chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blood pressure increased, Heart rate increased, Hypoaesthesia, Visual impairment
Clinical narrative: associate states she has hx of allergic reactions to vaccines; i.e flu.  patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable Nurse. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 (reported as about 3 days ago, as of 30Dec2020) at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She received the vaccine about 3 days ago and later tested positive in Dec2020 and asked if the patient needs to restart the 2 doses series. Outcome of the events were unknown.  Lot/Batch and Expiration date has been requested.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent conditions and are unrelated to BNT162B2 based on the short temporal relation between vaccination and onset of event.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caller stated that a patient tested positive for covid 19 after the first dose of the vaccine; Caller stated that a patient tested positive for covid 19 after the first dose of the vaccine; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age (age: 74; unit- unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID 19 after the first dose of the vaccine. Reporter wants to know if the patient can be treated with monoclonal antibodies after having received the vaccine. Reporter also wanted to know if the storage in the thermal shipper can be extended past the 30 days. Event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events drug ineffective and COVID-19 are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient who got the vaccine a week ago tested positive now for COVID; Patient who got the vaccine a week ago tested positive now for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The pharmacist reported the patient who got the vaccine a week ago tested positive now for covid on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included covid: positive on Dec2020. the doctor is thinking of giving antibody. The event was reported at non-serious.  Information on lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Moderate to severe Chills; body and head aches; head aches; Fever (99.6 F); This is a spontaneous report from a non-contactable other hcp.  A 32-year-old male patient received BNT162b2 (COVID 19, Lot number: EK9231, dose number was 1), intramuscular at right arm on 28Dec2020 08:00 AM at single dose for COVID-19 immunization in hospital.  Medical history was none. There was no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. There was no other vaccine in four weeks.   The patient experienced Moderate to severe Chills, body and head aches, and Fever (99.6 F) on 28Dec2020 20:30(08:30 P.M). There was no treatment. There was no COVID prior vaccination nor COVID tested post vaccination. Outcome was recovering.  Events were assessed as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported event chills cannot be excluded based on known safety profile of suspect drug and compatible temporal relation.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: bell's palsy; This is a spontaneous report from a contactable physician.  A female patient of an unspecified age  (age: 37 unit: unknown), received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced bell's palsy on 30Dec2020.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bell's palsy might not be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Oropharyngeal discomfort
Clinical narrative: Patient complained of increased heart rate(148) and " mu throat feels funny" holding her hand to her throat. mild shortness of breath with great anxiety. 0.5 of epinephrine and 50 mg of Benadryl given IM and EMS notified , after evaluation by EMS ,and 30 minutes of time had elapsed,patient declined transport, stating " I am better" she called and family member and left with them. heart rate was 148, respiration 32 and blood pressure 186/102
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Fatigue, Influenza like illness
Clinical narrative: felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there.  Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown.  Information on the Lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Myalgia, Nausea
Clinical narrative: felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there.  Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown.  Information on the Lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Paranasal sinus discomfort, Sensation of foreign body, Sinus congestion
Clinical narrative: felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there.  Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown.  Information on the Lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there.  Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown.  Information on the Lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate irregular, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: heart rate (HR) was 180; tongue and lips tingled; walking for a short distance and felt "off; This is a spontaneous report from a contactable Nurse reported for herself. This 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 29Dec2020 15:15 at single dose on left arm for Covid-19 immunisation. Medical history included allergies to hepatitis B vaccine rhbsag (HEY B VACCINE) booster and poison ivy. Concomitant medication included biotin / calcium pantothenate / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / riboflavin / thiamine mononitrate (B COMPLEX), fexofenadine, ascorbic acid (VIT C) and Multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Immediately after shot (29Dec2020 15:15), her tongue and lips tingled but it went away quickly. She was walking for a short distance and felt "off." The patient checked her pulse and pulse ox and her heart rate (HR) was 180. Her HR had bounced around from 150-180 with minimal exertion and was in the 90s at rest. No treatment received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of not recovered. The events were non-serious.; Sender's Comments: A causal association between BNT162B2 and the event heart rate increased cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diaphragmatic spasm, Dizziness, Flushing, Muscle tightness, Paraesthesia
Clinical narrative: 1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located.  the feeling went away and pt went back to his office.    1045-Symptoms began again flushed/faintness accomapanied the initial quivering.  Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight.  1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic.  1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated.  PT given water and granola bar as he reported he did not eat that morning, only took Excedrin.  1115-BP 165/86 HR 92 SPO2 98%RA.  pt reports symptoms starting to resolve.  1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work.  pt asked to not leave the hospital for 4-6 hours, not even to work offsite.  pt agrees to report to ED if symptoms return.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: 1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located.  the feeling went away and pt went back to his office.    1045-Symptoms began again flushed/faintness accomapanied the initial quivering.  Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight.  1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic.  1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated.  PT given water and granola bar as he reported he did not eat that morning, only took Excedrin.  