chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal haemorrhage
Clinical narrative: retinal hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in left arm on 12Aug2021 10:30 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included Hypertension(controlled with  medication), Hypercholestremia (controlled with medication), and allergies with Mango fruit. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced retinal hemorrhage on 14Aug2021 08:00. The patient reported that she has not had one before to her knowledge. It has been examined and is resolving. There was no blunt force trauma. She was just sitting in a chair when the event occurred spontaneously. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was given in response to the event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Gait disturbance, Loss of consciousness, Myocardial infarction
Clinical narrative: heart attack; couldn't take a breath/she couldn't breathe; passed out a few times; couldn't walk or make use of her legs; got so cold; This is a spontaneous report from a contactable consumer (patient).    A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 08:00 (Batch/Lot number was not reported) at the age of 33-year-old as single dose for covid-19 immunization. The patient's medical history was none, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were 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. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28May2021 08:00 AM at the age of 33-year-old, administered in Right arm for covid-19 immunization. On 10Aug2021, she woke up at 2 am and felt like she was having a heart attack; she couldn't take a breath/she couldn't breathe, and she passed out a few times. She also couldn't walk or make use of her legs so her husband had to carry her around. Her breathing eventually returned but she was not breathing properly for the next few minutes that followed. After a while, she got so cold like she was stuck in a deep freezer and nothing was successful in warming her up. This episode lasted for about an hour before it passed. She asked her husband to hold off on calling the ambulance because she knew they could not afford the cost but she scheduled a full physical with her doctor the next day because she knew something was very wrong. The events resulted in [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event)]. No treatment received for the events. The outcome of the events was recovered on an unspecified date. No covid prior vaccination, no covid tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer stage IV
Clinical narrative: stage 4 breast cancer; This is a spontaneous report from a contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to ask if she needed to get the booster or third shot of the Pfizer BioNtech COVID-19 vaccine. The patient stated that she already took the first and second dose of the vaccines and that she had stage 4 breast cancer on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive for covid this morning; test positive for covid this morning; This is a spontaneous report received from a non-contactable consumer (patient) received via a sales representative. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ep7533), via intramuscular route of administration on 01Apr2021 (at the age of 48-year-old), as dose 2, single in left arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: en6208), via intramuscular route of administration on 11Mar2021 (at the age of 48-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history included allergy to shellfish. Concomitant medications received within in two weeks of vaccination included atorvastatin calcium (LIPITOR), cetirizine hydrochloride (ZYRTEC) and celecoxib (CELEBREX); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 16Aug2021 at 08:00, 4 months 15 days and 8 hours after vaccination, the patient tested positive for COVID this morning. No treatment medication was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 16Aug2021. The clinical outcome of the event COVID-19 was resolving.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Rheumatoid arthritis, Rheumatoid factor, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: After getting my 1st shot I began experiencing severe symptoms of ASIA syndrome, a sudden onset of multiple autoimmune disorders; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) dose 1, via an unspecified route of administration, administered in arm right on 08Apr2021 14:00 (45-year-old at vaccination) as single dose for COVID-19 immunisation. Facility type vaccine was Public Health Clinic/Veterans Administration facility. Medical history included morbid obesity. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. No Covid prior vaccination. Shortly after getting his 1st shot, he began experiencing severe symptoms of autoimmune/inflammatory syndrome induced by adjuvants (ASIA) syndrome, a sudden onset of multiple autoimmune disorders. He had rheumatology results from June pointing towards rheumatoid arthritis (RA), sjogren's syndrome & lupus. Adverse event start date was 12Apr2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Number days hospitalization was 1. Treatment for AE included steroid injection. He got his 2nd shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Apr2021 at 11:00 AM in right arm, because he didn't correlate his issues with the shot at that time. The patient was not recovered from the events. It was unknown if covid tested post vaccination.  The lot number for BNT162B2, was not provided and will be requested during follow up
