chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: "FULL BLOWN" (severe) COVID19; "FULL BLOWN" (severe) COVID19; This is a spontaneous report from a contactable Nurse (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 13May2021 (Batch/Lot number was not reported) as dose 2, single both for covid-19 immunisation. Family history included she lost her 79-years-old mom on 21Jun2021 due to covid-19. Her mom's cause of death was pulmonary embolism and had some underlying condition like heart disease and had some heart attack. The patient's concomitant medications were not reported. On an unknown date, the patient reported that she diagnosed with a full blown (severe) covid-19. She had no known underlying conditions. Patient also reported that her PCP refused to see her due to her condition and that she was forwarded to the ER for additional consultation. In line with this, she was staying at home, staying in bed, drinking a lot of fluids, never lets her O2 gets lower than 90%, get ups and walks on her room and had felt 20% felt better since then.   Follow-up (02Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of DI, COVID 19 and suspect drug BNT162B2 cannot be excluded
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pancreatitis acute
Clinical narrative: Acute Pancreatitis; Administration date: 15May2021/Dose number: 1/vaccine date: 15May2021/dose number: 2; This is a spontaneous report from a contactable consumer (patient). This 17-year-old male patient received bnt162b2 (brand: Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 15May2021 17:30 (Batch/Lot Number: EW0182) as dose 1, single at the age of 17-year-old; dose 2 via an unspecified route of administration, administered in arm left on 15May2021 (Batch/Lot Number: EW0179) as dose 2, single at the age of 17-year-old for covid-19 immunisation. No other medical history. No known allergies. No Covid prior vaccination. No Covid tested post vaccination. The patient's concomitant medications were not reported. Facility type vaccine: School or Student Health Clinic. No other vaccine in four weeks. The patient experienced acute pancreatitis on 27Jun2021 03:00. The event 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). The patient was hospitalized for acute pancreatitis for 4 days. Therapeutic measures were taken as a result of acute pancreatitis included IV fluids and starvation. The outcome of event acute pancreatitis was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Body mass index abnormal, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Died of COVID; Died of COVID; BMI greater than 40; This is a spontaneous report received from a contactable physician communicated to a sales representative. A 23-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), first dose as dose 1 single and second dose as dose 2 single, both via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Event took place after use of product. The patient experienced died of COVID, BMI greater than 40 on an unspecified date. The events drug ineffective and covid-19 assessed as serious (death, medically significant) and while for other was non-serious. The patient underwent lab tests and procedures which included body mass index: greater than 40, COVID test: died of covid on unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events drug ineffective and covid-19 was reported as fatal and while for other was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events) 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.; Reported Cause(s) of Death: Died of COVID; Died of COVID
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drainage, Influenza, Malaise
Clinical narrative: didn't feel very good after the second dose of the COVID Vaccine; COVID; COVID; drainage; a small, little cough; itchy throat; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 09Jan2021 as dose 2, single (at the age of 56-year-old) for COVID-19 immunization. Medical history included allergies (environmental or seasonal allergies. She has had allergies for a long time). Concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 22Dec2020 in left upper arm as dose 2 single (at the age of 56-year-old) for COVID-19 immunization. Patient stated that she had received second dose of COVID vaccine on 09Jan2021 and now has COVID. On 26Jul2021 (yesterday) patient diagnosed with COVID. They did a nasal COVID test and it took about 20 minutes to get results. Her symptoms started Saturday 24Jul2021. She thought it was a head cold. She had stuff running down the back of her throat. She had drainage and a small, little cough on 24Jul2021. She didn't feel bad. Today she felt a little worse. She was really stopped up, super stopped up. She doesn't feel good today.  It sounds like the Delta variant. She had a little bit of an itchy throat on Saturday, 24Jul2021, and Sunday, 25Jul2021, but it was not a sore throat. She thought it was just the stuff draining down the back of her throat like she normally has. On 27Jul2021, patient experienced didn't feel very good after the second dose of the COVID Vaccine, She gets a red arm and all that with the flu shot. Caller doesn't have the lot, and expiry for the flu shot. They would have that information at the hospital or work care. Her primary care doctor was not the one that diagnosed COVID. Quick Care was the facility that diagnosed COVID.  Patient only had phone number to provide for her primary care doctor. Vaccination facility type was hospital. It is the company she works for. The patient underwent lab test and procedures included nasal covid test resulted positive and Flu test resulted negative on 26Jul2021. The outcome of the events was unknown.   Information about lot and batch number was requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation, Vaccination failure