1115-BP 165/86 HR 92 SPO2 98%RA.  pt reports symptoms starting to resolve.  1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work.  pt asked to not leave the hospital for 4-6 hours, not even to work offsite.  pt agrees to report to ED if symptoms return.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area; redness; to the arm/deltoid area; inflammation; to the arm/deltoid area; swelling/cellulitis in her left arm/swelling; to the arm/deltoid area; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at left deltoid on 16Dec2020 16:45 at single dose for Covid-19 immunization at a hospital facility and not in a military facility. Medical history included ongoing acne. Concomitant medications included ongoing spironolactone for acne. The patient did not receive any other vaccines the day or 4 weeks prior Covid-19 vaccine. The patient informed that after 8 days of getting Covid vaccine she has swelling/cellulitis in her left arm. The patient got the COVID-19 vaccine and had kind of a delayed reaction. She got the vaccine on 16Dec2020 16:45 pm at her workplace. The patient informed that she had no reaction right after the vaccine. On 24Dec2020, the patient experienced redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area. The patient got antibiotics and it has improved. The reporter informed that the events required visit to physician office. The outcome of the events swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area was recovering. The patient was queried regarding seriousness of the events and the patient stated "it could have potentially dangerous." The patient wanted to know if she should get second dose of the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site cellulitis, vaccination site erythema, vaccination site inflammation and vaccination site swelling cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin reaction
Clinical narrative: swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area; redness; to the arm/deltoid area; inflammation; to the arm/deltoid area; swelling/cellulitis in her left arm/swelling; to the arm/deltoid area; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at left deltoid on 16Dec2020 16:45 at single dose for Covid-19 immunization at a hospital facility and not in a military facility. Medical history included ongoing acne. Concomitant medications included ongoing spironolactone for acne. The patient did not receive any other vaccines the day or 4 weeks prior Covid-19 vaccine. The patient informed that after 8 days of getting Covid vaccine she has swelling/cellulitis in her left arm. The patient got the COVID-19 vaccine and had kind of a delayed reaction. She got the vaccine on 16Dec2020 16:45 pm at her workplace. The patient informed that she had no reaction right after the vaccine. On 24Dec2020, the patient experienced redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area. The patient got antibiotics and it has improved. The reporter informed that the events required visit to physician office. The outcome of the events swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area was recovering. The patient was queried regarding seriousness of the events and the patient stated "it could have potentially dangerous." The patient wanted to know if she should get second dose of the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site cellulitis, vaccination site erythema, vaccination site inflammation and vaccination site swelling cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid disorder, Facial pain, Oral pain, Pain in jaw, Pain of skin
Clinical narrative: . Woke up  in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth.  I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Lethargy, Somnolence
Clinical narrative: very tired; foggy headed; slight sore injection site; feel very lethargic; hard to focus at work; just want to sleep; This is a spontaneous report from a contactable nurse (patient). An adult patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the left arm on 29Dec2020 17:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to bee stings. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took intravenous (IV) magnesium and experienced head to toe rash. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 07:00, the patient was very tired, a bit foggy headed, slight sore injection site, overall just feel very lethargic/tired. The patient just want to sleep. It was a bit hard to focus at work. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very tired; foggy headed; slight sore injection site; feel very lethargic; hard to focus at work; just want to sleep; This is a spontaneous report from a contactable nurse (patient). An adult patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the left arm on 29Dec2020 17:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to bee stings. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took intravenous (IV) magnesium and experienced head to toe rash. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 07:00, the patient was very tired, a bit foggy headed, slight sore injection site, overall just feel very lethargic/tired. The patient just want to sleep. It was a bit hard to focus at work. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she had developed symptoms and tested positive to COVID-19; she had developed symptoms and tested positive to COVID-19; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She tested negative on 18Dec2020. She received the first dose of the COVID 19 vaccine on 20Dec2020. On the following Friday (25Dec2020), she had developed symptoms and tested positive to COVID-19. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19; received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from a Pfizer-sponsored Program Pfizer First Connect. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscularly on left deltoid on 21Dec2020 (between 2:15PM and 2:30PM) at single dose (reported as 225mcg/.45ml intramuscular suspension) for COVID-19 immunization. The relevant medical history included birth control. Concomitant medications included ongoing ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA) for birth control. The patient received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19. She wanted to know if the vaccine could have caused a positive test result, if the test assesses IgM or IgG (to the viral spike proteins), could a false positive result be caused by the vaccine. She hadn't been able to get up with her primary care on the phone. This was her first dose. The window to get the second vaccine is 07Jan2021 through 11Jan2021. The patient did not require a visit to emergency room or physician office. The outcome of the events was unknown.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dysphonia, Oral pruritus, Oropharyngeal pain, Pain
Clinical narrative: At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva.  Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness.  Vitals were normal.  Did not notice any flushing, rash under skin or swelling.  The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal hypoaesthesia, Tongue pruritus
Clinical narrative: At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva.  Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness.  Vitals were normal.  Did not notice any flushing, rash under skin or swelling.  The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature decreased, Body temperature increased, Dysphagia, Pharyngeal hypoaesthesia, Respiratory rate increased
