chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Deafness neurosensory, Deafness unilateral, Tinnitus
Clinical narrative: right sensorineural hearing loss; Had tinnitus to right ear (no hx of tinnitus); This is a spontaneous report from a contactable nurse (patient). A 45-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via an unspecified route of administration in left arm on 18Dec2020 08:00 at single dose for COVID-19 immunization. No other vaccine administered in four weeks. Medical history included diabetes type 2, asthma, and latex allergy. Concomitant medication included metformin, glipizide. No Covid prior vaccination. No Covid tested post vaccination. The patient previously took clarithromycin and experienced allergy. The patient experienced 29 hours (as reported) after vaccine dose (19Dec2020 12:00) - woke up and had tinnitus to right ear (no hx of tinnitus) - went to urgent care - MD did tests and found right sensorineural hearing loss. Prescribed prednisone 60 mg daily for 10 days. The outcome of events was not recovered.; Sender's Comments: Considering temporal relationship, a causal association between the onset of events right sensorineural hearing loss and tinnitus and the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reassessed should additional information become 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: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: the individual has had seizures that have lasted apprx 3 days; anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020. 12-15 mins after receiving the vaccine, the individual has had seizures that have lasted approximately 3 days, has had multiple seizures since then. The patient was taken to the Emergency department, given epipen (Epi pen), was without symptoms for 24 hours at some point, during the 3 day time period and as of 22Dec2020, the patient was continuing to have seizures. The patient started having issues again on 21Dec2020 and 22Dec2020 (yesterday and today). He had more issues with seizures last night on 21Dec2020 and had seizures this morning. The individual also had an anaphylactic reaction in Dec2020 but didn't not elaborate on this. The reporter was wondering if he can get information that this has happened before and wanted information on reversing the situation because the doctors need help. Outcome of the event seizures was not recovered, of other event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events seizures and anaphylactic reaction cannot be excluded based on compatible 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: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory arrest, Seizure
Clinical narrative: the individual has had seizures that have lasted apprx 3 days; anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020. 12-15 mins after receiving the vaccine, the individual has had seizures that have lasted approximately 3 days, has had multiple seizures since then. The patient was taken to the Emergency department, given epipen (Epi pen), was without symptoms for 24 hours at some point, during the 3 day time period and as of 22Dec2020, the patient was continuing to have seizures. The patient started having issues again on 21Dec2020 and 22Dec2020 (yesterday and today). He had more issues with seizures last night on 21Dec2020 and had seizures this morning. The individual also had an anaphylactic reaction in Dec2020 but didn't not elaborate on this. The reporter was wondering if he can get information that this has happened before and wanted information on reversing the situation because the doctors need help. Outcome of the event seizures was not recovered, of other event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events seizures and anaphylactic reaction cannot be excluded based on compatible 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: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Seizure
Clinical narrative: the individual has had seizures that have lasted apprx 3 days; anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020. 12-15 mins after receiving the vaccine, the individual has had seizures that have lasted approximately 3 days, has had multiple seizures since then. The patient was taken to the Emergency department, given epipen (Epi pen), was without symptoms for 24 hours at some point, during the 3 day time period and as of 22Dec2020, the patient was continuing to have seizures. The patient started having issues again on 21Dec2020 and 22Dec2020 (yesterday and today). He had more issues with seizures last night on 21Dec2020 and had seizures this morning. The individual also had an anaphylactic reaction in Dec2020 but didn't not elaborate on this. The reporter was wondering if he can get information that this has happened before and wanted information on reversing the situation because the doctors need help. Outcome of the event seizures was not recovered, of other event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events seizures and anaphylactic reaction cannot be excluded based on compatible 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: Dizziness, Flushing, Rash, Tachycardia, Tremor
