chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pruritus, Urticaria
Clinical narrative: whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened also to the soles of feet/hands also became red and itchy; hands also became red; hives; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient (non-pregnant) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 11:45 at single dose at left arm for immunization. Medical history included known allergies: sulfa. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Immediately following vaccination, patient whole left arm was numb, the numbness slightly improved, but then only palms of hands were numb. Later that night, the numbness and itching happened also to the soles of feet, hands also became red and itchy, and then patient got hives that lasted 48 hours, but nightly hives after that, the hives would resolve after taking PO (per oral) diphenhydramine hydrochloride (BENADRYL), and then would come back again that night. Patient was still having them. The adverse events resulted in emergency room/department or urgent care. Outcome of events was reported as recovered/resolved with sequel. The report is considered as non-serious.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Migraine, Myalgia
Clinical narrative: Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose at left arm for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced migraine 1 day after injection, headache, arthralgias, myalgia, chills, low grade fever on days 1-6 post injection which are improving. Patient received Ibuprofen 400 mg daily for events. The report is considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose at left arm for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced migraine 1 day after injection, headache, arthralgias, myalgia, chills, low grade fever on days 1-6 post injection which are improving. Patient received Ibuprofen 400 mg daily for events. The report is considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: neck stiffness; left thumb joint pain; right arm pain around injection site; This is a spontaneous report from a contactable unspecified health professional. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: unknown, intramuscular at the right arm, from 22Dec2020 12:15 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included simvastatin. On 22Dec2020 18:00 (Tuesday night), the patient experienced left thumb joint pain and right arm pain around injection site. On Wednesday, above issues continued. On 24Dec2020 18:00, Thursday, patient had neck stiffness. The joint pain all over was not severe but noticeable. Outcome of events was reported as unknown. There was no treatment or hospitalization involved. This case is non-serious.  No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pruritus, Urticaria
Clinical narrative: anxiety; hives; itching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 45; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms of hives, itching and anxiety on Dec2020. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: Muscle ache; Chills; Headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work; Left arm is too sore way it was administered; This is a spontaneous report from a contactable consumer who reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Concomitant medications were reported as none. On an unspecified date ("roughly" 6 hours after the vaccine was administered) the patient experienced "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" and "left arm is too sore way it was administered". The patient reported that he called "because he took the COVID-19 vaccine last night and he had been having reactions from last time till this time" (as reported). The patient stated that there was no doctor that prescribed the medication, it was administered to him because he was a healthcare worker (certified nursing assistant). He stated that he had been having "muscle ache, chills and severe headache, the headache is so severe, the most disturbing one." He reported that one of the Tylenol doses was administered to him by the nurse that administered the vaccine. He reported that he took some Tylenol and ibuprofen but this time it was not helping. He stated that he received the vaccine about 24 hours ago and started to experience muscle ache, chills and severe headache roughly about 6 hours after the administration. He reported that "I could hang in, but it was getting too bad, my head wanted to fall off, so I am driving home now so I could not work." When the patient was asked about the vaccine dose and route he stated "I believe normal dose I believe, I cannot remember I cannot recap anything, but I know it was administered in my left arm, my left arm is too sore the way it was administered." He stated that he received the vaccination for prevention and to be on the safe side. The patient stated that he did lab work with his doctor a few months ago, probably around 6 or 7 months ago. The clinical outcome of the events "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" were all not recovered/not resolved, while the clinical outcome of the event "left arm is too sore way it was administered" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Paraesthesia, Throat tightness, Vision blurred
Clinical narrative: Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history included ongoing high blood pressure.  Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site pain
