chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: The arm was achy; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (tradename unspecified, lot/batch number was unknown) solution for injection in pre-filled syringe, via an unspecified route of administration on an unspecified date at a single dose for pneumonia; influenza vaccine (FLU) , via an unspecified route of administration in Oct2020 at a single dose for influenza. Medical history included breast cancer, hypertension, hiatal hernia, and glaucoma. The patient's concomitant medications were not reported. The patient reported she has had no issues with vaccines in the past. She had pneumonia and flu vaccine. She reported that her arm was achy, but she doesn't remember anything like lymph nodes, feet, or legs having symptoms. She got a Flu Vaccine at work in Oct2020. She got the Pneumonia vaccine at the doctor's office, she does not know when, unknown, but maybe in the last 5-3 years. Outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Chills; Nauseated; my incision or the shot site is red and swollen and very sore; my incision or the shot site is red and swollen and very sore; my incision or the shot site is red and swollen and very sore; headache; This is a spontaneous report from a contactable consumer medical social worker in the emergency department (patient).  A 24-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EK5730, Expiry Date Mar2021) intramuscularly at single dose in arm in Dec2020 about 12 hours ago before this report for Covid-19 immunisation, administered at the hospital that she work at.  Medical history was none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) daily for birth control.  In Dec2020, about 10 hours after vaccination was received, the patient experienced chills, felt nauseated, her incision or the shot site is red and swollen and very sore and headache. No lab test performed. No treatment received. The outcome of headache was unknown of the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Chills; Nauseated; my incision or the shot site is red and swollen and very sore; my incision or the shot site is red and swollen and very sore; my incision or the shot site is red and swollen and very sore; headache; This is a spontaneous report from a contactable consumer medical social worker in the emergency department (patient).  A 24-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EK5730, Expiry Date Mar2021) intramuscularly at single dose in arm in Dec2020 about 12 hours ago before this report for Covid-19 immunisation, administered at the hospital that she work at.  Medical history was none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) daily for birth control.  In Dec2020, about 10 hours after vaccination was received, the patient experienced chills, felt nauseated, her incision or the shot site is red and swollen and very sore and headache. No lab test performed. No treatment received. The outcome of headache was unknown of the other events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactable consumer nurse assistant (patient).   A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EH9899) at single dose on 28Dec2020 for covid-19 immunisation, administered at the hospital she worked at.  Medical history included cholesterol. The patient reported taking unspecified concomitant medications. The patient got lightness in my head, had been dizzy and experienced headache in Dec2020. No treatment received. The outcome of events was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: body aches; Fever; Chills; Pain at injection site; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, batch/lot: EL1284), intramuscular in the right arm on 28Dec2020 17:45 at a single dose for Covid-19 immunisation. The patient's medical history was none. Patient has no known allergies. Concomitant medication included paracetamol (TYLENOL), ibuprofen and multivitamins. On 29Dec2020, the patient experienced fever, chills, pain at injection site, and body aches. They all started the day after the injection and where mostly gone by the day after that. No treatment was given to the patient for the event. The outcome of the event was recovered in Dec2020. Vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID prior to vaccination. Patient has not been tested positive for COVID post vaccination.
Sex: F
Vaccine: UNK
Symptoms: Gait inability
Clinical narrative: couldn't walk for a couple of days; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. The patient couldn't walk for a couple of days on an unspecified date. Clinical outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Feeling tired; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231) via an unspecified route of administration on the right upper arm on 30Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril (LISINOPRIL) for high blood pressure. The patient experienced feeling tired, nauseous and a little headache on 30Dec2020 08:15. Outcome of events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea
Clinical narrative: nausea; chills; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 49-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via unspecified route of administration at left arm on 23Dec2020 15:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included Sjogren's syndrome, and chronic sinusitis. The patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks prior to Covid vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), colestyramine (questran), lifitegrast (XIIDRA), and chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX); all from unspecified date for unspecified indication. The patient previously took codeine and Ceftin; both experienced allergies. On 26Dec2020 08:00 three days after receiving vaccine, the patient experienced nausea, chills and malaise. The symptoms lasted for four days (Dec2020). The patient has not been tested for Covid-19 since the vaccination. The patient received no treatment due to the events. The outcome of the events nausea, chills and malaise was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a non-contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 23Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Covid-19 diagnosed prior to vaccination. Concomitant medications included "OCP" (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Dec2020, the patient experienced arm pain, shooting up to neck. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events arm pain, shooting up to neck was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Movement disorder, Nausea, Parosmia, SARS-CoV-2 antibody test
Clinical narrative: Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Pain in extremity, Urinary tract infection
Clinical narrative: left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported.  Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) at the public health department via unspecified route of administration at right arm on 28Dec2020 12:30 as single dose to prevent getting the Covid virus. Medical history included medication allergies (allergic to like 3 to 4 medications), allergic to sulfur/sulfa, allergic to penicillin, allergic to "-mycins", allergic to dye (for a CT scan). The patient informed that she was given the Pfizer shot, clarified to Pfizer-BioNTech COVID-19 vaccine on Monday (verified to be the 28th). The patient informed that since then she has had a low grade fever and the patient would like to talk to someone to see if that was normal, since it was still not gone. The patient got her first dose of the vaccine injected into her right arm around 12:30 PM Monday (28Dec2020), and her fever started Monday night and got to 100 degrees Fahrenheit and since then she has been running 99.2 degrees Fahrenheit (Dec2020), it was 99.8 degrees Fahrenheit now (30Dec2020). The patient stated "it didn't say on the vaccine card, but the sheet they gave with it says it is the Pfizer-BioNTech COVID-19 vaccine. All that is on there is the date she got it, 18Nov2020 and the healthcare girl put her initials on it" (unable to clarify discrepancy between the dates provided as caller continued speaking). The patient informed that she was supposed to have turned around on the 18th to get the second shot (unable to clarify statement and the caller may have meant that she was supposed to get the second dose of the shot on 18Jan2021, and misread the card as she seemed to have difficulty reading the nurse's handwriting on it). The reporter informed that the LOT number was written with an E and then either a V or a K, it looks like a V but the girl put a leg on there so maybe it was a K then 9231, or EV or 9231 or 9731. The outcome of the event "pyrexia" was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse.  