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Nausea, Vertigo
Clinical narrative: Dizziness; room spinning; Loss of balance; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,solution for injection; lot number- EW0176 and expiry date not reported) via an unspecified route of administration into Left arm on 06Aug2021 15:00, at the age of 65-year-old,dose1, single for COVID-19 immunization in a Pharmacy or Drug Store. Relevant medical history includes allergies to Indocin and Tramadol. Concomitant medications include allopurinol and Synthroid. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 15Aug2021 9:00,the patient experienced dizziness, room spinning,loss of balance and nausea. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Moles were gone/ COVID 19 vaccine helped eliminate the moles; This is a spontaneous report from a contactable consumer (patient) and physician (dermatologist). A 81-year-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on Jan2021 (at the age of 81 years old) as dose 1, single and dose 2 via an unspecified route of administration on 15Feb2021, lot number was not reported as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On an unspecified date of 2021 the patient experienced moles were gone/ covid 19 vaccine helped eliminate the moles. The clinical outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea
Clinical narrative: nausea; bronchitis like cough that is bringing up flim; This is a spontaneous report from a contactable Consumer (patient). A 40-year-old female received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 12Aug2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history included Cold (she had a cold she had just gotten over before receiving the vaccine.) on an unknown date and not ongoing. The concomitant medications were not reported. On Aug2021 patient had experienced nausea and bronchitis like cough that is bringing up flim and also reported that, are these normal side effects following the vaccine. The clinical outcome of the events were unknown .  Information on the lot/batch number has been requested
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, batch/lot#, expiration date not reported), at age 61, via an unspecified route of administration, left arm, on Aug 8, 2021, 13:00, single dose, for COVID-19 immunization at a pharmacy or drug store. Medical history included heart stents. The patient has no known allergies. The patient's concomitant medications not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and no other medications administered within two weeks. The patient has not tested with COVID-19 since the vaccination. The patient was extremely tired and weak, low-grade fever, cough, short-of-breath, nauseated and diarrhea on Aug 8, 2021; 13:00. No treatment received for the events, with outcome of recovering. The lot number for BNT162B2: not provided (will be requested during follow-up).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, batch/lot#, expiration date not reported), at age 61, via an unspecified route of administration, left arm, on Aug 8, 2021, 13:00, single dose, for COVID-19 immunization at a pharmacy or drug store. Medical history included heart stents. The patient has no known allergies. The patient's concomitant medications not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and no other medications administered within two weeks. The patient has not tested with COVID-19 since the vaccination. The patient was extremely tired and weak, low-grade fever, cough, short-of-breath, nauseated and diarrhea on Aug 8, 2021; 13:00. No treatment received for the events, with outcome of recovering. The lot number for BNT162B2: not provided (will be requested during follow-up).
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She was diagnosed with covid-19; She was diagnosed with covid-19; This is a spontaneous report from a contactable nurse and a contactable consumer (patient) via Pfizer-sponsored program.   A 41-year-old female patient (unknown if pregnant) received tofacitinib citrate (XELJANZ XR 11 mg; Expiration date: 28Feb2023), oral from 2019 to an unspecified date, at 11 mg, daily for Illness unspecified (as reported).  Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), via an unspecified route of administration, in Jan2021 at single dose for covid-19 immunisation .The patient medical history and concomitant medications were not reported. The patient previously took infliximab (REMICADE) and experienced allergy.  The patient was diagnosed with covid-19 on 05Aug2021. Patient stated she received monoclonal antibodies for treatment. The outcome of the event was not recovered.  The action taken in response to the event for tofacitinib citrate was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 cannot be excluded for events drug ineffective and COVID-19 infection. A contributory role of tofacitinib cannot be fully excluded in the development of event COVID-19 based on its immunomodulatory properties. However, the temporal association is unclear based on the currently available information. Of note, there is an increased risk for  COVID-19 infection overall in light of the current pandemic. Event drug ineffective is related to BNT162B and is unrelated to tofacitinib. This case will be reassessed upon receipt of additional information.