Clinical narrative: Elevated heart rate (150-160)/ elevated heart rate of 160; shakiness/ shaky; dizziness; hives on her neck; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EH9899), via an unspecified route of administration on the left arm on 18Dec2020 11:30 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient wanted to know if she should receive the second dose after experiencing this type of reaction after the first dose. On 18Dec2020, she experienced elevated heart rate 160 (also reported as 150-160), shaky, dizziness and hives on her neck; stated she received the vaccine at 11:30 am and symptoms started at 11:40 am. She was monitored for one hour to make sure heart rate went down and stated that her heart rate went down after 35-40 minutes. The patient was not diagnosed with COVID prior to vaccination and has not been tested post-vaccination. No treatment was given for the events. Outcome of the events elevated heart rate, shaky and dizziness was recovered and of hives on her neck was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Tremor, Urticaria
Clinical narrative: Elevated heart rate (150-160)/ elevated heart rate of 160; shakiness/ shaky; dizziness; hives on her neck; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EH9899), via an unspecified route of administration on the left arm on 18Dec2020 11:30 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient wanted to know if she should receive the second dose after experiencing this type of reaction after the first dose. On 18Dec2020, she experienced elevated heart rate 160 (also reported as 150-160), shaky, dizziness and hives on her neck; stated she received the vaccine at 11:30 am and symptoms started at 11:40 am. She was monitored for one hour to make sure heart rate went down and stated that her heart rate went down after 35-40 minutes. The patient was not diagnosed with COVID prior to vaccination and has not been tested post-vaccination. No treatment was given for the events. Outcome of the events elevated heart rate, shaky and dizziness was recovered and of hives on her neck was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Dizziness, Dyspnoea, Electrocardiogram ambulatory
Clinical narrative: sudden onset of a fainting sensation/not wanting to stand up due to fear of fainting; mild shortness of breath; heart beating faster then normal; intense anxiety; hyperventilation; tingling in limbs, top of head; headache; general weakness; This is a spontaneous report from a contactable consumer (patient).  This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right arm on 18Dec2020 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included depression and allergy to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR) 150 mg daily and escitalopram oxalate (LEXAPRO) 10 mg daily. On 18Dec2020 at 12:15, the patient experienced sudden onset of a fainting sensation, mild shortness of breath, heart beating faster than normal, intense anxiety/hyperventilation, tingling in limbs, top of head, headache, general weakness, not wanting to stand up due to fear of fainting. The events resulted in the emergency room/department visit or urgent care. The patient underwent a nasal swab for COVID-19 on 18Dec2020 which resulted negative. The patient recovered from the events in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Emotional distress, Fibrin D dimer, Full blood count, Headache, Metabolic function test
Clinical narrative: sudden onset of a fainting sensation/not wanting to stand up due to fear of fainting; mild shortness of breath; heart beating faster then normal; intense anxiety; hyperventilation; tingling in limbs, top of head; headache; general weakness; This is a spontaneous report from a contactable consumer (patient).  This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right arm on 18Dec2020 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included depression and allergy to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR) 150 mg daily and escitalopram oxalate (LEXAPRO) 10 mg daily. On 18Dec2020 at 12:15, the patient experienced sudden onset of a fainting sensation, mild shortness of breath, heart beating faster than normal, intense anxiety/hyperventilation, tingling in limbs, top of head, headache, general weakness, not wanting to stand up due to fear of fainting. The events resulted in the emergency room/department visit or urgent care. The patient underwent a nasal swab for COVID-19 on 18Dec2020 which resulted negative. The patient recovered from the events in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Panic reaction, Paraesthesia
Clinical narrative: sudden onset of a fainting sensation/not wanting to stand up due to fear of fainting; mild shortness of breath; heart beating faster then normal; intense anxiety; hyperventilation; tingling in limbs, top of head; headache; general weakness; This is a spontaneous report from a contactable consumer (patient).  This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right arm on 18Dec2020 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included depression and allergy to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR) 150 mg daily and escitalopram oxalate (LEXAPRO) 10 mg daily. On 18Dec2020 at 12:15, the patient experienced sudden onset of a fainting sensation, mild shortness of breath, heart beating faster than normal, intense anxiety/hyperventilation, tingling in limbs, top of head, headache, general weakness, not wanting to stand up due to fear of fainting. The events resulted in the emergency room/department visit or urgent care. The patient underwent a nasal swab for COVID-19 on 18Dec2020 which resulted negative. The patient recovered from the events in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Dyspnoea, Headache
