chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Phone call
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: phone call Treatment drugs:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, Blood test, Dyspnoea, Erythema, Flushing
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Pulse abnormal, Tunnel vision
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Anaphylactic reaction, Aspartate aminotransferase increased, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Flushing, Full blood count normal
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypokalaemia, Intensive care, Metabolic function test abnormal, Rash erythematous, Thyroxine free normal
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hyperventilation, Respiratory rate increased
Clinical narrative: couldnt catch breath; feeling dizzy; breathing fast, deep; This is a spontaneous report from a contactable nurse and physician. A 32-year-old female patient received the first dose of bnt162b2 (solution for injection, lot number: EK5730), intramuscular (IM) on the right arm on 15Dec2020 17:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) from 2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Dec2020 17:55, 10 min after injection, she reported feeling dizzy and couldn't catch breath, so she stood up. She was breathing fast, deep but no wheezing and no chest tightness. The adverse events resulted in emergency room department urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL) 25 mg oral (PO) at 6 pm and 1:1000 0.3 ml IM epinephrine (epi). Outcome of the events was recovered on 15Dec2020. The events were considered non-serious by the reporter.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events feeling dizzy, couldn't catch breath and breathing fast and deep, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Patient presented to pharmacy on December 22, 2020 and described side effects after immunization that included pain, swelling and also generalized hives and rash especially facial
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Nausea, Pollakiuria, Pruritus
Clinical narrative: Patient presented to pharmacy on December 22, 2020 and described side effects after immunization that included pain, swelling and also generalized hives and rash especially facial
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient presented to pharmacy on December 22, 2020 and described side effects after immunization that included pain, swelling and also generalized hives and rash especially facial
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Swelling, Urticaria
Clinical narrative: Patient presented to pharmacy on December 22, 2020 and described side effects after immunization that included pain, swelling and also generalized hives and rash especially facial
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dry throat, Rash
Clinical narrative: Generalized rash; Dry throat; This is a spontaneous report from a contactable nurse (patient herself).  A 50-year-old female patient received first dose of bnt162b2 (lot number EK5730) via intramuscular in right deltoid on 16Dec2020 at single dose for covid-19 prevention. There were no concomitant medications or medical history. The patient experienced generalized rash and dry throat on 16Dec2020. The generalized rash was reported as life-threatening and dry throat was reported as medically significant. The reporter reported that she received the vaccine on 16Dec2020, and her adverse event started with a dry throat, and then it progressed to a generalized rash over her entire body. The reporter stated that the dry throat was definitely medically significant. The reporter stated that she hated the ER (emergency room), but that was where she ended up. The reporter stated that she immediately took 50mg of diphenhydramine (BENADRYL) orally for treatment. She bought both liquid and capsule formulation. She also took 650mg of paracetamol (TYLENOL), and 20mg of famotidine (PEPCID) the day before the reporting time. The reporter met with her doctor on the reporting day, who gave her dexamethasone, and a prescription for a steroid pack, and the patient could get it if her symptoms should worsen, or not improve. The reporter stated that the rash was resolving, but if she had not taken the actions that she did for treatment, and going to the ER, then it could have been life-threatening. The reporter stated that this event excluded her from being able to get the second dose of the product, and her doctor told her that it excluded her from getting any future COVID vaccines. The outcome of the events was recovering.; Sender's Comments: Based on the information available as reported at this point, a possible contributory role of the suspect products cannot be excluded for the reported events dry throat and rash based on temporal association.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Rash
Clinical narrative: Generalized rash; Dry throat; This is a spontaneous report from a contactable nurse (patient herself).  A 50-year-old female patient received first dose of bnt162b2 (lot number EK5730) via intramuscular in right deltoid on 16Dec2020 at single dose for covid-19 prevention. There were no concomitant medications or medical history. The patient experienced generalized rash and dry throat on 16Dec2020. The generalized rash was reported as life-threatening and dry throat was reported as medically significant. The reporter reported that she received the vaccine on 16Dec2020, and her adverse event started with a dry throat, and then it progressed to a generalized rash over her entire body. The reporter stated that the dry throat was definitely medically significant. The reporter stated that she hated the ER (emergency room), but that was where she ended up. The reporter stated that she immediately took 50mg of diphenhydramine (BENADRYL) orally for treatment. She bought both liquid and capsule formulation. She also took 650mg of paracetamol (TYLENOL), and 20mg of famotidine (PEPCID) the day before the reporting time. The reporter met with her doctor on the reporting day, who gave her dexamethasone, and a prescription for a steroid pack, and the patient could get it if her symptoms should worsen, or not improve. The reporter stated that the rash was resolving, but if she had not taken the actions that she did for treatment, and going to the ER, then it could have been life-threatening. The reporter stated that this event excluded her from being able to get the second dose of the product, and her doctor told her that it excluded her from getting any future COVID vaccines. The outcome of the events was recovering.; Sender's Comments: Based on the information available as reported at this point, a possible contributory role of the suspect products cannot be excluded for the reported events dry throat and rash based on temporal association.