Clinical narrative: in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm where she received the shot, her hand and wrist go numb with pins and needles; her arm is sore; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (left arm) on 20Dec2020 06:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There was no other vaccine administered on same date of the Pfizer vaccine. The patient reported that she had the vaccine on Sunday (20Dec2020) and had a side effect that she didn't see listed. She stated that in the arm where she received the shot, her hand and wrist go numb with pins and needles, it was getting progressively less. She added that her arm is sore, but she expected that. She further stated that last night it just happened one time and it feels a lot better now. The patient asked if those were an expected side effect. The patent clarified that she received the COVID 19 vaccine on 20Dec2020 0600 in the left arm. On 21Dec2020 in the night at 0200 she woke up with pins and needles in her hand and wrist. It happened only when she was asleep and not moving her arm. She added that actually she feels it very faint off and on in the day but each night it has improved. She further clarified that the pins and needles are in her lower arm and wrist radiating up the arm. She added that she will be scheduled for the second dose. The outcome of event vaccination site pain was unknown, while the outcome of other events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Headache, Pain, Vaccination site pain
Clinical narrative: 2 hours later, had a slight headache; Right arm that I took the vaccine is really hurting; Feeling like heavy; I am just really sore, my whole body; This is a spontaneous report from a contactable consumer reporting for self.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the right arm  on 23Dec2020 at single dose for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient experienced 2 hours after receiving the vaccine   a slight headache and took Tylenol (taken as treatment) the patient just felt like heavy. The right arm  where the vaccine  was given was really hurting. the patient was just really sore, the  whole body. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting  for herself.  A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm  on 23Dec2020 07:00 at single dose for covid-19 immunisation .  Medical history included covid-19 from Jul2020 to an unknown date.  There were no concomitant medications.  The patient experienced chills  on 24Dec2020 with outcome of recovering , nausea  on 23Dec2020 23:00 with outcome of recovering , headache  on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit  on 24Dec2020 with outcome of not recovered , feeling unwell  on 23Dec2020 with outcome of not recovered , resting heart rate went to 130  on 24Dec2020 with outcome of recovering , she could not stop shaking  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit,  100.4 Fahrenheit, heart rate: 130   (66-72.  Normally) , sars-cov-2 test: negative   on 21Dec2020   , sars-cov-2 test: negative on 24Dec2020  .    Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting  for herself.  A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm  on 23Dec2020 07:00 at single dose for covid-19 immunisation .  Medical history included covid-19 from Jul2020 to an unknown date.  There were no concomitant medications.  The patient experienced chills  on 24Dec2020 with outcome of recovering , nausea  on 23Dec2020 23:00 with outcome of recovering , headache  on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit  on 24Dec2020 with outcome of not recovered , feeling unwell  on 23Dec2020 with outcome of not recovered , resting heart rate went to 130  on 24Dec2020 with outcome of recovering , she could not stop shaking  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit,  100.4 Fahrenheit, heart rate: 130   (66-72.  Normally) , sars-cov-2 test: negative   on 21Dec2020   , sars-cov-2 test: negative on 24Dec2020  .    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Received the vaccine and tested positive for Covid today; Received the vaccine and tested positive for Covid today; This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at single dose for Covid Vaccine/ COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that the patient received the vaccine and tested positive for COVID today (24Dec2020). She was having symptoms on Saturday (unspecified date in Dec2020), she received her vaccine on Thursday 17Dec2020.  The reporter asked several questions, if do they get the second vaccination in 3 weeks and what will be the process, does it do anything to it, or if does it make it worse or better. The outcome of the event was unknown.   Information on the lot/batch 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.,Linked Report(s) : US-PFIZER INC-2020513377 same reporter, same drug, similar event,  different patient.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received the vaccine and tested positive for Covid today; Received the vaccine and tested positive for Covid today; This is a spontaneous report from a contactable nurse. This Nurse reported similar events for two different patients. This is second of two reports.  A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and tested positive for covid today (24Dec2020).It was further reported that the patient showed up positive today (24Dec2020) and her symptoms have been on and off, she just got her vaccine 21Dec2020. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Preventive effect of BNT162b2 is documented after 7 days from the second dosing. This case does not match this requirement.,Linked Report(s) : US-PFIZER INC-2020513367 same reporter/drug. different patient and event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: 54 hours after injection SEVERE joint pains (including to touch) lasting overnight; This is a spontaneous report from a contactable nurse (patient). A 67-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm in Dec2020 04:30 PM at a single dose for COVID-19 immunization at the hospital. Medical history included gastric distress from cow milk products, and allergies to statins, dust/ dust mites. Concomitant medications included loratadine, boswellia serrata (BOSWELLIA), famotidine (PEPCID), and vitamin C. The patient did not received other vaccine within four weeks of COVID vaccine. The patient previously took ciprofloxacin (CIPRO) and experienced allergies. The patient has not been diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. It was reported that on 23Dec2020 20:00, 54 hours after injection, the patient had severe joint pains (including to touch) lasting overnight. The event was partially improved with Tylenol, loratadine, Benadryl, boswellia; and subsided next day. Outcome of the event was reported as recovering. The event was assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: I experienced nasal congestion the next morning, and redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; This is a spontaneous report from a contactable physician. A 30-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 23Dec2020 13:30 at a single dose for covid-19 vaccination. Vaccination was done in the hospital. There were no relevant medical history and no concomitant medications. The patient was not pregnant. The patient experienced nasal congestion the next morning, on 24Dec2020 07:00, and redness, induration and pain on the injection site. The induration and redness was around 1-1.5 inches diameter. The outcome of the events was recovering. There were no treatment involved for the events. This was assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling cold, SARS-CoV-2 antibody test
Clinical narrative: Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I get up, I get light headed; I had COVID back in March and I feel the same way I felt then except the breathing is normal; Very weak; This is a spontaneous report from a contactable consumer reporting for herself.  A 66-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on  23Dec2020 at single dose for covid-19 immunisation .  Medical history included blood pressure measurement on an unknown date. The patient had been up all night long freezing, shaking; had to take a hot bath just to warm up  on 24Dec2020 with outcome of unknown , every time she got up, she got light headed  on 24Dec2020 with outcome of unknown , she had Covid back in March and she felt the same way except the breathing is normal  on 24Dec2020 with outcome of unknown , very weak  on 24Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Mar2020.  Information about Lot /batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Drug ineffective; tested positive; chills; fever; headache; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 2nd of two reports.   A female patient of an unspecified age (30-40 year-old)started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration on 02Dec2020 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient was tested positive to COVID-19 on 24Dec2020 after having chills, fever and a headache. The outcome of the events was unknown. The reporter stated that these were worse than just side effects. The reporter is wondering if the patient can receive the second dose.  Information on the lot/batch number has been requested.; Sender's Comments: Preventive effect of BNT162b2 is documented 7 days after the 2 dose. This case does not match this requirement,Linked Report(s) : US-PFIZER INC-2020512742 different patient, same drug and event
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Right arm swelling; Right arm itching; injection site pain; injection site warm to touch; This is a spontaneous report from a contactable other nurse (patient herself). A 34-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), intramuscularly at site of right arm at 16:00 on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took ciprofloxacin (CIPRO) and experienced allergies: ciprofloxacin. The patient right arm swelling and itching, injection site pain and warm to touch on 23Dec2020. No treatment received for events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was not recovered by day 4 after the vaccination (as reported).   Information about Batch/Lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pain
Clinical narrative: pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself.     A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on  23Dec2020 10:30 at single dose for Covid-19 immunisation .  Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE).  The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids.  Stated if condition goes on much longer or worse  then she will have to go to the hospital.  Lot/Batch and Expiration date has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Swelling, Vaccination site pain
Clinical narrative: pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself.     A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on  23Dec2020 10:30 at single dose for Covid-19 immunisation .  Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE).  The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids.  Stated if condition goes on much longer or worse  then she will have to go to the hospital.  Lot/Batch and Expiration date has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness postural, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Starting the day after I got flu like symptoms. Headache, night sweats, chills. Starting last night, after sweating an obscene amount, I started feeling dizziness. Not a normal dizziness, but a severe one with brain zaps. The type of brain zaps someone has when coming on or off affexor/venlafaxine (which I?m currently on). The dizziness only happens when I stand and the brain zaps happen more frequently than when the dose changes or is forgotten with the snri. Before someone asks... yes... I?m taking my affexor properly and haven?t changed how I?m taking it since my covid shot.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Starting the day after I got flu like symptoms. Headache, night sweats, chills. Starting last night, after sweating an obscene amount, I started feeling dizziness. Not a normal dizziness, but a severe one with brain zaps. The type of brain zaps someone has when coming on or off affexor/venlafaxine (which I?m currently on). The dizziness only happens when I stand and the brain zaps happen more frequently than when the dose changes or is forgotten with the snri. Before someone asks... yes... I?m taking my affexor properly and haven?t changed how I?m taking it since my covid shot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Feeling cold, Heart rate