Clinical narrative: sudden onset of a fainting sensation/not wanting to stand up due to fear of fainting; mild shortness of breath; heart beating faster then normal; intense anxiety; hyperventilation; tingling in limbs, top of head; headache; general weakness; This is a spontaneous report from a contactable consumer (patient).  This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right arm on 18Dec2020 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included depression and allergy to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR) 150 mg daily and escitalopram oxalate (LEXAPRO) 10 mg daily. On 18Dec2020 at 12:15, the patient experienced sudden onset of a fainting sensation, mild shortness of breath, heart beating faster than normal, intense anxiety/hyperventilation, tingling in limbs, top of head, headache, general weakness, not wanting to stand up due to fear of fainting. The events resulted in the emergency room/department visit or urgent care. The patient underwent a nasal swab for COVID-19 on 18Dec2020 which resulted negative. The patient recovered from the events in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hyperventilation, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: sudden onset of a fainting sensation/not wanting to stand up due to fear of fainting; mild shortness of breath; heart beating faster then normal; intense anxiety; hyperventilation; tingling in limbs, top of head; headache; general weakness; This is a spontaneous report from a contactable consumer (patient).  This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right arm on 18Dec2020 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included depression and allergy to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR) 150 mg daily and escitalopram oxalate (LEXAPRO) 10 mg daily. On 18Dec2020 at 12:15, the patient experienced sudden onset of a fainting sensation, mild shortness of breath, heart beating faster than normal, intense anxiety/hyperventilation, tingling in limbs, top of head, headache, general weakness, not wanting to stand up due to fear of fainting. The events resulted in the emergency room/department visit or urgent care. The patient underwent a nasal swab for COVID-19 on 18Dec2020 which resulted negative. The patient recovered from the events in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: sudden onset of a fainting sensation/not wanting to stand up due to fear of fainting; mild shortness of breath; heart beating faster then normal; intense anxiety; hyperventilation; tingling in limbs, top of head; headache; general weakness; This is a spontaneous report from a contactable consumer (patient).  This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right arm on 18Dec2020 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included depression and allergy to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR) 150 mg daily and escitalopram oxalate (LEXAPRO) 10 mg daily. On 18Dec2020 at 12:15, the patient experienced sudden onset of a fainting sensation, mild shortness of breath, heart beating faster than normal, intense anxiety/hyperventilation, tingling in limbs, top of head, headache, general weakness, not wanting to stand up due to fear of fainting. The events resulted in the emergency room/department visit or urgent care. The patient underwent a nasal swab for COVID-19 on 18Dec2020 which resulted negative. The patient recovered from the events in Dec2020.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia
Clinical narrative: swelling in face (lip); swelling in face (lip); tingling in skin; becoming harder to breathe; having much more trouble breathing or speaking; heart rate was elevated; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) received BNT162B2 (Lot Number: EJ1685) on 20Dec2020 07:30 AM at single dose (anatomical location: arm left) for COVID-19 immunization. Medical history included asthma and allergies to soy. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), tiotropium bromide (SPIRIVA), all from Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine and during the 30 minute monitoring period it was noticed she had swelling in face (lip) on 20Dec2020 13:30. She moved to the emergency department, and was treated and monitored for four hours. Two hours after being released, she was in her home when she started noticing tingling in skin and it was becoming harder to breathe. She went to the nearest hospital at that time. By the time she arrived she was having much more trouble breathing or speaking. Her heart rate was elevated. She was released at about 6:30 pm. The event swelling in face (lip) was reported as resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of swelling in face (lip) was recovered with sequel, outcome of other events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: swelling in face (lip); swelling in face (lip); tingling in skin; becoming harder to breathe; having much more trouble breathing or speaking; heart rate was elevated; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) received BNT162B2 (Lot Number: EJ1685) on 20Dec2020 07:30 AM at single dose (anatomical location: arm left) for COVID-19 immunization. Medical history included asthma and allergies to soy. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), tiotropium bromide (SPIRIVA), all from Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine and during the 30 minute monitoring period it was noticed she had swelling in face (lip) on 20Dec2020 13:30. She moved to the emergency department, and was treated and monitored for four hours. Two hours after being released, she was in her home when she started noticing tingling in skin and it was becoming harder to breathe. She went to the nearest hospital at that time. By the time she arrived she was having much more trouble breathing or speaking. Her heart rate was elevated. She was released at about 6:30 pm. The event swelling in face (lip) was reported as resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of swelling in face (lip) was recovered with sequel, outcome of other events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Apparent life threatening event, Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia
Clinical narrative: swelling in face (lip); swelling in face (lip); tingling in skin; becoming harder to breathe; having much more trouble breathing or speaking; heart rate was elevated; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) received BNT162B2 (Lot Number: EJ1685) on 20Dec2020 07:30 AM at single dose (anatomical location: arm left) for COVID-19 immunization. Medical history included asthma and allergies to soy. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), tiotropium bromide (SPIRIVA), all from Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine and during the 30 minute monitoring period it was noticed she had swelling in face (lip) on 20Dec2020 13:30. She moved to the emergency department, and was treated and monitored for four hours. Two hours after being released, she was in her home when she started noticing tingling in skin and it was becoming harder to breathe. She went to the nearest hospital at that time. By the time she arrived she was having much more trouble breathing or speaking. Her heart rate was elevated. She was released at about 6:30 pm. The event swelling in face (lip) was reported as resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of swelling in face (lip) was recovered with sequel, outcome of other events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder, Swelling face
Clinical narrative: swelling in face (lip); swelling in face (lip); tingling in skin; becoming harder to breathe; having much more trouble breathing or speaking; heart rate was elevated; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) received BNT162B2 (Lot Number: EJ1685) on 20Dec2020 07:30 AM at single dose (anatomical location: arm left) for COVID-19 immunization. Medical history included asthma and allergies to soy. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), tiotropium bromide (SPIRIVA), all from Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine and during the 30 minute monitoring period it was noticed she had swelling in face (lip) on 20Dec2020 13:30. She moved to the emergency department, and was treated and monitored for four hours. Two hours after being released, she was in her home when she started noticing tingling in skin and it was becoming harder to breathe. She went to the nearest hospital at that time. By the time she arrived she was having much more trouble breathing or speaking. Her heart rate was elevated. She was released at about 6:30 pm. The event swelling in face (lip) was reported as resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of swelling in face (lip) was recovered with sequel, outcome of other events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: swelling in face (lip); swelling in face (lip); tingling in skin; becoming harder to breathe; having much more trouble breathing or speaking; heart rate was elevated; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) received BNT162B2 (Lot Number: EJ1685) on 20Dec2020 07:30 AM at single dose (anatomical location: arm left) for COVID-19 immunization. Medical history included asthma and allergies to soy. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), tiotropium bromide (SPIRIVA), all from Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine and during the 30 minute monitoring period it was noticed she had swelling in face (lip) on 20Dec2020 13:30. She moved to the emergency department, and was treated and monitored for four hours. Two hours after being released, she was in her home when she started noticing tingling in skin and it was becoming harder to breathe. She went to the nearest hospital at that time. By the time she arrived she was having much more trouble breathing or speaking. Her heart rate was elevated. She was released at about 6:30 pm. The event swelling in face (lip) was reported as resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of swelling in face (lip) was recovered with sequel, outcome of other events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram, Tachycardia, Throat tightness