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cold sweat, Dyspnoea, Throat tightness
Clinical narrative: feeling clammy; made it harder to breathe; tightness in her chest and throat; tightness in her chest and throat; blood pressure of 130/100, and she was reportedly normotensive usually; This is a spontaneous report from a contactable pharmacist.  A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899), intramuscular in the left arm on 17Dec2020 at 08:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization.  Medical history included anxiety from an unknown date and unknown if ongoing.  The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), and ethynylestradiol/norethisterone acetate (LOESTRIN); all for unknown indications from unknown dates and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020 at 08:30, the patient reported feeling clammy with a tightness in her chest and throat that made it harder to breathe and elevated blood pressure. She had left the vaccine clinic and was on her way home at symptom onset, and she returned immediately. At the clinic, she was given diphenhydramine (MANUFACTURER UNKNOWN) 25mg orally and her blood pressure was periodically monitored. At onset, she had a blood pressure of 130/100, and she was reportedly normotensive usually. The patient was monitored for 30-45 minutes. The clinical outcomes of feeling clammy, tightness in her chest and throat, and hard to breathe was recovered on 17Dec2020; while the outcome of elevated blood pressure was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Cold sweat, Dyspnoea, Throat tightness
Clinical narrative: feeling clammy; made it harder to breathe; tightness in her chest and throat; tightness in her chest and throat; blood pressure of 130/100, and she was reportedly normotensive usually; This is a spontaneous report from a contactable pharmacist.  A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899), intramuscular in the left arm on 17Dec2020 at 08:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization.  Medical history included anxiety from an unknown date and unknown if ongoing.  The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), and ethynylestradiol/norethisterone acetate (LOESTRIN); all for unknown indications from unknown dates and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020 at 08:30, the patient reported feeling clammy with a tightness in her chest and throat that made it harder to breathe and elevated blood pressure. She had left the vaccine clinic and was on her way home at symptom onset, and she returned immediately. At the clinic, she was given diphenhydramine (MANUFACTURER UNKNOWN) 25mg orally and her blood pressure was periodically monitored. At onset, she had a blood pressure of 130/100, and she was reportedly normotensive usually. The patient was monitored for 30-45 minutes. The clinical outcomes of feeling clammy, tightness in her chest and throat, and hard to breathe was recovered on 17Dec2020; while the outcome of elevated blood pressure was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Paraesthesia oral, Swollen tongue
Clinical narrative: tingling to the tip of the tongue and further back to the middle of tongue, oral tingling (upper lip and then into the lower lip); mild swelling to the tip of the tongue; This is a spontaneous report from a contactable nurse.  A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), intramuscularly in the left deltoid on 17Dec2020 11:15 at a single dose for COVID-19 immunization.  Medical history included palpitations multiple premature ventricular contractions (PVC)s from 11Jan2020 to an unknown date.  The patient's concomitant medications were not reported. Patient denied any history of previous adverse reactions to vaccines.  The patient previously took dexamethasone (DECADRON) and experienced tingling of lips and tongue and sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies and acute kidney injury.  The patient experienced tingling to the tip of the tongue and further back to the middle of tongue, oral tingling (upper lip and then into the lower lip) and mild swelling to the tip of the tongue on 17Dec2020 11:15.  During the 15-minute waiting period after the injection, the patient began to experience oral tingling (upper lip and then into the lower lib).   It then progressed to the tongue and she reported tingling to the tip of the tongue and further back to the middle of tongue. She thought there might be some mild swelling to the tip of the tongue. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling and lip swelling. The patient went to the emergency room/department or urgent care. The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the events.  The outcome of the events was recovered in Dec2020.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: tingling to the tip of the tongue and further back to the middle of tongue, oral tingling (upper lip and then into the lower lip); mild swelling to the tip of the tongue; This is a spontaneous report from a contactable nurse.  A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), intramuscularly in the left deltoid on 17Dec2020 11:15 at a single dose for COVID-19 immunization.  