chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: wakes up at night because of the headache; headaches were intermittent; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: 30Apr2021), via an unspecified route of administration on 07Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included allergy to trees and grass; and asthma. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), and oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient experienced headaches on 07Jan2021. She sometimes wakes up at night because of the headache. The headaches were not as terrible as before and they were on and off. She took Tylenol for it. She was concerned about the 2nd dose side effects as it may be worse. She got the vaccine on a Thursday, and she laughingly states that she didn't feel human till Tuesday, it was a rough few days. The headaches were intermittent but the headache was to the point that they make her have to lay down. The intensity of the headache has gotten better, her pain was at 7 before but now max pain is a 5. The frequency varies, it could be 3-4 hours but then might only get it for 1 hour or so then go away. Her 2nd dose is scheduled for 29Jan2021. She has not had labs for like 6 months. She has had no positive test for COVID. She does work with COVID patients but has had no symptoms like cold or nothing. She has had no antibody test. She has had no issues with vaccine in the past. The patient is recovering from headaches. Outcome of the event "wakes up at night because of the headache" was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Poor quality sleep
Clinical narrative: wakes up at night because of the headache; headaches were intermittent; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: 30Apr2021), via an unspecified route of administration on 07Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included allergy to trees and grass; and asthma. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), and oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient experienced headaches on 07Jan2021. She sometimes wakes up at night because of the headache. The headaches were not as terrible as before and they were on and off. She took Tylenol for it. She was concerned about the 2nd dose side effects as it may be worse. She got the vaccine on a Thursday, and she laughingly states that she didn't feel human till Tuesday, it was a rough few days. The headaches were intermittent but the headache was to the point that they make her have to lay down. The intensity of the headache has gotten better, her pain was at 7 before but now max pain is a 5. The frequency varies, it could be 3-4 hours but then might only get it for 1 hour or so then go away. Her 2nd dose is scheduled for 29Jan2021. She has not had labs for like 6 months. She has had no positive test for COVID. She does work with COVID patients but has had no symptoms like cold or nothing. She has had no antibody test. She has had no issues with vaccine in the past. The patient is recovering from headaches. Outcome of the event "wakes up at night because of the headache" was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Mobility decreased, Nausea
Clinical narrative: impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory loss, Visual impairment
Clinical narrative: impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Impaired driving ability, Nausea, Panic reaction, Visual impairment
Clinical narrative: impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Fatigue, Headache
Clinical narrative: Coughing; Jaw pain; Fatigue the same day as vaccine; This is a spontaneous report from a non-contactable other healthcare professional (HCP; patient herself). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the right arm on 18Jan2021 at 10:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported; she had no allergies to medications, food, or other products. Concomitant medications included dexamethasone, bupropion, and hydroxyzine hydrochloride (HYDROXIZINE). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fatigue the same day as vaccine on 18Jan2021 at 13:00. Two days later, on 20Jan2021, the patient experienced coughing and jaw pain. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. The patient was recovering from all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Coughing; Jaw pain; Fatigue the same day as vaccine; This is a spontaneous report from a non-contactable other healthcare professional (HCP; patient herself). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the right arm on 18Jan2021 at 10:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported; she had no allergies to medications, food, or other products. Concomitant medications included dexamethasone, bupropion, and hydroxyzine hydrochloride (HYDROXIZINE). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fatigue the same day as vaccine on 18Jan2021 at 13:00. Two days later, on 20Jan2021, the patient experienced coughing and jaw pain. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. The patient was recovering from all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Pain in jaw