Clinical narrative: didn't feel very good after the second dose of the COVID Vaccine; COVID; COVID; drainage; a small, little cough; itchy throat; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 09Jan2021 as dose 2, single (at the age of 56-year-old) for COVID-19 immunization. Medical history included allergies (environmental or seasonal allergies. She has had allergies for a long time). Concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 22Dec2020 in left upper arm as dose 2 single (at the age of 56-year-old) for COVID-19 immunization. Patient stated that she had received second dose of COVID vaccine on 09Jan2021 and now has COVID. On 26Jul2021 (yesterday) patient diagnosed with COVID. They did a nasal COVID test and it took about 20 minutes to get results. Her symptoms started Saturday 24Jul2021. She thought it was a head cold. She had stuff running down the back of her throat. She had drainage and a small, little cough on 24Jul2021. She didn't feel bad. Today she felt a little worse. She was really stopped up, super stopped up. She doesn't feel good today.  It sounds like the Delta variant. She had a little bit of an itchy throat on Saturday, 24Jul2021, and Sunday, 25Jul2021, but it was not a sore throat. She thought it was just the stuff draining down the back of her throat like she normally has. On 27Jul2021, patient experienced didn't feel very good after the second dose of the COVID Vaccine, She gets a red arm and all that with the flu shot. Caller doesn't have the lot, and expiry for the flu shot. They would have that information at the hospital or work care. Her primary care doctor was not the one that diagnosed COVID. Quick Care was the facility that diagnosed COVID.  Patient only had phone number to provide for her primary care doctor. Vaccination facility type was hospital. It is the company she works for. The patient underwent lab test and procedures included nasal covid test resulted positive and Flu test resulted negative on 26Jul2021. The outcome of the events was unknown.   Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal
Clinical narrative: Stroke; I am not feeling well; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, manufacturer: Unspecified; Lot number; NDC number; UPC number; Expiry Date: Unknown) 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. Patient stated that she received the first dose and is scheduled to get the second dose, but she had a stroke and is now on blood thinners. She stated that she had the stroke after receiving the first dose of the COVID-19 vaccine. She wanted to know if there was any contraindication for getting the second dose of the vaccine while on blood thinners and also patient reported that she is not feeling well on an unknown date. She works in a hospital and she involve with people every day with covid but she is not a doctor, nurse but she is working in emergency. Therapeutic measures were taken as a result of stroke with blood thinner. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: leg weakness; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received  first dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose (Batch/Lot number was not reported), and received second dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose (Batch/Lot number was not reported) for covid-19 immunisation; teriflunomide (AUBAGIO), oral from 16Aug2019 and was ongoing, at 14 mg, 1x/day for multiple sclerosis. The patient medical history and concomitant medications were not reported. On an unknown date the patient developed a non-serious legs weakness after receiving both covid vaccines. The action taken for teriflunomide was unknown. It was not reported if the patient received a corrective treatment for the event (legs weakness after receiving both covid vaccines). At time of reporting, the outcome was Unknown for the event legs weakness after receiving both covid vaccines.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Blood pressure measurement, Blood test, Hepatic enzyme abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: unknown), dose 1, via an unspecified route of administration, administered in right arm on 08Mar2021 at 12:30 (at the age of 63-year-old) as dose 1 single for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing, cerebrovascular accident from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, psoriatic arthropathy from an unknown date and unknown if ongoing, splenomegaly from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing, non-alcoholic steatohepatitis from an unknown date and unknown if ongoing, platelet count decreased from an unknown date and unknown if ongoing. no past drug reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did receive an extensive list other medication within 2 weeks of COVID vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Mar2021 at 12:00, the patient experienced his blood sugars, blood pressure, liver enzymes and other blood chemistries doubled and have remained at this level, other blood chemistries doubled and have remained at this level. It was reported that, he had Stage 4 NASH. He was under the care of a local gastroenterologist and a liver transplant specialist. Prior to his first vaccine dose, his blood chemistries were in relatively normal range.  