chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Lymphadenopathy, Myalgia, Nausea, Pharyngeal swelling
Clinical narrative: I found out im allergic to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, expiration date unspecified), via an unspecified route of administration on 13Jan2021 14:00 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergies. On 13Jan2021, at 22:00, the patient found out she was allergic to the vaccine. Treatment was received for the events included antibiotics, pain meds and muscle relaxers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: I found out im allergic to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, expiration date unspecified), via an unspecified route of administration on 13Jan2021 14:00 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergies. On 13Jan2021, at 22:00, the patient found out she was allergic to the vaccine. Treatment was received for the events included antibiotics, pain meds and muscle relaxers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I found out im allergic to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, expiration date unspecified), via an unspecified route of administration on 13Jan2021 14:00 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergies. On 13Jan2021, at 22:00, the patient found out she was allergic to the vaccine. Treatment was received for the events included antibiotics, pain meds and muscle relaxers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Fall, Hyperhidrosis, Injection site pain
Clinical narrative: Lost consciousness; Lightheaded/Dizzy; Lost balance; Broke into a sweat; Site injection soreness; A spontaneous report was received from a 37 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: B28L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, after receiving the vaccine, the patient had site injection soreness at night.  On the morning of 20 Jan 2021, the patient woke up feeling lightheaded and dizzy. She tried to walk and broke into a sweat, lost her balance and lost consciousness. A few moments later, everything came back.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness were resolved on 20 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Based on possible temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Lost consciousness; Lightheaded/Dizzy; Lost balance; Broke into a sweat; Site injection soreness; A spontaneous report was received from a 37 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: B28L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, after receiving the vaccine, the patient had site injection soreness at night.  On the morning of 20 Jan 2021, the patient woke up feeling lightheaded and dizzy. She tried to walk and broke into a sweat, lost her balance and lost consciousness. A few moments later, everything came back.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness were resolved on 20 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Based on possible temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Hyperhidrosis, Injection site pain, Loss of consciousness
Clinical narrative: Lost consciousness; Lightheaded/Dizzy; Lost balance; Broke into a sweat; Site injection soreness; A spontaneous report was received from a 37 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: B28L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, after receiving the vaccine, the patient had site injection soreness at night.  On the morning of 20 Jan 2021, the patient woke up feeling lightheaded and dizzy. She tried to walk and broke into a sweat, lost her balance and lost consciousness. A few moments later, everything came back.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness were resolved on 20 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Based on possible temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in arm after injection; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284), intramuscular in left arm, on 29Dec2020 at 13:00 (01:00 PM), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfadiazine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 29Dec2020 at 01:01 PM (1 minute after injection), the patient experienced tingling in arm after injection. The rapid response was observed for 30 minutes. No other intervention was done; no treatment was received for the event. The event was considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on an unspecified date.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: Tingling in arm after injection; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284), intramuscular in left arm, on 29Dec2020 at 13:00 (01:00 PM), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfadiazine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 29Dec2020 at 01:01 PM (1 minute after injection), the patient experienced tingling in arm after injection. The rapid response was observed for 30 minutes. No other intervention was done; no treatment was received for the event. The event was considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on an unspecified date.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are drying , reports it is a burning sensation; This is a spontaneous report from a contactable consumer reporting for self.  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Dose 1) as a single dose, right arm for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 31Dec2020 in the morning, she had very tiny rashes on the back of her right hand, opposite side of her palm; she received the injection in the right arm. The very tiny rashes were there for 4 or 5 days and then slowly disappeared. Then the same rashes came back again on the same hand. She stated she "cannot see them but she can feel them since they are drying;" she reported it as a burning sensation and she wished she could put something cool on there. At the time of the report, the rashes and burning sensation were going away(recovering). She took a picture of it and she can send that in. She can get the second dose today or tomorrow and wanted to know if it was ok for her to get the second dose.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are drying , reports it is a burning sensation; This is a spontaneous report from a contactable consumer reporting for self.  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Dose 1) as a single dose, right arm for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 31Dec2020 in the morning, she had very tiny rashes on the back of her right hand, opposite side of her palm; she received the injection in the right arm. The very tiny rashes were there for 4 or 5 days and then slowly disappeared. Then the same rashes came back again on the same hand. She stated she "cannot see them but she can feel them since they are drying;" she reported it as a burning sensation and she wished she could put something cool on there. At the time of the report, the rashes and burning sensation were going away(recovering). She took a picture of it and she can send that in. She can get the second dose today or tomorrow and wanted to know if it was ok for her to get the second dose.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Dysgraphia, Speech disorder
