chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: short of breath; had a high heart rate afterwards; anxiety; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686; expiration date: Mar2021), via an unspecified route of administration left upper arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included ongoing blood pressure high, ongoing hyperthyroidism reported as hyperthyroid, historically tachycardia from time to time resting, wears glasses, stressed and ongoing thyroid (thyroid disorder). Ongoing concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid and losartan for blood pressure high. She did not received other vaccination within 4 weeks. The patient stated that she first dose of the Covid vaccine and became short of breath and had a high heart rate afterwards after she got her vaccine. She mentioned that she had a high heart rate and shortness of breath on 31Dec2020 immediately after getting the vaccine. She received it at her workplace (in the hospital conference room) and was taken to the ER to be checked out. It was like soon as she sat down after getting the vaccine, she immediately started to have the high heart rate and shortness of breath. She wasn't sure if it was anxiety or a true adverse reaction. She further added that at first, she was thinking it was anxiety because she was stressed when first went there. However, she was reading the paperwork and it said high heart rate and shortness of breath could occur. After reading that she realized it may not be anxiety. When she was taken the Emergency Room and her heart rate then was 115-120 [units unspecified], she felt like it could have been higher before it was checked. She was kept in the Emergency Room for like 30 minutes or so for further observation. As a whole, the high heart rate and shortness of breath probably lasted no more than ten minutes. She confirmed she has recovered completely from the high heart rate and shortness of breath as she has not had any other episodes. She added, she gets tachycardia historically from time to time resting. However, she has never had shortness of breath and that is why she was concerned. She wants to know if she should get the second dose. The patient underwent lab tests and procedures which included EKG (electrocardiogram) and troponin were normal on 31Dec2020. The outcome of the events was recovered on 31Dec2020.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: short of breath; had a high heart rate afterwards; anxiety; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686; expiration date: Mar2021), via an unspecified route of administration left upper arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included ongoing blood pressure high, ongoing hyperthyroidism reported as hyperthyroid, historically tachycardia from time to time resting, wears glasses, stressed and ongoing thyroid (thyroid disorder). Ongoing concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid and losartan for blood pressure high. She did not received other vaccination within 4 weeks. The patient stated that she first dose of the Covid vaccine and became short of breath and had a high heart rate afterwards after she got her vaccine. She mentioned that she had a high heart rate and shortness of breath on 31Dec2020 immediately after getting the vaccine. She received it at her workplace (in the hospital conference room) and was taken to the ER to be checked out. It was like soon as she sat down after getting the vaccine, she immediately started to have the high heart rate and shortness of breath. She wasn't sure if it was anxiety or a true adverse reaction. She further added that at first, she was thinking it was anxiety because she was stressed when first went there. However, she was reading the paperwork and it said high heart rate and shortness of breath could occur. After reading that she realized it may not be anxiety. When she was taken the Emergency Room and her heart rate then was 115-120 [units unspecified], she felt like it could have been higher before it was checked. She was kept in the Emergency Room for like 30 minutes or so for further observation. As a whole, the high heart rate and shortness of breath probably lasted no more than ten minutes. She confirmed she has recovered completely from the high heart rate and shortness of breath as she has not had any other episodes. She added, she gets tachycardia historically from time to time resting. However, she has never had shortness of breath and that is why she was concerned. She wants to know if she should get the second dose. The patient underwent lab tests and procedures which included EKG (electrocardiogram) and troponin were normal on 31Dec2020. The outcome of the events was recovered on 31Dec2020.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient).  A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative.  Medical history included high blood pressure from 2016 and ongoing.  Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Immediate post-injection reaction, Influenza like illness, Injection site nodule
Clinical narrative: a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient).  A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative.  Medical history included high blood pressure from 2016 and ongoing.  Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Malaise, Nodule, Pain, Pain of skin