Clinical narrative: At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva.  Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness.  Vitals were normal.  Did not notice any flushing, rash under skin or swelling.  The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue pruritus
Clinical narrative: At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva.  Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness.  Vitals were normal.  Did not notice any flushing, rash under skin or swelling.  The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: acute pericarditis; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if other vaccines were given in four weeks and unknown if patient had Covid prior vaccination. The patient experienced acute pericarditis on 24Dec2020. Clinical course as follows: Doctor colleagues at the institution admitted (at Emergency room/department or urgent care) and treated a patient with acute pericarditis who received his first dose of Pfizer SARS-CoV-2 EUA vaccine on 23Dec2020. The physician (reporter) considered the event as non-serious. The outcome of the event was recovering.  Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event acute pericarditis cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the vaccine last week and tested positive for covid this week; received the vaccine last week and tested positive for covid this week; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 23Dec2020 at single dose by injection in the right arm for COVID-19 immunization (to be protected and to protect her family with other conditions like diabetes). The patient's medical history and concomitant medications were none. The patient got the first dose of the COVID vaccine last week on 23Dec2020 and then she tested positive for COVID on Monday on 28Dec2020. She was asking if it was safe to get the second dose. Patient was a pharmacy technician. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Moderna COVID-19 Vaccine EUA Vaccine recipient stated that a few days after her vaccination she started noticing small mostly flesh colored raised "bumps" on both sides of her neck, behind her ears, and on her right cheek.  She stated that the rash was not bothersome, but some of the bumps were red.  If worsened, she would contact her PCP.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Hypoaesthesia, Vision blurred
Clinical narrative: Headache; blurred vision; unable to read at time; Difficulty focusing; right hand numbness; This is a spontaneous report from a contactable Nurse (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 04:15 PM, Intramuscularly at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history was reported none. Concomitant medications were not reported. Patient did not have any allergies. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced Headache, blurred vision and unable to read at time, Difficulty focusing and right hand numbness on 30Dec2020 12:00 AM. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.    Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events headache, vision blurred, cognitive disorder, disturbance in attention and hypoaesthesia cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: Nausea; Diarrhea; All over weakness; I have 100.4°F temp; Vomiting projectile; Body aches and pains; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0140), via an unspecified route of administration at single dose on 29Dec2020 06:30 at the hospital for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Dec2020, after receiving vaccine, the patient experienced nausea, diarrhea, all over weakness, I have 100.4°F temp, vomiting projectile, body aches and pains, shortness of breath. The outcome of the events was unknown. The patient stated: "I didn't have any of the symptoms until I got the vaccine, the nausea is a big issue for because I have connected tissue disease and I have to take my medication today. I take Cellcept and Prednisone, every day and I am hoping to get them. I just need to get it in."
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting projectile
Clinical narrative: Nausea; Diarrhea; All over weakness; I have 100.4°F temp; Vomiting projectile; Body aches and pains; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0140), via an unspecified route of administration at single dose on 29Dec2020 06:30 at the hospital for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Dec2020, after receiving vaccine, the patient experienced nausea, diarrhea, all over weakness, I have 100.4°F temp, vomiting projectile, body aches and pains, shortness of breath. The outcome of the events was unknown. The patient stated: "I didn't have any of the symptoms until I got the vaccine, the nausea is a big issue for because I have connected tissue disease and I have to take my medication today. I take Cellcept and Prednisone, every day and I am hoping to get them. I just need to get it in."
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Vomiting
Clinical narrative: around 1:00 a.m. I awoke with stomach pain and had diarrhea. I continued to have stomach pains and had diarrhea again around 2-3:00a.m.  Stomach pain continued. At approximately 4:00 a.m. I vomited.  I continued to have stomach pain, back pain, vomiting and diarrhea.  I vomited every hour from 4:00 a.m. to 10:00 a.m. whether or not I consumed any liquids. At approximately 10:45a.m. I took an anti-nausea medication proscribed by a healthcare provider and the vomiting ceased.  I continued to have stomach and back pains for the remainder of the day.  I felt better the following day, but still had back pain/soreness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, SARS-CoV-2 test, Upper-airway cough syndrome
Clinical narrative: post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself).  A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk; severe palm itching, severe feet itching; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 22Dec2020 16:00 at single dose at left arm for COVID-19 immunization. Medical history included allergies Ct contrast. The patient's concomitant medications were not reported. ON 23Dec2020 04:00, 12 hours post injection- the patient experienced Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk. 24 hours after the first incident, the patient experienced severe palm itching, another 24 hours later, the patient then experienced severe feet itching. The AE resulted in emergency room/department care. The patient received treatment for the events (Solumedrol). The events was assessed as non-serious. The outcome of the events was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Limb discomfort
Clinical narrative: Sore arm and flu like symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: hard time breathing; This is a spontaneous report from a contactable consumer (patient's daughter-in-law). This consumer reported for two patients. This is the second of two reports. A 92-year-old female patient received single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 29Dec2020 for immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccine the day before reporting (29Dec2020). The patient had a "hard time breathing" at the start but was resolved now (Dec2020). The reporter was asking for recommendations.The event was considered as non-serious by the reporter.  Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520754 same reporter/drug, different patient/event
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.6