After his vaccine, his blood sugars, blood pressure, liver enzymes and other blood chemistries doubled and have remained at this level (since Mar2021). He has not had COVID-19. He does have cardiac issues, psoriasis, psoriatic arthritis, have had a stroke, He have low blood platelets (in the 59k range). He understands that (as there was not a lot of data out there). But wanted to report these changes. He has seen many research reports of people having COVID and liver issues/transplants. But have found none with individuals not having COVID with severe liver disease. Can this be my issue with the vaccine and my blood chemistries. The patient underwent lab tests and procedures which included blood glucose increased: increased on 16Mar2021, blood pressure measurement: increased on 16Mar2021, blood test: increased on 16Mar2021, hepatic enzyme abnormal: increased on 16Mar2021, platelet count decreased: 59k on 16Mar2021 59k range. adverse event result in patient visited doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the event was reported as unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Platelet count decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: unknown), dose 1, via an unspecified route of administration, administered in right arm on 08Mar2021 at 12:30 (at the age of 63-year-old) as dose 1 single for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing, cerebrovascular accident from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, psoriatic arthropathy from an unknown date and unknown if ongoing, splenomegaly from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing, non-alcoholic steatohepatitis from an unknown date and unknown if ongoing, platelet count decreased from an unknown date and unknown if ongoing. no past drug reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did receive an extensive list other medication within 2 weeks of COVID vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Mar2021 at 12:00, the patient experienced his blood sugars, blood pressure, liver enzymes and other blood chemistries doubled and have remained at this level, other blood chemistries doubled and have remained at this level. It was reported that, he had Stage 4 NASH. He was under the care of a local gastroenterologist and a liver transplant specialist. Prior to his first vaccine dose, his blood chemistries were in relatively normal range.  After his vaccine, his blood sugars, blood pressure, liver enzymes and other blood chemistries doubled and have remained at this level (since Mar2021). He has not had COVID-19. He does have cardiac issues, psoriasis, psoriatic arthritis, have had a stroke, He have low blood platelets (in the 59k range). He understands that (as there was not a lot of data out there). But wanted to report these changes. He has seen many research reports of people having COVID and liver issues/transplants. But have found none with individuals not having COVID with severe liver disease. Can this be my issue with the vaccine and my blood chemistries. The patient underwent lab tests and procedures which included blood glucose increased: increased on 16Mar2021, blood pressure measurement: increased on 16Mar2021, blood test: increased on 16Mar2021, hepatic enzyme abnormal: increased on 16Mar2021, platelet count decreased: 59k on 16Mar2021 59k range. adverse event result in patient visited doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the event was reported as unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient received both doses of his Pfizer COVID-19 vaccination & now months after has tested positive for COVID-19 and is currently in the hospital.; the patient received both doses of his Pfizer COVID-19 vaccination & now months after has tested positive for COVID-19 and is currently in the hospital.; This is a spontaneous report from a contactable consumer or other non-hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 (Lot Number: EW0158, Expiry date: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states that he received both doses of Pfizer COVID-19 vaccination and now months after has tested positive for COVID-19 and is currently in the hospital. He stated that patient was in the ER right now and is pretty sure the ER will complete a report. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine; My sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional (reporter's sister) via medical information team.  An 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date unknown), via an unspecified route of administration in an unspecified anatomical location on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that the patient contracted COVID-19 after receiving first dose of the Pfizer COVID-19 Vaccine on an unspecified date in 2021. The outcome of the events 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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was informed that this person was given the full regimen of the Pfizer vaccine and just recently tested positive for Covid-19; Drug ineffective; This is a spontaneous report from a contactable consumer reported for a male patient.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was given the full regimen of the Pfizer vaccine and was tested positive for COVID-19 on 27Jul2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 27Jul2021. Treatment received was reported as unknown. The patient had no COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear discomfort, Feeling abnormal, Malaise, Nasopharyngitis