Clinical narrative: a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient).  A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative.  Medical history included high blood pressure from 2016 and ongoing.  Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient).  A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative.  Medical history included high blood pressure from 2016 and ongoing.  Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia
Clinical narrative: patient presented with 2 day history of myalgias and headache, no concerning findings in ED
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mouth swelling, Swelling face, Throat tightness, Urticaria
Clinical narrative: anaphylaxis; A spontaneous report was received from a nurse who was also a 43-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16 Jan 2021, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient had anaphylaxis within 10 minutes of receiving the Moderna COVID-19 vaccine. She was sent to a hospital by ambulance and was treated emergently. Treatment was not specified.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a 43-years old female patient. The medical history and concomitant medications are not provided. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant. The event occurred within 10 minutes after receiving their first of two planned doses of mRNA-1273 (Lot number: 013L20A). Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; A spontaneous report was received from a nurse who was also a 43-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16 Jan 2021, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient had anaphylaxis within 10 minutes of receiving the Moderna COVID-19 vaccine. She was sent to a hospital by ambulance and was treated emergently. Treatment was not specified.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a 43-years old female patient. The medical history and concomitant medications are not provided. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant. The event occurred within 10 minutes after receiving their first of two planned doses of mRNA-1273 (Lot number: 013L20A). Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Malaise, Urticaria
Clinical narrative: anaphylaxis; A spontaneous report was received from a nurse who was also a 43-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16 Jan 2021, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient had anaphylaxis within 10 minutes of receiving the Moderna COVID-19 vaccine. She was sent to a hospital by ambulance and was treated emergently. Treatment was not specified.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a 43-years old female patient. The medical history and concomitant medications are not provided. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant. The event occurred within 10 minutes after receiving their first of two planned doses of mRNA-1273 (Lot number: 013L20A). Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Rash pruritic, Urticaria
Clinical narrative: Itchy hives; This is a spontaneous report from a contactable other health professional (Child life specialist) reporting for herself. A 32-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included fluoxetine for anti depressant. Patient stated, "I am here to report side effect with the vaccine (Later clarified as Covid Vaccine Pfizer). 48 hours after getting the vaccine, itchy hives (on 16Jan2021)." Treatment received for the event included Cortisone and Benadryl. The outcome of the event was unknown. Causality reporter stated, "Yes."
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Itchy hives; This is a spontaneous report from a contactable other health professional (Child life specialist) reporting for herself. A 32-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included fluoxetine for anti depressant. Patient stated, "I am here to report side effect with the vaccine (Later clarified as Covid Vaccine Pfizer). 48 hours after getting the vaccine, itchy hives (on 16Jan2021)." Treatment received for the event included Cortisone and Benadryl. The outcome of the event was unknown. Causality reporter stated, "Yes."
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Lymphadenopathy, Swelling face, Throat tightness
Clinical narrative: glands/throat swollen; glands/throat swollen; bad problem swallowing.; face started to get puffy; After 15 minutes, felt light headed; throat felt tight; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL1284), via an unspecified route of administration on 14Jan2021 09:00, at right arm, at single dose for covid-19 immunization.  Medical history included Allergies chronic and known allergies to Shellfish, papaya, cats, latex, wool, pollens, mold. Concomitant medication included azelastine.  After 15 minutes vaccination, the patient felt lightheaded and throat felt tight. Took an Allegra and seemed better after about 30 minutes. Took a benedryl that afternoon and night, and next day (Friday, 15Jan2021) seemed ok. Took benedryl on Friday night because face started to get puffy. Then awoke at 3:50 am Saturday (16Jan2021) morning and glands/throat swollen and was having bad problem swallowing. Treatment steroid was received to get selling down. The outcome of the events lightheaded and throat felt tight was recovered on 15Jan2021. The outcome of the other events was unknown. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Lymphadenopathy, Pharyngeal swelling, Swelling face