Medical history included palpitations multiple premature ventricular contractions (PVC)s from 11Jan2020 to an unknown date.  The patient's concomitant medications were not reported. Patient denied any history of previous adverse reactions to vaccines.  The patient previously took dexamethasone (DECADRON) and experienced tingling of lips and tongue and sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies and acute kidney injury.  The patient experienced tingling to the tip of the tongue and further back to the middle of tongue, oral tingling (upper lip and then into the lower lip) and mild swelling to the tip of the tongue on 17Dec2020 11:15.  During the 15-minute waiting period after the injection, the patient began to experience oral tingling (upper lip and then into the lower lib).   It then progressed to the tongue and she reported tingling to the tip of the tongue and further back to the middle of tongue. She thought there might be some mild swelling to the tip of the tongue. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling and lip swelling. The patient went to the emergency room/department or urgent care. The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the events.  The outcome of the events was recovered in Dec2020.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphonia, Rash, Swollen tongue, Tachycardia, Throat irritation
Clinical narrative: tingling tongue; flushed; shortness of breath; This is a spontaneous report from a contactable consumer, the patient.  A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at 11:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included mild bee sting reaction and allergy to scallops.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unknown indication on 17Dec2020 at 10:45 1 hour prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020, the patient experienced tingling tongue, flushed, and shortness of breath; all of which required an emergency room/urgent care visit. The clinical course was as follows: 15 minutes after administration (reported as 10:45), the symptoms of tingling tongue, flushed, and shortness of breath appeared. The symptoms did not improve. The patient was treated with epinephrine (MANUFACTURER UNKNOWN) for 2 doses, diphenhydramine hydrochloride, and montelukast (SINGULAIR). The symptoms did slowly resolve after treatment and the clinical outcomes of tingling tongue, flushed, and shortness of breath were recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Tryptase
Clinical narrative: tingling tongue; flushed; shortness of breath; This is a spontaneous report from a contactable consumer, the patient.  A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at 11:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included mild bee sting reaction and allergy to scallops.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unknown indication on 17Dec2020 at 10:45 1 hour prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020, the patient experienced tingling tongue, flushed, and shortness of breath; all of which required an emergency room/urgent care visit. The clinical course was as follows: 15 minutes after administration (reported as 10:45), the symptoms of tingling tongue, flushed, and shortness of breath appeared. The symptoms did not improve. The patient was treated with epinephrine (MANUFACTURER UNKNOWN) for 2 doses, diphenhydramine hydrochloride, and montelukast (SINGULAIR). The symptoms did slowly resolve after treatment and the clinical outcomes of tingling tongue, flushed, and shortness of breath were recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Paraesthesia oral
Clinical narrative: tingling tongue; flushed; shortness of breath; This is a spontaneous report from a contactable consumer, the patient.  A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at 11:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included mild bee sting reaction and allergy to scallops.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unknown indication on 17Dec2020 at 10:45 1 hour prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020, the patient experienced tingling tongue, flushed, and shortness of breath; all of which required an emergency room/urgent care visit. The clinical course was as follows: 15 minutes after administration (reported as 10:45), the symptoms of tingling tongue, flushed, and shortness of breath appeared. The symptoms did not improve. The patient was treated with epinephrine (MANUFACTURER UNKNOWN) for 2 doses, diphenhydramine hydrochloride, and montelukast (SINGULAIR). The symptoms did slowly resolve after treatment and the clinical outcomes of tingling tongue, flushed, and shortness of breath were recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain at the injection site for 2 days.; This is a spontaneous report from a contactable consumer.  A 23-year-old non- pregnant female patient received the first dose of the bnt162b2 (BNT162B2; also reported as COVID 19, brand=Pfizer-BioNTech; Lot Number: EH9899), via an unspecified route of administration in the left arm on 15Dec2020 at 08:30 at 23-years-old at a single dose for COVID-19 immunization. The vaccination facility was a hospital. It was also reported that there were no other vaccinations in four weeks, and there were no other medications in two weeks prior to the vaccination. The patient's medical history was reported as none. The patient did not have COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies (allergies to medications, food, or other products: no). Concomitant medications were not reported. On 15Dec2020 at 21:30, the patient experienced: pain at the injection site for 2 days. There was no treatment for the adverse event; nor did the event require hospitalization. The clinical outcome of the event, pain at the injection site for 2 days, was recovered on an unspecified date in Dec2020.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site for 2 days.; This is a spontaneous report from a contactable consumer.  