Clinical narrative: Positive SARS COV-2 Rapid antigen test; Positive SARS COV-2 Rapid antigen test; Feeling sick, like a head cold; Head cold; Ears are clogged too, her brain is clogged; Ears are clogged too, her brain is clogged; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 25Mar2021 (age at vaccination 60-years-old) in morning as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 at 09:30 (in the morning) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccinations was administered within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date in Jul2021, the patient ears are clogged too, her brain is clogged. When querying her ears and brain feel clogged, she clarified she started feeling sick with a head cold on Sunday. Feeling sick, like a head cold on 25Jul2021. On 28Jul2021, the patient experienced positive sars cov-2 rapid antigen test. Went to a wedding Saturday night and thought she had a head cold. Can she tell if she has the delta variant from that test? Advised caller to follow up with primary care physician. Difficult to provide product information from the patient record card stating it is handwritten. She had not used any medication to treat a fever. Has had no fevers. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The outcome of the event (malaise, nasopharyngitis) was recovering and other events were unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive SARS COV-2 Rapid antigen test; Positive SARS COV-2 Rapid antigen test; Feeling sick, like a head cold; Head cold; Ears are clogged too, her brain is clogged; Ears are clogged too, her brain is clogged; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 25Mar2021 (age at vaccination 60-years-old) in morning as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 at 09:30 (in the morning) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccinations was administered within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date in Jul2021, the patient ears are clogged too, her brain is clogged. When querying her ears and brain feel clogged, she clarified she started feeling sick with a head cold on Sunday. Feeling sick, like a head cold on 25Jul2021. On 28Jul2021, the patient experienced positive sars cov-2 rapid antigen test. Went to a wedding Saturday night and thought she had a head cold. Can she tell if she has the delta variant from that test? Advised caller to follow up with primary care physician. Difficult to provide product information from the patient record card stating it is handwritten. She had not used any medication to treat a fever. Has had no fevers. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The outcome of the event (malaise, nasopharyngitis) was recovering and other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Nasal dryness, Syncope, Vomiting
Clinical narrative: I slipped down because I was getting a fainting symptoms; Vomiting; dry nose; I still not feeling well; I am feeling sick; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), 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 medical history and concomitant medications were not reported. On an unspecified date the patient experienced Vomiting, dry nose right now and Patient slipped down because Patient was getting a fainting symptoms Patient asked my husband for help Patient called him after that he came and we went together to the hospital then in the hospital the doctor said do something, take some medicine, then Patient took medicine, and then after Patient slept then Patient still not feeling well 3 days have passed felt sick and think she need help because she might be very sick but then she may not be sick, she was not sure what's happening. Outcome for the events syncope, vomiting, nasal dryness was unknown, for malaise, illness was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller reports she received both doses in Mar2021 and was diagnosed with Covid-19 yesterday.; Caller reports she received both doses in Mar2021 and was diagnosed with Covid-19 yesterday.; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female 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 Mar2021 as single dose and 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 on Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received both doses in Mar2021 and was diagnosed with COVID-19 yesterday on 28Jul2021. The patient (45 years old, female) inquired about reporting testing positive for COVID-19 after receiving both doses of the Pfizer Covid-19 vaccine. She received both doses in Mar2021 and was diagnosed with COVID-19 yesterday. She received an email last night, she believed it was from something she sent in on the website, with a request to call us directly. She said "my cousin and his wife also got diagnosed a couple days earlier than I did. The patient just wanted to make sure this got reported because I know you are still trying to figure all this out. Especially when the patient found out her cousin and his wife had both doses and tested positive". On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the Health Authority and 95.3% effective in preventing severe disease as defined by the Agency Vaccine was 100% effective in preventing COVID-19 cases, where the lineage is prevalento Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at: Withheld Please note that the Pfizer-BioNTech COVID-19 Vaccine-Antibody Persistence and Duration of Immunity. Data has been updated to include the Press Release information. Proposed response: Please confirm "Pfizer Covid 19 Vaccine" and speak from attached documents. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Shock symptom
Clinical narrative: shock sensation that would travel from her shoulder to her belly, to her knees and ankles, elbows and legs; This is a spontaneous report from a contactable consumer. A female patient of 62-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Her main concern is getting the 2nd dose of the vaccine. She had her 1st dose of the vaccine on 12May2021, she had a weird reaction that is not indicated in the side effects form, and she had re-ported it already. On 19May2021 patient experienced a shock sensation that would travel from her shoulder to her belly, to her knees and ankles, elbows and legs 7 days after the injection and it lasted for about a week. She's supposed to receive the 2nd dose in June, but her brother passed away and she needs to get to (place withheld) to handle everything, she just got back home in (place withheld) and now she needs guidance in getting the 2nd dose of the vaccine. The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Dizziness, Investigation, Optic nerve injury, Photopsia