Clinical narrative: glands/throat swollen; glands/throat swollen; bad problem swallowing.; face started to get puffy; After 15 minutes, felt light headed; throat felt tight; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL1284), via an unspecified route of administration on 14Jan2021 09:00, at right arm, at single dose for covid-19 immunization.  Medical history included Allergies chronic and known allergies to Shellfish, papaya, cats, latex, wool, pollens, mold. Concomitant medication included azelastine.  After 15 minutes vaccination, the patient felt lightheaded and throat felt tight. Took an Allegra and seemed better after about 30 minutes. Took a benedryl that afternoon and night, and next day (Friday, 15Jan2021) seemed ok. Took benedryl on Friday night because face started to get puffy. Then awoke at 3:50 am Saturday (16Jan2021) morning and glands/throat swollen and was having bad problem swallowing. Treatment steroid was received to get selling down. The outcome of the events lightheaded and throat felt tight was recovered on 15Jan2021. The outcome of the other events was unknown. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: glands/throat swollen; glands/throat swollen; bad problem swallowing.; face started to get puffy; After 15 minutes, felt light headed; throat felt tight; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL1284), via an unspecified route of administration on 14Jan2021 09:00, at right arm, at single dose for covid-19 immunization.  Medical history included Allergies chronic and known allergies to Shellfish, papaya, cats, latex, wool, pollens, mold. Concomitant medication included azelastine.  After 15 minutes vaccination, the patient felt lightheaded and throat felt tight. Took an Allegra and seemed better after about 30 minutes. Took a benedryl that afternoon and night, and next day (Friday, 15Jan2021) seemed ok. Took benedryl on Friday night because face started to get puffy. Then awoke at 3:50 am Saturday (16Jan2021) morning and glands/throat swollen and was having bad problem swallowing. Treatment steroid was received to get selling down. The outcome of the events lightheaded and throat felt tight was recovered on 15Jan2021. The outcome of the other events was unknown. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Palpitations
Clinical narrative: 5 minutes after the shot was placed my heart rate increased to 120 and my blood pressure increased to 150/90.  I felt weird, almost like I was under water.  I remained under observation for 45 minutes.  I was sent home and told to continue monitoring myself and to come back if I get worse.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Heart rate increased, Immediate post-injection reaction
Clinical narrative: 5 minutes after the shot was placed my heart rate increased to 120 and my blood pressure increased to 150/90.  I felt weird, almost like I was under water.  I remained under observation for 45 minutes.  I was sent home and told to continue monitoring myself and to come back if I get worse.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: At approximately 7 hrs after first injection started feeling extremely dizzy. Became severe. Has lasted approximately 6-8 hrs Feeling slightly less now; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 17Jan2021 13:45 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medication included escitalopram and ethinylestradiol, norgestrel (LOW-OGESTREL). The patient previously took Vitamin E and experienced Allergy. On 17Jan2021 21:00 approximately 7 hours after first injection, the patient started feeling extremely dizzy. Became severe. Has lasted approximately 6-8 hrs Feeling slightly less now. The patient did not received treatment for the event. The outcome of the event was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Delayed allergic reaction. Significant swelling at injection site, swelling of lymph nodes. Redness, itching at site. Petechia upon resolving
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lymphadenopathy, Petechiae
Clinical narrative: Delayed allergic reaction. Significant swelling at injection site, swelling of lymph nodes. Redness, itching at site. Petechia upon resolving
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Started with lips tingling, then fingers, hands, toes, legs then throat.  Face was numb with a ?pulling? sensation around my nose and mouth.  Head felt ?full?.  They had to call an ambulance.  Symptoms started to resolve after about 20 mins.  Been having headaches since.  Also had fever/chills and slept for two days after it. I declined to get in ambulance and go to hospital as my symptoms were resolving and I didn?t want to risk getting sick at ER
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Head discomfort, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Started with lips tingling, then fingers, hands, toes, legs then throat.  Face was numb with a ?pulling? sensation around my nose and mouth.  Head felt ?full?.  They had to call an ambulance.  Symptoms started to resolve after about 20 mins.  Been having headaches since.  Also had fever/chills and slept for two days after it. I declined to get in ambulance and go to hospital as my symptoms were resolving and I didn?t want to risk getting sick at ER
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Pyrexia
Clinical narrative: Started with lips tingling, then fingers, hands, toes, legs then throat.  Face was numb with a ?pulling? sensation around my nose and mouth.  Head felt ?full?.  They had to call an ambulance.  Symptoms started to resolve after about 20 mins.  Been having headaches since.  Also had fever/chills and slept for two days after it. I declined to get in ambulance and go to hospital as my symptoms were resolving and I didn?t want to risk getting sick at ER
