chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Neck pain, Pyrexia, Retching
Clinical narrative: neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: the site is a little sore and tender; She may have had a slight fever of 98.6; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 80-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2, intramuscular, administered in right arm on 04Feb2021 at 14:03 (Batch/Lot Number: EL9264, Expiry date was not reported) as single dose covid-19 immunisation. Medical history included ongoing thyroid and underwent knee replacement in Jul2020 and sometimes have trouble with it. The patient has family cancer history. Concomitant medications included rivaroxaban (XARELTO) (20 mg daily by mouth) taken as blood thinner from an unspecified start date and ongoing; levothyroxine (50 mcg, take once daily by mouth) taken for thyroid ongoing from an unspecified start date; prednisone (Blister pack take six, then five, and down to one daily by mouth for six days) taken for intervertebral disc degeneration from 21Jan2021 to 26Jan2021 (She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain). The patient did not receive any vaccinations within 4 weeks prior to covid-19 vaccine administration. The patient did not have any illness at the time of vaccination. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm on 15Jan2021 at 09:57 (Batch/Lot Number: EL2346, Expiry date was not reported) as single dose covid-19 immunisation. On 04Feb2021, the patient experienced little sore and tender. On an unspecified date in Feb2021, the patient had slight fever of 98.6. Clinical course was reported as she received the second dose of the Pfizer COVID 19 vaccine 04Feb2021 1403PM in the right arm. Today the site is a little sore and tender. She may have had a slight fever of 98.6. The first time she felt great after the shot and was bragging to her friends about it. Add she thought the shot clinic was really well organized but when she went in to get the shot there was a guy sorting through the box and she wondered why. The events did not require any visit to physician office or emergency room visit. Outcome of the events little sore and tender was not recovered and slight slight fever of 98.6 was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 92 years-old male had pain for 2 days; This is a spontaneous report from a contactable consumer via medical information team. A 92-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported, a 92 years-old male had pain for 2 days. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a lady (Patient) down the road had pain for one day; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a lady (Patient) down the road had pain for one day on an unspecified date. Outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected..
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nervousness
Clinical narrative: Scheduled for vaccine and is nervous; Has allergies and is scheduled for vaccine; This is a spontaneous report from a contactable consumer (patient) received from Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH-COVID 19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was nervous and had allergies. The patient schedule for vaccine next morning and she was nervous. She had allergies and wanted to know thoughts on getting the COVID-19 Vaccine with her allergies. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected. Information on the Lot/Batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: body aches; Swelling and pain at injection site; Swelling and pain at injection site; fever; chills; intense headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number and expiration date were not reported), dose 2 via an unspecified route of administration, administered in arm right on 02Feb2021 at 16:00 (26-years age at the time of vaccination) as 2nd dose, single for COVID-19 immunisation. Medical history included known penicillin allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 12Jan2021 at 16:00 for COVID-19 immunisation and experienced body aches, swelling of upper arm, muscle pain, headache, chills and slight fever. The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced vaccination site swelling and pain, fever, chills, body aches, intense headache, and nausea on 02Feb2021 at 23:30. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unspecified date.  Information on Lot /Batch Number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: body aches; Swelling and pain at injection site; Swelling and pain at injection site; fever; chills; intense headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number and expiration date were not reported), dose 2 via an unspecified route of administration, administered in arm right on 02Feb2021 at 16:00 (26-years age at the time of vaccination) as 2nd dose, single for COVID-19 immunisation. Medical history included known penicillin allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 12Jan2021 at 16:00 for COVID-19 immunisation and experienced body aches, swelling of upper arm, muscle pain, headache, chills and slight fever. The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced vaccination site swelling and pain, fever, chills, body aches, intense headache, and nausea on 02Feb2021 at 23:30. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unspecified date.  Information on Lot /Batch Number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Rash pruritic
