chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Chest X-ray, Electrocardiogram
Clinical narrative: When got up I passed out; blood pressure shoot up to 180 over 100; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the covid dose yesterday and after he/she took it, he/she sat there for few minutes and then when he/she got up he/she just passed out. The patient mentioned that they called the code blue in the hospital, they tried to, they were going to, he/she doesn't know what they were going to do but they ended up taking the patient to the emergency room where they ran every test possible blood work they did chest X-ray, they did EKG. The patient stated that the only thing that was consistent was that after the vaccine his/her blood pressure shot up to 180 over 100 and they were trying to get it down, they gave the patient some fluid (unspecified) which stayed for over two hours. The patient added that he/she have never had any blood pressure issues, as he/she was not even on any medications. The patient mentioned that he/she was now afraid to take the second dose. The events occurred on 27Jan2021 with outcome of unknown. Unknown results for blood work, EKG and chest X-ray. The reporter considered the events serious per hospitalization on 27Jan2021.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: When got up I passed out; blood pressure shoot up to 180 over 100; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the covid dose yesterday and after he/she took it, he/she sat there for few minutes and then when he/she got up he/she just passed out. The patient mentioned that they called the code blue in the hospital, they tried to, they were going to, he/she doesn't know what they were going to do but they ended up taking the patient to the emergency room where they ran every test possible blood work they did chest X-ray, they did EKG. The patient stated that the only thing that was consistent was that after the vaccine his/her blood pressure shot up to 180 over 100 and they were trying to get it down, they gave the patient some fluid (unspecified) which stayed for over two hours. The patient added that he/she have never had any blood pressure issues, as he/she was not even on any medications. The patient mentioned that he/she was now afraid to take the second dose. The events occurred on 27Jan2021 with outcome of unknown. Unknown results for blood work, EKG and chest X-ray. The reporter considered the events serious per hospitalization on 27Jan2021.   Information on the lot/ batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Anaphylaxis; High blood pressure; Feeling faint; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, left arm on 27Jan2021 09:45 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not have COVID prior to vaccination. On 27Jan2021 at 09:45, the patient experienced anaphylaxis, high blood pressure and feeling faint. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. AE treatment included unspecified medication and observation. The patient was recovering from the adverse events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the assuming compatible time association, the possible contribution of suspect vaccine BNT162B2 to the event anaphylaxis 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: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: Anaphylaxis; High blood pressure; Feeling faint; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, left arm on 27Jan2021 09:45 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not have COVID prior to vaccination. On 27Jan2021 at 09:45, the patient experienced anaphylaxis, high blood pressure and feeling faint. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. AE treatment included unspecified medication and observation. The patient was recovering from the adverse events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the assuming compatible time association, the possible contribution of suspect vaccine BNT162B2 to the event anaphylaxis 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: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Dizziness
Clinical narrative: Anaphylaxis; High blood pressure; Feeling faint; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, left arm on 27Jan2021 09:45 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not have COVID prior to vaccination. On 27Jan2021 at 09:45, the patient experienced anaphylaxis, high blood pressure and feeling faint. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. AE treatment included unspecified medication and observation. The patient was recovering from the adverse events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the assuming compatible time association, the possible contribution of suspect vaccine BNT162B2 to the event anaphylaxis 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: Condition aggravated, Hallucination, Incoherent
Clinical narrative: Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed; Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL9261), via an unspecified route of administration on 25Jan2021 16:00 at Left arm at single dose for covid-19 immunization. Vaccine was administered in hospital. Medical history included Parkinson's with dementia. There has been some history of hallucination. None known allergies. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA), galantamine, memantine and others. No other vaccine in four weeks. No COVID prior vaccination and COVID was not tested post vaccination. Upon awakening the day after receiving the vaccination, he was incoherent and had hallucinations which were much more pronounced than previously observed. This lasted for about 3 hours and he slowly returned to his baseline status on 26Jan2021. The outcome of the events was recovered on 26Jan2021. No treatment received.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Face injury, Fall, Hyperhidrosis, Pallor