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I got COVID. First symptoms appeared 05Aug2021.; I got COVID. First symptoms appeared 05Aug2021.; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 10Mar2021 at 13:00 (age at vaccination 27-year-old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, administered in arm left on 31Mar2021 at 13:00 (age at vaccination: 27-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No medical history was reported and no known allergies. No other vaccines were administered in four weeks of vaccination. The patient received birth control (unspecified) in two weeks of vaccination. The patient had no covid prior vaccination. The patient got covid, first symptoms appeared on 05Aug2021 at 03:00 AM. The patient had a vaccination failure. No treatment was received for the events. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction) which was positive on 08Aug2021 (Nasal Swab). The outcome of the events was recovered on an unknown date in Aug2021.  No follow-up attempts are possible, no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: heavy periods; earaches; I got my period on July 30th and then I got the vaccine and it started again; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced heavy periods, earaches, got her period on 30Jul2021 and then got the vaccine and it started again. The reporter wanted to know if these were side effects from the vaccine. The outcome of all 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional
Clinical narrative: shortness of breath/ after talking or walking up the stairs; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER COVID-19 VACCINE, Batch/Lot number 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. On an unspecified date, 48 hours after receiving the first dose of the vaccine, the patient experienced shortness of breath that lasted a few hours and then the next day she had shortness of breath, which was not significant. The event happened sometimes after talking or walking up the stairs. She also stated she did not experienced any arm soreness at all. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 12Aug2021 after receiving last vax dose; Tested positive for COVID on 12Aug2021 after receiving last vax dose; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on 21Apr2021 (Lot Number: ER2613) (at the age of 23-years-old) as dose 2, single for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD). Concomitant medication included pantoprazole taken daily for gastrooesophageal reflux disease. The patient tested positive for COVID on 12Aug2021 after receiving last vaccine dose. The patient experienced loss of taste and smell, headache, stuffy nose, sore throat and fatigue. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sluggishness
Clinical narrative: headache; felt sluggish; This is a spontaneous report from a contactable consumer.  A 77-year-old female patient received second 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 single dose for COVID-19 immunisation. The patient had received the first dose of  BNT162B2 on 21Jan2021 and experienced numbness at injection site, swelling and itchy, then dizziness and little taste in mouth. There were no medical history and concomitant medications. It was reported that the night of second vaccine the patient had headache that lasted overnight and felt sluggish the whole day the day after.  Admission to hospital due to the event was reported. Treatment was not received. The patient was fine at the time of reporting.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021100456 Same reporter/patient/product, different dose/AE.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: menstrual irregularities/she only had one period after receiving the vaccine; This is a spontaneous report from a contactable Pharmacist reported for herself. A 48-year-old non-pregnant female pharmacist received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 29Jan2021 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine included bnt162b2 in Jan2021 as dose 1, single for COVID-19 immunisation. She had her both doses of the vaccine last Jan2021, she was 47 years old when she got the vaccine and now, she's 48-years old. She got her 2nd dose on 29Jan2021. She's asking for additional information regarding the menstrual irregularities on an unknown date in 2021. She only had one period after receiving the vaccine - there's no hot flushes, she did pregnancy test 3x and the results were negative - she's not pregnant, and she stated that it's unusual for her to be late. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: almost killed my fiance; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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's medical history and concomitant medications were not reported. It was reported: "The vaccine almost killed my Fiance I assume you need to know things like that please contact so we can have a dialog. Others know I have contacted you in case something happens to me." The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Internal haemorrhage
