chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia
Clinical narrative: experienced sick like symptoms; fever; headaches; This is a spontaneous report received from a contactable consumer (patient) reported for herself via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced sick like symptoms with a fever and headaches. Outcome of the events was resolved on an unspecified date in 2021.   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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: body aches; chills; joint pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 592671000001) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 23:00 the patient experienced body aches, chills, joint pain and fever. Therapeutic measures were taken as a result of events included treatment with paracetamol (TYLENOL) for pain and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events general body pain, chills, joint pain and fever were recovering at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Diarrhea; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mentioned that "Well I tried going to the website but I can't even go through the website for some reasons, but I had the COVID vaccine on Thursday and I have been expect. I have been having these different things like injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and diarrhea that different things here on an unspecified date. The patient want to find out how long these stuff was going to last, I mean if it last a few days, or weeks, or what I don't know, that's my question Well if I have any problems I will come back. Outcome of all events was unknown.    The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Diarrhea; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mentioned that "Well I tried going to the website but I can't even go through the website for some reasons, but I had the COVID vaccine on Thursday and I have been expect. I have been having these different things like injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and diarrhea that different things here on an unspecified date. The patient want to find out how long these stuff was going to last, I mean if it last a few days, or weeks, or what I don't know, that's my question Well if I have any problems I will come back. Outcome of all events was unknown.    The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump under armpit; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 24Jul2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included chronic asthma and a known allergy to seafood. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 31Jul2021, the patient experienced lump under armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump under armpit was not resolved at the time of this report.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101.1; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa7485) via an unspecified route of administration in the left arm on 30Jul2021 at 15:00 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 01Aug2021 at 06:00, the patient experienced fever of 101.1. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/ department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with ibuprofen (MOTRIN) 400 mg. On 01Aug2021 at 06:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101.1 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 101.1 was unknown at the time of this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site discolouration
Clinical narrative: Fingers are tight like they are paralyzed; Fingers are tight; Pain from shoulder to wrist; Cannot carry anything heavy in his hands; Spot where vaccine was placed is purple colored; Intense pain in bones; Itching and little zits; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported for himself that he started to receive BNT162B2 (Bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via unknown route of administration on 28Jun2021 at DOSE 1, SINGLE on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported.  Patient got the first dose in a pharmacy a month ago, he went for the second dose and told them about the problems he had and they told they couldn't give him the second dose and to talk to Pfizer to make the report. It was reported that patient started having problem on 28th when he had the vaccine. Two days after that, started having this problem. Been having this problem for one month now. It's the first time this happened to him. This is the first time he had a vaccine like this. Clarified side effects as: First day after the vaccine, 1-2 day after that, the spot where the vaccine was placed, it was purple colored. Three days after that, started having pain from the shoulder to wrist. Experiencing an intense pain in the bones. Cannot carry anything heavy in his hands. Cannot even carry his phone in his left hand. Wakes up and his fingers are tight like they are paralyzed. Caller clarified he is only experiencing this on the left side where he received the vaccine. Outcome: lasted one week more or less. It was the whole area. Stated pain from shoulder to wrist and in his bones is the same. Has not improved at all. Will see the doctor tomorrow because he is not ok. It is not worse. Fingers are tight like they are paralyzed: Today was worse. He feels terrible today. Itching and little zits: Itches a lot from the wrist to elbow. There are little zits there and looks like he has been bitten by insects. Lots of itching. Is only on the left side. Received vaccine in left arm. It is nowhere else. Started 2-3 days after the vaccine. Still has it now. While he is reporting to this agent, he is experiencing the pain and itching. Patient reported that everyone in his family got the vaccine. He didn't want to have it. People said it was important. Didn't want to be the difficult child in the family. Stated the after results were worse. History and Investigations: Is not a friend of medicines. He doesn't like taking medications. He stated that tomorrow will see doctor about cholesterol tests. Will take advantage of tests, cholesterol tests, and will have blood work done as well. He is worried about it a lot. The outcome of events for paralysis, musculoskeletal stiffness, pain in extremity, muscular weakness, bone pain, and pruritus was not recovered. Outcome for event vaccination site discoloration was recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Influenza like illness, Muscular weakness, Pyrexia
