chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Presyncope
Clinical narrative: 10 min after the vaccine had sudden cold hands; palpit; dizziness; BP 150/90 - high for patient; a sensation of chest awareness (not pain, but a bit of tension); anxiety; a clear sensation of chest warmth; presyncopal episodes; chest tightness; Still with waves of chest warmth/heat/burning sensation and chest awareness; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 15:00 at single dose at left arm for immunization. Medical history included hypothyroidism, migraine from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT). There's no other vaccine in four weeks. 10 min after the vaccine patient had sudden cold hands (the kind of inside cold like Propofol gives you), with palpit and dizziness, self-limited in a few mins. BP 150/90 - high for patient. Similar episode but shorter and less intense within next half an hour. Also a sensation of chest awareness (not pain, but a bit of tension, which patient had experienced before with anxiety and put it on anxiety). Decided to go home and while walking patient noticed a clear sensation of chest warmth. Patient decided to stick around the hospital a bit more, pondering about going into the ER. Drank 2 bottles of orange juice and headed home. Then on the way home patient had 2 presyncopal episodes. The fact that patient had not eaten all day and wasn't well hydrated might have contributed. Patient didn't go to the ER. Patient ate, drank juice, took diphenhydramine hydrochloride (BENADRYL) 25 mg. The chest tightness got better. Still with waves of chest warmth/heat/burning sensation and chest awareness. Never had such sxs 2/2 anxiety. Patient received acetylsalicylic acid (ASPIRIN), diphenhydramine hydrochloride, clonazepam as treatment. Outcome of all events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination, and no COVID tested post vaccination. Events were reported as non-serious.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Chest pain, Dizziness
Clinical narrative: 10 min after the vaccine had sudden cold hands; palpit; dizziness; BP 150/90 - high for patient; a sensation of chest awareness (not pain, but a bit of tension); anxiety; a clear sensation of chest warmth; presyncopal episodes; chest tightness; Still with waves of chest warmth/heat/burning sensation and chest awareness; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 15:00 at single dose at left arm for immunization. Medical history included hypothyroidism, migraine from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT). There's no other vaccine in four weeks. 10 min after the vaccine patient had sudden cold hands (the kind of inside cold like Propofol gives you), with palpit and dizziness, self-limited in a few mins. BP 150/90 - high for patient. Similar episode but shorter and less intense within next half an hour. Also a sensation of chest awareness (not pain, but a bit of tension, which patient had experienced before with anxiety and put it on anxiety). Decided to go home and while walking patient noticed a clear sensation of chest warmth. Patient decided to stick around the hospital a bit more, pondering about going into the ER. Drank 2 bottles of orange juice and headed home. Then on the way home patient had 2 presyncopal episodes. The fact that patient had not eaten all day and wasn't well hydrated might have contributed. Patient didn't go to the ER. Patient ate, drank juice, took diphenhydramine hydrochloride (BENADRYL) 25 mg. The chest tightness got better. Still with waves of chest warmth/heat/burning sensation and chest awareness. Never had such sxs 2/2 anxiety. Patient received acetylsalicylic acid (ASPIRIN), diphenhydramine hydrochloride, clonazepam as treatment. Outcome of all events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination, and no COVID tested post vaccination. Events were reported as non-serious.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Peripheral coldness, Presyncope
Clinical narrative: 10 min after the vaccine had sudden cold hands; palpit; dizziness; BP 150/90 - high for patient; a sensation of chest awareness (not pain, but a bit of tension); anxiety; a clear sensation of chest warmth; presyncopal episodes; chest tightness; Still with waves of chest warmth/heat/burning sensation and chest awareness; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 15:00 at single dose at left arm for immunization. Medical history included hypothyroidism, migraine from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT). There's no other vaccine in four weeks. 10 min after the vaccine patient had sudden cold hands (the kind of inside cold like Propofol gives you), with palpit and dizziness, self-limited in a few mins. BP 150/90 - high for patient. Similar episode but shorter and less intense within next half an hour. Also a sensation of chest awareness (not pain, but a bit of tension, which patient had experienced before with anxiety and put it on anxiety). Decided to go home and while walking patient noticed a clear sensation of chest warmth. Patient decided to stick around the hospital a bit more, pondering about going into the ER. Drank 2 bottles of orange juice and headed home. Then on the way home patient had 2 presyncopal episodes. The fact that patient had not eaten all day and wasn't well hydrated might have contributed. Patient didn't go to the ER. Patient ate, drank juice, took diphenhydramine hydrochloride (BENADRYL) 25 mg. The chest tightness got better. Still with waves of chest warmth/heat/burning sensation and chest awareness. Never had such sxs 2/2 anxiety. Patient received acetylsalicylic acid (ASPIRIN), diphenhydramine hydrochloride, clonazepam as treatment. Outcome of all events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination, and no COVID tested post vaccination. Events were reported as non-serious.