chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: after the second shot of covid-19 vaccine he had a stroke; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from AbbVie Inc. (MFR Control No. #21K-163-4017811-00) from a contactable consumer (patient).   A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; glecaprevir, pibrentasvir (MAVYRET), oral from Nov2020 (Batch/Lot number was not reported) to an unspecified date, at unknown dose, 3x/day for an unspecified indication.  The patient medical history was not reported.  The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for Covid-19 Immunization. The patient had other concomitant therapy of unspecified blood pressure medication. It was reported after the second shot of covid-19 vaccine he had a stroke on an unspecified date with outcome of unknown. On an unknow date, the aptient experienced stroke, Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient Reported that 64 hours after the second shot of covid+19 vaccine he had a stroke. He did confirm that the stroke happened after the second dose of the Covid-19 vaccine but was not able to probe further.It was unknown if the patient was enrolled in the covid vaccine trail. On unknown, patient received 1st dose covid-19 vaccine manufactured by pfizer, lot number. The event was reported as serious as other medically important condition. The action taken for glecaprevir, pibrentasvir was Permanently Withdrawn on unknown date.  Causality for Mavyret: The reporter's casualty for the event of the stroke was not provided. Abbvie's opinion is that there is no reasonable possibilities that the event of stroke is related to the Mavyret.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between the event stroke and bnt162b2 cannot be completely excluded. Other risk factors to be considered include the patient advanced age and history of high blood pressure. 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.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Multiple sclerosis
Clinical narrative: Patient stated that she is on gilenya for MS; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as Dose 2,Single and dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Concomitant medication(s) included fingolimod hydrochloride (GILENYA) taken for multiple sclerosis, start and stop date were not reported. The patient experienced antibody tests performed prior at a research clinic for facility, all came back negative for antibody (medically significant) on an unspecified. Patient stated that she is on gilenya for MS which research has shown affect the Pfizer vaccine effectiveness, because it is a an Immunosuppressive drug. She us a in a research at facility. I am afraid that the only way for me to get protection is to get off gilenya for 60 days and then get the vaccine again, and than get back on the gilenya, which when you been off it that long it take s all kinds of heart studies to get back on the drug again. Besides the fact that there are multiple reports of cases of people who go off that drug, and do not go immediately on another drug, there are increase exacerbation of MS, and 35 cases in the last 8 years, people have gone from being mobile and living a normal life to being in a wheelchair after who come off gilenya, within 12 weeks. The patient underwent lab tests and procedures which included antibody test: negative. 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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 24Feb2021 at dose 2, single and first dose on 03Feb2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no serious underlying health conditions. The patient began feeling ill with symptoms of coughing, congestion, headache, body aches and fever on 21Aug2021. Patient went for COVID testing on morning of 23Aug2021 and COVID test was positive. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has received two does of the Covid vaccine, and tested positive; has received two does of the Covid vaccine, and tested positive; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date in Apr2021 (Lot number was not reported) as single dose and first dose via an unspecified route of administration on an unknown date in Apr2021 (Lot number was not reported) as single dose, both for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had received two doses of the Covid vaccine in Apr2021 and tested positive for Covid on 22Aug2021 (reported as yesterday 8/22) through a rapid test waiting on. Outcome of the event was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hurting more in different joints now; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FD8448, Expiration Date: not reported) via an unspecified route of administration in right arm on 19Aug2021 as dose 1, single for COVID-19 immunization (at the age of 64-year-old). Medical history included hurting and cataract. The patient's concomitant medications were not reported. The patient experienced hurting more in different joints now on an unspecified date in 2021. It was reported that, she took the first covid shot last Thursday, she wanted to find out if she could take tramadol. She saw something about anti inflammatory cannot be taken and she was just hurting. Patient clarified that, she had not consumed the tramadol or anti inflammatory yet, she didn't take anything because she was fine, she had only taken a Tylenol. Her hurting was something that was prior to receiving the covid vaccine, it was before. She was just hurting more in different joints now, she just did not think about it. She was more worried about what she saw on the internet that 4 weeks down the line, people getting moderna broke out in shingles. she was waiting to find out more information first. The outcome of the events was unknown.  