A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks.  Medical history included allergies to penicillin and shrimp.  There were no concomitant medications.  The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse.  A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks.  Medical history included allergies to penicillin and shrimp.  There were no concomitant medications.  The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she received the COVID Vaccine on the evening of Christmas, and then she tested positive for COVID on Sunday; she received the COVID Vaccine on the evening of Christmas, and then she tested positive for COVID on Sunday; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE);  in the left arm on 25Dec2020 as a single dose, for COVID-19 immunization.  The patient had no known medical history. There were no concomitant medications. Caller confirmed the product was not specifically prescribed to her, but she received it via an options at her company and had received no other vaccines on the same day as the COVID vaccine. The patient received the COVID Vaccine on the evening of Christmas 25Dec2020, and then she tested positive for COVID on Sunday, 27Dec2020. The patient had a positive SARS-CoV-2 test on 27Dec2020. The clinical outcome of the event Drug ineffective and COVID-19 was unknown.  Information regarding lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient.  A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient.  A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: as a person with severe cough variant asthma, he/she immediately noticed a change in his/her breathing/ breathing so much better; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization.  Medical history included ongoing severe cough variant asthma. The patient's concomitant medications were not reported.  The patient reported he/she just received the covid vaccine the day before reporting date and wanted to let company know that as a person with severe cough variant asthma, he/she immediately noticed a change in his/her breathing. It was very noticeable all of the day 28Dec2020 and even this morning (29Dec2020). He/she was breathing so much better. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Fatigue, Limb discomfort, Muscle tightness
Clinical narrative: developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Fever 100.0; severe headache; malaise; fatigue; This is a spontaneous report from a contactable pharmacist (the patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the left arm on 22Dec2020 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included multiple sclerosis. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: ergocalciferol (VITAMIN D), natalizumab, and topiramate, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 09:00, the patient experienced fever 100.0, severe headache, malaise, and fatigue post injection. No treatment was given for these events. The clinical outcome of fever 100.0, severe headache, malaise, and fatigue post injection was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 28Dec2020 at 14:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergies to medications, food, or other products: nickel. Concomitant medications included ascorbic acid/biotin/tocopheryl acetate (BIOTIN GUMMY); ergocalciferol (VITAMIN D); and WOMEN'S ONE A DAY MULTIVITAMIN. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020, the patient experienced index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy despite the fact that I have not worn any jewelry or did anything out of the norm. Treatment was provided for the event rash included applying hydrocortisone and diphenhydramine (BENADRYL). The outcome of the event rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pain in extremity
Clinical narrative: Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization.  Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies.  Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19.  On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit   The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with  Heating pads,  Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered.   Information regarding lot number has been requested.
Age: 1.17
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: currently nursing my baby who is 14 months old.; This is a spontaneous report from a contactable nurse practitioner. This nurse practitioner reported information for both mother (Self) and her 14-month-old patient infant. A 14-months-old of an unspecified gender started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), (age at vaccination 14-month-old) transmammary on an unspecified date in Dec2020.  The infant's mother received the vaccine for COVID-19 immunisation. The infant's mother reported she was a nurse practitioner working at a local urgent care center. She was currently nursing her baby who is 14 months old. Due to the high risk of getting COVID19, the mother decided to get COVID 19 vaccination despite lack of data on lactating women. She received my Pfizer COVID 19 vaccination 3 days ago (Dec2020).  Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021001535 mother case
Sex: U
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 contactable consumer (patient). The consumer reported for self and husband. This is the first of two reports, and concerns the reporter (patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: 31Mar2021), via an unspecified route of administration, on 19Dec2020, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unspecified date in Dec2020, the patient tested positive for COVID. The outcome of the event tested positive for COVID was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; Flu; This is a spontaneous report from a contactable consumer. The consumer reported for self and husband. This is the second of two reports and concerns the reporter's husband. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: not provided), via an unspecified route of administration, on 18Dec2020, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unspecified date in Dec2020, the patient experienced the flu after receiving the vaccine. On an unspecified date in Dec2020, the flu symptoms went away and the patient tested positive for COVID. The outcome of the event flu was recovered in Dec2020 and the outcome of tested positive for COVID was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation .  Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter.  Concomitant medication included vitamin c [ascorbic acid].  The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00.  No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: developed a fever as high as 101.8; chills; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EK9231), via intramuscular route of administration, on 23Dec2020 at 02:00 PM (at the age of 37 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020, at 03:00 PM, the patient developed a fever as high as 101.8 (no units provided) with no other symptoms beyond fever and chills. The patient did not take any anti-pyretics to treat the fever and her temperature came down on its own overnight. By the next day, she felt back to normal. No treatment was received for the events fever and chills. The outcome of the events fever and chills was recovered on 30Dec2020. Since the vaccination, the patient had been tested for COVID-19 (via saliva polymerase chain reaction [PCR]) with negative result.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Headache, Nasal congestion
Clinical narrative: Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Pain at injection site; headache; muscle pain; chills; joint pain; tiredness; fever; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 28Dec2020 at 09:15 AM (at the age of 43 years old) as a single dose in the right arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 11:30 PM, the patient experienced pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. No treatment was received for the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. The outcome of the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea was recovered on an unspecified date in Dec2020. 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.