chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Throat irritation, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tongue warm, tingling, and numb-ish.; Injection site 5 inch swollen; fevered; injection site red; Under same arm, lymph gland swollen about same size and tender; Under same arm, lymph gland swollen about same size and tender; Tongue warm, tingling, and numb-ish.; Tongue warm, tingling, and numb-ish.; Glands in throat itchy and random sharp pain.; Glands in throat itchy and random sharp pain.; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 13Aug2021 at 12:00 (Lot Number: FC3180) at the age of 56-year-old as single dose for COVID-19 immunization. Medical history included multiple environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  Known allergies included demerol. Since the vaccination, the patient had not been test for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Spring Valley 10. The patient previously received Demerol and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23Jul2021 at 10:00 AM (Lot Number: FA6780) at the age of 56-year-old as single dose for COVID-19 immunization. On 13Aug2021 at 14:00, the patient experienced injection site 5 inch swollen, fevered, and red. Under same arm, lymph gland swollen about same size and tender. Glands in throat itchy and random sharp pain. Tongue warm, tingling, and numb-ish. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible;  No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Rash, Urticaria
Clinical narrative: Painful swollen lymph nodes under injection side arm; Hives/rash; Hives/rash; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 14-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 14Aug2021 17:00 at age of 14-years-old (Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen; paracetamol (TYLENOL).  The patient experienced Painful swollen lymph nodes under injection side arm, hives, rash, sore arm on 16Aug2021 05:00 with outcome of recovering.  The patient received Benadryl, hydrocortisone cream as treatment.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extra dose administered, Fatigue, Gait disturbance, Off label use
Clinical narrative: difficulty staying awake; dizziness; difficulty walking/could hardly walk; received third dose; received third dose; tiredness; This is a spontaneous report from a contactable Consumer. A 76-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 16Aug2021 at around 17:00 (age at the time of vaccination was 76-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration in Jan2021 (age at the time of vaccination was 76-year-old) as a single dose, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. On 16Aug2021, the patient experienced tiredness, difficulty walking/could hardly walk and received third dose. On 17Aug2021, the patient experienced dizziness. On an unspecified date, the patient experienced difficulty staying awake. Subsequently experienced dizziness, tiredness, difficulty walking, and difficulty staying awake. Caller states he and his wife both received booster doses (third doses) of the Pfizer BioNTech Covid-19 Vaccine yesterday at 5PM. Caller states his wife began experiencing side effects such as ty walking, and difficulty staying awake. Caller states his wife has been lying down since she can hardly walk. Caller states his wife was sitting up now but her eyes are closed. Caller states they both received their first doses of the vaccine in Jan. He's calling about the Pfizer Covid 19 booster, clarified the third dose. He reports he and his wife both received their booster dose yesterday afternoon, 16Aug2021 around 5:00PM. In the last 10-15 minutes his wife got dizzy and could hardly walk, she had to lay down. He was asking if this could be a side effect. Outcome of all the events was unknown. Outcome of all the events was unknown.  The lot no number of the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: difficulty staying awake; dizziness; difficulty walking/could hardly walk; received third dose; received third dose; tiredness; This is a spontaneous report from a contactable Consumer. A 76-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 16Aug2021 at around 17:00 (age at the time of vaccination was 76-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration in Jan2021 (age at the time of vaccination was 76-year-old) as a single dose, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. On 16Aug2021, the patient experienced tiredness, difficulty walking/could hardly walk and received third dose. On 17Aug2021, the patient experienced dizziness. On an unspecified date, the patient experienced difficulty staying awake. Subsequently experienced dizziness, tiredness, difficulty walking, and difficulty staying awake. Caller states he and his wife both received booster doses (third doses) of the Pfizer BioNTech Covid-19 Vaccine yesterday at 5PM. Caller states his wife began experiencing side effects such as ty walking, and difficulty staying awake. Caller states his wife has been lying down since she can hardly walk. Caller states his wife was sitting up now but her eyes are closed. Caller states they both received their first doses of the vaccine in Jan. He's calling about the Pfizer Covid 19 booster, clarified the third dose. He reports he and his wife both received their booster dose yesterday afternoon, 16Aug2021 around 5:00PM. In the last 10-15 minutes his wife got dizzy and could hardly walk, she had to lay down. He was asking if this could be a side effect. Outcome of all the events was unknown. Outcome of all the events was unknown.  