Clinical narrative: Lost 95% vision in his right eye; Nerve damage in right eye/Optic nerve damage; Blood clots that cut off blood flow to optic nerve/Blood clotting; Dizziness; Seeing lights when he closed his eyes "bright blue arches of lights"; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Mar2021 as single for COVID-19 immunisation. Medical history included influenza A from an unknown date and unknown if ongoing (was diagnosed with Influenza A but as more information came out, we suspected it was covid), COVID-19 from Jan2021 to an unknown date (had Covid-19 infection before getting the vaccines in Jan; had an antibody test on an unspecified date in Feb2021 that confirmed he had it, he got it and survived). The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown) via unspecified route of administration on 24Feb2021 (at the age of 66years) as single for COVID-19 immunisation. In May2021 (2 months after getting the second dose of the vaccine), the patient began experiencing dizziness, seeing lights when he closed his eyes "bright blue arches of lights", lost 95% vision in his right eye due to blood clots that cut off blood flow to optic nerve, and nerve damage in right eye. It was a sudden onset just within 2 months period after getting the vaccine so the patient can't explain it any other way, it was either the infection or the vaccine. He didn't know if this blindness was because of the vaccine but he was waiting to find out. The patient was in the hospital and had multiple tests done and that's where they detected the optic nerve damage and the blood clotting on an unspecified date on 2021. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Thrombosis
Clinical narrative: Lost 95% vision in his right eye; Nerve damage in right eye/Optic nerve damage; Blood clots that cut off blood flow to optic nerve/Blood clotting; Dizziness; Seeing lights when he closed his eyes "bright blue arches of lights"; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Mar2021 as single for COVID-19 immunisation. Medical history included influenza A from an unknown date and unknown if ongoing (was diagnosed with Influenza A but as more information came out, we suspected it was covid), COVID-19 from Jan2021 to an unknown date (had Covid-19 infection before getting the vaccines in Jan; had an antibody test on an unspecified date in Feb2021 that confirmed he had it, he got it and survived). The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown) via unspecified route of administration on 24Feb2021 (at the age of 66years) as single for COVID-19 immunisation. In May2021 (2 months after getting the second dose of the vaccine), the patient began experiencing dizziness, seeing lights when he closed his eyes "bright blue arches of lights", lost 95% vision in his right eye due to blood clots that cut off blood flow to optic nerve, and nerve damage in right eye. It was a sudden onset just within 2 months period after getting the vaccine so the patient can't explain it any other way, it was either the infection or the vaccine. He didn't know if this blindness was because of the vaccine but he was waiting to find out. The patient was in the hospital and had multiple tests done and that's where they detected the optic nerve damage and the blood clotting on an unspecified date on 2021. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Dizziness, Inappropriate schedule of product administration, Polymerase chain reaction, SARS-CoV-1 test
Clinical narrative: Lost 95% vision in his right eye; Nerve damage in right eye/Optic nerve damage; Blood clots that cut off blood flow to optic nerve/Blood clotting; Dizziness; Seeing lights when he closed his eyes "bright blue arches of lights"; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Mar2021 as single for COVID-19 immunisation. Medical history included influenza A from an unknown date and unknown if ongoing (was diagnosed with Influenza A but as more information came out, we suspected it was covid), COVID-19 from Jan2021 to an unknown date (had Covid-19 infection before getting the vaccines in Jan; had an antibody test on an unspecified date in Feb2021 that confirmed he had it, he got it and survived). The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown) via unspecified route of administration on 24Feb2021 (at the age of 66years) as single for COVID-19 immunisation. In May2021 (2 months after getting the second dose of the vaccine), the patient began experiencing dizziness, seeing lights when he closed his eyes "bright blue arches of lights", lost 95% vision in his right eye due to blood clots that cut off blood flow to optic nerve, and nerve damage in right eye. It was a sudden onset just within 2 months period after getting the vaccine so the patient can't explain it any other way, it was either the infection or the vaccine. He didn't know if this blindness was because of the vaccine but he was waiting to find out. The patient was in the hospital and had multiple tests done and that's where they detected the optic nerve damage and the blood clotting on an unspecified date on 2021. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Blindness unilateral, Botulinum toxin injection, COVID-19, Computerised tomogram