Additional information is requested.  Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; has received the vaccinations has joint pain; This is a spontaneous report from a Pfizer sponsored Regulatory Authority support. A consumer (patient's father) reported for a female patient (reporter's oldest daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller reported that, his oldest daughter, one who has received the vaccinations has joint pain, however he was uncertain if this joint pain was before or after receiving the injections. He was trying to call her during the INT but was not successful and stated he will call back to provide more clarity. He stated that she was having a lot of joint pain and they have diagnosed her with Rheumatoid Arthritis and the caller was unsure if it may had been vaccine related. The outcome of the event has received the vaccinations has joint pain was not resolved. The outcome of the event rheumatoid arthritis was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vaccinated with Pfizer covid vaccine with second dose Feb 15. She was now diagnosed with covid on August 20; Vaccinated with Pfizer covid vaccine with second dose Feb 15. She was now diagnosed with covid on August 20; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with Pfizer covid vaccine with second dose on Feb 15 and was diagnosed with covid on 20Aug2021. Event took place after use of product. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: brain bleeds that happened 45 or 60 days after the vaccine.; This is a spontaneous report from a Pfizer sponsored program . A contactable Consumer (patient s wife) reported for a patient (reporter s husband). A male patient of 90-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9629, and Expiration date: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 89-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), on 14Jan2021 (at the age of 89-year-old) for COVID-19 immunization. The caller (reporter) mentioned that her husband had "brain bleeds that happened 45 or 60 days after the vaccine" on an unspecified date in 2021. The caller had not been vaccinated she recently discovered she had an Iron overload in her blood. Asked if the Pfizer COVID-19 vaccine (COMIRNATY) was going to be toxic. No Information found regarding product medical question. Spoke from attached CONS document, referred to HCP, offered to email for review. The caller asked how she can get ingredient list and she was offered to email ingredient list. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, SARS-CoV-2 test
Clinical narrative: hospitalized for a medical emergency she had two surgeries from sinus fluid leaking into her brain; This is a spontaneous report from a contactable consumer. A female patient of unspecified  age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 04Apr2021 at unknown Dose 2, Single for Covid-19 immunization. Medical history include historical vaccine as first dose , asthma and diabetes. No concomitant medications reported. On 30Jun2021, the patient was hospitalized for a medical emergency she had two surgeries from sinus fluid leaking into her brain. The patient underwent SARS-CoV-2 test and found negative. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; Covid-19 Positive; This is a spontaneous report from a contactable other HCP (Nurse). A 50-year-old male patient received bnt162b2 (BNT162B2 Formulation; Solution for injection), dose 2 intramuscularly, administered in Arm Left on 05Feb2021 07:00 (Batch/Lot Number: EL3248) as DOSE 2, SINGLE (at the age of 49-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had covid prior vaccination. Historical vaccine included received first dose of bnt162b2 intramuscularly administered in Arm Left on 15Jan2021 07:00 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE (at the age of 49-year-old) for COVID-19 immunisation. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Aug2021, the patient had fever, congestion and coughing. The patient underwent lab tests and procedures which included Nasal Swab which was positive on 24Aug2021 (COVID positive post vaccination). The patient visited physician office due to the event. It was unknown if patient received treatment for event or not. The outcome of the events reported as recovering.   No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Vaccination Failure, Covid-19) and the administration of the vaccine cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she was fully vaccinated with the Pfizer BioNtech covid 19 vaccines in March and April of last year. She now has the covid 19 infection; she was fully vaccinated with the Pfizer BioNtech covid 19 vaccines in March and April of last year. She now has the covid 19 infection; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 66-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Apr2020 ,at the age of 66 years old,as Dose 2,single and dose 1 via an unspecified route of administration on Mar2020 (Batch/Lot number was not reported) as Dose 1,single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced after she was fully vaccinated with the pfizer biontech covid 19 vaccines in march and april of last year she now has the covid 19 infection on an unspecified date. The patient wanted to know if not feeling cold would have impacted the efficacy of vaccine. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal infection