Clinical narrative: fever; chills; muscle weakness; diarrhea; basically had the flu; This is a spontaneous report from a contactable pharmacist.    A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unknown route in Dec2020 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, muscle weakness, diarrhea and basically had the flu. The outcome of events was unknown.  Information about the Lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: nausea; headache; tired; felt like she has to throw up; I was feeling a little light headed; she cant shake this feeling it wont leave her; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration on an unspecified date 2021 (age at the time of vaccination 50-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient experienced nausea, headache, tired, felt like she has to throw up, I was feeling a little light headed, and she cant shake this feeling it wont leave her. Consumer was informed about the role of Pfizer Drug Safety. Consumer was suggested to contact Medical Information Department for the concern. As the consumer was unwilling to complete the report, further probing could not be done. Hence, limited information available over the call. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea; headache; tired; felt like she has to throw up; I was feeling a little light headed; she cant shake this feeling it wont leave her; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration on an unspecified date 2021 (age at the time of vaccination 50-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient experienced nausea, headache, tired, felt like she has to throw up, I was feeling a little light headed, and she cant shake this feeling it wont leave her. Consumer was informed about the role of Pfizer Drug Safety. Consumer was suggested to contact Medical Information Department for the concern. As the consumer was unwilling to complete the report, further probing could not be done. Hence, limited information available over the call. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Nausea, Pyrexia, Syncope
Clinical narrative: Fever; Nausea; Headache; Fainted twice this morning; This is a spontaneous report from a contactable consumer. This consumer reported events for both herself and her daughter. This case refers to reporter's daughter.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,), via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. On 01Aug2021, patient experienced fainted twice this morning , fever, nausea , headache .   In the place where patient had vaccine, they only say to take Tylenol (treatment), or to go to emergency room.  The mother does not want to go there. She is wondering if she can skip the second dose as she does not want to put in danger her daughter's life. The patient underwent lab tests which included antibody test for COVID-19 on unknown date and she has really good antibodies. Outcome of the events was unknown.   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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: shortness of breath; chest tightness; hives; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0198), via an unspecified route of administration in left arm on 30Jul2021 at 14:15 (at the age of 54-years-old) at dose 1, single for COVID-19 immunisation. Medical history included diabetes type 2 and asthma. She has no history of COVID prior to vaccination. Concomitant medications included metformin, dulaglutide (TRULICITY), empagliflozin (JARDIANCE), and omeprazole (PROTONIX). The patient previously took lisinopril and IMITREX and experienced allergies to both. There were no other vaccines administered in four weeks. The vaccine was administered at a pharmacy or drug store. The patient was not tested for COVID post vaccination. On 30Jul2021 at 14:45, the patient experienced shortness of breath, chest tightness, and hives which required doctor or other healthcare professional office/clinic visit and treatment with steroids, BENADRYL, and ZYRTEC. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events dyspnea, chest discomfort, urticaria and the suspect drug  BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested (+) for Covid; Tested (+) for Covid; This is a spontaneous report from a contactable other hcp. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: El3247, Expiration date: Unknown), intramuscular, administered in left arm on 11Feb2021 06:45 (at the age of 50-years-old) as dose 2, single and first dose via intramuscular, administered in left arm on Jan2021 04:45 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. It was unknown that, other vaccine was administered in four weeks. It was unknown that, other cations were given in two weeks. The patient did not have Covid prior vaccination. It was unknown that, if Covid tested post vaccination. Known allergies was reported as unknown. The patient's medical history and concomitant medications were not reported. On 02Aug2021, the patient tested positive for covid. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. No treatment was received for the event. The outcome of the event was recovering. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and Vaccination failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the drug is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Rheumatoid arthritis, SARS-CoV-2 antibody test negative
Clinical narrative: Rheumatoid Arthritis; she is not showing that she has any antibodies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 27Feb2021 (lot number and expiry date was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included methotrexate (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 06Feb2021 for COVID-19 immunization and had no reaction on previous exposure to vaccine. It was reported that the patient has rheumatoid arthritis since an unknown date and had a Rituxin infusion on 25Mar2021, and then again 2 weeks later. The patient reported that she is not showing that she has any antibodies in 2021. She wanted to know why she got a negative antibody test. The patient also wanted to know if Pfizer has already provided as statement on the need for a booster dose (3rd dose). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested for covid-19 and the test was positive; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received the 1st dose of the vaccine and then 3 days later tested for Covid-19. The patient's husband stated his wife got the first dose last Tuesday, then clarified and stated it was two weeks ago. Then after the first dose, three days later on an unspecified date in 2021, she got covid-19. He further clarified and confirmed after the vaccine she went to a lab, was tested for covid-19 and the test was positive. Now it has been 15-16 days since, he stated she passed, but clarified 'she passed' as she is okay. Right now, she is doing okay. He stated patient is scheduled for the second dose and he has questions. The second dose is scheduled for 03 Aug2021. He does not know what he should do. He wants to know if she should get the second dose and when she should get the second dose. The outcome of the event was recovered in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Body temperature, Chills, Headache, Protein urine present