The lot no number of the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; headache; muscle ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: FA7485) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The Patient reported that he and his wife got vaccinated yesterday (on 16Aug2021), and are experiencing some flu like symptoms. He was wondering if there was any reason they could not take Tylenol or Ibuprofen. He and his wife decided to get a 3rd vaccination; that it had been over 6 months and they are over 65, not immunocompromised. Patient stated now the symptoms are very mild just got some muscle ache and headache. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: rashes; like lots all over his body/rash in the hand; Fever; body is aching/body pain; Sweating; Headache; legs, and soreness; having a reaction; chemical reaction with his skin; breaking out like with pimples; Itchy; getting swollen; This is a spontaneous report from two contactable consumers (patient's wife and patient's son). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's son stated the patient was having a reaction through a chemical reaction with his skin like, he was breaking out like with pimples in Aug2021 and asked if that was normal. The patient also had like a rash over, rash like rash in his body that he was just like make some itchy and getting swollen and then fever and then like legs, and soreness. The patient's son said the patient had like rashes and like lots all over his body and he had headache and then sore and all that. The patient's wife stated the patient got the rashes and he had fever and his body was aching. The patient had not gone to the hospital yet. She stated they got the shot yesterday (15Aug2021) and 2 hours later the patient got the fever, sweating, pain and body pain and rash in the hand. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin disorder, Swelling
Clinical narrative: rashes; like lots all over his body/rash in the hand; Fever; body is aching/body pain; Sweating; Headache; legs, and soreness; having a reaction; chemical reaction with his skin; breaking out like with pimples; Itchy; getting swollen; This is a spontaneous report from two contactable consumers (patient's wife and patient's son). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's son stated the patient was having a reaction through a chemical reaction with his skin like, he was breaking out like with pimples in Aug2021 and asked if that was normal. The patient also had like a rash over, rash like rash in his body that he was just like make some itchy and getting swollen and then fever and then like legs, and soreness. The patient's son said the patient had like rashes and like lots all over his body and he had headache and then sore and all that. The patient's wife stated the patient got the rashes and he had fever and his body was aching. The patient had not gone to the hospital yet. She stated they got the shot yesterday (15Aug2021) and 2 hours later the patient got the fever, sweating, pain and body pain and rash in the hand. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: I peed out blood; I haven't had period in over a year; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received 1st dose of bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Lot Number: EW0183; Expiration Date: 31Aug2021), via an unspecified route of administration on 13Aug2021 as Dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced peed out blood; not had period in over a year on 15Aug2021.Consumer was provided with the number of Pfizer Medical Information Department was requested to select option 3, timings as 8 am to 8 pm on Monday to Friday as per EST. When asked for reporter, it was stated as cardiac technician (Further not clarified hence captured as consumer or other non-health care professional in tab). Consumer was informed to file a safety report as the consumer experienced side effect after receiving the vaccine. Further probing could not be done as consumer was unwilling to share any further information. Hence, limited information was available over the call. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Contracted COVID on 12Aug2021; Contracted COVID on 12Aug2021; This is a spontaneous report from a contactable consumer (patient).  A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: F7484) via an unspecified route of administration on 04Aug2021 (at the age of 47-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient received unknown concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. The patient contracted covid on 12aug2021 (coded to covid-19 and drug ineffective). The patient underwent lab tests and procedures which included sars-cov-2 test (PCE nasal swab): positive on 11Aug2021. The patient did not receive any treatment. The outcome of both the events was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: fever, low grade if anything; Sweaty; Cold; Stomach upset; Nausea; Headache; She said that she also was maybe a little short of breath.; kind of allergies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jul2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller was a consumer who reported that, she had the first dose of the Pfizer Covid vaccine. Stated that, she had no reaction for 2-3 days after the dose. The caller stated that, she had no fever, well she never checked it, but stated that, it was low grade if anything. Stated that, she was sweaty kind of cold and it was mild. Stated that, she got stomach upset, nausea and headache. Stated that, it was time to take her second dose, was it safe to take the second one. Stated that, just on the other side of feeling better, she has felt ok for a couple of days, how long can she wait or can she go ahead and get the second dose. Stated that, she also was maybe a little short of breath. Stated that, the caller had nausea, headache and kind of allergies but the caller was get that. Not enough to even call the doctor. Stated that, she was ready to get her second dose, wondering whether it was ok. First dose was on 26Jul2021 and when can she get it. The caller stated that, her daughter was going to go get her second vaccine and she wanted to go with her. The caller declined to complete a report as she was in a hurry and wanted to have her questions addressed. On an unspecified date, the patient underwent lab tests and procedures which included fever (body temperature), resulted as low grade, she had maybe a low grade fever. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: fever, low grade if anything; Sweaty; Cold; Stomach upset; Nausea; Headache; She said that she also was maybe a little short of breath.; kind of allergies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jul2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller was a consumer who reported that, she had the first dose of the Pfizer Covid vaccine. Stated that, she had no reaction for 2-3 days after the dose. The caller stated that, she had no fever, well she never checked it, but stated that, it was low grade if anything. Stated that, she was sweaty kind of cold and it was mild. Stated that, she got stomach upset, nausea and headache. Stated that, it was time to take her second dose, was it safe to take the second one. Stated that, just on the other side of feeling better, she has felt ok for a couple of days, how long can she wait or can she go ahead and get the second dose. Stated that, she also was maybe a little short of breath. Stated that, the caller had nausea, headache and kind of allergies but the caller was get that. Not enough to even call the doctor. Stated that, she was ready to get her second dose, wondering whether it was ok. First dose was on 26Jul2021 and when can she get it. The caller stated that, her daughter was going to go get her second vaccine and she wanted to go with her. The caller declined to complete a report as she was in a hurry and wanted to have her questions addressed. On an unspecified date, the patient underwent lab tests and procedures which included fever (body temperature), resulted as low grade, she had maybe a low grade fever. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility tests, Menstrual disorder
Clinical narrative: period has been varying; This is a spontaneous report from a contactable nurse (patient) via Pfizer via the Regulatory Authority Support. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Batch/Lot Number: ER2613) (at age 33-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 26Feb2021 (lot number: EN6201) on the right arm at age 33-years-old. Medical history included  immune system disorder from an unknown date and unknown if ongoing. Concomitant medication included unspecified immune disorder medication. Patient initially explained from Feb2021 to Mar2021 her period was late, it was about four or five days late. She later clarified start date as Mar2021. She explained she had gotten her period in Feb2021 right just before the vaccine or the day she got the vaccine, there or about. After she got the second vaccine was when she noticed it was delayed.  Throughout the rest of the months her period has been varying. She used to be able to tell time it down to the day when it would come on. Now she cannot. It was varying. It was 33 to 27 to 29 to 30 and now it has been 33 days and she still does not have it. She felt it was getting worse because it's longer in between.  She commented she has done fertility testing and her fertility is normal/good. She had this done Oct2020. It should not be dropping or changing like this. Outcome of the event was not recovered. Event did not led to emergency room visit nor physician office. The reporter considered the event medically significant.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded.  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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Blood in urine; Pain in their arms; Little bit dizzy; Urine test showed extreme blood and protein; This is a spontaneous report from a contactable consumer. This consumer reported for a 52-year-old male patient that. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 31Jul2021 (Batch/Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunization(Age at vaccination 52 years) The patient past Medical history included ongoing hypertension, myocardial infarction from 22Jun2021 to an unknown date Verbatim: Heart attack , stent placement from 22Jun2021 to an unknown date , renal failure from an unknown date and unknown if ongoing Father:  third stage renal failure , blood cholesterol from an unknown date and unknown if ongoing Cholesterol , ongoing angina pectoris  Angina , myocarditis from an unknown date and unknown if ongoing  States she doesn't know if it is from dye or if it has to do with myocarditis that has been spoken about. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; isosorbide (ISOSORBIDE) taken for angina pectoris, amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing and lisinopril (LISINOPRIL) taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller states she is calling more about her boyfriend than herself. About 2 weeks after the second shot, he started having blood in his urine on 15Aug2021. States she doesn't know if it is from dye or if it has to do with myocarditis that has been spoken about.  States she does not know if the vaccine helped bring this about. Caller states they are testing her boyfriend for Glomerulonephritis and Hematuria. Caller states she doesn't know if it is an interaction from the dye he had during his stent, or if it is an underlying condition coming up. Caller states that so far, she is doing good after her vaccines. States that her and her boyfriend had pain in their arms that lingered for days. Says so far that is the only side effect she knows of.  States they were a little bit dizzy also after the second vaccine, but that only lasted about an hour or so.  States otherwise they are doing good. The patient underwent lab tests and procedures which included urine analysis: extreme blood; protein on 17Aug2021. The event outcome was Not recovered for Blood in urine, Unknown for Pain in their arms and Urine test showed extreme blood and protein and recovered for Little bit dizzy on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills with the first shot; Fever; Headache; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter was reporting adverse event and mentions her daughter's brother had chills with the first shot, fever, a headache and he was down for a couple of days. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Dyspnoea