Clinical narrative: I started to have throat and chest tightness within 25 minutes of receiving the vaccine. I went to the ER and received epinephrine, solu-medrol, famotidine, and benadryl.; I started to have throat and chest tightness within 25 minutes of receiving the vaccine. I went to the ER and received epinephrine, solu-medrol, famotidine, and benadryl.; Feverish; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first single dose of BNT162B2 (Lot number: EK5730, exp date not reported), via an unspecified route of administration (anatomical location: arm right) on 20Dec2020 16:00 (4:00 pm) for immunization. Medical history included birth control. The patient had no known allergies and no other medical history. Concomitant medication included ethinylestradiol, norgestimate (PREVIFEM) started 2 months ago (Oct2020) and still taking (ongoing) for birth control within two weeks of vaccine administration. The most recent dose was taken the morning of vaccination around 8 Am, got vaccine around 4. The patient had not received other vaccine within four weeks. The patient was administered vaccine in the hospital. Patient started to have throat and chest tightness within 25 minutes of receiving the vaccine (reported as 20Dec2020 at 16:30 [4:30 pm]). Patient went to the ER and received epinephrine, methylprednisolone sodium succinate (SOLUMEDROL), famotidine, and diphenhydramine hydrochloride (BENADRYL). The patient was also under observation due to the adverse events. Patient further stated that she felt like throat was tight, but not significantly swollen; and had chest tightness. Patient was feverish the day before reporting (20Dec2020) but was better on the day of reporting. She was not sure if it would have gotten worse if she had not received treatment. She never had an allergic reaction before and reaction after vaccine was within 25 minutes. The patient did not have COVID prior/post vaccination. The patient recovered from throat and chest tightness on an unspecified date in Dec2020. The outcome of feverish was recovering. The patient considered reasonable possibility that the events was related to suspect product.; Sender's Comments: The reported events throat and chest tightness with fever were probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. This case will be reassessed should additional information become 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: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Pharyngeal swelling, Pyrexia, Throat tightness
Clinical narrative: I started to have throat and chest tightness within 25 minutes of receiving the vaccine. I went to the ER and received epinephrine, solu-medrol, famotidine, and benadryl.; I started to have throat and chest tightness within 25 minutes of receiving the vaccine. I went to the ER and received epinephrine, solu-medrol, famotidine, and benadryl.; Feverish; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first single dose of BNT162B2 (Lot number: EK5730, exp date not reported), via an unspecified route of administration (anatomical location: arm right) on 20Dec2020 16:00 (4:00 pm) for immunization. Medical history included birth control. The patient had no known allergies and no other medical history. Concomitant medication included ethinylestradiol, norgestimate (PREVIFEM) started 2 months ago (Oct2020) and still taking (ongoing) for birth control within two weeks of vaccine administration. The most recent dose was taken the morning of vaccination around 8 Am, got vaccine around 4. The patient had not received other vaccine within four weeks. The patient was administered vaccine in the hospital. Patient started to have throat and chest tightness within 25 minutes of receiving the vaccine (reported as 20Dec2020 at 16:30 [4:30 pm]). Patient went to the ER and received epinephrine, methylprednisolone sodium succinate (SOLUMEDROL), famotidine, and diphenhydramine hydrochloride (BENADRYL). The patient was also under observation due to the adverse events. Patient further stated that she felt like throat was tight, but not significantly swollen; and had chest tightness. Patient was feverish the day before reporting (20Dec2020) but was better on the day of reporting. She was not sure if it would have gotten worse if she had not received treatment. She never had an allergic reaction before and reaction after vaccine was within 25 minutes. The patient did not have COVID prior/post vaccination. The patient recovered from throat and chest tightness on an unspecified date in Dec2020. The outcome of feverish was recovering. The patient considered reasonable possibility that the events was related to suspect product.; Sender's Comments: The reported events throat and chest tightness with fever were probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. This case will be reassessed should additional information become 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: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Heart rate increased, Hot flush
Clinical narrative: he was going to pass out so he had to pull over; arm is still kind of cold and numb throughout the evening; arm is still kind of cold and numb throughout the evening; felt a very fast rush and then heart rate raised up to 170; difficulty in breathing/ couldn't breathe because heart was beating so hard and fast; arm was numb and cold where the injection was; arm was numb and cold where the injection was; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (lot number: EL0140), intramuscularly on 19Dec2020 at site of arm at single dose for COVID-19 immunization. Medical history included high blood pressure, acid reflux, high cholesterol, hypertension and SVT (supraventricular tachycardia). Concomitant medication included omeprazole, atorvastatin for high cholesterol and amlodipine for