chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Vaccination site pain
Clinical narrative: She experienced soreness at the site; fatigue; numbness in the left pinky finger; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Dec2020 at SINGLE DOSE for COVID-19 IMMUNIZATION. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid Vaccine at on 27Dec. She experienced soreness at the site and fatigue on 28Dec-29Dec and numbness in the left pinky finger (same arm as vaccination). She also started another med the same day, so she is unsure if the fatigue is from vaccination or the other drug. I do not know the name of that drug. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Induration, Pyrexia, Vomiting
Clinical narrative: large induration; fever; Chills; vomiting; This is a spontaneous report from a contactable consumer. A 3-decade-old (precise age unknown, early-to-mid 20s) female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and  concomitant medications were not reported. It was reported that post dose 1 of "COMIRNATY COVID-19 mRNA-based vaccine" on 28Dec2020, the patient experienced large induration, fever, chills and vomiting. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: I just developed a very sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included multivitamins (unspecified). The patient just developed a very sore throat on 29Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).  This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), intramuscular, on 29Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at hospital, age at vaccination was 58-years-old. No other vaccine was received in four weeks. Medical history was unknown. Concomitant medications included rosuvastatin calcium (CRESTOR) and lisinopril. On 29Dec2020 at 04:00 PM, the patient experienced elevated heart rate, headache. The event was reported as non-serious. Outcome was recovered on Dec2020. No treatment was received for the event.   No follow up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Headache, Investigation
Clinical narrative: headache; constipation; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 23Dec2020 at a single dose for covid-19 vaccination. The vaccine was administered in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant. On 24Dec2020, the patient experienced constipation and headache since vaccine (7 days). The outcome of the events was unknown. There was no treatment for the events. ON 24Dec2020, the patient had COVID test type post vaccination=Nasal Swab with a negative result. The events were assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), Intramuscular on 22Dec2020 17:45 at single dose for covid-19 immunisation. Vaccine administered in left arm. Medical history included Anemia and Hypothyroidism. Patient is not pregnant. Concomitant medication was not reported. Patient had allergies to Levaquin. The patient experienced extreme fatigue, body aches, and headaches that began around day 4 post vaccine on 26Dec2020. Patient has not been tested for coronavirus disease (COVID-19). Patient was not diagnosed with COVID-19. Outcome of events was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: Stye developed over right eyelid; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) intramuscularly at left arm on 17Dec2020 14:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced stye developed over right eyelid on 18Dec2020 06:00. No treatment received. The event is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date in Dec2020.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: Lot of swelling at my injection site and my glands under my arms; Lot of swelling at my injection site and my glands under my arms; This is a spontaneous report from a contactable consumer (patient). The 49-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1284), unknown on an unknown date in Dec2020 at single dose for COVID-19 immunisation. Medical history included Allergy and asthma. Patient also took take allergy medicine and have to use an asthma inhaler. It was reported " I got the Pfizer COVID Vaccine and I had a lot of swelling at my injection site and my glands under my arms". When talking about treatment, Consumer stated, "I did ice, I did heat, I did allergy cream (Unspecified Medication), I didn't go to the doctor where they follow up with you and check on you, the swelling got up to like 6 inches." The outcome of the events was unknown.  No follow-up attempts are needed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia oral, Tongue disorder
Clinical narrative: Felt tongue tingle; had a weird sensation on tongue. At first I thought I was tasting something but I wasn't; felt a bit of nausea which is a normal side effect; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 29Dec2020 09:30 at single dose for COVID-19 immunization. No medical history. No known allergies. The patient's concomitant medications were not reported. The patient felt tongue tingle and had a weird sensation on tongue. At first she thought she was tasting something but she wasn't. This lasted for about 30 mins. She also felt a bit of nausea which was a normal side effect. She was not sure what the tongue feeling was. Events onset date was 29Dec2020 10:00. No treatment received. This report is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Vaccination site rash
Clinical narrative: developed a circular rash at injection site/localized; This is a spontaneous report from a contactable physician. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The reporting physician was inquiring about information related to development of a rash at the injection site, and to report an adverse event. The patient got vaccine on 18Dec2020. 10 days later, on 28Dec2020, the patient developed a circular rash at injection site/localized (circular "like lyme disease"). Localized rash was 3cm in diameter. Per reporter, the patient was "feeling otherwise okay". The patient had been tested negative for lyme disease. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tenderness
