam was consistent with sensorineural dysfunction. The patient was reluctant to receive the second dose scheduled for Wednesday, 17Mar2021. The events were assessed as serious due to disability or permanent damage and resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for Covid post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure, Deafness neurosensory, Deafness unilateral, Ear discomfort, Hypoacusis
Clinical narrative: developed coryzal sxs of nasal stuffiness; developed coryzal sxs of nasal stuffiness; ear fullness; decreased hearing L ear; unilateral hearing loss without dizziness or pain; sensorineural dysfunction; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), intramuscular, administered in left arm on 17Feb2021 09:15 as single dose for covid-19 immunisation at a hospital. Medical history included allergies to sulfa-urticaria, hypertension (HNT), hyperlipidemia, hypothyroidism, GERD, osteoarthritis, and coronary artery calcification per cardiac CT scan. Concomitant medications included levothyroxine sodium (SYNTHROID), atorvastatin, metformin hydrochloride (METFORMIN ER), hctz, famotidine, ergocalciferol (VIT D), and melatonin. The patient had no other vaccine in four weeks. The patient previously took fenofibrate and experienced allergies: photosensitivity. The patient received IM injection on 17Feb2021 with no sequelae initially. On or about 03Mar2021 at 13:00, the patient developed coryzal sxs of nasal stuffiness and ear fullness. The patient used Flonase and Z pack and Afrin. The patient also developed decreased hearing L ear confirmed yesterday by ENT doc. This was unilateral hearing loss without dizziness or pain. Hearing has improved but is still abnormal. Tympanograms are normal. Exam was consistent with sensorineural dysfunction. The patient was reluctant to receive the second dose scheduled for Wednesday, 17Mar2021. The events were assessed as serious due to disability or permanent damage and resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for Covid post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Nasal congestion, Rhinitis, Tympanometry
Clinical narrative: developed coryzal sxs of nasal stuffiness; developed coryzal sxs of nasal stuffiness; ear fullness; decreased hearing L ear; unilateral hearing loss without dizziness or pain; sensorineural dysfunction; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), intramuscular, administered in left arm on 17Feb2021 09:15 as single dose for covid-19 immunisation at a hospital. Medical history included allergies to sulfa-urticaria, hypertension (HNT), hyperlipidemia, hypothyroidism, GERD, osteoarthritis, and coronary artery calcification per cardiac CT scan. Concomitant medications included levothyroxine sodium (SYNTHROID), atorvastatin, metformin hydrochloride (METFORMIN ER), hctz, famotidine, ergocalciferol (VIT D), and melatonin. The patient had no other vaccine in four weeks. The patient previously took fenofibrate and experienced allergies: photosensitivity. The patient received IM injection on 17Feb2021 with no sequelae initially. On or about 03Mar2021 at 13:00, the patient developed coryzal sxs of nasal stuffiness and ear fullness. The patient used Flonase and Z pack and Afrin. The patient also developed decreased hearing L ear confirmed yesterday by ENT doc. This was unilateral hearing loss without dizziness or pain. Hearing has improved but is still abnormal. Tympanograms are normal. Exam was consistent with sensorineural dysfunction. The patient was reluctant to receive the second dose scheduled for Wednesday, 17Mar2021. The events were assessed as serious due to disability or permanent damage and resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for Covid post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Cough, Fatigue, SARS-CoV-2 test positive
Clinical narrative: tested positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reporting for himself) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had tested positive (for sars-cov-2 test) on 15Jan2021 but he didn't know he had Covid at the time. He thought he was just having side effects from the vaccine. He ended up in the hospital for 8 days where he was given Remdesivir and steroids. Patient was wondering on what he's supposed to do about the second dose. Patient went in the hospital on 19Jan2021 and was released on the 26Jan2021. His second dose was supposed to be on 05Feb2021. The outcome of event was unknown.    Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reporting for himself) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had tested positive (for sars-cov-2 test) on 15Jan2021 but he didn't know he had Covid at the time. He thought he was just having side effects from the vaccine. He ended up in the hospital for 8 days where he was given Remdesivir and steroids. Patient was wondering on what he's supposed to do about the second dose. Patient went in the hospital on 19Jan2021 and was released on the 26Jan2021. His second dose was supposed to be on 05Feb2021. The outcome of event was unknown.    Information about lot/batch number has been requested.