Clinical narrative: feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension
Clinical narrative: feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Nausea, Pain, Vomiting
Clinical narrative: On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his bilateral flank; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced rash on his bilateral flank on 23Dec2020. It doesn't itch and within 24 hours was beginning to subside. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye swelling, Facial pain, Fatigue, Headache
Clinical narrative: left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Nausea, Neck pain, Periorbital swelling, Pyrexia
Clinical narrative: left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: I just woke up with like a sore and itchy throat; I just woke up with like a sore and itchy throat; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Dec2020 at a singe dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient just woke up with like a sore and itchy throat on 24Dec2020. The patient was trying to get information if that is a possible side effect of that or if he should be worried about something else. The patient was due for the next shot on 13Jan2021. Outcome of the events was unknown. No treatment was given for the events.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Off label use, Product use issue, Rash
Clinical narrative: I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Heart rate, Heart rate increased, Palpitations
Clinical narrative: About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth.  She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine on Wednesday this week (23Dec2020) and she tested positive for COVID yesterday (25Dec2020). She wanted to know if she should take the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: 99 fever , major fatigue
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I received the covid-19 vaccine and then afterwards contracted covid-19; I received the covid-19 vaccine and then afterwards contracted covid-19; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age 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 vaccine.  The patient medical history and concomitant medications were not reported.  The patient stated on an unspecified date, "I received the covid-19 vaccine and then afterwards contracted covid-19. I was told by my hospital that because of this I needed to defer the second dose for 90 days. Is this best practice? Or should I take the second dose in 3 weeks as scheduled?". The outcome of the events was unknown.    Information on the batch/lot number has been requested.; Sender's Comments: BNT162b2 provides protection against COVID-19 seven days after the second dose is administered. This case does not match this condition
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Fatigue, weakness, chills, sweats, headache. Soreness around injection site. No treatment. Went away with time.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Fatigue, weakness, chills, sweats, headache. Soreness around injection site. No treatment. Went away with time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; No symptoms at present time; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV1685) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history included Covid-19 12 weeks before 25Dec2020. The concomitant drug was reported as levothyroxine sodium (SYNTHROID), hydrochlorothiazide and vitamins. The patient got the vaccine (Covid 19 Vaccine) on 22Dec2020 (Tuesday) and then on 25Dec2020 (today) had to be tested at work and was tested positive for Covid. So, she was wondering if that might have something to do with the vaccine or it was not for sure. Patient had already had Covid once and this is the first time she got tested since for 12 weeks. It just happened to be three days after the vaccine. So, the lady she work with told her a study was done and people were shown to test positive like two days after they got the vaccine. So, that's what she wanted to find out. If that could be." She states the test on 25Dec2020 was a routine follow up Covid-19 test. No symptoms at present time. The outcome of the events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this condition.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Patient has had a fever and flu like symptoms for over 3 days; Patient has had a fever and flu like symptoms for over 3 days; This is a spontaneous report from a non-contactable other healthcare professional, the patient.  A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: Ek5730, via intramuscular, on 18Dec2020 at 09:15 (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included other vaccine (not specified) on 03Dec2020. The vaccine was given at a hospital. On Dec2020,  the patient experienced had a fever and flu like symptoms for over 3 days. The event resulted in emergency room visit. No treatment was received for had a fever and flu like symptoms for over 3 days. The clinical outcome of had a fever and flu like symptoms for over 3 days was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.