Clinical narrative: significant/visible amount of blood and protein in urine; significant/visible amount of blood and protein in urine; mild fever noted "of 100"; chills; headache; This is a spontaneous report from a contactable consumer (mother) reported for her son from a Pfizer-sponsored program.  An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced significant/visible amount of blood and protein in urine, mild fever noted "of 100", chills, headache. The outcome of the events was unknown.  The visible blood in urine prompted mother to take son in for HCP evaluation.  Finally, she explains he is due for second dose of vaccine in a couple of days and would like to know if he is a candidate.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: significant/visible amount of blood and protein in urine; significant/visible amount of blood and protein in urine; mild fever noted "of 100"; chills; headache; This is a spontaneous report from a contactable consumer (mother) reported for her son from a Pfizer-sponsored program.  An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced significant/visible amount of blood and protein in urine, mild fever noted "of 100", chills, headache. The outcome of the events was unknown.  The visible blood in urine prompted mother to take son in for HCP evaluation.  Finally, she explains he is due for second dose of vaccine in a couple of days and would like to know if he is a candidate.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mast cell activation syndrome
Clinical narrative: Developed an environmental illness (mast cell activation syndrome) from mold exposure; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient, self-reporting). A 30-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 as single dose for COVID-19 immunization. No medical history and no concomitant medications were not reported. It was reported that she got the first dose a few weeks ago. She has now developed an environmental illness caused by molds which has resulted in her developing a symptom called mast cell syndrome. The patient explains she was at a fragile state and finds she was reacting to benign medication and supplements. She goes on to explain she had delayed reaction to the first dose that started a week later, for 2 weeks was very fatigued. The patient wants to know if have any information on people with environmental illness getting the shot and if it is recommended that she take the second shot. The outcome for the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (05Aug2021): 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: Appendix disorder
Clinical narrative: emergency appendectomy; This is a spontaneous report from a contactable pharmacist received from medical information team and Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNTech COVID-19 vaccine last 03Jun2021 and "underwent emergency appendectomy (which was not related to the vaccine as per reporter) so the patient missed his schedule for the second dose of the vaccine". Reporter wanted to know if the patient can still get the second dose of the vaccine. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is no reasonable possibility of causal association between the event Appendix disorder and the suspect product BNT162B2 .The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 69-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Apr2021 on left arm as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications and information about investigation assessment were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date, as dose 1, single for COVID-19 immunization and experienced no adverse events. On an unknown date in Apr2021 the patient complained that her left arm was continuously feeling as if it had gone to sleep and had ants walking down her arm after the second dose of the Pfizer Covid-19 vaccine. Caller asked if this was a reported side effect of the Pfizer Covid-19 vaccine. Caller asked how these symptoms would resolve. The event outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, SARS-CoV-2 test
Clinical narrative: Primarily exhaustion; Lack of energy; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8731) via an unspecified route of administration in the right arm on 16Apr2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Patient had medical history which was unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of taking COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8727) via an unspecified route of administration in the right arm on 25Mar2021 at 14:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced primarily exhaustion, lack of energy. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10May2021, the patient underwent SARS-CoV-2 PCR (Nasal Swab) and the result was Negative. The clinical outcome of the events primarily exhaustion, lack of energy was not recovered at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: From the first dose she had body pain in the arm and slight headache; From the first dose she had body pain in the arm and slight headache; My wife was Pregnant and she received her vaccine at one week of gestation; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). This consumer reported for a 35-year-old female Patient (Wife) that: A 35-years-old Pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 35-year-old). Patient has ongoing pregnancy. The patient's concomitant medications were not reported. The reporter stated that the patient was pregnant, and she received her first dose of vaccine at one week of gestation on 17Mar2021. The reporter also stated that on an unspecified date after first dose the patient had body pain in the arm and slight headache. The mother was 1 Weeks pregnant at the onset of the event and her last menstrual cycle was on 10March2021. The mother was due to deliver on 24Dec2021. The outcomes of the events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Has a fever like 99.4; Sore throat; Stuffy nose; This is a spontaneous report from a contactable consumer. This contactable consumer (mother) reported for a male patient (son). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (Batch/Lot was not reported) as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, the patient had a fever like 99.4 and he had a sore throat and he had like a stuffy nose and she just wanted to know that like how long the side effects was supposed to be or he was experiencing something else. The patient underwent lab tests and procedures which included body temperature: 99.4 on an unspecified date in 2021. The clinical outcome of the events were unknown.  Follow-up activities closed. Batch/lot number is not available.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Hypertension, Palpitations
Clinical narrative: Felt her blood pressure go up and reclarifies, early Saturday morning at 1 am it was 185/91; She was not breathing properly; Her heart was pounding in her chest and had palpitations; Her heart was pounding in her chest and had palpitations; She began to shake forcefully/the next day she was feeling shaky again; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Jul2021 13:35 (Batch/Lot Number: EW0198) as dose 1, single (at the age of 75 years old) for COVID-19 immunisation.  Medical history included ongoing hypertension from: maybe 15 years ago, around age 60, diabetic type 2 from 2006 and ongoing, thyroid condition from 2012 and ongoing, pericarditis in 1996 she had her first episode, a small effusion, and a couple years later, another small effusion, and in 2016, a moderate effusion and was hospitalized, ongoing glaucoma for more than 10 years, suspected covid-19 from 13Mar2020, she was never tested for Covid. Her symptoms lasted 8 weeks. She believed she might have gotten inflammation in chest but was not diagnosed. She felt chest tightness, but the doctors didn't want to do test that year.  In May2020, she was negative for Covid, and all the other symptoms went away, except chest tightness and chest tightnessConcomitant medications included valsartan (DIOVAN) taken for hypertension, amlodipine besilate (NORVASC) taken for hypertension, insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus, levothyroxine taken for thyroid disorder, acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, brimonidine tartrate (ALPHAGAN P) taken for glaucoma from 2008 and ongoing; bimatoprost (LUMIGAN) taken for glaucoma.  The patient will be seeing her PCP this week to double check her health, her heart rate and her blood pressure. She did experience and adverse effect, she is considering where to get the second dose which is suppose to be two weeks from Wednesday. She has a history of pericarditis and does have hypertension. She felt her blood pressure go up and reclarifies, early saturday morning at 1 am it was 185/91 on 31Jul2021 01:00. She was not breathing properly, hypertension, her whole body was shaky, at around 10 in the evening, she began to shake forcefully and the next day she was feeling shaky again. Her heart was pounding in her chest and had palpitations.  She did not go to the emergency room, because her blood pressure came down to 143/82. On Saturday morning, she had a normal blood pressure of 141/79, but she still had the shakes and palpitations. The outcome of blood pressure go up was recovered on an unspecified date, not breathing properly was unknown and other events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Felt her blood pressure go up and reclarifies, early Saturday morning at 1 am it was 185/91; She was not breathing properly; Her heart was pounding in her chest and had palpitations; Her heart was pounding in her chest and had palpitations; She began to shake forcefully/the next day she was feeling shaky again; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Jul2021 13:35 (Batch/Lot Number: EW0198) as dose 1, single (at the age of 75 years old) for COVID-19 immunisation.  Medical history included ongoing hypertension from: maybe 15 years ago, around age 60, diabetic type 2 from 2006 and ongoing, thyroid condition from 2012 and ongoing, pericarditis in 1996 she had her first episode, a small effusion, and a couple years later, another small effusion, and in 2016, a moderate effusion and was hospitalized, ongoing glaucoma for more than 10 years, suspected covid-19 from 13Mar2020, she was never tested for Covid. Her symptoms lasted 8 weeks. She believed she might have gotten inflammation in chest but was not diagnosed. She felt chest tightness, but the doctors didn't want to do test that year.  In May2020, she was negative for Covid, and all the other symptoms went away, except chest tightness and chest tightnessConcomitant medications included valsartan (DIOVAN) taken for hypertension, amlodipine besilate (NORVASC) taken for hypertension, insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus, levothyroxine taken for thyroid disorder, acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, brimonidine tartrate (ALPHAGAN P) taken for glaucoma from 2008 and ongoing; bimatoprost (LUMIGAN) taken for glaucoma.  The patient will be seeing her PCP this week to double check her health, her heart rate and her blood pressure. She did experience and adverse effect, she is considering where to get the second dose which is suppose to be two weeks from Wednesday. She has a history of pericarditis and does have hypertension. She felt her blood pressure go up and reclarifies, early saturday morning at 1 am it was 185/91 on 31Jul2021 01:00. She was not breathing properly, hypertension, her whole body was shaky, at around 10 in the evening, she began to shake forcefully and the next day she was feeling shaky again. Her heart was pounding in her chest and had palpitations.  