Clinical narrative: Rash on her torso, front and back that was itchy; This is a spontaneous report from a contactable consumer (Reported for herself). A 55-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Dec2020 (at the age of 55-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Dec2020, the reporter stated that after the first dose same evening, she got a rash on her torso, front and back that was itchy. Reporter states that she does not know if the rash was from the vaccine, or if it was just bad timing. Reporter states that the rash remained for a about a month. reporter states that she did have a virtual appointment with her doctor, and they talked about recommendations for the second dose. Reporter states that her doctor told her that it is up to the caller if she wants the second dose or not, but that if she does get the second dose, she should ensure she gets it in a hospital setting and wait for 45 minutes, instead of the standard 15, after receiving the dose. Reporter decided ultimately to not get the second dose, as the event scared her. Reporter states that here she has, and it is early on an unspecified date in Feb2021, and she did not get the second dose because of the event she experienced, and now she is just trying to seek out more information or guidance. Reporter states that she also did get an antibody test this week and it came back as negative, non-responsive, with something like a .44 protein spike. Reporter was not sure of exact results as she has not seen the results herself, they were just provided to her over the phone. Reporter just thought she would call Pfizer directly and see what information was available on her reaction, and on getting just one dose of the product. Reporter states that she has no other medical issues, she takes no medications, there were no other red flags. Patientstateed that the funny thing was, when she went back to the hospital to have the second dose done, she spoke with the doctor who was overseeing the COVID administration stuff, and he was the one who told the caller that it was up to her if she wanted the second dose because of the reaction she had after the first, but the caller does not think that doctor ever reported this event to anyone. The patient underwent lab tests and procedures which included antibody test: negative, 44 protein spike on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information on the lot/batch number cannot be requested. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout; This is a spontaneous report from a contactable Other HCP who was dentist (reporting himself).  A 68 year old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246, expiration date: unknown), via intramuscularly in right arm on 14Jan2021 at 14:00 as a single dose for COVID-19 immunization. The patient had no known medical history and concomitant medications. The patient did not receive any other vaccines administered on same date of the COVID vaccine. The patient did not receive any vaccine with 4 weeks of Pfizer vaccine. The patient had no AE's prior COVID vaccination. The patient did not undergo any lab test. On 15Jan2021, the day after vaccination, the patient had gout which was never had in his life. The patient did not go to any emergency room or physician office. The patient took unspecified medication for the event and it went away in about two days. The patient stated that the event was not too serious and it just hurt when walked. The patient thought he never had gout before and was very coincidental. The patient was in good health. The patient related the event. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9265, expiration date: unknown), via intramuscularly in right arm on 04Feb2021 at 13:00 as a single dose for COVID-19 immunization. The patient was far did not have gout after the second dose and hoping he would not get it. The outcome of the event gout was resolved in Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: whole body ache; dizziness; chills overnight; bad headache; Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiration date: not reported) first dose via an unspecified route of administration, administered in arm left on 14Jan2021 at 15:30 as 1st dose, single and second dose via an unspecified route of administration, administered in arm left on 04Feb2021 at 15:30 (lot number: EN5318; expiration date: not reported) as 2nd dose, single (age at vaccination was 17 years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks and had no COVID prior vaccination. On 05Feb2021 at 01:30, the patient experienced chills overnight, whole body ache, bad headache, dizziness, and nausea. No treatment for reported for the events. The patient had not COVID tested post vaccination. The outcome of the events was resolving.   No follow up attempts are possible. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Nausea, Pain
Clinical narrative: Weakness; Nausea; In bad shape; Pain; This is a spontaneous report from a contactable consumer.This Consumer reported for a male patient. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID19-VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced weakness, nausea, in bad shape, pain. The outcome event was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Myalgia