Clinical narrative: internal bleeding; cardio issues; This is a spontaneous report from a non contactable consumer. An 86-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported: "Consumer calling about her Mother in law dying from the side effects of the Pfizer Covid Vaccine at 3:00 am Sunday, 15Aug2021. Caller asked How many deaths have there been called that they believe was caused by the Pfizer vaccine? My MIL was 86 y/o and she had just started PT in the hospital. She started having cardio issues and internal bleeding and now she is dead. She had started PT and was up walking, so her doctor suggested she get the this because she was having PT, then she started having internal bleeding and cardio issues and now she's dead. With in 48 hours of taking that vaccine. She developed symptoms where there was blood gushing out of her mouth and my father in law saw this. They couldn't stop the bleeding because of her health condition." The patient experienced internal bleeding, cardio issues on an unspecified date. The outcome of events was fatal. The patient died on 15Aug2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: internal bleeding; cardio issues
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Hypertension, Renal disorder
Clinical narrative: diabetes; high blood pressure; kidney disease; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021 as dose 1, single and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was seeking information on the booster dose of the Pfizer COVID-19 vaccine. He stated that he received both doses of the Pfizer COVID-19 vaccine back in Feb2021. On an unspecified date 2021, the patient experienced high blood pressure, diabetes and kidney disease and stated that he really needs the booster dose. Referred to health care professional (HCP) for further guidance and medical recommendation. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: missed his second dose scheduled; he tested positive on 04Aug2021; he tested positive on 04Aug2021; This is a spontaneous report contactable consumer (patient) from a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 13Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he tested positive on 04aug2021, missed his second dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 04Aug2021 he tested positive on 04Aug2021. Medical Information was yes. Customer and/or medical inquiry forwarded or referred to MI. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lung adenocarcinoma, Lymphadenopathy
Clinical narrative: lymph node swelling on the right side of my neck; Lung Adenocarcinoma with spread to the lymphs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Lot Number: EL9265) at the age of 74-year-old as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. Concomitant medication included fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2(lot number: EL3249) on 14Jan2021 at the age of 74-year-old at left arm for covid-19 immunisation. There was no other vaccine in four weeks. By end of February the patient noticed lymph node swelling on the right side of his neck. When he questioned it he was told that lymph swelling a common side effect and should subside in 4 to 6 weeks. In the interim rather than subsiding they increased in number of nodes and in size. When he reported it to his PCP, he look at them and assured him that it was not cancerous because they were mobile. They did not test or investigate as a precaution. On 06Aug2021, the patient was given a cancer diagnosis of lung adenocarcinoma with spread to the lymphs. It seemed the vaccine triggered something to get the cancer process rolling. He lost valuable time adhering to the guidance pertaining to the 4 to 6 week waiting period for the lymphs to go down. He believed that line should be discarded and replaced with more proactive wording to prevent future situations. Right now, his life was possibly on the line for waiting. And he really could use some assistance in this battle. Adverse events start date was 25Feb2021. Events resulted in: Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment received for the events. AE treatment reported as exam and diagnosis. The outcome of the events was not recovered. The patient had no COVID prior vaccination. No COVID tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter reported that, patient was in a nursing home and on 16Aug2021, patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine. The patient underwent the lab test and procedure which included tested for covid last Wednesday (11Aug2021) and received the positive result today 16Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Vertigo