She did not go to the emergency room, because her blood pressure came down to 143/82. On Saturday morning, she had a normal blood pressure of 141/79, but she still had the shakes and palpitations. The outcome of blood pressure go up was recovered on an unspecified date, not breathing properly was unknown and other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: bad arm pain; Pain at injection site; This is a spontaneous report from a contactable consumer or other non HCP (patient reported for herself) Pfizer sponsored program.  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2; Solution for an injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 23Feb2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for an injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on 02Feb2021 for covid-19 immunisation. Patient reported that she received first dose of the COVID-19 vaccination 02Feb2021 and then her 2nd dose 23Feb2021. After the 1st dose she did experience sick like symptoms with a fever and headaches that resolved. On 23Feb2021, patient experienced bad arm pain was intermittent although it continued to persist and affect her ability to raise her arm after the 2nd dose of the vaccine. Patient also had pain at injection site and its not going away post second vaccine on unspecified date in Feb2021. Patient wanted to know what she could do for the pain. At the time of this report, outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fall, Presyncope, Vaccination site coldness
Clinical narrative: dizziness; Pass out; Fall; Around my injection site; It feels like there is something cold like cold water running down my arm; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced around my injection site; it feels like there is something cold like cold water running down my arm, dizziness and queried if that is normal. He had his first dose of the vaccine yesterday and is now having dizziness and asks if this is a side effect. The vaccine he felt a cold dripping, and then today he slept 14 hours and is feeling dizzy, but his blood pressure is ok, he feels like he going to fall or feels like he does right before he is going to pass out. The patient underwent lab tests and procedures which included blood pressure resulted as ok on an unspecified date. The clinical outcome of the event dizziness was not resolved, and rest of the events was unknown.  Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer(patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 24Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer covid vaccine on 24Jul2021 but tested positive after the first dose on unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was positive on 2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling hot, Loss of consciousness, Nervousness
Clinical narrative: Felt like she was going to black out; Felt like she was dying; Generalized hotness / whole body was super hot; Lightheadedness/dizziness; Vision troubles/ couldn't see; Nervous; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 29Jul2021 (at the age of 42 years old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Jul2021, patient got the vaccine, and was driving she felt generalized hotness (whole body was super hot), dizziness, lightheadedness, vision troubles (couldn't see), nervous, felt like she was dying and felt like she was going to black out. She had these complaints for five minutes and denied the events at the time of reporting. The outcome of the events was recovered on 29Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Felt like she was going to black out; Felt like she was dying; Generalized hotness / whole body was super hot; Lightheadedness/dizziness; Vision troubles/ couldn't see; Nervous; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 29Jul2021 (at the age of 42 years old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Jul2021, patient got the vaccine, and was driving she felt generalized hotness (whole body was super hot), dizziness, lightheadedness, vision troubles (couldn't see), nervous, felt like she was dying and felt like she was going to black out. She had these complaints for five minutes and denied the events at the time of reporting. The outcome of the events was recovered on 29Jul2021.  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: Feeling hot, Flushing, Heart rate, Heart rate increased, Nasal discomfort
Clinical narrative: Felt she was going to pass out; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Heart was beating fast and hard; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 29Jul2021 12:45 (at the age of 48 years old) as dose 1, single for covid-19 immunization. Medical history included a fib (atrial fibrillation as one isolated event) from an unknown date to an unknown date; patient had a cardiac ablation in 2018; and allergy to penicillin from an unknown date and unknown if ongoing. The patient had no family history. Concomitant medication included aspirin [acetylsalicylic acid] at 81 mg taken for an unspecified indication, start and stop date were not reported. Patient had no prior vaccinations (within 4 weeks). The patient had no history of all previous immunization with the Pfizer vaccine suspect product. Most recent vaccine was administered at military facility. Patient received her first dose of the Pfizer Covid-19 Vaccine on 29Jul2021.  As soon as it was injected, she began experiencing a hot, flushed and tingly sensation to her whole arm.  She went and sat down and the feeling went to her entire body, then to her nose, throat, and tongue.  Her heart was beating fast and hard.  She felt she was going to pass out.  Everything subsided after 10 minutes and went away. Patient further reported that when the lady put the needle in the patient's arm and pushed the medicine the patient's arm went hot and tingly. The patient sat down for a minute and then her whole body went completely hot and flush and tingly. The back of the patient's nose, throat, and tongue was tingly. Then it felt like the patient's heart started beating fast and hard. Patient asked if this was normal. These events happened within 5 minutes of the patient getting the shot. Behind the patient's nose, throat and tongue was also hot. Patient asked if she could get the second dose. The events were non-serious as per reporter. The events did not require emergency room or physician office visits. The outcome of the events was reported as recovered on 29Jul2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.