Clinical narrative: muscle in upper left arm hurting; This is a spontaneous report from a contactable consumer or other non health care professional (patient). An 85-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9810, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 04Feb2021 08:30-08:45 (at the age of 85-year-old) as a single dose for COVID-19 immunisation in hospital. The patient's medical history and family medical history was reported as none. The initial assessment was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations were not available was reported as none. Concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that the muscle was hurting but has calmed down on 04Feb2021 17:00-18:00. This has bothered the patient on the vaccination day. Patient wanted to know if he can take a muscle relaxer pill. Patient clarified that it was for the Virus 19 shot. The event did not result in Emergency Room or Physician Office. The patient underwent lab tests and procedures which included blood test, the day before he got the shot when he went to the doctor and came up good. The patient has tried to move it around as much as he can as a treatment for the event. The outcome of event was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Dysstasia, Pain in extremity, Peripheral swelling
Clinical narrative: hands and legs swollen; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 93-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3246 and expiry date was not provided), via Intramuscularly, in right shoulder (right arm)on 04Feb2021 at 10:30 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. No previous immunization history with the Pfizer vaccine considered as suspect. No additional vaccine was administered on same date of the suspect. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. On 04Feb2021, patient experienced hands and legs swollen and arm was a little sore. Patient's arm was a little sore last night but that did not bother him. About 10 hours later between 19:00 and 21:00 he got up to go home from watching a movie and both of his legs and both of his hands were swollen up. Reports he had a heck of time getting up for a bowel movement. Patient's wants to know if this will reoccur itself tonight or was it a onetime thing. Reports it was not life threatening. His hands were swollen and he could not make a fist. The swelling was in both his hands and legs. Sometime during the night it got down to normal, and his hands and legs appear to be normal now. Since waking up about 30 minutes ago his hands and legs appear to be normal. He was just surprised and shocked that he experienced that about 8 to 10 hours after the injection. Patient did not feel the darn thing when he received the injection. As reported he takes a whole bunch of things for his other problems but they do not have anything to do with this. No treatment was received. Events does not require a visit to emergency room or physician office. Lab test included body height and result was shrinking. Second dose of vaccine was due on 25Feb2021. The outcome for event hands and legs swollen was recovered and for arm was a little sore was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Lung disorder, Malaise, Nausea
Clinical narrative: Her lungs are not 100%; Dizziness; Weakness; Nausea; In bad shape; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 3 patients. This is 1 of 3 reports. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Feb2021 15:00 (Batch/Lot Number: EL9762) as single dose for COVID-19 immunisation. Medical history included high blood pressure, High cholesterol (Blood cholesterol increased), Asthma, Triglycerides high (Blood triglycerides increased), Problems with her stomach, Has shoulder problems and needs surgery on both shoulders. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL); alendronate sodium; amlodipine; calcium, colecalciferol (CALCIUM PLUS D3); fish oil; hydrochlorothiazide; meloxicam; metoprolol; omeprazole; fish oil (OMEGA 3); simvastatin; budesonide, formoterol fumarate (SIMBICORT TURBUHALER); colecalciferol (VITAMIN D); Senofidrate 106 mg, all taken for an unspecified indication, start and stop date were not reported. Three days ago, on 03Feb2021, the patient got first COVID-19 Vaccine at 3PM (15.00). Waited 15 minutes and then 15 more minutes in her car. Had no problem at all. Had a good night's sleep. Last day (04Feb2021), around 9, the patient had dizziness, weakness, and nausea all day long. She was in bad shape. As of today (05Feb2021), she felt much better. Her health was in bad shape. Her lungs were not 100%. She was afraid now to get the second dose. Second dose was in 24 days. Later, clarified her next appointment was on 24Feb2021 at 08:30, not 24 days. She did not want to take second dosage. She wanted her appointment changed and a stamp on her patient card saying she did not want second COVID-19 Vaccine. Advised caller to follow up with vaccination facility. She was afraid. Lot of comments about the COVID-19 Vaccine. Friends comment stating feeling sick, fever, in bad shape. Seen on TV that people die after first COVID-19 Vaccine. Some facility where old people only get first vaccine. Have to get second COVID-19 Vaccine and a lot of people have died but doesn't know how many. Looked on Google and the history of the COVID-19 vaccine. Looked at how many people have died and what happened to them (No further details provided). Read every day about COVID. She wanted to know how long does it take for the COVID-19 Vaccine to help. Outcome of the event lungs were not 100% was unknown and other events was recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Chills; dizziness; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) intramuscular, administered in Arm Left on 04Feb2021 14:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 12:00AM the patient experienced chills, dizziness and headache. Patient had not received any treatment for adverse event. The outcome of events was not recovered.    No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: a little bit of a sore arm/It was worse with the first injection.; a little bit of a sore arm/It was worse with the first injection.; This is a spontaneous report from a contactable consumer or other non-health care professional. Consumer reported for her husband. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EK3750) via an unspecified route of administration on an unspecified date (at the age of 67-yeras-old) as 1st dose, single for COVID-19 immunization at hospital. Medical history included and concomitant medications were reported as none. The second dose Lot number was reported was EJ1686. On an unspecified date, the patient experienced a little bit of a sore arm and it was worse with the first injection. He did not have a fever or anything. Investigation Assessment was reported as No. The outcome of the event sore arm was not recovered, and the outcome of "it was worse with the first injection" was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First COVID-19 vaccine: arm was really, really painful; This is a spontaneous report from a contactable consumer. This 76-Year-old  female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via Intramuscular route of administration on 14Jan2021 (at 76-years old) on left arm, as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant products included thyroid pills. No further details provided or obtained regarding this statement. On 14Jan2021 15 minutes after the first vaccine her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. On 15Jan2021 the patient recovered. It was mentioned that the caller declined to include a healthcare professional for this report. It was attempted to gather product information for the first and second vaccine, but caller stated that she could not read the writing.   There was a product complaint: The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Face oedema, Lip swelling, Swollen tongue
Clinical narrative: his lips swelled and his tongue swelled, so edema of the facial area around his mouth; his lips swelled and his tongue swelled, so edema of the facial area around his mouth; his lips swelled and his tongue swelled, so edema of the facial area around his mouth; This is a spontaneous report from a contactable consumer.  A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ENS318; Expiration Date: May2021), dose 1 via an unspecified route of administration on 04Jan2021 at 11:30 (at the age of 65-years-old) as 1st dose, single for COVID-19 immunization. Patient medical history included ongoing multiple sclerosis had for 30 years. Patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no adverse event prior to vaccination. Patient had no relevant family history. Patient did not perform any relevant test. Patient concomitant medication history was not reported. The patient experienced lips and tongue started swelling started on 04Jan2021 at 16:00. The patient was given Benadryl, Tylenol and Aleve. It was completely gone at 04:00 in the morning on 05Jan2021. It was reported that, never had a reaction to a vaccine previously but he did have a reaction to a medication, that was 15 years ago. It was the same type of reaction which was why she knew what to do. She only has the name of the medication, it was modafinil.. Patient did not visit to emergency room/physician office. The doctor advised that patient to not get the 2nd shot due to this reaction. The outcome of the events were recovered on 05Jan2021 at 04:00.    Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, SARS-CoV-2 test
Clinical narrative: nauseous; dizzy; fuzzy; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EM0477, expiry date was not reported) via an unspecified route of administration in left arm on 04Feb2021 at 16:30 (at the age of 50-year-old) as 1st dose, single for COVID-19 immunization. Medical history of the patient included one kidney. Patient have not received any other medications in two weeks and have not received any other vaccine in four weeks. Patient previously received antibiotic (unspecified) on an unspecified date for unspecified indication and experienced allergy. On 04Feb2021, at 17:30, the patient experienced Nauseous, dizzy, fuzzy. Reportedly, patient was tested for COVID post vaccination on an unspecified date, result of test (not reported). On 01Feb2021, patient underwent a lab test of COVID- SARS-CoV-2 test (Nasal swab) and tested negative. Patient did not receive any treatment for the events. Outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Mild fatigue; mild headaches; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 13:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. There were no allergies reported. The patient did not took concomitant medications (no other medications in two weeks). The patient did not receive any other vaccines in 4 weeks. The patient previously took first dose of BNT162B2 at left arm on 14Jan2021 at 01:00 PM for COVID-19 immunization. No covid prior vaccination and not tested for covid post vaccination. On 05Feb2021 at 02:00Am 12 hours after the injection, the patient experienced mild fatigue and mild headaches. No treatment received for event. The event outcome was recovering.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore the night the patient got the shot; This is a spontaneous report from a non-contactable Nurse reporting for a patient. An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 02Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 02Feb2021, the patient experienced arm was a little sore the night the patient got the shot. No treatment was received for adverse event. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Facial flushing within 5 minutes of injection; resolved in 2 hours. Took Benadryl 25 mg.