chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body Aches; Chills; 101/102 fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 29Dec2020 13:30 at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 30Dec2020, the patient experienced body aches, chills, and 101/102 fever. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Body Aches; Chills; 101/102 fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 29Dec2020 13:30 at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 30Dec2020, the patient experienced body aches, chills, and 101/102 fever. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dizziness, Dry mouth, Dry throat, Dysphonia
Clinical narrative: Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips numb; tachycardia with throat tightness; tachycardia with throat tightness.; This is a spontaneous report from a contactable nurse (patient).  The 37-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), unknown on 05Jan2021 07:45 at SINGLE DOSE on left arm for COVID-19 immunisation. The patient is not pregnant. No covid tested post vaccination. Medical history included Idiopathic angioedema, HTN, PCOS, Allergies to medications, food, or other products: Latex, penicillin, coconut. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included spironolactone (ALDACTONE), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, amlodipine besilate (NORVASC). The patient did not take other vaccine in four weeks. The patient experienced Angioedema event occurred approximately 18 hrs later with repeat of treatment in ER on 06Jan2021, tongue numb observer notified about 10 minutes after vaccine, then tongue and lower lips numb on 05Jan2021 08:00, taken to ER became tachycardia with throat tightness on 05Jan2021 08:00. EPIPEN administered, benadryl and prednisone (steroids), and famotidine administered along with a saline bolus. The outcome of the events was recovered.  No follow-up attempts are needed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including complement levels, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Hypoaesthesia oral, Swollen tongue, Tachycardia
Clinical narrative: Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips numb; tachycardia with throat tightness; tachycardia with throat tightness.; This is a spontaneous report from a contactable nurse (patient).  The 37-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), unknown on 05Jan2021 07:45 at SINGLE DOSE on left arm for COVID-19 immunisation. The patient is not pregnant. No covid tested post vaccination. Medical history included Idiopathic angioedema, HTN, PCOS, Allergies to medications, food, or other products: Latex, penicillin, coconut. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included spironolactone (ALDACTONE), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, amlodipine besilate (NORVASC). The patient did not take other vaccine in four weeks. The patient experienced Angioedema event occurred approximately 18 hrs later with repeat of treatment in ER on 06Jan2021, tongue numb observer notified about 10 minutes after vaccine, then tongue and lower lips numb on 05Jan2021 08:00, taken to ER became tachycardia with throat tightness on 05Jan2021 08:00. EPIPEN administered, benadryl and prednisone (steroids), and famotidine administered along with a saline bolus. The outcome of the events was recovered.  No follow-up attempts are needed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including complement levels, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Hypoaesthesia oral, Tachycardia, Throat tightness
Clinical narrative: Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips numb; tachycardia with throat tightness; tachycardia with throat tightness.; This is a spontaneous report from a contactable nurse (patient).  The 37-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), unknown on 05Jan2021 07:45 at SINGLE DOSE on left arm for COVID-19 immunisation. The patient is not pregnant. No covid tested post vaccination. Medical history included Idiopathic angioedema, HTN, PCOS, Allergies to medications, food, or other products: Latex, penicillin, coconut. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included spironolactone (ALDACTONE), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, amlodipine besilate (NORVASC). The patient did not take other vaccine in four weeks. The patient experienced Angioedema event occurred approximately 18 hrs later with repeat of treatment in ER on 06Jan2021, tongue numb observer notified about 10 minutes after vaccine, then tongue and lower lips numb on 05Jan2021 08:00, taken to ER became tachycardia with throat tightness on 05Jan2021 08:00. EPIPEN administered, benadryl and prednisone (steroids), and famotidine administered along with a saline bolus. The outcome of the events was recovered.  No follow-up attempts are needed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including complement levels, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache; Nausea; Minor fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. caller wanted to know it the adverse reactions that she is experiencing could be due to the administration of the vaccine. She received the vaccine a week ago and she started to present the following side effects yesterday (05Jan2021): headache, nausea and minor fever. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Nausea; Minor fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. caller wanted to know it the adverse reactions that she is experiencing could be due to the administration of the vaccine. She received the vaccine a week ago and she started to present the following side effects yesterday (05Jan2021): headache, nausea and minor fever. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Disturbance in attention, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin, Headache, Limb discomfort, Metabolic function test normal, Neurological examination normal
Clinical narrative: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Red blood cell sedimentation rate normal, Type III immune complex mediated reaction, Vitamin B12
Clinical narrative: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site paraesthesia, Paraesthesia
Clinical narrative: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Coronavirus infection, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: sore arm the next day; cold sweats; Loss of smell /Last night he noticed very little aroma from food or candles; This is a spontaneous report from a contactable pharmacist.  A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021at single dose for COVID-19 immunisation. Medical history included cough and laryngitis. He had symptoms that started prior to vaccine with cough and laryngitis, he was vaccinated on 04Jan2021. He had a sore arm the next day, woke up in cold sweats, he ate a cookie, orange flavor, it didn't taste the same, He thought it was because he kept the package open. He could still kinda smell the 3 drugs he sniffed yesterday, (when counting drugs some drugs have certain smells). Last night he noticed very little aroma from food or candles. He currently is still with Loss of smell and laryngitis. The outcome of Loss of smell was not recovered, of other events were unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Cold sweat, Pain in extremity
