chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient had tested positive for Covid virus, after being fully vaccinated; patient had tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer via medical information team. This consumer reported similar events for 37 patients. This is 34 of 37 reports. This consumer reported for an 67-years-old male patient who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318, Expiry date was not reported), via an unspecified route of administration on 28Jan2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266, Expiry date was not reported), via an unspecified route of administration on 23Feb2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus. The patient concomitant medications were not reported. It was reported that patient had tested positive for Covid virus, after being fully vaccinated on 12Aug2021. The patient underwent lab tests and procedures which included body mass index was 33.9 on an unknown date and NAAT Covid test (sars-cov-2 test) was positive on 12Aug2021. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients;US-PFIZER INC-202101081376 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Thrombosis
Clinical narrative: had a blood clot; stroke; lost her speech; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported)), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unspecified date patient who had a blood clot, stroke, lost her speech, and was hospitalized. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075369 same reporter/product, different patient / event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: schedule for second dose today however prior doing that she had a test for COVID-19 (Result of the test were unknown); schedule for second dose today however prior doing that she had a test for COVID-19 (Result of the test were unknown); This is a spontaneous report from a contactable consumer or other non HCP (patient) from a Pfizer-sponsored program via Regulatory Authority. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 19Aug2021 the patient was scheduled for second dose on same day however prior doing that she had a test for COVID-19 and further stated that result of the of the test were unknown. On 19Aug2021 the patient underwent lab tests and procedures which included test for COVID-19 which results was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Neoplasm malignant
Clinical narrative: a very rare cancer; couldn't walk after 2 weeks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on 06Jun2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: unknown) on an unspecified date at single dose for COVID-19 immunisation. After the second shot on 06Jun2021, the patient couldn't walk after 2 weeks, and was diagnosed with a very rare cancer in Jul2021. The event rare cancer resulted in doctor or other healthcare professional office/clinic visit, death, life-threatening and caused hospitalization. It was unknown whether the patient had been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of rare cancer and couldn't walk. The patient died on 19Aug2021. It was not reported if an autopsy was performed. Reported cause of patient death was cancer. The outcome of event rare cancer was fatal. The outcome of event couldn't walk was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: a very rare cancer
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paralysis, SARS-CoV-2 test
Clinical narrative: became completely paralyzed/couldn't move or talk, just tears flow through eyes; Began a horrible pain in patient's arm; Began a horrible pain in patient's arm and immediately went through patient's whole body; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left, on 01Apr2021 13:45 (at the age of 60-year-old, not pregnant) as single dose, for covid-19 immunisation. Medical history included lupus, asthma, lupus anticoagulant, stroke, allergies to sulfa and iodine. Patient did not have COVID prior vaccination. Concomitant medications included alprazolam (XANAX); valsartan; apixaban (ELIQUIS); vitamin D nos (VIT D); and magnesium probiotics. No other vaccine in four weeks. The patient previously took morphine, codeine, hydromorphone hydrochloride (DILAUDID) and oxycodone hydrochloride;paracetamol (PERCOCET), all experienced allergies. On 01Apr2021 22:00, the adverse events began at time for sleep. Began a horrible pain in patient's arm and immediately went through patient's whole body and patient became completely paralyzed. Patient couldn't move or talk, just tears flow through eyes. It lasted about 24 hrs and the slowly it took 2 day for the pain to leave. Events resulted in life threatening illness (immediate risk of death from the event. The patient underwent lab tests and procedures which included Sars-Cov-2 test (Nasal Swab) was negative on 07Aug2021. Therapeutic measures were taken as a result of events included muscle relaxants and paracetamol (TYLENOL). The outcome of events was recovered in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events paralysis, pain in extremity, and pain the suspect drug.  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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Leukaemia