Clinical narrative: vertigo; blood pressure a little bit higher; This is a spontaneous report from a contactable consumer or non health care professional. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3180), dose 1 via an unspecified route of administration on 12Aug2021 Thursday (Age at vaccination: 61 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing hypertension Verbatim: High Blood Pressure. Concomitant medications included Low dose high blood pressure pill. Prior vaccinations within 4 weeks were None. Reporter states that her husband takes this on an as needed basis. The patient experienced vertigo and blood pressure a little bit higher (condition aggravated) on 13Aug2021. Reporter wants to know if these symptoms are associated with Pfizer COVID-19 vaccine. Reporter says that her husband blood pressure has been fluctuating since before the vaccine; but since the vaccine it has been higher. Patient was taking low dose high blood pressure pill. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Pressure on chest; Hard time breathing/ got winded even talking; Heart beating weird + fast; heart felt like it was palpitating; This is a spontaneous report from a contactable other healthcare professional (medical assistant). This other healthcare professional reported similar events for two patients. This is the second of two reports.  A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced pressure on chest, hard time breathing/got winded even talking, heart beating weird + fast, and heart felt like it was palpitating. The events were considered serious, medically significant. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.,Linked Report(s) : US-PFIZER INC-202100956501 same reporter, drug and events/ different patient
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoptysis, Renal failure
Clinical narrative: complete kidney failure in DKA; can hardly breathe; coughing up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EL9267) as dose 1, single; dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6200) as dose 2, single for Covid-19 immunization. Medical history included DKA (diabetic ketoacidosis). The patient's concomitant medications were not reported. The patient experienced complete kidney failure in DKA and can hardly breathe along with coughing up blood on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Deafness unilateral, Ear disorder, Ear infection, Ear pain
Clinical narrative: Ear felt full with fluid; Slowly became more painful over the couple of a week; Pain/fluid spread to jaw; Could only sleep all day; Lost some hearing in my left ear; Fluid constantly in my ears now and infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose. This report is serious. The additional report is non-serious.  A 21-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an intramuscular route of administration in the left arm on 15Apr2021 at 15:00 (Batch/Lot Number: ER8731 at the age of 21-years-old patient at vaccination) as a single dose for COVID-19 immunisation at a Pharmacy or drug store (non-military facility). Medical history included vertigo from 08Jan2020 and ongoing and ear pain from 08Jan2020 and ongoing (no surgeries, unexplained occurrence). The patient underwent computerised tomogram and found nothing abnormal in Sep2020. The patient did not have COVID-19 prior to the vaccination. COVID-19 test in Oct2020 was negative. There were no concomitant medications. Historical vaccine information includes the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an intramuscular route of administration in the left arm, on 18Mar2021 at 15:00 (Batch/Lot Number: EP6935) as a single dose for COVID-19 immunization and experienced ear infection, nausea, vomiting, dizziness, intense menstrual cramps/bleeding, swollen lymph nodes, loss of appetite, weight loss and fast heart rate. The patient did not receive any prior vaccinations (within 4 weeks) of the COVID-19 vaccine. On 15Apr2021, the patient received the second dose of the BNT162B2 vaccine. On 17Apr2021, a couple days after the second vaccine, the patient experienced the ear felt full with fluid, slowly became more painful over a week. The pain/fluid spread to the jaw. The patient missed work and could only sleep all day. The patient found relief with antibiotics, but the pain/fluid never fully went away. The patient was still fighting constant fluid in ears. The damage was so bad that the patient lost some hearing in the left ear. It was somewhat better but he/she has fluid constantly in ears now and infection wherever the fluid does not drain. The events required visit to urgent care, physician office. Seriousness criteria was reported as persistent/significant disability. Treatment: included antibiotics. The outcome of the events lost some hearing in my left ear, fluid constantly in my ears now and infection, ear felt full with fluid, slowly became more painful, pain/fluid spread to jaw and could only sleep all day was reported as not recovered.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021899547 same patient, drug/ different dose
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in jaw, SARS-CoV-2 test, Somnolence