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; at the site of vaccination was redness, soreness, and heat; possible cellulitis; This is a spontaneous report from a contactable other HCP. A 60-years-old female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 16:45 at single dose (lot number: EK4176) for covid-19 immunisation. Medical history included hypertension (HTN), anxiety, arthritis, seasonal allergy, known allergies: Penicillin, Sulfa, Bactrim. No covid prior vaccination. Concomitant medication included losartan, citalopram, cetirizine. The patient experienced vaccine resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On 15Jan2021 a couple hours after exercising (elliptical use and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up 16Jan2021, the redness, soreness and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to (urgent care withheld) which she did and was prescribed Doxycycline for possible cellulitis. Today 18Jan2021, redness, soreness, and heat have much improved. Treatment received for the events. Events resulted in physician office/clinic visit. Outcome of events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; at the site of vaccination was redness, soreness, and heat; possible cellulitis; This is a spontaneous report from a contactable other HCP. A 60-years-old female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 16:45 at single dose (lot number: EK4176) for covid-19 immunisation. Medical history included hypertension (HTN), anxiety, arthritis, seasonal allergy, known allergies: Penicillin, Sulfa, Bactrim. No covid prior vaccination. Concomitant medication included losartan, citalopram, cetirizine. The patient experienced vaccine resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On 15Jan2021 a couple hours after exercising (elliptical use and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up 16Jan2021, the redness, soreness and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to (urgent care withheld) which she did and was prescribed Doxycycline for possible cellulitis. Today 18Jan2021, redness, soreness, and heat have much improved. Treatment received for the events. Events resulted in physician office/clinic visit. Outcome of events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: no) received first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm on 17Jan2021 12:00 at single dose for covid-19 immunization. Medical history included occasional migraines from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), ethinylestradiol, norgestimate (TRI LO MARZIA). The patient experienced lightheadedness, labored breathing on 17Jan2021 12:00, mild body aches on 17Jan2021, nausea, severe headache, vomited all on 18Jan2021 10:00. The event resulted in a visit to emergency room/department or urgent care. Treatment diphenhydramine hydrochloride (BENADRYL) 2mg was introduced. The patient developed lightheadedness within 2 minutes of receiving the COVID 19 vaccination. She did not faint. She was seen and evaluated in the emergency room. She developed labored breathing as well. She developed mild body aches the evening of the vaccine. The morning after the vaccine- around 10 am, She developed nausea, severe headache and vomited once. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: no) received first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm on 17Jan2021 12:00 at single dose for covid-19 immunization. Medical history included occasional migraines from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), ethinylestradiol, norgestimate (TRI LO MARZIA). The patient experienced lightheadedness, labored breathing on 17Jan2021 12:00, mild body aches on 17Jan2021, nausea, severe headache, vomited all on 18Jan2021 10:00. The event resulted in a visit to emergency room/department or urgent care. Treatment diphenhydramine hydrochloride (BENADRYL) 2mg was introduced. The patient developed lightheadedness within 2 minutes of receiving the COVID 19 vaccination. She did not faint. She was seen and evaluated in the emergency room. She developed labored breathing as well. She developed mild body aches the evening of the vaccine. The morning after the vaccine- around 10 am, She developed nausea, severe headache and vomited once. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: no) received first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm on 17Jan2021 12:00 at single dose for covid-19 immunization. Medical history included occasional migraines from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), ethinylestradiol, norgestimate (TRI LO MARZIA). The patient experienced lightheadedness, labored breathing on 17Jan2021 12:00, mild body aches on 17Jan2021, nausea, severe headache, vomited all on 18Jan2021 10:00. The event resulted in a visit to emergency room/department or urgent care. Treatment diphenhydramine hydrochloride (BENADRYL) 2mg was introduced. The patient developed lightheadedness within 2 minutes of receiving the COVID 19 vaccination. She did not faint. She was seen and evaluated in the emergency room. She developed labored breathing as well. She developed mild body aches the evening of the vaccine. The morning after the vaccine- around 10 am, She developed nausea, severe headache and vomited once. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling cold, Headache, Loss of consciousness, Nausea
Clinical narrative: Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cold sweat, Dizziness, Feeling cold, Headache
Clinical narrative: Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.