hypertension. Clinical course: After vaccination, patient waited 50 minutes after the shot so that he was able to clear and then he was driving home approximately half hour into the event or after the initial injection he felt basically his arm was numb, his arm was cold where the injection was and then half hour later his body felt a very fast rush and then his heart rate raised up to 170. He thought he was going to pass out, so he had to pull over and it passed after about 2 minutes and then he was able to continue on home. Before he got home, he had to pull over again because it happened again in a longer duration it last about 3-4 minutes still raising up to 170. Still felt like he had difficulty in breathing, but it wasn't anaphylactic reaction it felt like he couldn't breathe because his heart was beating so hard and fast. He could take a breath during that time period, it did pass after about an hour he felt no other symptoms, his arm was still kind of cold and numb throughout the evening on 19Dec2020, on 20Dec2020, he felt perfectly fine. No treatment received for events. The outcome of event 'passed out' was unknown; of events 'heart rate increased and difficulty breathing' was not recovered; of rest events was recovered on 20Dec2020.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Muscular weakness, Palpitations, Peripheral coldness, Sinus tachycardia
Clinical narrative: he was going to pass out so he had to pull over; arm is still kind of cold and numb throughout the evening; arm is still kind of cold and numb throughout the evening; felt a very fast rush and then heart rate raised up to 170; difficulty in breathing/ couldn't breathe because heart was beating so hard and fast; arm was numb and cold where the injection was; arm was numb and cold where the injection was; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (lot number: EL0140), intramuscularly on 19Dec2020 at site of arm at single dose for COVID-19 immunization. Medical history included high blood pressure, acid reflux, high cholesterol, hypertension and SVT (supraventricular tachycardia). Concomitant medication included omeprazole, atorvastatin for high cholesterol and amlodipine for hypertension. Clinical course: After vaccination, patient waited 50 minutes after the shot so that he was able to clear and then he was driving home approximately half hour into the event or after the initial injection he felt basically his arm was numb, his arm was cold where the injection was and then half hour later his body felt a very fast rush and then his heart rate raised up to 170. He thought he was going to pass out, so he had to pull over and it passed after about 2 minutes and then he was able to continue on home. Before he got home, he had to pull over again because it happened again in a longer duration it last about 3-4 minutes still raising up to 170. Still felt like he had difficulty in breathing, but it wasn't anaphylactic reaction it felt like he couldn't breathe because his heart was beating so hard and fast. He could take a breath during that time period, it did pass after about an hour he felt no other symptoms, his arm was still kind of cold and numb throughout the evening on 19Dec2020, on 20Dec2020, he felt perfectly fine. No treatment received for events. The outcome of event 'passed out' was unknown; of events 'heart rate increased and difficulty breathing' was not recovered; of rest events was recovered on 20Dec2020.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Heart rate increased, Hypoaesthesia
Clinical narrative: he was going to pass out so he had to pull over; arm is still kind of cold and numb throughout the evening; arm is still kind of cold and numb throughout the evening; felt a very fast rush and then heart rate raised up to 170; difficulty in breathing/ couldn't breathe because heart was beating so hard and fast; arm was numb and cold where the injection was; arm was numb and cold where the injection was; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (lot number: EL0140), intramuscularly on 19Dec2020 at site of arm at single dose for COVID-19 immunization. Medical history included high blood pressure, acid reflux, high cholesterol, hypertension and SVT (supraventricular tachycardia). Concomitant medication included omeprazole, atorvastatin for high cholesterol and amlodipine for hypertension. Clinical course: After vaccination, patient waited 50 minutes after the shot so that he was able to clear and then he was driving home approximately half hour into the event or after the initial injection he felt basically his arm was numb, his arm was cold where the injection was and then half hour later his body felt a very fast rush and then his heart rate raised up to 170. He thought he was going to pass out, so he had to pull over and it passed after about 2 minutes and then he was able to continue on home. Before he got home, he had to pull over again because it happened again in a longer duration it last about 3-4 minutes still raising up to 170. Still felt like he had difficulty in breathing, but it wasn't anaphylactic reaction it felt like he couldn't breathe because his heart was beating so hard and fast. He could take a breath during that time period, it did pass after about an hour he felt no other symptoms, his arm was still kind of cold and numb throughout the evening on 19Dec2020, on 20Dec2020, he felt perfectly fine. No treatment received for events. The outcome of event 'passed out' was unknown; of events 'heart rate increased and difficulty breathing' was not recovered; of rest events was recovered on 20Dec2020.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site coldness, Palpitations