Clinical narrative: Ear felt full with fluid; Slowly became more painful over the couple of a week; Pain/fluid spread to jaw; Could only sleep all day; Lost some hearing in my left ear; Fluid constantly in my ears now and infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose. This report is serious. The additional report is non-serious.  A 21-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an intramuscular route of administration in the left arm on 15Apr2021 at 15:00 (Batch/Lot Number: ER8731 at the age of 21-years-old patient at vaccination) as a single dose for COVID-19 immunisation at a Pharmacy or drug store (non-military facility). Medical history included vertigo from 08Jan2020 and ongoing and ear pain from 08Jan2020 and ongoing (no surgeries, unexplained occurrence). The patient underwent computerised tomogram and found nothing abnormal in Sep2020. The patient did not have COVID-19 prior to the vaccination. COVID-19 test in Oct2020 was negative. There were no concomitant medications. Historical vaccine information includes the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an intramuscular route of administration in the left arm, on 18Mar2021 at 15:00 (Batch/Lot Number: EP6935) as a single dose for COVID-19 immunization and experienced ear infection, nausea, vomiting, dizziness, intense menstrual cramps/bleeding, swollen lymph nodes, loss of appetite, weight loss and fast heart rate. The patient did not receive any prior vaccinations (within 4 weeks) of the COVID-19 vaccine. On 15Apr2021, the patient received the second dose of the BNT162B2 vaccine. On 17Apr2021, a couple days after the second vaccine, the patient experienced the ear felt full with fluid, slowly became more painful over a week. The pain/fluid spread to the jaw. The patient missed work and could only sleep all day. The patient found relief with antibiotics, but the pain/fluid never fully went away. The patient was still fighting constant fluid in ears. The damage was so bad that the patient lost some hearing in the left ear. It was somewhat better but he/she has fluid constantly in ears now and infection wherever the fluid does not drain. The events required visit to urgent care, physician office. Seriousness criteria was reported as persistent/significant disability. Treatment: included antibiotics. The outcome of the events lost some hearing in my left ear, fluid constantly in my ears now and infection, ear felt full with fluid, slowly became more painful, pain/fluid spread to jaw and could only sleep all day was reported as not recovered.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021899547 same patient, drug/ different dose
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died from the Pfizer Covid-19 vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient died from the pfizer covid-19 vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died from the Pfizer Covid-19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in the arm that I had the shot in; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm on Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in the arm that i had the shot in, in Aug2021. Outcome of the event was unknown. PQC Details: Request Name: REQ- Withheld. Product: Pfizer BioNTech COVID-19 Vaccine. Question: Transfer in from DSU Dori: Withheld. Reportum: Withheld. E-transmit, additional information gathered. Did not gather patient's age. Caller is a consumer asking about how long side effects of the Pfizer-Biontech Covid19 vaccine typically last? She did clarify and stated she received her first dose last Tuesday, and that she's been experiencing "tingling in the arm that I had the shot in" and that it "started yesterday, and also today". Response: Answered per 'VR-no info' as there are no reports of "tingling" or "paresthesia" listed in the fact sheet. Explained that frequency data for AEs was gathered in the 7 days after either dose (Tables 1-6). [LAB- Withheld; Revised: 12Aug2021]. Spoke from attached cons doc regarding duration of AEs, "In general, local side effects resolved within 1 to 2 days (systemic side effects) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter," Referred caller back to HCP for evaluation and treatment if symptoms continue.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer patient; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included neoplasm malignant from an unknown date. The Concomitant medication included osimertinib mesilate (TAGRISSO) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient had the vaccine with the cancer which was medically significant. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pyrexia
Clinical narrative: chest pain/ It was around mid-chest radiating up to his shoulder and midback; had really bad headaches for 5 days; fever; This is a spontaneous report from a contactable other hcp (Nurse). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced chest pain and it was around mid-chest radiating up to his shoulder and midback; had really bad headaches for 5 days and fever. It was reported that reporter son had it the worst reaction. Her son had chest pain that anticipated before he go to the emergency. Patient had It for several hours and it went away. Patient had been fine since then. It was around mid-chest radiating up to his shoulder and midback. Caller wants to know if her son should receive the second dose or not. Serious: No. The clinical outcome of event fever was unknown and other events were recovered on unspecified date in 2021.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in jaw
Clinical narrative: the worst headache of her life; jaw is also sore and hurts very very bad; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Paracetamol (TYLENOL) and Naproxen Sodium (ALEVE). On 13Aug2021 the patient experienced the worst headache of her life since friday and her jaw were also sore and hurts very very bad. She wants to know if jaw pains are common side effects of the vaccine, because she knows that headaches were common. The outcome of both events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.