A 23-year-old non- pregnant female patient received the first dose of the bnt162b2 (BNT162B2; also reported as COVID 19, brand=Pfizer-BioNTech; Lot Number: EH9899), via an unspecified route of administration in the left arm on 15Dec2020 at 08:30 at 23-years-old at a single dose for COVID-19 immunization. The vaccination facility was a hospital. It was also reported that there were no other vaccinations in four weeks, and there were no other medications in two weeks prior to the vaccination. The patient's medical history was reported as none. The patient did not have COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies (allergies to medications, food, or other products: no). Concomitant medications were not reported. On 15Dec2020 at 21:30, the patient experienced: pain at the injection site for 2 days. There was no treatment for the adverse event; nor did the event require hospitalization. The clinical outcome of the event, pain at the injection site for 2 days, was recovered on an unspecified date in Dec2020.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Pt. received part one covid vaccine on 12/15 at 4:30 pm.  The next morning at 10:30 when she woke up, she had moderate facial swelling and redness. (No rash, no GI discomfort, no difficulty breathing) Pt. took Benadryl, Zyrtec, and iced face. The following day it resolved after another dose of Benadryl.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: hands, arms and fingers itching, the itching continued to the rest of her body; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 VACCINE, Pharmaceutical form (Dosage form): Injection, lot/batch# EK5730), via an unspecified route of administration to right upper arm on 17Dec2020 11:00 at single dose for COVID-19 immunization. The patient had no medical history, no concomitant medications. Investigation Assessment: No.  The patient experienced hands, arms and fingers itching, the itching continued to the rest of her body on 17Dec2020 21:30 with outcome of recovered in Dec2020. This consumer works in healthcare. She received the Pfizer-BioNTech COVID-19 Vaccine on 17Dec2020 at approximately 11:00 am from her employment/work. She was monitored for 30 minutes after the vaccine and everything was fine. About 9:30pm she woke up to her hands, arms and fingers itching. She got up, wiped them off with warm water which did not help, the itching continued to the rest of her body; so she went to emergency room who said it was an adverse event. The only thing different in her day was the COVID-19 Vaccine. She was not admitted to the hospital, she was just treated in the emergency room with steroids, antihistamines and beta blocker and her symptoms subsided within about 1.5 hours. She is scheduled to receive the next dose within 3 weeks, and there has been no prescribed change made at this point; they will reach out to her and decide if that will continue.  Reporter verified that there are no relevant concomitant medications or other medical conditions to provide for this report. There was nothing new or different. Reporter verified that there was no relevant testing, labwork, imaging or other investigations performed to provide for this report. They just started IVs and monitored her.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Pruritus
Clinical narrative: hands, arms and fingers itching, the itching continued to the rest of her body; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 VACCINE, Pharmaceutical form (Dosage form): Injection, lot/batch# EK5730), via an unspecified route of administration to right upper arm on 17Dec2020 11:00 at single dose for COVID-19 immunization. The patient had no medical history, no concomitant medications. Investigation Assessment: No.  The patient experienced hands, arms and fingers itching, the itching continued to the rest of her body on 17Dec2020 21:30 with outcome of recovered in Dec2020. This consumer works in healthcare. She received the Pfizer-BioNTech COVID-19 Vaccine on 17Dec2020 at approximately 11:00 am from her employment/work. She was monitored for 30 minutes after the vaccine and everything was fine. About 9:30pm she woke up to her hands, arms and fingers itching. She got up, wiped them off with warm water which did not help, the itching continued to the rest of her body; so she went to emergency room who said it was an adverse event. The only thing different in her day was the COVID-19 Vaccine. She was not admitted to the hospital, she was just treated in the emergency room with steroids, antihistamines and beta blocker and her symptoms subsided within about 1.5 hours. She is scheduled to receive the next dose within 3 weeks, and there has been no prescribed change made at this point; they will reach out to her and decide if that will continue.  Reporter verified that there are no relevant concomitant medications or other medical conditions to provide for this report. There was nothing new or different. Reporter verified that there was no relevant testing, labwork, imaging or other investigations performed to provide for this report. They just started IVs and monitored her.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Rash macular
Clinical narrative: she developed coughing and blotchiness within an hour after receiving the first vaccine; she developed coughing and blotchiness within an hour after receiving the first vaccine; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: Mar2021), intramuscular (deltoid right) on 15Dec2020 12:55 at a single dose for Covid Prophylaxis. Medical history was reported as none. There were no concomitant medications. On 15Dec2020, the patient developed coughing and blotchiness within an hour after receiving the first vaccine. She had coughing and blotchiness all over her. The patient was sent to the ER (emergency room). The reporter said that the patient was eating lunch and a coworker looked at her and told her that she was getting really blotchy. The reporter said that the patient could not hold a conversation and was coughing like with every 2nd or 3rd word, kind of like a Lopressor cough, it was like a medication induced cough. It was dry and hacky and she had to cough to get other words out. The patient was sent to the emergency room. The patient was treated with steroids, ethionamide and breathing treatment, and she was prescribed with EpiPen and Benadryl OTC. The reporter wants to know if they should administer steroids, ethionamide, EpiPen and Benadryl OTC in a second dose to a patient who presented coughing and blotchiness on her first administration of the COVID vaccine. Outcome of the events was recovered on 15Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of coughing and blotchiness 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eosinophil percentage decreased, Throat irritation, Tongue pruritus