Clinical narrative: Coughing; Jaw pain; Fatigue the same day as vaccine; This is a spontaneous report from a non-contactable other healthcare professional (HCP; patient herself). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the right arm on 18Jan2021 at 10:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported; she had no allergies to medications, food, or other products. Concomitant medications included dexamethasone, bupropion, and hydroxyzine hydrochloride (HYDROXIZINE). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fatigue the same day as vaccine on 18Jan2021 at 13:00. Two days later, on 20Jan2021, the patient experienced coughing and jaw pain. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. The patient was recovering from all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymphnodes in the left collarbone area and my neck; Sore arm; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), and sambucus nigra (ELDERBERRY). On 16Jan2021 06:00, the patient experienced sore arm. Then on 17Jan2021 14:00 (reported as 48 hours after vaccination), the patient experienced swollen lymph nodes in the left collarbone area and on her neck on the same side as vaccination. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Antinuclear antibody, Arteriogram carotid, C-reactive protein, Computerised tomogram head
Clinical narrative: 'I received my covid vaccine on 1/3 around 0830 AM. By 1/5 around 2200 (approximately 60 hrs post vaccination)I started having worsening neck pain and headache. I went to the ED and CT's were negative. Deferred the LP because I was afebrile at the time. Less than 4 hours after leaving the ER I had fevers with Tmax of 102.1. Returned to ER the next day (1/7) where an LP was completed and I was diagnosed with aseptic meningitis. I was hospitalized for two days and unable to work for approximately two weeks due to ongoing headaches, migraines, etc. I reached out to Moderna to speak with someone but it took 3.5 weeks to just be able to speak to someone who was non clinical. Still have not spoken with anyone who clinical. I don't think anything was done incorrectly, just a adverse reaction to the vaccine. There does need to be better tracking and follow up though.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram neck, Fatigue, Full blood count, Headache, Lumbar puncture abnormal
Clinical narrative: 'I received my covid vaccine on 1/3 around 0830 AM. By 1/5 around 2200 (approximately 60 hrs post vaccination)I started having worsening neck pain and headache. I went to the ED and CT's were negative. Deferred the LP because I was afebrile at the time. Less than 4 hours after leaving the ER I had fevers with Tmax of 102.1. Returned to ER the next day (1/7) where an LP was completed and I was diagnosed with aseptic meningitis. I was hospitalized for two days and unable to work for approximately two weeks due to ongoing headaches, migraines, etc. I reached out to Moderna to speak with someone but it took 3.5 weeks to just be able to speak to someone who was non clinical. Still have not spoken with anyone who clinical. I don't think anything was done incorrectly, just a adverse reaction to the vaccine. There does need to be better tracking and follow up though.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Meningitis aseptic, Metabolic function test, Neck pain, Pyrexia
Clinical narrative: 'I received my covid vaccine on 1/3 around 0830 AM. By 1/5 around 2200 (approximately 60 hrs post vaccination)I started having worsening neck pain and headache. I went to the ED and CT's were negative. Deferred the LP because I was afebrile at the time. Less than 4 hours after leaving the ER I had fevers with Tmax of 102.1. Returned to ER the next day (1/7) where an LP was completed and I was diagnosed with aseptic meningitis. I was hospitalized for two days and unable to work for approximately two weeks due to ongoing headaches, migraines, etc. I reached out to Moderna to speak with someone but it took 3.5 weeks to just be able to speak to someone who was non clinical. Still have not spoken with anyone who clinical. I don't think anything was done incorrectly, just a adverse reaction to the vaccine. There does need to be better tracking and follow up though.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Venogram
Clinical narrative: 'I received my covid vaccine on 1/3 around 0830 AM. By 1/5 around 2200 (approximately 60 hrs post vaccination)I started having worsening neck pain and headache. I went to the ED and CT's were negative. Deferred the LP because I was afebrile at the time. Less than 4 hours after leaving the ER I had fevers with Tmax of 102.1. Returned to ER the next day (1/7) where an LP was completed and I was diagnosed with aseptic meningitis. I was hospitalized for two days and unable to work for approximately two weeks due to ongoing headaches, migraines, etc. I reached out to Moderna to speak with someone but it took 3.5 weeks to just be able to speak to someone who was non clinical. Still have not spoken with anyone who clinical. I don't think anything was done incorrectly, just a adverse reaction to the vaccine. There does need to be better tracking and follow up though.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Headache, Impaired work ability, Lumbar puncture abnormal, Meningitis aseptic
Clinical narrative: 'I received my covid vaccine on 1/3 around 0830 AM. By 1/5 around 2200 (approximately 60 hrs post vaccination)I started having worsening neck pain and headache. I went to the ED and CT's were negative. Deferred the LP because I was afebrile at the time. Less than 4 hours after leaving the ER I had fevers with Tmax of 102.1. Returned to ER the next day (1/7) where an LP was completed and I was diagnosed with aseptic meningitis. I was hospitalized for two days and unable to work for approximately two weeks due to ongoing headaches, migraines, etc. I reached out to Moderna to speak with someone but it took 3.5 weeks to just be able to speak to someone who was non clinical. Still have not spoken with anyone who clinical. I don't think anything was done incorrectly, just a adverse reaction to the vaccine. There does need to be better tracking and follow up though.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Neck pain, Pyrexia