Clinical narrative: if her recent experience of shortness of breath (beginning about 01Jun2021) could have a link to her recent 2nd Pfizer; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Apr2021 13:00 (at the age of 82-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. the patient was no pregnant. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 12:45 for COVID-19 Immunization. The consumer questioned if the patient recent experienced shortness of breath (beginning about 01Jun2021) could have a link to her recent 2nd pfizer. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for AE. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included heart Stress Test scheduled end of Jun in Jun2021. The outcome of the event was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: About a month after my 2nd vaccination I started feeling very tired with full body muscle and joint pain.  I have rheumatic disease and my doctor did recommend that I get the COVID vaccine.  In April; About a month after my 2nd vaccination I started feeling very tired with full body muscle and joint pain.  I have rheumatic disease and my doctor did recommend that I get the COVID vaccine.  In April; About a month after my 2nd vaccination I started feeling very tired with full body muscle and joint pain.  I have rheumatic disease and my doctor did recommend that I get the COVID vaccine.  In April; This is a spontaneous report from a contactable consumer (patient). A female non-pregnant patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5318, Expiration date: Not reported), dose 2 intramuscularly administered in Arm Right on 16Feb2021 as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included, drug hypersensitivity (Sulpha allergy) and rheumatic disorder reported as, I have rheumatic disease. There were no chronic conditions. Concomitant medications received within 2 weeks of vaccination included hydroxychloroquine and celecoxib (CELEBREX) both taken for an unspecified indication. The patient historical vaccine includes received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5318), dose 1 via unspecified route of administration on Arm Right on 26Jan2021 as a DOSE 1, SINGLE for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 by Nasal Swab on Apr2021 that was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, on Mar2021, about a month after my 2nd vaccination I started feeling very tired with full body muscle and joint pain. I have rheumatic disease and my doctor did recommend that I get the covid vaccine, In April. It was reported that, about a month after my 2nd vaccination I started feeling very tired with full body muscle and joint pain. I have rheumatic disease and my doctor did recommend that I get the COVID vaccine. In April I had blood drain for testing of my ANA levels and CPR markers. All results came back in the normal range, but muscle and joint pain remained until roughly June. No treatment was received for the event. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included antinuclear antibody which was normal on Apr2021 and sars-cov-2 test which was negative on Apr2021. Outcome of all the muscle and joint pain were resolved in Jun2021 whereas, feeling very tired was resolved on an unspecified date in 2021.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood calcium, Blood glucose, Pain
Clinical narrative: severe pain under his ribs on both sides,more towards the stomach; impaired fasting blood glucose; This is a spontaneous report from a contactable consumer. This 84-Year-old male consumer (patient).  An 84-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 09Feb2021 (at the age of 83-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 83-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, after the vaccination, the patient waited for 15 minutes and then had a 1520-minute car ride home and during that drive he had severe pain under his ribs on both sides, more towards the stomach. When he does his blood work up checking his calcium and such, instead of giving him a number on glucose it doesn't give a number, it reads impaired fasting blood glucose. Caller is wondering if that sever hurt that he had damage something that is causing his blood work to say impaired fasting blood glucose. He gets his blood work done every three months unless something is going on. He takes a couple of different medications and the vaccine has caused him some expense. The patient lab data includes blood calcium on an unspecified date with unknown result and blood glucose levels on an unspecified date with a result of impaired fasting blood glucose. The outcome of the event Fasting blood glucose abnormal was unknown and pain was recovered on an unspecified date.  No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Menstrual disorder