Clinical narrative: he was going to pass out so he had to pull over; arm is still kind of cold and numb throughout the evening; arm is still kind of cold and numb throughout the evening; felt a very fast rush and then heart rate raised up to 170; difficulty in breathing/ couldn't breathe because heart was beating so hard and fast; arm was numb and cold where the injection was; arm was numb and cold where the injection was; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (lot number: EL0140), intramuscularly on 19Dec2020 at site of arm at single dose for COVID-19 immunization. Medical history included high blood pressure, acid reflux, high cholesterol, hypertension and SVT (supraventricular tachycardia). Concomitant medication included omeprazole, atorvastatin for high cholesterol and amlodipine for hypertension. Clinical course: After vaccination, patient waited 50 minutes after the shot so that he was able to clear and then he was driving home approximately half hour into the event or after the initial injection he felt basically his arm was numb, his arm was cold where the injection was and then half hour later his body felt a very fast rush and then his heart rate raised up to 170. He thought he was going to pass out, so he had to pull over and it passed after about 2 minutes and then he was able to continue on home. Before he got home, he had to pull over again because it happened again in a longer duration it last about 3-4 minutes still raising up to 170. Still felt like he had difficulty in breathing, but it wasn't anaphylactic reaction it felt like he couldn't breathe because his heart was beating so hard and fast. He could take a breath during that time period, it did pass after about an hour he felt no other symptoms, his arm was still kind of cold and numb throughout the evening on 19Dec2020, on 20Dec2020, he felt perfectly fine. No treatment received for events. The outcome of event 'passed out' was unknown; of events 'heart rate increased and difficulty breathing' was not recovered; of rest events was recovered on 20Dec2020.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Muscular weakness, Tachycardia
Clinical narrative: he was going to pass out so he had to pull over; arm is still kind of cold and numb throughout the evening; arm is still kind of cold and numb throughout the evening; felt a very fast rush and then heart rate raised up to 170; difficulty in breathing/ couldn't breathe because heart was beating so hard and fast; arm was numb and cold where the injection was; arm was numb and cold where the injection was; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (lot number: EL0140), intramuscularly on 19Dec2020 at site of arm at single dose for COVID-19 immunization. Medical history included high blood pressure, acid reflux, high cholesterol, hypertension and SVT (supraventricular tachycardia). Concomitant medication included omeprazole, atorvastatin for high cholesterol and amlodipine for hypertension. Clinical course: After vaccination, patient waited 50 minutes after the shot so that he was able to clear and then he was driving home approximately half hour into the event or after the initial injection he felt basically his arm was numb, his arm was cold where the injection was and then half hour later his body felt a very fast rush and then his heart rate raised up to 170. He thought he was going to pass out, so he had to pull over and it passed after about 2 minutes and then he was able to continue on home. Before he got home, he had to pull over again because it happened again in a longer duration it last about 3-4 minutes still raising up to 170. Still felt like he had difficulty in breathing, but it wasn't anaphylactic reaction it felt like he couldn't breathe because his heart was beating so hard and fast. He could take a breath during that time period, it did pass after about an hour he felt no other symptoms, his arm was still kind of cold and numb throughout the evening on 19Dec2020, on 20Dec2020, he felt perfectly fine. No treatment received for events. The outcome of event 'passed out' was unknown; of events 'heart rate increased and difficulty breathing' was not recovered; of rest events was recovered on 20Dec2020.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Flushing, Syncope, Tachycardia
Clinical narrative: syncope; Tachycardia; heat flash; dizziness; This is a spontaneous report from a contactable nurse.  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration into the right arm on 21Dec2020, at 08:45 as single dose for covid-19 immunization.  Medical history included allergies to medications, food, or other products: including sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), cobamamide (VITAMIN B12), melatonin (MELATOL).  The patient experienced syncope, tachycardia, heat flash, and dizziness on 21Dec2020, at 09:00.  No treatment was given. The outcome of syncope, tachycardia, heat flash, and dizziness was recovered in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the event syncope cannot be excluded based on a compatible 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.