Clinical narrative: tenderness or soreness; tenderness or soreness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 73-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL) for lupus. The patient experienced tenderness or soreness in Dec2020. She mentioned she read the fact sheet and felt nothing, there was only tenderness or soreness but it didn't bother. The outcome was unknown.   Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Absolutely no side effects other than a sore arm; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (BNT162B2; reported as Pfizer Covid-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that it's been a week since the patient received the Pfizer Covid-19 vaccine. There were absolutely no side effects other than a sore arm for 2ish days (unspecified date). The patient will be the first to admit that the patient was skeptical and wasn't eager to jump in line. After a few conversations with trusted colleagues and researching reliable websites, the patient decided that this was the least the patient could do. The patient was eager to see friends and family. The patient also mentioned that the patient was eager for the hospital to not be busting at the seams. Eager to not work 5 nights a week to do his/her part and eager to not see his/her friends/colleagues exhausted. The patient was also selfishly anxious to travel again. This vaccine gives us a light at the end of a very long dark tunnel. It gives us the first glimmer of hope we've had all year. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient receive the first dose of the vaccine and has now tested positive for Covid; patient receive the first dose of the vaccine and has now tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program.  A contactable pharmacist reported a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that they had a patient receive the first dose of the vaccine and has now tested positive for Covid. He stated the patient is a week out from receiving the second dose and asks what information Pfizer can provide on receiving the second dose for someone with Covid infection. Outcome of the event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Limb discomfort
Clinical narrative: Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; This is a spontaneous report from a contactable other HCP. This 36-year-old female other HCP reported for herself that that she received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular at right arm at single dose for COVID-19 immunisation on 22Dec202008:00 AM.  Relevant history included Endometriosis and allergies with Keflex, Levsin. Concomitant drug included bupropion SR which received within 2 weeks of vaccination. The patient experienced shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of neck 4 days after vaccine. Tightness on chest was gradually improving but comes and goes daily for the past week. The events was considered as non-serious. No treatment was received. The outcome of events was reported as recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 with negative result per Nasal Swab on 23Dec2020.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; This is a spontaneous report from a contactable other HCP. This 36-year-old female other HCP reported for herself that that she received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular at right arm at single dose for COVID-19 immunisation on 22Dec202008:00 AM.  Relevant history included Endometriosis and allergies with Keflex, Levsin. Concomitant drug included bupropion SR which received within 2 weeks of vaccination. The patient experienced shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of neck 4 days after vaccine. Tightness on chest was gradually improving but comes and goes daily for the past week. The events was considered as non-serious. No treatment was received. The outcome of events was reported as recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 with negative result per Nasal Swab on 23Dec2020.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Headache, Migraine, Myalgia
Clinical narrative: swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Rhinorrhoea, Sneezing
Clinical narrative: swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for seasonal allergy. On 29Dec2020 (within a few minutes), she broke out and was sweating. She had sweat at her face and sweated in her clothes. The patient also have a terrible headache, her body hurt and have chills. The patient did not receive any treatment for the events and was going to ask if she can take diphenhydramine (BENADRYL) as she do not know what to do. She doesn't know if she can take medicine because it was terrible. Outcome of the events were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test positive
Clinical narrative: lost my sense of smell and tested positive for Covid; lost my sense of smell and tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The content of a post was noted that on Dec2020, "Got mine! And in a stroke of weird ironic awfulness, lost my sense of smell and tested positive for Covid later that day....If only a month sooner! Thank you for creating this vaccine. I know it had nothing to do with my diagnosis!". The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Sender's Comments: The events drug ineffective and COVID 19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on the short temporal relation between vaccination and onset of events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sinus headache
Clinical narrative: Mild to severe headache behind her eye and sinus area; Mild to severe headache behind her eye and sinus area; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020 at 10:15 AM, at single dose, for COVID-19 immunisation. Medical history included peanut allergy, penicillin allergy and nut allergy (unknown if ongoing). Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced mild to severe headache in Dec2020, days after the COVID-19 injection. Main complaint was headache behind her eye and sinus area. The event required physician office visit on 29Dec2020. It was unknown if the event required any treatment. The events was considered as non serious. The patient was unsure if this was related to the vaccine but informed the reporter.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Wrong product administered