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: I got a mild headache. Within an hour it was severe; I became diaphoretic and felt flushed; I became diaphoretic and felt flushed; felt my heart pounding; GI upset; vomited; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ej1685), via an unspecified route of administration at single dose in the right arm on 16Dec2020 14:30 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included estradiol (ESTRACE), levothyroxine in Dec2020. The patient previously took amoxicillin and experienced drug allergy.   The patient stated that "on 17Dec2020 14:30, I got a mild headache. Within an hour it was severe. I became diaphoretic and felt flushed. and felt my heart pounding. Experienced GI upset and vomited once. Took Tylenol and went to sleep for 8 hours. Woke up feeling normal. Therapeutic measures were taken as a result of the events included Tylenol. The outcome of the events was recovered. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: I got a mild headache. Within an hour it was severe; I became diaphoretic and felt flushed; I became diaphoretic and felt flushed; felt my heart pounding; GI upset; vomited; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ej1685), via an unspecified route of administration at single dose in the right arm on 16Dec2020 14:30 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included estradiol (ESTRACE), levothyroxine in Dec2020. The patient previously took amoxicillin and experienced drug allergy.   The patient stated that "on 17Dec2020 14:30, I got a mild headache. Within an hour it was severe. I became diaphoretic and felt flushed. and felt my heart pounding. Experienced GI upset and vomited once. Took Tylenol and went to sleep for 8 hours. Woke up feeling normal. Therapeutic measures were taken as a result of the events included Tylenol. The outcome of the events was recovered. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Flushing, Headache, Hyperhidrosis, Palpitations
Clinical narrative: I got a mild headache. Within an hour it was severe; I became diaphoretic and felt flushed; I became diaphoretic and felt flushed; felt my heart pounding; GI upset; vomited; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ej1685), via an unspecified route of administration at single dose in the right arm on 16Dec2020 14:30 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included estradiol (ESTRACE), levothyroxine in Dec2020. The patient previously took amoxicillin and experienced drug allergy.   The patient stated that "on 17Dec2020 14:30, I got a mild headache. Within an hour it was severe. I became diaphoretic and felt flushed. and felt my heart pounding. Experienced GI upset and vomited once. Took Tylenol and went to sleep for 8 hours. Woke up feeling normal. Therapeutic measures were taken as a result of the events included Tylenol. The outcome of the events was recovered. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Bilateral arm and hands numbness/traveling up to right facial and lip numbness; pins and needles sensation; burning like sensation; traveling up to right facial and lip numbness; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number=EJ1685), intramuscular in left arm on 17Dec2020 09:00 at a single dose for covid-19 immunization. Medical history included Hashimoto Thyroiditis and allergy to MRI contrast. The patient's concomitant medications were not reported. The patient was not pregnant. The patient experienced bilateral arm and hands numbness/traveling up to right facial and lip numbness, pins and needles sensation and burning like sensation on 18Dec2020 12:00. The patient resulted in an emergency/urgent care where IV dexamethasone was given. The outcome of the events was not recovered.; Sender's Comments: 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: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Bilateral arm and hands numbness/traveling up to right facial and lip numbness; pins and needles sensation; burning like sensation; traveling up to right facial and lip numbness; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number=EJ1685), intramuscular in left arm on 17Dec2020 09:00 at a single dose for covid-19 immunization. Medical history included Hashimoto Thyroiditis and allergy to MRI contrast. The patient's concomitant medications were not reported. The patient was not pregnant. The patient experienced bilateral arm and hands numbness/traveling up to right facial and lip numbness, pins and needles sensation and burning like sensation on 18Dec2020 12:00. The patient resulted in an emergency/urgent care where IV dexamethasone was given. The outcome of the events was not recovered.; Sender's Comments: 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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Ventricular extrasystoles