Clinical narrative: blood pressure (1:10 PM): 143/92; Syncopal episode; Patient was pale; Diaphoretic; feeling light-headed; This is a spontaneous report from a contactable nurse. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EL8982), intramuscularly into the left arm on 27Jan2021 13:00 at a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 27Jan2021 13:05 patient had a syncopal episode but regained consciousness immediately and was assessed for injury and other reactions. The patient was pale, diaphoretic and reported feeling light-headed on 27Jan2021 13:05. The patient underwent lab tests and procedures on 27Jan2021 which included blood pressure measurement (units unspecified): 143/92 (1:10 pm), 125/90 (1:15 pm), 131/89 (1:20 pm), 135/81 (1:25 pm) and 130/89  (while standing upright); body temperature (unit unspecified): 98.6 (1:10 pm), 99.0 (1:25 pm) and 98.6 (oral; while standing upright); heart rate (unit unspecified): 74 (1:10 pm), 81 (1:15 pm), heart rate: 85 (1:20 pm), 79 (1:25 pm), 72 (while standing upright); oxygen saturation: 96% (1:10 pm), 99% (1:15 pm), 97% (1:25 pm), 96% (while standing upright); respiratory rate (unit unspecified): 20 (1:10 pm), 20 (1:15 pm), 20 (1:20 pm), 20 (1:25 pm), 18 (while standing up). Outcome of events recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope 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: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: blood pressure (1:10 PM): 143/92; Syncopal episode; Patient was pale; Diaphoretic; feeling light-headed; This is a spontaneous report from a contactable nurse. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EL8982), intramuscularly into the left arm on 27Jan2021 13:00 at a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 27Jan2021 13:05 patient had a syncopal episode but regained consciousness immediately and was assessed for injury and other reactions. The patient was pale, diaphoretic and reported feeling light-headed on 27Jan2021 13:05. The patient underwent lab tests and procedures on 27Jan2021 which included blood pressure measurement (units unspecified): 143/92 (1:10 pm), 125/90 (1:15 pm), 131/89 (1:20 pm), 135/81 (1:25 pm) and 130/89  (while standing upright); body temperature (unit unspecified): 98.6 (1:10 pm), 99.0 (1:25 pm) and 98.6 (oral; while standing upright); heart rate (unit unspecified): 74 (1:10 pm), 81 (1:15 pm), heart rate: 85 (1:20 pm), 79 (1:25 pm), 72 (while standing upright); oxygen saturation: 96% (1:10 pm), 99% (1:15 pm), 97% (1:25 pm), 96% (while standing upright); respiratory rate (unit unspecified): 20 (1:10 pm), 20 (1:15 pm), 20 (1:20 pm), 20 (1:25 pm), 18 (while standing up). Outcome of events recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope 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: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: blood pressure (1:10 PM): 143/92; Syncopal episode; Patient was pale; Diaphoretic; feeling light-headed; This is a spontaneous report from a contactable nurse. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EL8982), intramuscularly into the left arm on 27Jan2021 13:00 at a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 27Jan2021 13:05 patient had a syncopal episode but regained consciousness immediately and was assessed for injury and other reactions. The patient was pale, diaphoretic and reported feeling light-headed on 27Jan2021 13:05. The patient underwent lab tests and procedures on 27Jan2021 which included blood pressure measurement (units unspecified): 143/92 (1:10 pm), 125/90 (1:15 pm), 131/89 (1:20 pm), 135/81 (1:25 pm) and 130/89  (while standing upright); body temperature (unit unspecified): 98.6 (1:10 pm), 99.0 (1:25 pm) and 98.6 (oral; while standing upright); heart rate (unit unspecified): 74 (1:10 pm), 81 (1:15 pm), heart rate: 85 (1:20 pm), 79 (1:25 pm), 72 (while standing upright); oxygen saturation: 96% (1:10 pm), 99% (1:15 pm), 97% (1:25 pm), 96% (while standing upright); respiratory rate (unit unspecified): 20 (1:10 pm), 20 (1:15 pm), 20 (1:20 pm), 20 (1:25 pm), 18 (while standing up). Outcome of events recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope 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: Audiogram abnormal, Audiogram normal, Deafness, Ear discomfort, Tinnitus
Clinical narrative: Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a spontaneous report from a contactable physician (patient herself). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL8982 and expiry date unknown) intramuscular at the left arm on 21Jan2021 15:00PM at a single dose for COVID-19 immunization. The patient's medical history included osteoarthritis and exercise-induced asthma, both from an unknown date and unknown if ongoing. Concomitant medications included celecoxib, paracetamol (TYLENOL), and Vitamin D (NOS); the patient received these medications within 2 weeks of vaccination. The patient is not pregnant at the time of vaccination. She received the first dose of BNT162B2 (lot number: EK9231, expiry date unknown) intramuscular at the left arm on 30Dec2020, 8:30AM at a single dose for COVID-19 immunization. The patient previously took metronidazole from an unknown date and had allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Five days after the second vaccine, on 26Jan2021, 6:00AM, the patient had a sudden onset of right sensory neural hearing loss. Leading up to the sudden loss of hearing, bilateral increased auditory fullness and tinnitus began one to two days after vaccine. The patient received intratympanic steroid injection as treatment for the adverse events. Outcome of the events was not recovered. The case report was assessed as Serious since the events were reported as disabling/incapacitating.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on the temporal relationship. Case will be reassessed if additional information is received. 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: Auditory disorder, Deafness neurosensory, Deafness unilateral, Tinnitus
Clinical narrative: Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a spontaneous report from a contactable physician (patient herself). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL8982 and expiry date unknown) intramuscular at the left arm on 21Jan2021 15:00PM at a single dose for COVID-19 immunization. The patient's medical history included osteoarthritis and exercise-induced asthma, both from an unknown date and unknown if ongoing. Concomitant medications included celecoxib, paracetamol (TYLENOL), and Vitamin D (NOS); the patient received these medications within 2 weeks of vaccination. The patient is not pregnant at the time of vaccination. She received the first dose of BNT162B2 (lot number: EK9231, expiry date unknown) intramuscular at the left arm on 30Dec2020, 8:30AM at a single dose for COVID-19 immunization. The patient previously took metronidazole from an unknown date and had allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Five days after the second vaccine, on 26Jan2021, 6:00AM, the patient had a sudden onset of right sensory neural hearing loss. Leading up to the sudden loss of hearing, bilateral increased auditory fullness and tinnitus began one to two days after vaccine. The patient received intratympanic steroid injection as treatment for the adverse events. Outcome of the events was not recovered. The case report was assessed as Serious since the events were reported as disabling/incapacitating.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on the temporal relationship. Case will be reassessed if additional information is received. 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: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: BILATERAL REDDENED RASH ON BOTH ARMS BEGINNING 2 DAYS AFTER VACCINATION ALONG WITH CONSTANT NECK PAIN. RASH STILL PRESENT, HOWEVER IMPROVED AS OF TODAY, SEEMS TO DISAPPEAR AND REAPPEAR. NECK PAIN CONTINUES AND IS CONSTANT