Clinical narrative: 'I received my covid vaccine on 1/3 around 0830 AM. By 1/5 around 2200 (approximately 60 hrs post vaccination)I started having worsening neck pain and headache. I went to the ED and CT's were negative. Deferred the LP because I was afebrile at the time. Less than 4 hours after leaving the ER I had fevers with Tmax of 102.1. Returned to ER the next day (1/7) where an LP was completed and I was diagnosed with aseptic meningitis. I was hospitalized for two days and unable to work for approximately two weeks due to ongoing headaches, migraines, etc. I reached out to Moderna to speak with someone but it took 3.5 weeks to just be able to speak to someone who was non clinical. Still have not spoken with anyone who clinical. I don't think anything was done incorrectly, just a adverse reaction to the vaccine. There does need to be better tracking and follow up though.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Headache, Hypoaesthesia
Clinical narrative: Headache; complete left sided facial burning; complete numbness starting from the neck to the top of the head; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included depression and metabolic syndrome from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN SR), metformin hydrochloride (METFORMIN) and vitamin B complex (VITAMIN B). The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021 05: 00 PM, the patient experienced moderate to severe headache, complete left sided facial burning and complete numbness starting from the neck to the top of the head. No treatment was given to the patient for the events. The outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Malaise, Medical observation, Retching
Clinical narrative: feeling unwell; dizzy; dry heaving; This is a spontaneous report received from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 17:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included allergies to contrast dye, obesity, osteoarthritis (OA), hyperlipidemia and being pre-diabetes. The patient was not pregnant during the time of vaccination. Concomitant medication included atorvastatin, meloxicam and multivitamins. The patient did not receive any other vaccines within four weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient experienced feeling unwell, dizzy and was dry heaving on 23Dec2020 17:30. No treatment was given for the events. The reporter assessed the events as non-serious. The outcome of the event was recovered on an unspecified date.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Malaise, Retching
Clinical narrative: feeling unwell; dizzy; dry heaving; This is a spontaneous report received from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 17:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included allergies to contrast dye, obesity, osteoarthritis (OA), hyperlipidemia and being pre-diabetes. The patient was not pregnant during the time of vaccination. Concomitant medication included atorvastatin, meloxicam and multivitamins. The patient did not receive any other vaccines within four weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient experienced feeling unwell, dizzy and was dry heaving on 23Dec2020 17:30. No treatment was given for the events. The reporter assessed the events as non-serious. The outcome of the event was recovered on an unspecified date.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Injection site pruritus
Clinical narrative: Feeling itchy at the injection site; Felt not okay; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via intramuscular (left arm) on 30Dec2020 12:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included depression, Hyperlipidemia, Migraine with aura, NASH, Known allergies: penicillin from unspecified dates. The patient was not pregnant during vaccination time. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin, fluoxetine, fluticasone (FLUTICASONE), omeprazole, for unspecified indications; rizatriptan for migraine, and norethisterone (MICRONOR) for Oral contraceptive, all from unspecified dates. The patient experienced feeling itchy at the injection site, and felt not okay on 30Dec2020 12:15. No SOB, lightheadedness, hives or numbness. Rapid Response was called (emergency visit) and was advised extra observation time. No other intervention. Treatment was not given. Outcome of events was recovered. Events were considered non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Vaccination site pruritus
Clinical narrative: Feeling itchy at the injection site; Felt not okay; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via intramuscular (left arm) on 30Dec2020 12:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included depression, Hyperlipidemia, Migraine with aura, NASH, Known allergies: penicillin from unspecified dates. The patient was not pregnant during vaccination time. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin, fluoxetine, fluticasone (FLUTICASONE), omeprazole, for unspecified indications; rizatriptan for migraine, and norethisterone (MICRONOR) for Oral contraceptive, all from unspecified dates. The patient experienced feeling itchy at the injection site, and felt not okay on 30Dec2020 12:15. No SOB, lightheadedness, hives or numbness. Rapid Response was called (emergency visit) and was advised extra observation time. No other intervention. Treatment was not given. Outcome of events was recovered. Events were considered non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Headache, Hypoaesthesia oral