Clinical narrative: vaginal infection; This is a spontaneous report from a contactable physician received by Pfizer from (GL-052821-13037).  A 49-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; solution for injection, lot number, expiration date was not reported), via intramuscular route, on 16Mar2021, at dose 1, single for covid-19 immunization. Medical history included skin cancer and rosacea. She had no dental work in the past 6-12 months. The patient's concomitant medications were not reported. The patient experienced the vulva area removed (two weeks prior to 23Apr2021) and a vaginal infection post-surgery on 09Apr2021. The patient second dose of vaccination on 13Apr2021 for covid-19 immunization. Therapeutic measures included anti-biotics taken as a result of vaginal infection. The outcome of the events was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Low immune system; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced low immune system on an unspecified date. Patient due for a refill: Patient stated, "she had a low immune system and had taken both the shots for COVID-19. She was concerned if I had to get the booster dose." Patient was prescribed Xeljanz XR 11mg. Therapeutic measures were taken as a result of low immune system (immune system disorder). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Myalgia, Pain, Scan
Clinical narrative: pain kind of like her hip area may be kind like at ovaries and by her hip; pains in the muscles; She is getting lot of pain; it was so bad; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14Aug2021 (at the age of 17-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient's mother stated that her daughter got the first dose of the COVID Vaccine on not this Saturday, So about a week ago. A couple of hour after she got the COVID shot on the 14Aug2021, Saturday and couple of hour after on 14Aug2021 she started getting the pain kind of like her hip area may be kind like at ovaries and by her hip and just started like, some pains in the muscles whatever and anyways kind off and line and then by Friday a couple of days ago to the last Friday it was so bad. Patients mother actually took her up to the Emergency room and they done a bunch of test (further clarifications unknown) on her to see if she either had an UTI (further clarifications unknown), there was they did also scan on her. They did a bunch of test and everything all over blood work everything come back completely normal. They couldn't find anything going on but the pain started like a said about 12 after she got a COVID vaccine. So were she was just trying to find out if this the pain. She took the emergency room that was the case she was had the shot and this pain came on a couple hour after and they thought maybe it was UTI or maybe there was a cyst on her ovary that everything came back negative they couldn't see cyst on her ovary, all those things came back negative they can't see cyst on her ovary, they can't see her urine came back fine like everything was come back completely fine. So, we got to know what's going on and she had not got any better at all, it was like worse and worse and so she doesn't know this was a side effect of that vaccine or something that she can do as we checked but don't know because everybody they done as scan on her, they done blood work on her, they given an IV, they given her pain meds, they done everything and everything shows no but she was getting lot of pain on 14Aug2021. The patient underwent lab tests which included blood test showed normal on an unknown date in 2021; scan was negative (they couldn't see cyst on her ovary) on an unknown date in 2021. Therapeutic measures were taken as a result of pain kind of like her hip area may be kind like at ovaries and by her hip, pains in the muscles, she was getting lot of pain; it was so bad with IV and pain medications. The outcome of the events was mot recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID incident after being fully vaccinated; COVID incident after being fully vaccinated; This is a spontaneous report from a contactable physician. A 47-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration and on 05May2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced a breakthrough COVID incident after being fully vaccinated. Symptoms were mild included runny nose, congestion, loss of taste and smell and a positive COVID test received on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE)  cannot be ruled out.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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID test; positive COVID test; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05May2021 (lot Number: ER8735) as single dose, and dose 1 via an unspecified route of administration on 14Apr2021 (Lot: EW0151) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced positive covid test on 25Aug2021. As reported, Breakthrough mild COVID symptoms (runny nose, congestion and loss of smell and taste and positive COVID test) was reported. The patient was weighed 168 lbs. The patient experienced a breakthrough COVID incident after being fully vaccinated. Symptoms were mild included runny nose, congestion, loss of taste and smell and a positive COVID test received on 25Aug2021. She was vaccinated on 05May2021 for the second dose. The patient underwent lab tests and procedures which included COVID-19 of positive on 25Aug2021. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be totally excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: bad headache; felt lethargic; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Aug2021,at the age of 45 years old, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced he had bad headache on Aug2021 and felt lethargic on Aug2021.The outcome of the event was recovered.Upon followup received on 26 aug 2021,The patient stated that he took the first shot 3 weeks ago and within 15 mins he got a real bad headache for 3 days with being real lethargic.After second shot of Pfizer vaccine,the headache started 15 to 20 minutes after and he didn't feel right.The patient didn't visit the doctor.His employer said he would get fired if he didn't have a shot. Now he feels terrible and he doesn't know what to do. Response received from DSU end was,6 OVERALL SAFETY SUMMARY In clinical studies, adverse reactions in participants 16 years of age  fatigue (62.9%), headache (55.1%), chills (31.9%), and fever (14.2%). LAB-1457-12.0 Revised: 23 August 2021 Follow-up (26Aug2021): This is a follow-up spontaneous report received from a contactable consumer. This 45-year-old male consumer (patient) reported for himself that Dates for same experience, only worse and the headache start 15 to 20 minutes after was unspecified,He just wants to make someone aware and to see if its normal. His left side of his head down to his neck and face is on fire.Patient wanted to know whether these adverse events are related to the Pfizer covid vaccine.Address, Alternative Telephone, Email address - Caller declined to provide at this time.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. Was PCR tested CV19 positive on 25Aug2021; received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. Was PCR tested CV19 positive on 25Aug2021; This is a spontaneous report from a contactable other HCP. A 38-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via intramuscular route of administration, in the left arm, on 15Feb2021 (at the age of 38-year-old), as single dose and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via intramuscular route of administration, in the left arm, on 27Jan2021 (at the age of 38-year-old), as single dose, both the doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Unknown if other vaccine in four weeks and Unknown if other medications in two weeks. Unknown if COVID prior vaccination. On 21Aug2021, reporter staes patient received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. patient was PCR tested CV19 positive on 25Aug2021. Event resulted in doctor or other healthcare professional office/clinic visit. Unknown if patient received treatment for events. The patient underwent the lab tests and procedure which included the rapid test (Nasal Swab): result was positive on 23Aug2021 and PCR test (Nasal Swab): result was positive on 25Aug2021. Outcome of the event was recovering.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, COVID-19 and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: breakthrough infection and died; This is a spontaneous report from 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 dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer stated that on the website, it says that it's not FDA approved, as well as voicemails. She went on to say that it only takes a minute to update those things, and she would think with something this large, they would have been ready. She stated that she was aware that the VAERS website contains side effects and things that have happened. She stated that other vaccines have been halted after 1 to 2 deaths. She is aware of a couple of people dying as a direct result of the Pfizer BioNTech vaccine, as well as as friend that had a breakthrough infection and died on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: breakthrough infections and has died
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Product lot number issue
Clinical narrative: severe headache; numbness on the right side of her face; lot number on her vaccination card did not match any Pfizer inventory of the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3184; Expiration Date: Oct2021), via an unspecified route of administration on an unspecified date of 2021 (Sunday) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient experienced severe headache and numbness on the right side of her face. Patient stated that she learned that the lot number on her vaccination card did not match any Pfizer inventory of the vaccine. She said she confirmed the number with Walmart (even showing us a photo of the vial and box: FC3184, expiration Oct2021) and also reported the matter to Pfizer. Eventually, some time on 25Aug2021 (yesterday), a representative of either Pfizer or Walmart (got this information third hand because patient spoke with an editor on this specific piece of info) contacted her to say that yes, the vaccine was legitimate and that there was an unexplained mix up with the Lot number. Reporter asked to confirm this incident with respect to the lot number and what was the mix up and how was this matter resolved. The events were subsiding but have not fully gone away. The outcome of the severe headache and numbness on the right side of her face was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Immunosuppressant drug therapy, SARS-CoV-2 antibody test negative