Clinical narrative: Patient diagnosed with Leukemia.; Blood work done shortly (1-2 weeks) after the vaccine, showed lowered platelet count.  Previous tests had always been normal (most recent being in Nov 2020). Subsequent blood work continued to show lo; This is a spontaneous report from a Contactable consumer (patient). A 79-year-old male patient received an unknown dose of BNT162B2 via an unspecified route of administration in May2021 at the age of 79-year-old as single dose for COVID-19 immunization. Medical history included Rheumatoid arthritis. The patient did not received other vaccine in four weeks. The patient was not COVID prior vaccination. The patient did not tested COVID post vaccination. Concomitant medication was not reported. In May2021, the patient diagnosed with Leukemia, blood work done shortly (1-2 weeks) after the vaccine, showed lowered platelet count. Previous tests had always been normal (most recent being in Nov 2020). Subsequent blood work continued to show lowered platelet counts. Previous tests had always been normal (most recent being in Nov2020). Ae resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer (the patient). An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 18Jul2021 14:00 at age of 18-year-old at single dose for COVID-19 immunisation, it also reported the patient received other vaccine at first dose on 18Jul2021 in right arm. Medical history was none. No known allergies, no other medical history. There were no concomitant medications (no other vaccine in four weeks, no other medications in two weeks). No prior COVID vaccination. No COVID tested post vaccination. The patient experienced appendicitis on 18Aug2021 18:00. The event resulted in hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 2 days. Treatment for the event included surgery. The outcome of the event was recovered with sequelae (Recovered with lasting effects) in Aug2021.  The lot number for BNT162B was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Electroencephalogram, Investigation, Magnetic resonance imaging heart, Ultrasound scan
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Batch/Lot Number: FC3181) via an unspecified route of administration in left arm on 14Aug2021 at 11:30 (at the age of 57-years-old) as first dose, single for COVID-19 immunization. Medical history included ongoing diabetic type II. Concomitant medications included metformin 500mg twice a day ongoing and glimepiride 4mg twice a day ongoing; both taken for diabetes/diabetic type II from an unknown date. No prior vaccinations (within 4 weeks). On 15Aug2021 at 12:30 afternoon, the patient experienced stroke. This adverse event required to visit emergency room taken by ambulance and the patient was hospitalized from 15Aug2021 to 18Aug2021. The treatment tPA was received for the stroke and that worked. The other medications he was placed on for stroke was Low dose Aspirin regimen, Plavix 75mg for three weeks and Crestor 40mg as a continuing medication. On an unspecified date, the patient underwent magnetic resonance imaging heart, electroencephalogram (EEG), sonogram of heart and computer scan; all with unknown results. Patient mentioned that it was hard to tell at the moment as far as outcome. He felt that he has recovered yes, but unable tell at this time if there will be any lasting effects. It's only been a couple days. The outcome of the event was recovered on Aug2021.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death, Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19 like symptoms; Covid-19 like symptoms; died; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On 07Aug2021, the patient started having Covid-19 like symptoms. He rapidly progressed to similar symptoms to the 12Apr2021. Patient's wife took him to the same hospital on unspecified date in 2021 and she was not allowed to go in. Within 8 hours her husband died. The outcome of the event died was fatal, for other events was unknown. The patient died on 2021. 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: Death
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bacterial infection, Chest discomfort, Cough
Clinical narrative: coughing/cough/non-productive cough; high fever/low grade fever; loss of taste; loss of taste and smell; tight chest; fatigue; metallic taste; itchy ears, lips, eyelash line; secondary bacterial infection; headache; lethargy; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6199) via an unspecified route of administration on 23Mar2021 at 14:30 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to animal dander and urine, pollen, dust, "etc." The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number EN5318) on 02Mar2021 at 14:00 (at the age of 46-years-old) as a single dose in the right arm for COVID-19 immunization and experienced headache and lethargy 4 to 6 hours after the vaccine for about 48 hours. On 23Mar2021 the patient experienced headache and lethargy 4 to 6 hours after the second dose for about 48 hours. On an unspecified date the patient traveled to an area with high delta cases. On 26Jul2021 the patient was notified of exposure (symptomatic with positive test) from 2 people staying in the same house as the patient. She had left at that point. On 28Jul2021 the patient experienced symptoms (coughing and lethargy) and peaked on 29Jul2021 to 01Aug2021 (high fever, headache, cough, and loss of taste and smell). The patient underwent lab tests and procedures which included a COVID-19 test nasal swab (NAAT/RT-PCR nucleic acid amplification) on 11Aug2021 with result of negative. The patient's symptoms persisted (nonproductive cough, tight chest, fatigue, and loss of taste and smell) with new symptoms of metallic taste, itchy ears, lips, and eyelash line, low grade fever, and headache. The patient consulted a tele doc on 18Aug2021 because the symptoms seemed to get worse instead of better. That night the patient started antibiotic treatment with amoxicillin 125 mg every 12 hours for 7 days in case of secondary bacterial infection. The outcomes of headache, lethargy, coughing, fever, loss of taste and smell, nonproductive cough, tight chest, metallic taste, and itchy ears, lips, and eyelash line were unknown.   Sender's Comments: Linked Report(s) :INC-202101081755 same patient, different vaccine doses/events
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Lethargy, Pruritus