Clinical narrative: perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty swallowing & breathing; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided), intramuscular in the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to garlic. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. On 23Dec2020 09:45, the patient experienced perioral numbness with HA, Difficulty swallowing and breathing. The patient felt it was likely due to the N95 mask. She was given procedural mask and reported improvement of symptoms. A Rapid response was contacted. No other intervention was done. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The patient has not tested for COVID post vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: nausea; Feels tired; anxiety; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284), intramuscular (left arm), on 23Dec2020 18:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported nausea, but it went away, feels tired and after conversation, possibly just anxiety. These adverse events started on 23Dec2020 18:00. No treatment was received for the events reported. The patient recovered from the events on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. The COVID call center advised to return to work.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Fatigue, Nausea
Clinical narrative: nausea; Feels tired; anxiety; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284), intramuscular (left arm), on 23Dec2020 18:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported nausea, but it went away, feels tired and after conversation, possibly just anxiety. These adverse events started on 23Dec2020 18:00. No treatment was received for the events reported. The patient recovered from the events on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. The COVID call center advised to return to work.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Nausea
Clinical narrative: Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 29Dec2020 (12:45) at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 29Dec2020 (13:00), the patient was feeling some nausea; and was feeling hot. The patient had received an unspecified treatment for 'feeling hot'; and had received ondansetron for 'nausea'. The outcome of the events, 'feeling some nausea' and 'feeling hot', was recovered on an unspecified date. The patient was not tested for COVID-19 post-vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 19Jan2021 12:45 at a single dose for covid-19 immunization. Medical history included RA (rheumatoid arthritis), cardiomyopathy, intervertebral disc degeneration, and known allergies to wheat and dairy. The patient was not diagnosed with covid prior vaccination. Concomitant medications included unspecified medication. The patient has not had other vaccine in the last 4 weeks. The patient previously took clindamycin but had allergies. The patient had severe diarrhea on 20Jan2021 12:00 PM. No treatment was received. The patient was not covid tested post vaccination. The outcome of the event was not recovered.  The following information on the batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site cellulitis, Pyrexia
Clinical narrative: cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 07:45 AM at a single dose for COVID-19 immunization in a hospital.  Medical history reported as none. The patient has no known allergies. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 23Dec2020 at 07:45 AM in left arm for COVID-19 immunization. Concomitant medications included dicyclomine; and unspecified birth control and multivitamin. The patient experienced fever, headache, chills, fatigue, and then got cellulitis in right arm below injection site following second dose of COVID vaccine on 14Jan2021 at 12:00 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received antibiotics (Keflex) as treatment for the events. The patient recovered from the events in Jan2021.   Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site cellulitis cannot be excluded.  The case will be reassessed if 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: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and lower extremities; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 26-years-old female patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3302, via an unspecified route of administration in right arm on 19Jan2021 at 17:30, at 26 years of age, at single dose for COVID-19 immunization as she was a front line worker. The vaccine was administered at the facility where the patient works. The patient had no relevant medical history and no concomitant medications. On 19Jan2021, about 20 minutes after receiving the vaccine dose (also reported at 18:00) she started having nonstop numbness and tingling in both feet and lower extremities, which has been going on for 46 hours straight. The events were assessed as medically significant, although a visit to emergency room or physician office was not required. The nurse reported that a doctor mentioned Guillain-Barre Syndrome which can lead to progressive muscle weakness and damaged nerves and she is severely concerned, although she has no health history. At the time of the report the reported events had not recovered yet.  The reporter assessed the event related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Method of assessment: Global Introspection).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Tenderness