Clinical narrative: The patient presents to the emergency department with his wife after he developed onset of difficulty speaking at 9:00 p.m. last night.  Patient did receive the COVID vaccine approximately 2 days ago.  Also received a recent injection to his left eye secondary to macular degeneration.  Wife states he has had difficulty getting his words out.  No focal weakness.  No headache.  No prior similar episodes.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram carotid abnormal, Arteriosclerosis, Cerebral arteriosclerosis, Cerebral ischaemia, Cerebrovascular accident
Clinical narrative: The patient presents to the emergency department with his wife after he developed onset of difficulty speaking at 9:00 p.m. last night.  Patient did receive the COVID vaccine approximately 2 days ago.  Also received a recent injection to his left eye secondary to macular degeneration.  Wife states he has had difficulty getting his words out.  No focal weakness.  No headache.  No prior similar episodes.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Electrocardiogram abnormal, Magnetic resonance imaging brain abnormal, Sinus tachycardia, Speech disorder
Clinical narrative: The patient presents to the emergency department with his wife after he developed onset of difficulty speaking at 9:00 p.m. last night.  Patient did receive the COVID vaccine approximately 2 days ago.  Also received a recent injection to his left eye secondary to macular degeneration.  Wife states he has had difficulty getting his words out.  No focal weakness.  No headache.  No prior similar episodes.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vasospasm
Clinical narrative: The patient presents to the emergency department with his wife after he developed onset of difficulty speaking at 9:00 p.m. last night.  Patient did receive the COVID vaccine approximately 2 days ago.  Also received a recent injection to his left eye secondary to macular degeneration.  Wife states he has had difficulty getting his words out.  No focal weakness.  No headache.  No prior similar episodes.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Paraesthesia oral, Swelling face
Clinical narrative: felt funny; eye lids tender; lips tingled; face was swollen more than before; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in 18Jan2021 at 15:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reporting on the COVID vaccine and who explained that she had a reaction to the vaccine. She had the vaccine yesterday (18Jan2021) about 03:30 in the afternoon and by the time she got home, within the hour, her lips tingled and she felt funny, and her eye lids tender. There was no one to call by that time and she did not think it was severe enough to go to the ER so she just took a Benadryl and went to bed. The patient woke up and her face was swollen more than before (onset reported as Jan2021). She doesn't think she is at the stage of life threatening, she can still breath, but doesn't know what to do at this point. Should she take more Benadryl or contact her healthcare provider. The patient asked if this makes her ineligible for the second dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid pain, Feeling abnormal, Paraesthesia oral, Swelling face
Clinical narrative: felt funny; eye lids tender; lips tingled; face was swollen more than before; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in 18Jan2021 at 15:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reporting on the COVID vaccine and who explained that she had a reaction to the vaccine. She had the vaccine yesterday (18Jan2021) about 03:30 in the afternoon and by the time she got home, within the hour, her lips tingled and she felt funny, and her eye lids tender. There was no one to call by that time and she did not think it was severe enough to go to the ER so she just took a Benadryl and went to bed. The patient woke up and her face was swollen more than before (onset reported as Jan2021). She doesn't think she is at the stage of life threatening, she can still breath, but doesn't know what to do at this point. Should she take more Benadryl or contact her healthcare provider. The patient asked if this makes her ineligible for the second dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient experienced body numbness and tingling immediately after vaccine administration. Resolved on own after approximately 10 minutes. Patient monitored for 30 minutes total, no other issues
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient experienced body numbness and tingling immediately after vaccine administration. Resolved on own after approximately 10 minutes. Patient monitored for 30 minutes total, no other issues
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Skin warm
Clinical narrative: Patient self reported through our  clinic ADR reporting system.  Unsure if they also self reported via VERS.  Per report "Day # 6 after getting 1st Moderna vaccine, I developed enlarged left clavical lymph node that is still the same size now on day #15"
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node abscess
Clinical narrative: Patient self reported through our  clinic ADR reporting system.  Unsure if they also self reported via VERS.  Per report "Day # 6 after getting 1st Moderna vaccine, I developed enlarged left clavical lymph node that is still the same size now on day #15"
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Nasal discomfort
Clinical narrative: Dry mouth and nose; Dry mouth and nose; Dizziness/Feeling of fainting; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL9261, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 19Jan2021 09:00 for COVID-19 immunization. Medical history included atrial fibrillation. Patient was not pregnant at the time of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had received other medications within 2 weeks of vaccination (not specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 11:00, the patient experienced dry mouth and nose, and dizziness/feeling of fainting. The events were considered as non-serious by the reporter. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Nasal dryness
Clinical narrative: Dry mouth and nose; Dry mouth and nose; Dizziness/Feeling of fainting; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL9261, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 19Jan2021 09:00 for COVID-19 immunization. Medical history included atrial fibrillation. Patient was not pregnant at the time of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had received other medications within 2 weeks of vaccination (not specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 11:00, the patient experienced dry mouth and nose, and dizziness/feeling of fainting. The events were considered as non-serious by the reporter. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient).  A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glossodynia, Hypoaesthesia oral, Pain in extremity, Paraesthesia oral, Tongue discomfort
Clinical narrative: Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient).  A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue erythema
Clinical narrative: Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient).  A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Nausea