Clinical narrative: ulcerative colitis; They think it was because he was on that medication. The test didn't show any antibodies; They think it was because he was on that medication. The test didn't show any antibodies; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first single dose of bnt162b2 on 04Feb2021 for covid-19 immunisation. He reported he received 2 doses of the Pfizer COVID vaccine. The first one on 04Feb2021, and the second one on 25Feb2021. He had physical and lab test done a few weeks ago in 2021. Lab results showed no protect/antibodies in the blood. He had ulcerative colitis in 2021 and take azathioprine (IMURAN) 150mg daily. It is an immunosuppressant medication. They think it was because he was on that medication. The test didn't show any antibodies in 2021.  He was going to take the booster dose. Patient wanted to know about time period he should stop or change the dose of azathioprine before he took the booster dose of Pfizer covid vaccine. The doctor's said that the test that was done at a local lab might not be accurate in judging what protection he did or didn't have. His doctor told him to call Pfizer to find a test that would be accurate. The previous agent said they have no information on what kind of test is accurate. That blows his mind. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test with negative in 2021. Outcome of events was unknown.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Malaise
Clinical narrative: husband tested positive for Covid-19 infection after the first dose of the vaccine; not feeling well; their arms were sore and tender; fever; chills; cold; coughing; diarrhea; Tension headache; This is a spontaneous report from contactable consumer (Patient's wife). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 (age at the time of vaccination was 55-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 infection after the first dose of the vaccine on 23Aug2021, not feeling well, their arms were sore and tender, fever, chills, cold, coughing, diarrhea, tension headache. It was reported that the Comirnaty vaccine and she had questions for herself and mentioned that her husband got it a week and a half ago and he tested positive after getting the 1st vaccine. Caller stated that they both had their Pfizer COVID vaccine on Monday 16Aug2021 and her husband tested positive for Covid on 23Aug2021. States they are scheduled for the 2nd dose 06Sep2021. The patient takes no medication and was very healthy, that if it was not for working with, that with his way of life. The patient normally would not have taken the vaccine but because of he did what was required. Caller stated that the patient was fine and she thought it was Thursday night into Friday he started not feeling well and he doesn't take any medications and was very healthy. Caller stated after they got their vaccines they sat for half an hour and they both were ok, their arms were sore and tender on the 2nd day they had very tender arms. States her husband did not feel anything and he thought it was just symptoms until Saturday and it was more severe Saturday into Sunday or Sunday into Monday he had chills, was cold, coughing, diarrhea and fever. Caller states her husband was very healthy and had a strict way of eating and living and he wears a mask, sometimes too much for her. Caller states they did get documents, information along with their card and was did not go into great detail and it was worrisome and it was not approved and did not consider how long after the 1st injection, it could be up to 7 days for side effect and it was still in clinical trials. States that now he felt warm today and was resting and has a tension headache since last night on the sides of his head. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Aug2021. The outcome for all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia, SARS-CoV-2 test, Tension headache
Clinical narrative: husband tested positive for Covid-19 infection after the first dose of the vaccine; not feeling well; their arms were sore and tender; fever; chills; cold; coughing; diarrhea; Tension headache; This is a spontaneous report from contactable consumer (Patient's wife). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 (age at the time of vaccination was 55-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 infection after the first dose of the vaccine on 23Aug2021, not feeling well, their arms were sore and tender, fever, chills, cold, coughing, diarrhea, tension headache. It was reported that the Comirnaty vaccine and she had questions for herself and mentioned that her husband got it a week and a half ago and he tested positive after getting the 1st vaccine. Caller stated that they both had their Pfizer COVID vaccine on Monday 16Aug2021 and her husband tested positive for Covid on 23Aug2021. States they are scheduled for the 2nd dose 06Sep2021. The patient takes no medication and was very healthy, that if it was not for working with, that with his way of life. The patient normally would not have taken the vaccine but because of he did what was required. Caller stated that the patient was fine and she thought it was Thursday night into Friday he started not feeling well and he doesn't take any medications and was very healthy. Caller stated after they got their vaccines they sat for half an hour and they both were ok, their arms were sore and tender on the 2nd day they had very tender arms. States her husband did not feel anything and he thought it was just symptoms until Saturday and it was more severe Saturday into Sunday or Sunday into Monday he had chills, was cold, coughing, diarrhea and fever. Caller states her husband was very healthy and had a strict way of eating and living and he wears a mask, sometimes too much for her. Caller states they did get documents, information along with their card and was did not go into great detail and it was worrisome and it was not approved and did not consider how long after the 1st injection, it could be up to 7 days for side effect and it was still in clinical trials. States that now he felt warm today and was resting and has a tension headache since last night on the sides of his head. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Aug2021. The outcome for all 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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: lack of efficacy- contracted COVID-19; lack of efficacy- contracted COVID-19; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  dose 1 intramuscular administered in Arm Right on 05Feb2021 (Lot Number: EM9810) at age of 37-year-old, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Lot Number: EN6202) at age of 37-year-old, both at single dose for covid-19 immunisation. Medical history included asthma. It was unknown if covid prior vaccination. Concomitant medications included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10). The patient previously took amoxicillin and experienced drug hypersensitivity. No other vaccine in four weeks. The patient experienced lack of efficacy- contracted covid-19 on 25Aug2021. Events resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 25Aug2021.  The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: lack of efficacy- contracted COVID-19; lack of efficacy- contracted COVID-19; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular administered in Arm Right on 05Feb2021 (Lot Number: EM9810) at age of 39-year-old, dose 2 intramuscular administered in Arm Right on 24Feb2021 (Lot Number: EN6202) at age of 39-year-old, both at single dose for covid-19 immunisation.  Medical history included asthma. No covid prior vaccination.   There were no concomitant medications. The patient previously took cefaclor (CECLOR) and experienced drug hypersensitivity. No other vaccine in four weeks. The patient experienced lack of efficacy- contracted covid-19 on 16Aug2021. Events resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Nasal Swab): positive on 25Aug2021.  The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart arrhythmias; This is a spontaneous report from a contactable pharmacist via Pfizer-sponsored Regulatory Authority Support via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Her patient stated she was experiencing heart arrhythmias after the Pfizer covid-19 vaccine. She had a medical question. She wanted to know why was there potassium chloride in the Pfizer COVID-19 vaccine. Her patient wanted to know why would they put something in it that will kill her. The outcome of the event was unknown.   This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Arrhythmia 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling hot, Headache, Pyrexia
Clinical narrative: burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face; fever; chills; headache; burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 45-years) on 25Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and experienced bad headache and felt lethargic. On an unspecified date in Aug2021, the patient experienced worse side effects including a burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face, fever, chills and headache. It was further reported that caller wanted to know if headache, feeling of lethargic, fever, chills, and feeling warm from the left side of his head down to his neck including the face is a reported adverse events after getting the Pfizer BionTech Covid-19 Vaccine. In clinical studies, adverse reactions in participants 16 years of age fatigue (62.9%), headache (55.1%), chills (31.9%), and fever (14.2%). LAB-1457-12.0. No information specific to warm sensation on the left side of the body.The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur
Clinical narrative: got both doses in late Apr2021 and in the middle of Jul found out I have a heart murmur now; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored Regulatory Authority Support and medical information team.  A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECG COVID-19 mRNA VACCINE), via an unspecified route of administration in Apr2021 (Lot number and Expiry date was not reported) as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 via an unspecified route of administration in Apr2021 (Lot number and Expiry date was not reported) as dose 1, single for Covid-19 immunization. It was reported, the patient had both doses in late Apr2021 and in the middle of Jul2021 the patient found out he have a heart murmur now (at the time of report). It was reported, he had undergone some tests and scheduled to have mitral valve replacement surgery because of this in the upcoming week (at the time of report). It was reported he got moved to front of the list (further details not specified) because it was so bad. The outcome for the event was not reported.   The lot number for BNT162B2  was not provided and will be requested during follow up.