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EN5318, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 05Feb2021 13:00 (at the age of 69-year-old) as 1st dose, single for covid-19 immunisation at hospital. The patient medical history included cardiomyopathy (resolved), breast cancer (hx breast cancer), blood cholesterol increased (high cholesterol), arthritis from an unknown date and unknown if ongoing. The patient does not have any allergies. Concomitant medications included atorvastatin, zolpidem tartrate (AMBIEN); omeprazole (PROTONIX [OMEPRAZOLE]); escitalopram oxalate (LEXAPRO). No other vaccine received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 05Feb2021 the patient experienced, facial flushing within 5 minutes of injection; resolved in 2 hours. Took Benadryl 25 mg. Therapeutic measures were taken as a result of facial flushing within 5 minutes of injection; resolved in 2 hours. took benadryl 25 mg. No treatment received for AE (as reported). The outcome of the event was reported as recovered on 05Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Paranasal sinus discomfort, Suspected COVID-19
Clinical narrative: Migraines; Suspected COVID-19; Sinus pressure; Fatigue; This is a spontaneous report from a non-contactable consumer reporting for aunt. This is 1 of 2 reports. A 70-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3246) intramuscularly in arm on 22Jan2021 as 1st dose, single (at the age of 70-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient was petite. On 27Jan2021, patient experienced cold symptoms, sinus pressure, fatigue. On 29Jan2021, patient experienced vomiting, migraines, loss of smell, loss of taste. Patient was scheduled to receive the second vaccine on 16Feb2021. The adverse events did not result in physician office or emergency room visit. When probed for the outcome of these events, the female explained her aunt was improving. She was not vomiting, she has had no migraines. She still had the loss of smell and loss of taste, and she was still experiencing fatigue. There was product complaint involved. Description of complaint was the caller was a Pfizer employee calling in regard to the COVID-19 vaccine. The female explained her aunt started having COVID symptoms on 27Jan2021. Female stated her aunt did not have any testing done. Her aunt's primary care physician told her that with the loss of smell and taste that was enough to confirm the diagnoses of COVID-19. She clarified those symptoms were enough to not test for COVID-19. Her cousin had loss of smell, loss of taste and fatigue. Caller did not know if her cousin was tested. After doing exposure tracing, it was discovered she was exposed at school, that was where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic. Her cousin was vaccinated the same date with the same Lot number as her aunt. The outcome of the events suspected COVID-19 and sinus pressure was unknown, of the event fatigue was not resolved and on an unspecified date in 2021, the outcome of the event migraine was resolved.   No further information was provided or obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chest discomfort, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered.    Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal discomfort, Pain, Sneezing
Clinical narrative: Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered.    Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Potentiating drug interaction
Clinical narrative: it was 1 day he was tired, and it lasted a day and half and he was fine so, he was fine for 3 days; he is on Immunotherapy, would that have any affect with the shot, have had on effect on of him being on Immunotherapy; This is a spontaneous report from a contactable consumer or other non hcp (patient wife).   A 78-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL9262, expiration date unspecified), via an unspecified route of administration on 30Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL1283, expiration date unspecified), via an unspecified route of administration on 09Jan2021 as 1ST DOSE. SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date it was reported that the patient took pfizer first it was fine the second, he took, patient had, it was 1 day patient was tired, and it lasted a day and half, and he was fine so, he was fine for 3 days, now it seems like he have another repeat of what happened the first time, on the second dose, the patient is on Immunotherapy, would that have any affect with the shot, have had on effect on of him being on Immunotherapy. The outcome of the event he was tired, and it lasted a day and half and he was fine so, he was fine for 3 days was reported as recovered, while for the other event it was reported as unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives on upper body; Rash and hives on upper body; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 03Feb2021 13:00 (age at vaccination: 78 years) as 1st dose, single for covid-19 immunisation. The patient was vaccinated in clinic The patient medical history included vascular dementia. The patient had allergies to medicines include Neosporin. Concomitant medications included citalopram; donepezil hydrochloride (DONPEZIL) 5mg and atorvastatin 40mg. The patient did not receive any other vaccine in four weeks. On 03Feb2021 13:00, the patient experienced rash and hives on upper body. The patient received Benadryl as treatment for the adverse events. The patient did not get covid prior to vaccination and was not tested post vaccination. The outcome of the events was reported to be recovering.  Information on the Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.