Clinical narrative: Lost 95% vision in his right eye; Nerve damage in right eye/Optic nerve damage; Blood clots that cut off blood flow to optic nerve/Blood clotting; Dizziness; Seeing lights when he closed his eyes "bright blue arches of lights"; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Mar2021 as single for COVID-19 immunisation. Medical history included influenza A from an unknown date and unknown if ongoing (was diagnosed with Influenza A but as more information came out, we suspected it was covid), COVID-19 from Jan2021 to an unknown date (had Covid-19 infection before getting the vaccines in Jan; had an antibody test on an unspecified date in Feb2021 that confirmed he had it, he got it and survived). The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown) via unspecified route of administration on 24Feb2021 (at the age of 66years) as single for COVID-19 immunisation. In May2021 (2 months after getting the second dose of the vaccine), the patient began experiencing dizziness, seeing lights when he closed his eyes "bright blue arches of lights", lost 95% vision in his right eye due to blood clots that cut off blood flow to optic nerve, and nerve damage in right eye. It was a sudden onset just within 2 months period after getting the vaccine so the patient can't explain it any other way, it was either the infection or the vaccine. He didn't know if this blindness was because of the vaccine but he was waiting to find out. The patient was in the hospital and had multiple tests done and that's where they detected the optic nerve damage and the blood clotting on an unspecified date on 2021. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Magnetic resonance imaging, Optic ischaemic neuropathy, Photopsia
Clinical narrative: Lost 95% vision in his right eye; Nerve damage in right eye/Optic nerve damage; Blood clots that cut off blood flow to optic nerve/Blood clotting; Dizziness; Seeing lights when he closed his eyes "bright blue arches of lights"; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Mar2021 as single for COVID-19 immunisation. Medical history included influenza A from an unknown date and unknown if ongoing (was diagnosed with Influenza A but as more information came out, we suspected it was covid), COVID-19 from Jan2021 to an unknown date (had Covid-19 infection before getting the vaccines in Jan; had an antibody test on an unspecified date in Feb2021 that confirmed he had it, he got it and survived). The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown) via unspecified route of administration on 24Feb2021 (at the age of 66years) as single for COVID-19 immunisation. In May2021 (2 months after getting the second dose of the vaccine), the patient began experiencing dizziness, seeing lights when he closed his eyes "bright blue arches of lights", lost 95% vision in his right eye due to blood clots that cut off blood flow to optic nerve, and nerve damage in right eye. It was a sudden onset just within 2 months period after getting the vaccine so the patient can't explain it any other way, it was either the infection or the vaccine. He didn't know if this blindness was because of the vaccine but he was waiting to find out. The patient was in the hospital and had multiple tests done and that's where they detected the optic nerve damage and the blood clotting on an unspecified date on 2021. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I have had problems with my breathing; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 42-years-old female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on Apr2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on Mar2021 for covid-19 immunization. It was reported that patient received shot back in March then April since then she had problems with her breathing. Patient wanted to know what is going on. Therapeutic measures were taken as a result of i had problems with my breathing with inhalers and prednisone. The outcome for the event was reported as unknown at the time of this report.   Information about lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested Positive for CoVid 19 on July 29th.; I tested Positive for CoVid 19 on July 29th.; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 21Apr2021 at 10:45 at the age of (23-years-old) as a single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered on 31Mar2021 at 15:45 at the age of (23-years-old) as a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for positive for COVID-19. Medical history included none. No known allergies. 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 There were no concomitant medications. It was reported on 29Jul2021 at 09:30 the patient was tested positive for covid-19. The patient underwent lab tests and procedures which included on 27Jul2021 Nasal Swab test: positive, on 29Jul2021 Nasal Swab: positive. Case was reported as non serious. No treatment was received for adverse event (ae). The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Anxiety, COVID-19, Drug ineffective
Clinical narrative: Contracted COVID; Contracted COVID; almost died; antibodies were 1100; This is a spontaneous report from a Pfizer via a Non-contactable female consumer (patient, self-reported).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included arthritus (she was unable to take Methotrexate for her arthritus). Concomitant medications were not reported. The patient reported that received both vaccines. On an unspecified date, she contracted COVID after first dose and was hospitalized on an unspecified date for 2 months where she was unable to take Methotrexate for her arthritis and stated almost died and antibodies were 1100, refused to get booster shot. The patient underwent lab test and procedure included antibody test on an unspecified date with a result of 1100 and SARS-CoV-2 test on an unspecified date with a result of Contracted COVID. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.