Clinical narrative: PVC's (about 3-6 per minute) from about 1 hour after minutes after injection; Tachycardia starting 30 minutes after injection; This is a spontaneous report from a contactable nurse (patient).    This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot_number 03121), intramuscular at single dose in the left arm on 17Dec2020 18:00 for Covid-19 immunisation. Medical history included bronchiolitis obliterans and ulcerative colitis. Concomitant medications were not reported. The patient previously took rifampin and experienced drug allergy (serious reaction).  The patient experienced tachycardia starting 30 minutes after injection on 17Dec2020 18:30, PVC's (about 3-6 per minute) from about 1 hour after minutes after injection on 17Dec2020 19:00. She took Benadryl and went to sleep (PVC's still occurring at same rate but heartrate within normal range) at 11pm.  Upon awakening - cardiac rhythm normal. No treatment required. The outcome of  the events was recovered. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of tachycardia /Premature ventricular contractions cannot be excluded, considering the plausible temporal relationship.  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: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Tongue started to tingle; mouth swelled up and tongue; mouth swelled up and tongue; my throat with swollen; This is a spontaneous report from a contactable nurse (patient herself). A 62-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# El040), via intramuscular on 19Dec2020 12:00 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Clinical course: The nurse received the covid vaccination on 19Dec2020 (also reported as 10Dec) within 6 minutes her tongue started to tingle. 15 minutes later her whole mouth started swelling up and was rushed to the emergency room. Her mouth swelled up and tongue. She was given diphenhydramine hydrochloride (BENADRYL), steroid and epinephrine. She could feel that her throat with swollen also.  She spent four hours in the emergency room. She had no allergies. She took no medications. She had no health history. She was healthy 62-year-old. Her son had a severe allergy to bees. And other family members are awesome. She had never gotten stung. Outcome of events were recovered on 19Dec2020. The events were reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events paraesthesia oral, mouth swelling, swollen tongue, and pharyngeal swelling 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.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Paraesthesia oral, Pharyngeal swelling, Swollen tongue
Clinical narrative: Tongue started to tingle; mouth swelled up and tongue; mouth swelled up and tongue; my throat with swollen; This is a spontaneous report from a contactable nurse (patient herself). A 62-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# El040), via intramuscular on 19Dec2020 12:00 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Clinical course: The nurse received the covid vaccination on 19Dec2020 (also reported as 10Dec) within 6 minutes her tongue started to tingle. 15 minutes later her whole mouth started swelling up and was rushed to the emergency room. Her mouth swelled up and tongue. She was given diphenhydramine hydrochloride (BENADRYL), steroid and epinephrine. She could feel that her throat with swollen also.  She spent four hours in the emergency room. She had no allergies. She took no medications. She had no health history. She was healthy 62-year-old. Her son had a severe allergy to bees. And other family members are awesome. She had never gotten stung. Outcome of events were recovered on 19Dec2020. The events were reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events paraesthesia oral, mouth swelling, swollen tongue, and pharyngeal swelling 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.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram normal, Feeling hot, Full blood count normal, Gait disturbance
Clinical narrative: presyncope-transient; chest discomfort; tachycardia-transient; episodic tachycardia; This is a spontaneous report from a contactable Physician reported for self. This 56-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 17Dec2020 12:00 PM on left Arm via Intramuscular at single dose (Lot # EK5730) for covid-19 immunisation. Facility type vaccine: Hospital. No other vaccine in four weeks. Medical history included Allergies to medications, food, or other products: Possibly Sulfas. Concomitant medications included famotidine (PEPCID AC) and colecalciferol (VITAMIN D). About 3 min post vaccine on 17Dec2020 12:03, chest discomfort and tachycardia-transient; then on 17Dec2020 12:15 episodic tachycardia and presyncope-transient 4 episodes in about 13 min; then taken to Emergency room/department or urgent care and treated/monitored and it stopped. IV fluids; Solumedrol; IV Famotidine were received for the events. The patient was a physician, and this was given at her medical center. Outcome of the events was recovered in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the events chest discomfort, tachycardia, and presyncope 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.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Peripheral coldness, Tachycardia, Throat tightness, Troponin normal