Clinical narrative: I was at the observation area and all of a sudden I started rapidly coughing and my throat felt itchy. I notified the nurse and she started observed me. The back of my tongue started feeling weird. She then hit me with an epi-pen as a precaution. Because of that I was moved to the ER for observation for 2 hours to make sure everything was ok. After the epi-pen all symptoms went away. Before I left they drew labs to check if I was having an allergic reaction. And the results came next day and it was 0.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Cough, Paraesthesia oral, Throat irritation
Clinical narrative: I was at the observation area and all of a sudden I started rapidly coughing and my throat felt itchy. I notified the nurse and she started observed me. The back of my tongue started feeling weird. She then hit me with an epi-pen as a precaution. Because of that I was moved to the ER for observation for 2 hours to make sure everything was ok. After the epi-pen all symptoms went away. Before I left they drew labs to check if I was having an allergic reaction. And the results came next day and it was 0.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration arm left on 16Dec2020 18:44, single for immunization. Medical history included Delta granule storage pool deficiency. Concomitant medication included fluoxetine. On 16Dec2020, received vaccine at 6:44pm; On 17Dec2020- woke up with nausea/ vomiting and a fever, had to call off work; 18Dec- continued to have nausea/vomiting and low grade fever, symptoms and fever resolved by 10 am. The outcome of the events was recovered.   Information on the Batch/Lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration arm left on 16Dec2020 18:44, single for immunization. Medical history included Delta granule storage pool deficiency. Concomitant medication included fluoxetine. On 16Dec2020, received vaccine at 6:44pm; On 17Dec2020- woke up with nausea/ vomiting and a fever, had to call off work; 18Dec- continued to have nausea/vomiting and low grade fever, symptoms and fever resolved by 10 am. The outcome of the events was recovered.   Information on the Batch/Lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Vision blurred
Clinical narrative: right eye fullness; blurred vision; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, via an unspecified route of administration in the right arm on 17Dec2020 11:30 at single dose for immunization. Medical history was reported as none.  The patient's concomitant medications include multivitamins within two weeks of vaccination. The patient experienced right eye fullness and blurred vision on 17Dec2020. The patient was vaccinated in the hospital and no other vaccine in four weeks was given. No treatment given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies. The events was considered non serious. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ocular discomfort, Vision blurred
Clinical narrative: right eye fullness; blurred vision; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, via an unspecified route of administration in the right arm on 17Dec2020 11:30 at single dose for immunization. Medical history was reported as none.  The patient's concomitant medications include multivitamins within two weeks of vaccination. The patient experienced right eye fullness and blurred vision on 17Dec2020. The patient was vaccinated in the hospital and no other vaccine in four weeks was given. No treatment given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies. The events was considered non serious. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Computerised tomogram head normal, Dizziness, Dizziness postural, Headache
Clinical narrative: 15 mins after the vaccine I had a bad headache and very dizzy  blood pressure 168/109 very hypertensive  Possibly stoke after vaccine ( No stoke ) Took ibuprofen Had Tylenol before the vaccine  12/22/2020 slight high blood pressure still
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: 15 mins after the vaccine I had a bad headache and very dizzy  blood pressure 168/109 very hypertensive  Possibly stoke after vaccine ( No stoke ) Took ibuprofen Had Tylenol before the vaccine  12/22/2020 slight high blood pressure still
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Headache, Hypertension
Clinical narrative: 15 mins after the vaccine I had a bad headache and very dizzy  blood pressure 168/109 very hypertensive  Possibly stoke after vaccine ( No stoke ) Took ibuprofen Had Tylenol before the vaccine  12/22/2020 slight high blood pressure still
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: At first it was just muscle ache in the left arm; then I started having body aches; headache; I'm feeling very nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 24-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899, expiry date: unknown), via an unspecified route of administration arm left on 17Dec2020 08:15 at, single (Dose Number: 1) for immunization. Medical history included asthma. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). Allergies to medications, food, or other products: Tylenol and Midol. On 17Dec2020 23:00, At first it was just muscle ache in the left arm and then I started having body aches and a headache and now I'm feeling very nauseous. The outcome of the events was unknown.