Clinical narrative: misses her period/I have never ever missed a period and I missed a period; I am experiencing side effects from the shot; This is a spontaneous report from a contactable consumer (patient herself). A 39-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181), via an unspecified route of administration on 10Aug2021 (age at vaccination: 39 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in August2021, she missed her period/ have never ever missed a period, she was experiencing side effects from the shot. She has always been in incredible health. She wanted to know what damage has been done to her that she might not be able to fix, she needs to get the ball rolling on how to get her body back to functioning the way it should, wants to know what the vaccine has done that has impacted her body not make it work. The outcome of the events was unknown. There was no product quality complaint (PQC) present.   The lot number for the vaccine was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Gastric ulcer, Herpes zoster, Inflammation, Neuralgia
Clinical narrative: Flare of plantar fasciitis; Inflammatory arthritis; shingles-like symptoms; 6 stomach ulcers; acute nerve pain in the head and neck; lost 39 pounds; Multisystem inflammatory response; shingles-like pain; This is a spontaneous report from a Non-contactable consumer reported for himself. A 71-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0169) via an unspecified route of administration in arm left on 28Apr2021 as dose 2, single (age at vaccination: 71 years) for COVID-19 immunisation. Medical history included heart attack from 2008 to an unknown date, GERD from an unknown date and unknown if ongoing, barrett's esophagus from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BISTOLIC); atorvastatin (ATORVASTATIN), lipidigril, taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: ew0151) via an unspecified route of administration in arm left on 07Apr2021 as dose 1, single (age at vaccination: 71 years) for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination and did not tested COVID post vaccination. No known allergies. On an unknown date May2021, the patient experienced multisystem inflammatory response. Flare of plantar fasciitis followed by inflammatory arthritis. Within two weeks experiencing shingles-like symptoms without the rash, developed 6 stomach ulcers, and acute nerve pain in the head and neck. No previous symptoms or complaints. As of 19Aug2021 patient has lost 39 pounds, presented at the emergency room 4 times, been hospitalized for 4 days, and is still experiencing shingles-like pain, and complications with ulcers. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. No of days hospitalization was 4 days. Treatment was received, medication to manage symptoms. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Plantar fasciitis, Weight decreased
Clinical narrative: Flare of plantar fasciitis; Inflammatory arthritis; shingles-like symptoms; 6 stomach ulcers; acute nerve pain in the head and neck; lost 39 pounds; Multisystem inflammatory response; shingles-like pain; This is a spontaneous report from a Non-contactable consumer reported for himself. A 71-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0169) via an unspecified route of administration in arm left on 28Apr2021 as dose 2, single (age at vaccination: 71 years) for COVID-19 immunisation. Medical history included heart attack from 2008 to an unknown date, GERD from an unknown date and unknown if ongoing, barrett's esophagus from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BISTOLIC); atorvastatin (ATORVASTATIN), lipidigril, taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: ew0151) via an unspecified route of administration in arm left on 07Apr2021 as dose 1, single (age at vaccination: 71 years) for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination and did not tested COVID post vaccination. No known allergies. On an unknown date May2021, the patient experienced multisystem inflammatory response. Flare of plantar fasciitis followed by inflammatory arthritis. Within two weeks experiencing shingles-like symptoms without the rash, developed 6 stomach ulcers, and acute nerve pain in the head and neck. No previous symptoms or complaints. As of 19Aug2021 patient has lost 39 pounds, presented at the emergency room 4 times, been hospitalized for 4 days, and is still experiencing shingles-like pain, and complications with ulcers. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. No of days hospitalization was 4 days. Treatment was received, medication to manage symptoms. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective, Magnetic resonance imaging
Clinical narrative: COVID-19; had a break thorough case of Covid after receiving both doses of the Pfizer Covid 19 Vaccine; Stroke; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included stroke from an unknown date and unknown if ongoing (Had the previous stroke several months ago. States that they were still picking up evidence of the previous stroke on the MRI. So it was probably within the last 6 months). The patient's concomitant medications were not reported. The patient had a break thorough case of covid after receiving both doses of the pfizer covid 19 vaccine and had a 2nd stroke on 08Aug2021 after getting covid. The patient was hospitalized due to the events. The caller states that they do not think that the stroke was related to Covid or the vaccines, but he still wanted to mention it. The patient's son does not know that the caller is reporting this. The patient went home from hospital yesterday (17Aug2021), but date of admission into hospital was not known. The caller thinks the patient was hospitalized due to the stroke, but was unsure if Covid played any part in the hospitalization. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): stroke on an unknown date. The outcome of all events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Erythema, Haemorrhage