Clinical narrative: presyncope-transient; chest discomfort; tachycardia-transient; episodic tachycardia; This is a spontaneous report from a contactable Physician reported for self. This 56-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 17Dec2020 12:00 PM on left Arm via Intramuscular at single dose (Lot # EK5730) for covid-19 immunisation. Facility type vaccine: Hospital. No other vaccine in four weeks. Medical history included Allergies to medications, food, or other products: Possibly Sulfas. Concomitant medications included famotidine (PEPCID AC) and colecalciferol (VITAMIN D). About 3 min post vaccine on 17Dec2020 12:03, chest discomfort and tachycardia-transient; then on 17Dec2020 12:15 episodic tachycardia and presyncope-transient 4 episodes in about 13 min; then taken to Emergency room/department or urgent care and treated/monitored and it stopped. IV fluids; Solumedrol; IV Famotidine were received for the events. The patient was a physician, and this was given at her medical center. Outcome of the events was recovered in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the events chest discomfort, tachycardia, and presyncope 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.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Presyncope, Tachycardia
Clinical narrative: presyncope-transient; chest discomfort; tachycardia-transient; episodic tachycardia; This is a spontaneous report from a contactable Physician reported for self. This 56-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 17Dec2020 12:00 PM on left Arm via Intramuscular at single dose (Lot # EK5730) for covid-19 immunisation. Facility type vaccine: Hospital. No other vaccine in four weeks. Medical history included Allergies to medications, food, or other products: Possibly Sulfas. Concomitant medications included famotidine (PEPCID AC) and colecalciferol (VITAMIN D). About 3 min post vaccine on 17Dec2020 12:03, chest discomfort and tachycardia-transient; then on 17Dec2020 12:15 episodic tachycardia and presyncope-transient 4 episodes in about 13 min; then taken to Emergency room/department or urgent care and treated/monitored and it stopped. IV fluids; Solumedrol; IV Famotidine were received for the events. The patient was a physician, and this was given at her medical center. Outcome of the events was recovered in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the events chest discomfort, tachycardia, and presyncope 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.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Erythema, Palpitations, Urticaria
Clinical narrative: About another 15min went by and I noticed red hives were on my upper chest that were a little itchy; About another 15min went by and I noticed red hives were on my upper chest that were a little itchy; Approximately 45min after the injection, I started feeling dizzy, palpitations and heart racing.; Approximately 45min after the injection, I started feeling dizzy, palpitations and heart racing.; This is a spontaneous report from a contactable consumer (the patient).  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EK5730, via an unspecified route of administration in left arm, on 18Dec2020 15:15 at single dose for COVID-19 immunization.  The vaccine was administered at Hospital Facility. The patient did not receive other vaccine in four weeks. The patient medical history included Hypothyroidism and allergy to Penicillin. The patient's concomitant medications included levothyroxine sodium (LEVOTHYROXINE). The patient on 18Dec2020 at 16:00 approximately 45min after the injection, started feeling dizzy, palpitations and heart racing. About another 15 min went by and the patient noticed red hives on her upper chest that were a little itchy. The events resulted in Emergency room/department or urgent care. The patient received Benadryl, Solumedrol and Pepcid all IV push as treatment. No Covid prior vaccination. Covid was not tested post vaccination. The outcome of the events feeling dizzy, palpitations, heart racing, red hives, little itchy was resolved in Dec2020.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Palpitations, Pruritus, Urticaria
Clinical narrative: About another 15min went by and I noticed red hives were on my upper chest that were a little itchy; About another 15min went by and I noticed red hives were on my upper chest that were a little itchy; Approximately 45min after the injection, I started feeling dizzy, palpitations and heart racing.; Approximately 45min after the injection, I started feeling dizzy, palpitations and heart racing.; This is a spontaneous report from a contactable consumer (the patient).  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EK5730, via an unspecified route of administration in left arm, on 18Dec2020 15:15 at single dose for COVID-19 immunization.  The vaccine was administered at Hospital Facility. The patient did not receive other vaccine in four weeks. The patient medical history included Hypothyroidism and allergy to Penicillin. The patient's concomitant medications included levothyroxine sodium (LEVOTHYROXINE). The patient on 18Dec2020 at 16:00 approximately 45min after the injection, started feeling dizzy, palpitations and heart racing. About another 15 min went by and the patient noticed red hives on her upper chest that were a little itchy. The events resulted in Emergency room/department or urgent care. The patient received Benadryl, Solumedrol and Pepcid all IV push as treatment. No Covid prior vaccination. Covid was not tested post vaccination. The outcome of the events feeling dizzy, palpitations, heart racing, red hives, little itchy was resolved in Dec2020.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Throat tightness