Clinical narrative: coughing/cough/non-productive cough; high fever/low grade fever; loss of taste; loss of taste and smell; tight chest; fatigue; metallic taste; itchy ears, lips, eyelash line; secondary bacterial infection; headache; lethargy; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6199) via an unspecified route of administration on 23Mar2021 at 14:30 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to animal dander and urine, pollen, dust, "etc." The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number EN5318) on 02Mar2021 at 14:00 (at the age of 46-years-old) as a single dose in the right arm for COVID-19 immunization and experienced headache and lethargy 4 to 6 hours after the vaccine for about 48 hours. On 23Mar2021 the patient experienced headache and lethargy 4 to 6 hours after the second dose for about 48 hours. On an unspecified date the patient traveled to an area with high delta cases. On 26Jul2021 the patient was notified of exposure (symptomatic with positive test) from 2 people staying in the same house as the patient. She had left at that point. On 28Jul2021 the patient experienced symptoms (coughing and lethargy) and peaked on 29Jul2021 to 01Aug2021 (high fever, headache, cough, and loss of taste and smell). The patient underwent lab tests and procedures which included a COVID-19 test nasal swab (NAAT/RT-PCR nucleic acid amplification) on 11Aug2021 with result of negative. The patient's symptoms persisted (nonproductive cough, tight chest, fatigue, and loss of taste and smell) with new symptoms of metallic taste, itchy ears, lips, and eyelash line, low grade fever, and headache. The patient consulted a tele doc on 18Aug2021 because the symptoms seemed to get worse instead of better. That night the patient started antibiotic treatment with amoxicillin 125 mg every 12 hours for 7 days in case of secondary bacterial infection. The outcomes of headache, lethargy, coughing, fever, loss of taste and smell, nonproductive cough, tight chest, metallic taste, and itchy ears, lips, and eyelash line were unknown.   Sender's Comments: Linked Report(s) :INC-202101081755 same patient, different vaccine doses/events
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: coughing/cough/non-productive cough; high fever/low grade fever; loss of taste; loss of taste and smell; tight chest; fatigue; metallic taste; itchy ears, lips, eyelash line; secondary bacterial infection; headache; lethargy; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6199) via an unspecified route of administration on 23Mar2021 at 14:30 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to animal dander and urine, pollen, dust, "etc." The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number EN5318) on 02Mar2021 at 14:00 (at the age of 46-years-old) as a single dose in the right arm for COVID-19 immunization and experienced headache and lethargy 4 to 6 hours after the vaccine for about 48 hours. On 23Mar2021 the patient experienced headache and lethargy 4 to 6 hours after the second dose for about 48 hours. On an unspecified date the patient traveled to an area with high delta cases. On 26Jul2021 the patient was notified of exposure (symptomatic with positive test) from 2 people staying in the same house as the patient. She had left at that point. On 28Jul2021 the patient experienced symptoms (coughing and lethargy) and peaked on 29Jul2021 to 01Aug2021 (high fever, headache, cough, and loss of taste and smell). The patient underwent lab tests and procedures which included a COVID-19 test nasal swab (NAAT/RT-PCR nucleic acid amplification) on 11Aug2021 with result of negative. The patient's symptoms persisted (nonproductive cough, tight chest, fatigue, and loss of taste and smell) with new symptoms of metallic taste, itchy ears, lips, and eyelash line, low grade fever, and headache. The patient consulted a tele doc on 18Aug2021 because the symptoms seemed to get worse instead of better. That night the patient started antibiotic treatment with amoxicillin 125 mg every 12 hours for 7 days in case of secondary bacterial infection. The outcomes of headache, lethargy, coughing, fever, loss of taste and smell, nonproductive cough, tight chest, metallic taste, and itchy ears, lips, and eyelash line were unknown.   Sender's Comments: Linked Report(s) :INC-202101081755 same patient, different vaccine doses/events
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: it tested positive for positive gamma oligoclonal bands; fever; continued to get really sick; horrible headaches/migraines; horrible headaches/migraines; severe nausea; her sedimentation rate has tripled; her C-Reactive protein level is high (In April it was 37); miss work for a week at a time including this week; her ferratin levels have dropped; inflammatory; feeling unwell; vomiting; This is a spontaneous report from a contactable Other health care professional, nurse (Patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot number were not reported) via an unknown route of administration on 11Jan2021 as dose 2, single for Covid-19 immunisation. Nurse reported that she has a history of migraines since she was a teenager. Reported an episode of anemia last year. The patient historical vaccine included bnt162b2 as dose 1, single for Covid-19 Immunization and experienced fever on an unspecified date in Dec2020. Following the second dose it was about two to three weeks later she continued to get really sick. She has seen several specialists to rule out diseases/infections. She feels that up to know her body has had an immune response that continues to make her sick. She has continued to experience horrible headaches/migraines, severe nausea requiring phenergan. With recurring fevers consumer has had a lumbar puncture for CSF sample, her provider was concerned CSF pressure was elevated and it tested positive for positive gamma oligoclonal bands in June. She has been evaluated by a Rheumatologist to rule out Lupus. She explained that her sedimentation rate has tripled and her