Clinical narrative: Bleeding disorder; Dizziness; I have little red dot all over the part of my hands; My legs, my arms and my torso broke up in bruises; This is a spontaneous report from a consumer (patient) via a Pfizer sponsored Regulatory Authority support. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date in Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced bleeding disorder (medically significant), legs, my arms and my torso broke up in bruises, little red dot all over the part of my hands and dizziness. Patient also stated she got her first dose back in June and she has bruising all over her legs, her arms and her torso. She got that a week after she got her first vaccine (Later consumer clarified consumer got bruising after the second shot) and on the second dose all she got was dizziness. I have a bleeding disorder (Further clarification was unknown if consumer had bleeding disorder after getting the vaccine or not) and I am on a blood thinner. On the last shot that we got afterwards (Further clarification was unknown) my legs, my arms and my torso broke up in bruises and I have little red dot all over the part of my hands. So I broke out with bruising after my second shot. Also after the second shot I became extremely dizzy. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Movement disorder, Pain in extremity
Clinical narrative: my left hand, and at times my right hand, would completely hurt; my left hand, and at times my right hand, would completely hurt, get random red spots/left leg and my right foot became red; I have trouble lifting things; This is a spontaneous report from a contactable consumer. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Right on 28May2021 (at the age of 37 year) as dose 2, single for COVID-19 immunisation. Medical history included none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was unknown if Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EW0182), dose 1 via an unspecified route of administration in Arm left 07May2021 for COVID-19 immunisation and experienced pain in my left eye. On 08Jun2021, consumer reported that about a month later, consumer left hand, and at times right hand, would completely hurt, get random red spots, and veins would be very visible. This was still happening. Except now, its gravitated to my left leg and my right foot became red for no reason. My left hand feels like destroyed a nerve and have trouble lifting things with it. This has been ongoing a month after my final vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. It was reported that no therapeutic measures were taken for the events experienced. The patient was hospitalized for all events for 1 days. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from contactable consumer.  This consumer reported for 37 patients. This report is for 30th patient of 37 patients.  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unknown route, on 15Jan2021 (Lot number EL3249) at single dose and the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unknown route, on 05Feb2021 (Lot number EN5318) at single dose, for COVID-19 immunisation. Relevant medical history included ongoing asthma. No relevant concomitant medications were provided. Patient's body mass index (BMI) is 44.6. The patient tested positive for COVID virus, after being fully vaccinated. The clinical course reported as follows, the reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the lot # or expiration date, however was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Caller reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller stated, reclarified later in report, she has 37 patients with partial identifiers. Caller stated she cannot provide some identifying details and that she would need to check with her legal department first. Caller provides the details she was allowed to identify. Caller stated unknown or could not provide to other questions. On 06Aug2021, antigen Covid test was done and resulted positive. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: fainted after receiving TRUMENBA; This is a spontaneous report from a contactable other health professional via Pfizer Sales Representative. This other health professional reported similar events for two patients. This is the first of two reports.  A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date (Batch/lot number and expiration date not reported), as dose number unknown, single, for immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient fainted after receiving TRUMENBA. The reporter stated that she had two patients who were unrelated approximately aged 16 and 17 who fainted after receiving TRUMENBA. One of these patients received GARDACIL in the same visit, the reporter could not remember which one. The reporter stated that she reported this at the time of the incident, and since had several cases of dizziness and pain from additional patients who received TRUMENBA. They are no longer using TRUMENBA due to this. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events faint based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-202101076778 same reporter, suspect product, event; different patients
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: fainted after receiving trumenba; This is a spontaneous report from a contactable other hcp via a sales representative. This other health care professional reported similar events for two patients. This is the second of two reports.  An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient's medical history was not reported. Concomitant medications included hpv vaccine vlp rl1 4v (yeast) (GARDASIL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, it was reported that the patient fainted. The patient is no longer using TRUMENBA due to this. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event faint based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-202101076767 same reporter, drug, and event, different patient.