Clinical narrative: Anaphylaxis; feeling faint; fast heart rate; Throat was closing; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left leg on 19Dec2020 12:15 at single dose for COVID-19 immunization. The patient medical history was not reported. No other vaccine administered in four weeks. There were no concomitant medications. No Covid prior vaccination. No Covid tested post vaccination. The patient previously took ampicillin and experienced allergy. The patient experienced anaphylaxis, throat was closing, fast heart rate and feeling faint on 19Dec2020 12:30. Resulted in emergency room/department or urgent care. Epinephrine, steroid, and Benadryl were administered as treatment. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Palpitations, Pharyngeal swelling
Clinical narrative: Anaphylaxis; feeling faint; fast heart rate; Throat was closing; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left leg on 19Dec2020 12:15 at single dose for COVID-19 immunization. The patient medical history was not reported. No other vaccine administered in four weeks. There were no concomitant medications. No Covid prior vaccination. No Covid tested post vaccination. The patient previously took ampicillin and experienced allergy. The patient experienced anaphylaxis, throat was closing, fast heart rate and feeling faint on 19Dec2020 12:30. Resulted in emergency room/department or urgent care. Epinephrine, steroid, and Benadryl were administered as treatment. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Heart rate increased, Throat tightness
Clinical narrative: Anaphylaxis; feeling faint; fast heart rate; Throat was closing; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left leg on 19Dec2020 12:15 at single dose for COVID-19 immunization. The patient medical history was not reported. No other vaccine administered in four weeks. There were no concomitant medications. No Covid prior vaccination. No Covid tested post vaccination. The patient previously took ampicillin and experienced allergy. The patient experienced anaphylaxis, throat was closing, fast heart rate and feeling faint on 19Dec2020 12:30. Resulted in emergency room/department or urgent care. Epinephrine, steroid, and Benadryl were administered as treatment. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: Angioedema; tongue experienced numbness and tingling; tongue experienced numbness and tingling; And at 10 minutes post administration throat was scratchy with a tickle; Symptoms decreased but then intensified to include numbness and tingling in lips; Symptoms decreased but then intensified to include numbness and tingling in lips; This is a spontaneous report from a contactable consumer (patient).  This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) via an unspecified route of administration in the left arm on 18Dec2020 at 16:30 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. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. Relevant medical history was not reported. Concomitant medications included quercetin, cyanocobalamin (B12), aminobenzoic acid/biotin/choline bitartrate/folic acid/inositol/lecithin/vitamin B NOS (B100) and melatonin. Past drug reaction included uncontrolled movement of tongue with promethazine (PHENERGAN). Within 8 minutes of receiving vaccine, patient's tongue experienced numbness and tingling. At 9 minutes post administration, symptom intensified. At 10 minutes post administration, throat was scratchy with a tickle. At 12 minutes post administration, the patient notified Pharmacy and Employee Health Workers. By approximately 16:50, health care professional administered diphenhydramine hydrochloride (BENADRYL) 50 mg IM to right arm. The patient was observed. Symptoms decreased but then intensified to include numbness and tingling in lips. The patient was transferred to Emergency Department for observation. She received dexamethasone acetate (DECADRON) 10 mg at 19:15 due to symptoms not resolving. The patient was discharged from ED with prednisone course. The discharge diagnosis was angioedema. The symptoms decreased approximately 6 hours post administration of vaccine. The patient was recovering from the events.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Cough, Dysphonia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Angioedema; tongue experienced numbness and tingling; tongue experienced numbness and tingling; And at 10 minutes post administration throat was scratchy with a tickle; Symptoms decreased but then intensified to include numbness and tingling in lips; Symptoms decreased but then intensified to include numbness and tingling in lips; This is a spontaneous report from a contactable consumer (patient).  This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) via an unspecified route of administration in the left arm on 18Dec2020 at 16:30 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. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. Relevant medical history was not reported. Concomitant medications included quercetin, cyanocobalamin (B12), aminobenzoic acid/biotin/choline bitartrate/folic acid/inositol/lecithin/vitamin B NOS (B100) and melatonin. Past drug reaction included uncontrolled movement of tongue with promethazine (PHENERGAN). Within 8 minutes of receiving vaccine, patient's tongue experienced numbness and tingling. At 9 minutes post administration, symptom intensified. At 10 minutes post administration, throat was scratchy with a tickle. At 12 minutes post administration, the patient notified Pharmacy and Employee Health Workers. By approximately 16:50, health care professional administered diphenhydramine hydrochloride (BENADRYL) 50 mg IM to right arm. The patient was observed. Symptoms decreased but then intensified to include numbness and tingling in lips. The patient was transferred to Emergency Department for observation. She received dexamethasone acetate (DECADRON) 10 mg at 19:15 due to symptoms not resolving. The patient was discharged from ED with prednisone course. The discharge diagnosis was angioedema. The symptoms decreased approximately 6 hours post administration of vaccine. The patient was recovering from the events.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Throat irritation, Throat tightness
Clinical narrative: Angioedema; tongue experienced numbness and tingling; tongue experienced numbness and tingling; And at 10 minutes post administration throat was scratchy with a tickle; Symptoms decreased but then intensified to include numbness and tingling in lips; Symptoms decreased but then intensified to include numbness and tingling in lips; This is a spontaneous report from a contactable consumer (patient).  This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) via an unspecified route of administration in the left arm on 18Dec2020 at 16:30 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. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. Relevant medical history was not reported. Concomitant medications included quercetin, cyanocobalamin (B12), aminobenzoic acid/biotin/choline bitartrate/folic acid/inositol/lecithin/vitamin B NOS (B100) and melatonin. Past drug reaction included uncontrolled movement of tongue with promethazine (PHENERGAN). Within 8 minutes of receiving vaccine, patient's tongue experienced numbness and tingling. At 9 minutes post administration, symptom intensified. At 10 minutes post administration, throat was scratchy with a tickle. At 12 minutes post administration, the patient notified Pharmacy and Employee Health Workers. By approximately 16:50, health care professional administered diphenhydramine hydrochloride (BENADRYL) 50 mg IM to right arm. The patient was observed. Symptoms decreased but then intensified to include numbness and tingling in lips. The patient was transferred to Emergency Department for observation. She received dexamethasone acetate (DECADRON) 10 mg at 19:15 due to symptoms not resolving. The patient was discharged from ED with prednisone course. The discharge diagnosis was angioedema. The symptoms decreased approximately 6 hours post administration of vaccine. The patient was recovering from the events.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Hypoaesthesia oral, Paraesthesia oral, Throat irritation
Clinical narrative: Angioedema; tongue experienced numbness and tingling; tongue experienced numbness and tingling; And at 10 minutes post administration throat was scratchy with a tickle; Symptoms decreased but then intensified to include numbness and tingling in lips; Symptoms decreased but then intensified to include numbness and tingling in lips; This is a spontaneous report from a contactable consumer (patient).  This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) via an unspecified route of administration in the left arm on 18Dec2020 at 16:30 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. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. Relevant medical history was not reported. Concomitant medications included quercetin, cyanocobalamin (B12), aminobenzoic acid/biotin/choline bitartrate/folic acid/inositol/lecithin/vitamin B NOS (B100) and melatonin. Past drug reaction included uncontrolled movement of tongue with promethazine (PHENERGAN). Within 8 minutes of receiving vaccine, patient's tongue experienced numbness and tingling. At 9 minutes post administration, symptom intensified. At 10 minutes post administration, throat was scratchy with a tickle. At 12 minutes post administration, the patient notified Pharmacy and Employee Health Workers. By approximately 16:50, health care professional administered diphenhydramine hydrochloride (BENADRYL) 50 mg IM to right arm. The patient was observed. Symptoms decreased but then intensified to include numbness and tingling in lips. The patient was transferred to Emergency Department for observation. She received dexamethasone acetate (DECADRON) 10 mg at 19:15 due to symptoms not resolving. The patient was discharged from ED with prednisone course. The discharge diagnosis was angioedema. The symptoms decreased approximately 6 hours post administration of vaccine. The patient was recovering from the events.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Deafness neurosensory, Hypoacusis, 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: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Acoustic stimulation tests abnormal, Deafness neurosensory, 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.