Clinical narrative: Body aches, chills and body temperature max of 101.2 F; Body aches, chills and body temperature max of 101.2 F; Body aches, chills and body temperature max of 101.2 F; she should not have taken the vaccine with us; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, chills and body temperature max of 101.2 F on 22Dec2020 with outcome of recovered on 23Dec2020. On 22Dec2020 she spent the day in bed. The reporting nurse stated that the patient was part of a trial study. She was vaccinated in a blind study on 28Nov2020. The patient told the reporter on 23Dec2020 that she called the intake person the week before and they told her to take the vaccine here with Pfizer. She called them back after she experienced the events and spoke with a different person who stated she should not have taken the vaccine with Pfizer. They will not un-blind her at this point either. The reporter felt certain based on her response last week that she must have received the vaccine on 28Nov2020 and not the placebo. The patient wished to drop from the study and take the 2nd Pfizer vaccine in 3 weeks. Her PCP agreed that she should do so.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: she is positive that she is positive" and is having symptoms, although not yet been tested; she is positive that she is positive" and is having symptoms, although not yet been tested; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reportedly asking if she should keep her appointment for the second dose of the vaccine as scheduled if she thinks she was positive for COVID and having symptoms. The patient had vaccine on Tuesday (Dec2020), and husband tested positive yesterday, "she was positive that she was positive" and was having symptoms, although not yet been tested. The 2nd dose was in 2 weeks. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the company considers that a causal relationship between the suspected COVID-19 and vaccination with BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test negative
Clinical narrative: she is positive that she is positive" and is having symptoms, although not yet been tested; she is positive that she is positive" and is having symptoms, although not yet been tested; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reportedly asking if she should keep her appointment for the second dose of the vaccine as scheduled if she thinks she was positive for COVID and having symptoms. The patient had vaccine on Tuesday (Dec2020), and husband tested positive yesterday, "she was positive that she was positive" and was having symptoms, although not yet been tested. The 2nd dose was in 2 weeks. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the company considers that a causal relationship between the suspected COVID-19 and vaccination with BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; Muscle aches; Chills; 102.5 fever; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at Arm Left at single dose for COVID-19 immunisation.  Medical history included Low thyroid, Covid (diagnosed with COVID-19: Yes). Concomitant medication included levothyroxine sodium (SYNTHROID).  The patient experienced muscle aches, chills, headache, 102.5 fever on 28Dec2020 18:00. All events were non serious. No treatment was received. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient underwent lab tests and procedures which included body temperature: 102.5 on 28Dec2020.  The outcome of the events was resolved in Dec2020.  No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Vaccination site pain
Clinical narrative: deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of vaccination, hard to lift up; she was feeling very tired and in day-2 she felt fatigue; This is a spontaneous report from a contactable consumer reporting for a patient.  A 48-year-old female patient received first dose of BNT162B2, (Pfizer-BioNTech Covid-19 Vaccine, lot number EH9899) , via an unspecified route of administration on 28Dec2020 10:00 at single dose on left arm for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were none.  The patient experienced deltoid muscle pain in left arm where she got the shot (28Dec2020 12:00). Left arm feeling heavy in within 2 hours of vaccination, hard to lift up (28Dec2020 12:00). In the afternoon she was feeling very tired and in day-2 she felt fatigue, took Tylenol multiple times a day. On day-3 she felt perfectly fine and no pain was left. Functioning properly. No known allergies. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of deltoid muscle pain in left arm where she got the shot. The outcome of the events was resolved on an unspecified date.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Fatigue, Headache
Clinical narrative: really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was anxious.; almost felt like her blood pressure was up.; Her heart rate is usually 60-65 bpm, but last night it was up to  75-80 bpm; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EIC9231), via an unspecified route of administration on 29Dec2020 11:30 at single dose for COVID-19 immunisation.  Medical history was none.  There were no concomitant medications. The patient was calling to report that she got the COVID vaccine yesterday, and she wanted to put input in on the effects she experienced last night. She is a pharmacy transition specialist. She doesn't have a prescribing doctor. A few hours after, she was really tired. She could have fallen asleep at her desk. Then, last night, her heart was like pounding but not beating fast if that makes since. Her heart rate wasn't up that much, but it felt like it was going to come out of her chest. She couldn't sleep because of it. She had a headache. She received the vaccine at 11:30. She is not as tired today. Yesterday, she could have just laid head back and went to sleep. The rest of the side effects started right after dinner. She couldn't sleep because she was anxious. Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm. It almost felt like her blood pressure was up. This happened right around after dinner.  The headache is hanging over into today. It could be still there because she didn't sleep. Her arm is sore still. It isn't serious. The handwriting was bad on her card so it was hard for her to read the lot number. The outcome of the event Headache, sore arm was not resolved, the outcome of the event really tired was resolving, the outcome of the event heart pounding was resolved in Dec2020, while the outcome of the other events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Pain in extremity, Palpitations
Clinical narrative: really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was anxious.; almost felt like her blood pressure was up.; Her heart rate is usually 60-65 bpm, but last night it was up to  75-80 bpm; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EIC9231), via an unspecified route of administration on 29Dec2020 11:30 at single dose for COVID-19 immunisation.  Medical history was none.  There were no concomitant medications. The patient was calling to report that she got the COVID vaccine yesterday, and she wanted to put input in on the effects she experienced last night. She is a pharmacy transition specialist. She doesn't have a prescribing doctor. A few hours after, she was really tired. She could have fallen asleep at her desk. Then, last night, her heart was like pounding but not beating fast if that makes since. Her heart rate wasn't up that much, but it felt like it was going to come out of her chest. She couldn't sleep because of it. She had a headache. She received the vaccine at 11:30. She is not as tired today. Yesterday, she could have just laid head back and went to sleep. The rest of the side effects started right after dinner. She couldn't sleep because she was anxious. Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm. It almost felt like her blood pressure was up. This happened right around after dinner.  The headache is hanging over into today. It could be still there because she didn't sleep. Her arm is sore still. It isn't serious. The handwriting was bad on her card so it was hard for her to read the lot number. The outcome of the event Headache, sore arm was not resolved, the outcome of the event really tired was resolving, the outcome of the event heart pounding was resolved in Dec2020, while the outcome of the other events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactable Other-HCP. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number Unknown), intramuscular at Left arm on 23Dec2020 10:00 at single dose for covid-19 immunisation.  Medical history included Diabetes mellitus, Known allergies: penicillin.  Concomitant medication included metformin. The patient experienced headache, extreme fatigue on 23Dec2020 23:00. Both events were non serious. No treatment was received. The patient was not Pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the events was resolved in Dec2020.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Photophobia
Clinical narrative: eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in arm for 72 hrs.  Continued pain for 2 more days.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Fatigue, Headache, Nausea
Clinical narrative: chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious.  Information about lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mucosa vesicle, Musculoskeletal stiffness, Oral mucosal eruption, Vaccination site pain
Clinical narrative: 2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/sore; Left arm also very stiff/sore; This is a spontaneous report from a contactable other healthcare professional (HCP). This 35-year-old female HCP reported for herself that she received BNT162B2 (lot number EH9899) 1st dose Intramuscular at left arm on 27Dec2020 at 12:00 PM for Covid-19 immunization. Medical history was not provided. Concomitant therapy included birth control. The patient experienced red bumps (rash) appeared in mouth, and 2 vesicles appeared on roof of mouth within 24-32 hours after receiving vaccine. Left arm also very stiff/sore for 24 hours after receiving vaccine. Event onset time was reported as 12:00 PM on 28Dec2020. No treatment was received for the events. The outcome of the event was resolving.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: some swelling on the underside of this same arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) at single dose via an unknown route in her right arm on 20Dec2020 09:50 for Covid-19 immunization. Medical history and concomitant drug were not provided. Past drug history included a reaction to an antibiotic, cefadroxil (DURICEF). Patient received her initial Covid-19 vaccine in her right arm and noted some swelling on the underside of this same arm on 21Dec2020. She wanted to know if this might be associated with the vaccine. Patient stated she had that got the vaccine on 20Dec2020 at 9:50AM in the right arm, that on Monday the next day, 21Dec2020, she got this swelling under her arm. Patient stated did not know if it had anything to do with that, wanted to know if it is a side effect. Patient stated that the swelling started on Monday the next day, 21Dec2020.  Patient stated the swelling has improved but she was going to the doctor to make sure everything was okay.  Patient stated that years ago she had a reaction to an antibiotic, cefadroxil. She asked her doctor if she should get the shot because of that and they told her she should, states this happened like 25 years ago as of 30Dec2020, no details known. Outcome of the event was resolving.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Rash, Rash erythematous
Clinical narrative: Red face rash morning of 2 days following vaccine Dull headache, day of vaccine
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Headache, Rash, Swelling face
Clinical narrative: Red face rash morning of 2 days following vaccine Dull headache, day of vaccine
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Rash, Rash erythematous
Clinical narrative: day of vaccine:  dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine:  minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Headache, Rash, Swelling face
Clinical narrative: day of vaccine:  dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine:  minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 at left arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes from about 3-4 years before, and an allergic reaction to the dye when testing heart - couldn't remember the dye put in. She was allergic to that and sent to the ER because her throat was starting to close up about 3 years before. Concomitant medications were none. Patient received the Covid vaccine and developed rash on 24Dec2020 that was worsening and she asked if there was any recommendation on whether this was it going to get worse. Patient received the vaccine and was very worried because she was really itchy in back and her legs were all rash and in her back. She was starting to itch really bad. This was after 2 days of the vaccine (on 24Dec2020). She didn't take note until it came to her back and her friend checked her back and told her there was a rash. She asked if this could be related to the vaccine. She asked was this a severe reaction and should she receive the next dose. Her second dose was scheduled for 08Jan2021. She did not know at this time if she would get the second dose as scheduled or not. Onset of rashes started on her legs; she thought it would go away; but the rashes had worsened; they were now on her back and were getting really itchy; she had a friend look at it who told her she had patches of rashes on her back. She reported that she was going to contact her doctor about this information because she was scared about the rashes. Outcome of the events was not resolved.  Lot/Batch and Expiration date has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Dysarthria, Fatigue, Flushing, Headache
Clinical narrative: Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscularly on 29Dec2020 08:00 at left arm at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. Patient previously took metronidazole (FLAGYL) and experienced allergy. Patient experienced headache, hypertension, face flushed, extremely tired, slow motion, and slurred speech on 29Dec2020 09:30. Treatment was not received for these events. Outcome of the events was resolving.