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Rash, Rash erythematous
Clinical narrative: BILATERAL REDDENED RASH ON BOTH ARMS BEGINNING 2 DAYS AFTER VACCINATION ALONG WITH CONSTANT NECK PAIN. RASH STILL PRESENT, HOWEVER IMPROVED AS OF TODAY, SEEMS TO DISAPPEAR AND REAPPEAR. NECK PAIN CONTINUES AND IS CONSTANT
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash maculo-papular, Skin warm
Clinical narrative: BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates.  Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Burning sensation, Feeling hot, Hypertension
Clinical narrative: BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates.  Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates.  Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Facial neuralgia
Clinical narrative: Facial nerve pain; This is a spontaneous report from a contactable pharmacist (patient). This 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 14Jan2021 16:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications. The patient received the first dose on 23Dec2020 13:00 on the left arm. Patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 21:00, one week after second shot, the patient started experiencing facial nerve pain. Patient has no medical history of any pain before. Negative etiology from dentist. Patient received 5 day course of prednisone 50 mg, daily which resolved the pain, however, one day after finishing course, the pain returned. It was worse at night with bouts of pain every 30 minutes when trying to sleep. Patient received steroids and carbamazepine 100 mg from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Nausea, Tremor
Clinical narrative: Nausea; Weakness; High blood pressure; Fogginess; Shaking all over; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital.  The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient had nausea; weakness; high blood pressure; fogginess; and was shaking all over. The outcome of the events, 'nausea', 'weakness', 'high blood pressure', 'fogginess' and 'shaking all over', was recovered on 15Jan2021 (17:00); blood pressure had come down to 136 (unit was not reported).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Feeling abnormal, Hypertension, Nausea
Clinical narrative: Nausea; Weakness; High blood pressure; Fogginess; Shaking all over; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital.  The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient had nausea; weakness; high blood pressure; fogginess; and was shaking all over. The outcome of the events, 'nausea', 'weakness', 'high blood pressure', 'fogginess' and 'shaking all over', was recovered on 15Jan2021 (17:00); blood pressure had come down to 136 (unit was not reported).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Nausea; Weakness; High blood pressure; Fogginess; Shaking all over; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital.  The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient had nausea; weakness; high blood pressure; fogginess; and was shaking all over. The outcome of the events, 'nausea', 'weakness', 'high blood pressure', 'fogginess' and 'shaking all over', was recovered on 15Jan2021 (17:00); blood pressure had come down to 136 (unit was not reported).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Lymphadenopathy, Pain in extremity
Clinical narrative: She has concerns that it could be a blood clot as it is on her left side (pain) and near her neck.; Clavicle pain; Swelling of her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021 the patient experienced clavical pain and swelling of lymph nodes and she had concerns that it could be a blood clot as it was on her left side (pain) and near her neck.  The final outcome of the event was unknown.Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: She has concerns that it could be a blood clot as it is on her left side (pain) and near her neck.; Clavicle pain; Swelling of her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021 the patient experienced clavical pain and swelling of lymph nodes and she had concerns that it could be a blood clot as it was on her left side (pain) and near her neck.  The final outcome of the event was unknown.Information about lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl  most likely contributed to the events as the patient is known allergic to antihistamine tabs. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tunnel vision, Wheezing
Clinical narrative: Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl  most likely contributed to the events as the patient is known allergic to antihistamine tabs. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Blood pressure increased, Chest discomfort, Dizziness
Clinical narrative: Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl  most likely contributed to the events as the patient is known allergic to antihistamine tabs. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Physical examination normal, Wheezing
Clinical narrative: Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl  most likely contributed to the events as the patient is known allergic to antihistamine tabs. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Slight redness, slight swelling, and rash around the shot site.  Applied benadryl cream for the itching.  Resolved within 24 hrs.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Slight redness, slight swelling, and rash around the shot site.  Applied benadryl cream for the itching.  Resolved within 24 hrs.