Clinical narrative: sore arm the next day; cold sweats; Loss of smell /Last night he noticed very little aroma from food or candles; This is a spontaneous report from a contactable pharmacist.  A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021at single dose for COVID-19 immunisation. Medical history included cough and laryngitis. He had symptoms that started prior to vaccine with cough and laryngitis, he was vaccinated on 04Jan2021. He had a sore arm the next day, woke up in cold sweats, he ate a cookie, orange flavor, it didn't taste the same, He thought it was because he kept the package open. He could still kinda smell the 3 drugs he sniffed yesterday, (when counting drugs some drugs have certain smells). Last night he noticed very little aroma from food or candles. He currently is still with Loss of smell and laryngitis. The outcome of Loss of smell was not recovered, of other events were unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ocular icterus, Pruritus, Yellow skin
Clinical narrative: Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Vaccine location was arm. None medical history. The patient's concomitant medications were not reported. Patient stated she had the COVID vaccine on Dec18th, her first one and she was fine, no issues and she would say the following Wednesday (23Dec2020), she started getting like a hot flash, it lasted whole day and then her feet started itching. And now, she have got itching all over her whole body and especially in her hands and her feet all the time. She went to her family doctor. She have not had this issue before and she don't have any known allergies. And she went to family doctor and he prescribed some antihistamines and of course they are still bothering patient. Besides itching, she was not having any other complication. Patient went to family doctor last week and he put her on a prescription of antihistamine trying to help. It is not helping, Benadryl helped her. When probed for the name of the product, patient stated she think the name of it is Lyrica. The events were persisting. She had better times but then it was other times when it is worse. When asked the causality, the patient stated she think so. She has never had a reaction like this and it has been going on everyday ever since. The only thing that worries is she was due to get her second one on the 8th which is this Friday and she have heard people rumors saying that when get second vaccine, whatever symptoms she was having are even worse. Patient don't know is it true. And of course everyone is saying like, normally they say - any reactions you get like the first 24-48 hours but her didn't happen until almost halfway till first week.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Pruritus
Clinical narrative: Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Vaccine location was arm. None medical history. The patient's concomitant medications were not reported. Patient stated she had the COVID vaccine on Dec18th, her first one and she was fine, no issues and she would say the following Wednesday (23Dec2020), she started getting like a hot flash, it lasted whole day and then her feet started itching. And now, she have got itching all over her whole body and especially in her hands and her feet all the time. She went to her family doctor. She have not had this issue before and she don't have any known allergies. And she went to family doctor and he prescribed some antihistamines and of course they are still bothering patient. Besides itching, she was not having any other complication. Patient went to family doctor last week and he put her on a prescription of antihistamine trying to help. It is not helping, Benadryl helped her. When probed for the name of the product, patient stated she think the name of it is Lyrica. The events were persisting. She had better times but then it was other times when it is worse. When asked the causality, the patient stated she think so. She has never had a reaction like this and it has been going on everyday ever since. The only thing that worries is she was due to get her second one on the 8th which is this Friday and she have heard people rumors saying that when get second vaccine, whatever symptoms she was having are even worse. Patient don't know is it true. And of course everyone is saying like, normally they say - any reactions you get like the first 24-48 hours but her didn't happen until almost halfway till first week.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: too sick; Fever; muscle aches; headache; body aches; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration left arm on 04Jan2021 19:30 (07:30 PM) at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included escitalopram oxalate (LEXAPRO) and ergocalciferol (VIT D). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered in a hospital. The patient experienced fever, muscle aches, headache and body aches on 05Jan2021 09:00 PM (21:00). The patient was too sick to get out of bed to find lot details. The patient did not received treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the event sickness was unknown while the outcome of the other events was recovering.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Illness, Myalgia, Pain, Pyrexia
Clinical narrative: too sick; Fever; muscle aches; headache; body aches; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration left arm on 04Jan2021 19:30 (07:30 PM) at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included escitalopram oxalate (LEXAPRO) and ergocalciferol (VIT D). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered in a hospital. The patient experienced fever, muscle aches, headache and body aches on 05Jan2021 09:00 PM (21:00). The patient was too sick to get out of bed to find lot details. The patient did not received treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the event sickness was unknown while the outcome of the other events was recovering.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Back pain, Chills, Headache, Myalgia
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness, Hypoacusis
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Back pain, Chills, Deafness unilateral
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Exposure to SARS-CoV-2, Middle ear effusion, Myalgia, Pain in extremity
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.