Clinical narrative: next day through the following week  List of symptoms includes:  headache, temp 102.5 - 101. for 5 days , nausea, fatigue, body aches
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: next day through the following week  List of symptoms includes:  headache, temp 102.5 - 101. for 5 days , nausea, fatigue, body aches
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: next day through the following week  List of symptoms includes:  headache, temp 102.5 - 101. for 5 days , nausea, fatigue, body aches
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dysphagia, Respiratory tract oedema
Clinical narrative: After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Lacrimation increased
Clinical narrative: After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rhinorrhoea, Throat tightness
Clinical narrative: After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pharyngeal swelling, Viral test negative
Clinical narrative: After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. 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: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Tachycardia
Clinical narrative: Within 2 min of injection, I walked out to waiting room felt tachycardic and dizzy.  I immediately informed pharmacist who took my BP.   BP first reading in left arm was 235/130 with a HR around 130. Second reading was 205/120 with HR in 120's about 4 min later.  I requested an ambulance due to the feeling of being very unwell and dizzy.  Trouble concentrating.    Ambulance ride was 190/112 ish EKG and BP monitoring at hospital.   No anaphalaxis diagnosed but unknown cause.   ER discharge after benadryl.    BP and HR would continue to cycle up and down for the next  18 hours.   Red spot formed about 2 inches away from where I was injected.      PCP and allergist thin it was an intravascular injection.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypertension, Injection site erythema, Malaise, Mental impairment
Clinical narrative: Within 2 min of injection, I walked out to waiting room felt tachycardic and dizzy.  I immediately informed pharmacist who took my BP.   BP first reading in left arm was 235/130 with a HR around 130. Second reading was 205/120 with HR in 120's about 4 min later.  I requested an ambulance due to the feeling of being very unwell and dizzy.  Trouble concentrating.    Ambulance ride was 190/112 ish EKG and BP monitoring at hospital.   No anaphalaxis diagnosed but unknown cause.   ER discharge after benadryl.    BP and HR would continue to cycle up and down for the next  18 hours.   Red spot formed about 2 inches away from where I was injected.      PCP and allergist thin it was an intravascular injection.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Within 2 min of injection, I walked out to waiting room felt tachycardic and dizzy.  I immediately informed pharmacist who took my BP.   BP first reading in left arm was 235/130 with a HR around 130. Second reading was 205/120 with HR in 120's about 4 min later.  I requested an ambulance due to the feeling of being very unwell and dizzy.  Trouble concentrating.    Ambulance ride was 190/112 ish EKG and BP monitoring at hospital.   No anaphalaxis diagnosed but unknown cause.   ER discharge after benadryl.    BP and HR would continue to cycle up and down for the next  18 hours.   Red spot formed about 2 inches away from where I was injected.      PCP and allergist thin it was an intravascular injection.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Blood test normal, Chills, Dermatitis, Hypoaesthesia
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Mass, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Rash maculo-papular, Skin test negative, Urticaria, Vomiting
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Muscular weakness, Nausea, Pruritus, Trismus
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Chills, Cough, Feeling cold, Headache
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hemiplegia, Hypoaesthesia, Hypoaesthesia oral, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Tremor, Urticaria, Vomiting
Clinical narrative: lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Vaccine Center documentation record notes patient had Pfizer vaccination. Pt did have a running nose the day she received the second vaccination. She has a rash all over her body with severe itching. She wants a referral to see an Immunologist.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rhinorrhoea
Clinical narrative: Vaccine Center documentation record notes patient had Pfizer vaccination. Pt did have a running nose the day she received the second vaccination. She has a rash all over her body with severe itching. She wants a referral to see an Immunologist.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Fatigue, Headache, Pain
Clinical narrative: Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish; Chills; Warm body; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 11:00 at single dose for covid-19 immunization. Medical history included asthma. Concomitant medication included salbutamol sulfate (PROVENTIL) for asthma. Patient previously took first dose of bnt162b2 on 30Dec2020 at single dose for covid-19 immunization. Patient got second vaccination on 18Jan2021 and may be around about 11 O'clock on same day patient felt to have a body ache all over which patient knew it was normal. However, it was getting worse throughout the day. And patient couldn't even get up and went to work. Also have very bad headache and patient blood pressure was 140/100. For about 3 hours patient did had left leg swell and caused severe pain in toes, that just subsided. Patient didn't have a fever but patient feel feverish, chills, warm body. Patient had been taking Ibuprofen on and off as treatment. Outcome of events left leg swell and caused severe pain in toes were recovering, and outcome of other events was unknown.    Information about Lot/Batch number is requested.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Feeling hot, Headache
Clinical narrative: Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish; Chills; Warm body; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 11:00 at single dose for covid-19 immunization. Medical history included asthma. Concomitant medication included salbutamol sulfate (PROVENTIL) for asthma. Patient previously took first dose of bnt162b2 on 30Dec2020 at single dose for covid-19 immunization. Patient got second vaccination on 18Jan2021 and may be around about 11 O'clock on same day patient felt to have a body ache all over which patient knew it was normal. However, it was getting worse throughout the day. And patient couldn't even get up and went to work. Also have very bad headache and patient blood pressure was 140/100. For about 3 hours patient did had left leg swell and caused severe pain in toes, that just subsided. Patient didn't have a fever but patient feel feverish, chills, warm body. Patient had been taking Ibuprofen on and off as treatment. Outcome of events left leg swell and caused severe pain in toes were recovering, and outcome of other events was unknown.    Information about Lot/Batch number is requested.