Clinical narrative: painful axillary lymphadenopathy; fever over 102.5; piercing headache; chills; dizziness; vertigo with movement; severe fatigue; sore throat; I felt so unwell; muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9261, via an unspecified route of administration on Left arm from 19Jan2021 14:45 to 19Jan2021 14:45 as SINGLE DOSE (dose 2) for COVID-19 immunisation.  Medical history included alpha thalassemia, chronic anemia, lactose intolerant, ADD. Historical vaccine includes first dose of BNT162B2 (lot number: EK9231), on 28Dec2020 at 01:15 PM, Left arm and experienced chills, piercing headache, fatigue, and vertigo. Concomitant medication included colecalciferol (VITAMIN D), and escitalopram oxalate (LEXAPRO). On 20Jan2021 2:00 AM, the patient experienced painful axillary lymphadenopathy, fever over 102.5, piercing headache, chills, dizziness and vertigo with movement, severe fatigue, sore throat, muscle aches. It took hours just for the patient to get out of bed in the morning, the patient felt so unwell. This all took place on the day after she got her second vaccine. The outcome of the events was recovering. Therapeutic measure has been given in response to the event which includes Tylenol 1000mg. The patient is not pregnant at the time of vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: painful axillary lymphadenopathy; fever over 102.5; piercing headache; chills; dizziness; vertigo with movement; severe fatigue; sore throat; I felt so unwell; muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9261, via an unspecified route of administration on Left arm from 19Jan2021 14:45 to 19Jan2021 14:45 as SINGLE DOSE (dose 2) for COVID-19 immunisation.  Medical history included alpha thalassemia, chronic anemia, lactose intolerant, ADD. Historical vaccine includes first dose of BNT162B2 (lot number: EK9231), on 28Dec2020 at 01:15 PM, Left arm and experienced chills, piercing headache, fatigue, and vertigo. Concomitant medication included colecalciferol (VITAMIN D), and escitalopram oxalate (LEXAPRO). On 20Jan2021 2:00 AM, the patient experienced painful axillary lymphadenopathy, fever over 102.5, piercing headache, chills, dizziness and vertigo with movement, severe fatigue, sore throat, muscle aches. It took hours just for the patient to get out of bed in the morning, the patient felt so unwell. This all took place on the day after she got her second vaccine. The outcome of the events was recovering. Therapeutic measure has been given in response to the event which includes Tylenol 1000mg. The patient is not pregnant at the time of vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: painful axillary lymphadenopathy; fever over 102.5; piercing headache; chills; dizziness; vertigo with movement; severe fatigue; sore throat; I felt so unwell; muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9261, via an unspecified route of administration on Left arm from 19Jan2021 14:45 to 19Jan2021 14:45 as SINGLE DOSE (dose 2) for COVID-19 immunisation.  Medical history included alpha thalassemia, chronic anemia, lactose intolerant, ADD. Historical vaccine includes first dose of BNT162B2 (lot number: EK9231), on 28Dec2020 at 01:15 PM, Left arm and experienced chills, piercing headache, fatigue, and vertigo. Concomitant medication included colecalciferol (VITAMIN D), and escitalopram oxalate (LEXAPRO). On 20Jan2021 2:00 AM, the patient experienced painful axillary lymphadenopathy, fever over 102.5, piercing headache, chills, dizziness and vertigo with movement, severe fatigue, sore throat, muscle aches. It took hours just for the patient to get out of bed in the morning, the patient felt so unwell. This all took place on the day after she got her second vaccine. The outcome of the events was recovering. Therapeutic measure has been given in response to the event which includes Tylenol 1000mg. The patient is not pregnant at the time of vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: painful axillary lymphadenopathy; fever over 102.5; piercing headache; chills; dizziness; vertigo with movement; severe fatigue; sore throat; I felt so unwell; muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9261, via an unspecified route of administration on Left arm from 19Jan2021 14:45 to 19Jan2021 14:45 as SINGLE DOSE (dose 2) for COVID-19 immunisation.  Medical history included alpha thalassemia, chronic anemia, lactose intolerant, ADD. Historical vaccine includes first dose of BNT162B2 (lot number: EK9231), on 28Dec2020 at 01:15 PM, Left arm and experienced chills, piercing headache, fatigue, and vertigo. Concomitant medication included colecalciferol (VITAMIN D), and escitalopram oxalate (LEXAPRO). On 20Jan2021 2:00 AM, the patient experienced painful axillary lymphadenopathy, fever over 102.5, piercing headache, chills, dizziness and vertigo with movement, severe fatigue, sore throat, muscle aches. It took hours just for the patient to get out of bed in the morning, the patient felt so unwell. This all took place on the day after she got her second vaccine. The outcome of the events was recovering. Therapeutic measure has been given in response to the event which includes Tylenol 1000mg. The patient is not pregnant at the time of vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Blood test, Cardiac monitoring, Electrocardiogram, Full blood count
Clinical narrative: Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient).  A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration at Left arm on 13Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included scoliosis and depression. Concomitant medications in two weeks included duloxetine hydrochloride (CYMBALTA), estradiol/norethisterone acetate (COMBIPATCH). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EH9899) received on 20Dec2020 05:00 PM at left arm for COVID-19 immunization. The patient previously took codeine and experienced drug allergies. The patient experienced episode of atrial fibrillation on 17Jan2021 at 05:45 AM. No treatment received, no COVID prior vaccination. The outcome of the event was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event episode of atrial fibrillation and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.