C-Reactive protein level is high (In April it was 37). These constellation of symptoms and illness has caused her to miss work for a week at a time including this week. She has had an MRI with and without contrast of her brain with non-specific changes that she reveals are related to her history of migraines. Her hematologist has run additional labs and noted her ferratin levels have dropped. She has received medrol dose pack for inflammatory response. Her occupational health department at work did not notify VAERS and consumer explains she waited this long to report these events as she was seeing specialist to rule out other disorders. She had a follow up today with a provider and will have another follow up soon. The patient underwent lab tests and procedures which included gamma oligoclonal bands: positive, it tested positive for positive gamma oligoclonal bands in June , CSF pressure: elevated - CSF pressure was elevated and it tested positive for positive gamma oligoclonal bands in June, magnetic resonance imaging with and without contrast of her brain with non-specific changes: migraines, She has had an MRI with and without contrast of her brain with non-specific changes that she reveals are related to her history of migraines, sedimentation rate: increase- sedimentation rate has tripled, ferratin levels: dropped. The outcome of all events was unknown.   Information about lot/batch number has been requested
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Malaise, SARS-CoV-2 test, Seizure
Clinical narrative: I had 2 seizures that we know of at home and then 2 more in the ER; had an infection; wasn't feeling well; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 13Aug2021 16:00 (Lot Number: FC3180) as dose 1, single at the age of 37-year-old for covid-19 immunisation. Medical history included known allergies: latex from an unknown date and unknown if ongoing. The patient was not pregnant. No other vaccine in four weeks. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. She had the dose 1 vaccine Friday (on 13Aug2021) and wasn't feeling well Saturday (on 14Aug2021) and then Sunday  (on 15Aug2021) didn't feel too well, all she remembered was walking up and going in the living room. Then next thing she knew her mom and paramedics were over top of her. She had 2 seizures that they know of at home and then 2 more in the ER. When she went to hospital they said she had an infection and had to get 2 IVs of antibiotics and now she was on seizure meds with no history of seizures. Never had seizures before and no infection prior to the dose 1. Seizures resulted in emergency room/department visit. The seriousness of seizures was hospitalized for 4 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. Treatment received for seizures and infection which included antibiotic and seizure medicine. No COVID prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Aug2021. The outcome of seizures was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covidTested positive for covid/Fever/Coughing/Sneezing/Congested/Tired; This is a spontaneous report from a contactable pharmacist (patient). A 59-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169, Expiry Date: Unknown), via an unspecified route of administration, administered in arm, left arm on 02May2021 (at the age of 59 years) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, NDC Number, UPC Number, NDC Number, Expiry Date: Unknown), via an unspecified route of administration, administered in her left arm on 09Apr2021 (at the age of 59 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) 10mg once a day take every day taken for allergies; fluticasone propionate, salmeterol xinafoate (ADVAIR) Dose unknown, it was the diskus once a day taken for allergies. Vaccination facility type was other (It was not in the hospital, but the clinic affiliated with the local hospital). It was not military facility. She reported that although she had two doses of the vaccine, she just had a positive COVID-19 test. She also had fever (on 16Aug2021) and other symptoms. Patient started to have fever Monday Morning. The fever went away. It lasted through Tuesday and by Wednesday she was better. She clarified that the other symptoms like coughing, sneezing, congested, tired (all on unspecified date Aug2021) especially in the beginning. She confirmed that these were still ongoing, a little better, but she was not 100 percent. These events started Sunday night into Monday. It was a rough night where she was coughing all night. She was not completely better. She mentioned that she had typical post vaccine reaction after getting the Covid Vaccine. She did not feel great the day after the vaccine. She did not run a fever, but felt out of it, under the weather. No emergency room, or physician office was required. She was not hospitalized, but just sick. The patient underwent lab tests and procedures which included Covid-19 Test, PCR/Nasal swab on 17Aug2021 and the results came back on 20Aug2021 as she was positive for Covid. The patient did not receive any additional therapies for COVID-19, only took Ibuprofen for the fever. The outcome of event COVID-19 was recovering and other event was unknown.   No follow-up attempts are possible. No further information is expected.; 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 vaccination failure and covid-19 cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stones; This is a spontaneous report from a contactable Nurse. A female patient of 35-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL1284), first dose on right arm via an intramuscular route of administration on 27Dec2021 at unknown DOSE 1, SINGLE for COVID-19 immunization. She was not pregnant at time of vaccination. Medical history includes Asthma, allergies: Laundry detergent. Concomitant medications includes Multivitamin, fish oil, vitamin d, b12. The patient experienced Kidney stones. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent SARS-CoV-2 test and found negative. The outcome of Event was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Nephrolithiasis and the administration of the vaccine 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.,Linked Report(s) : US-PFIZER INC-202101089640 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Call received both doses of the Pfizer Covid-19 Vaccine.  She tested positive for COVID-19 around 01Aug2021.; Call received both doses of the Pfizer Covid-19 Vaccine.  She tested positive for COVID-19 around 01Aug2021.; This is a spontaneous report from a contactable consumer (patient). This female consumer reported for herself.  A female patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on unspecified date at DOSE NUMBER UKNOWN, SINGLE for COVID-19 immunization. She received both doses of COVID-19 Vaccine. No medical history reported. No concomitant medications reported. On 01Aug2021 patient experienced Covid -19. The patient want to know whether she can take booster dose.  Believes she is eligible to receive it in Oct2021. The patient underwent SARS-CoV-2 test on 01Aug2021 and found positive. The outcome of event was unknown.  Agency: Possible duplicate AE details E-transmitted.  Limited details obtained as caller came from Agency.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Off label use, Product use issue
Clinical narrative: The day after I receive my vaccination/since then I have been bleeding heavily and passing unusually large clots. Non stop bleeding. Painful.; I haven't had a period since before I was pregnant, and have been breast feeding my 7 month old so I have got one yet. The day after I receive my vaccination/since then  I have been bleeding heavily a; I haven't had a period since before I was pregnant, and have been breast feeding my 7 month old so I have got one yet. The day after I receive my vaccination/since then  I have been bleeding heavily; The day after I receive my vaccination/since then I have been bleeding heavily and passing unusually large clots. Non stop bleeding. Painful.; have been breast feeding her 7-month-old so she have got one yet; have been breast feeding her 7-month-old so she have got one yet; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Left arm on 20Aug2021 at the age of 31-years-old as dose 1, single for covid-19 immunisation. Medical history included latex allergy and food allergy from an unknown date. The patient was diagnosed with COVID-19 prior vaccination on an unspecified date. The patient's concomitant medications were not reported. The patient previously took tamiflu and experienced allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that the patient hasn't had a period since before she was pregnant, and have been breast feeding her 7-month-old so she have got one yet. On 21Aug2021, the day after she received her vaccination/since then she has been bleeding heavily and passing unusually large clots. Nonstop bleeding. Painful. She can't keep up with it. She was bleeding though a tampon and a pad hourly. No treatment was received for adverse events. Adverse events resulted in none of the above. The outcome of off-label use and drug use in unapproved population was unknown while outcome of other events was not recovered.  Follow-up activities are closed; Information about lot/batch number cannot be obtained.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: dead from second dose of Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program by a non-contactable consumer. This report reported same event for two patients. This is the first dose of two reports. A 13-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 13-year-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) for covid-19 immunisation. A 13 years old female is dead from second dose of Pfizer Covid 19 vaccine. Both had no prior conditions with the heart and now are dead. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101091793 same report/drug/AE, different patients; Reported Cause(s) of Death: dead from second dose of Pfizer Covid 19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dry eye
Clinical narrative: Bell's Palsy; dry eyes; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date patient experienced Bells Palsy, dry eyes. it was reported that She was also reporting having dry eyes, which the caller clarifies related to her Bell's Palsy & she was not calling specifically questioning the dry eyes but more so the Bell's Palsy. Caller wants to know if Bell's Palsy is a reaction to the vaccine. She states she knows she was not the only one who came down with Bell's Palsy after the vaccine.  The outcome of the events was unknown.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: Died; Felt bad all day Saturday and Sunday/wasn't feeling good; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 09Apr2021(at the age of 63- year-old) as dose 2, single for covid-19 immunization. Medical history included Smoker user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations were none. Family Medical History Relevant to AE(s) and Relevant Tests were reported as none. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for covid-19 immunization. Reporter stated his wife received the first dose on 10Mar and the second on 09Apr2021, which was a Friday evening. He stated she felt bad all-day Saturday(10Apr2021) and Sunday, and she was going to go to the doctor on Monday. The patient went to sleep that night and the last time she spoke to anyone was 11:00 or 11:30 that evening, 11Apr2021. Then no one could get a hold of the patient and was found dead on 12Apr2021. The reporter believed that the patient died that night of 11Apr2021. The patient did not visit to emergency room or physician office. The patient died on 12Apr2021. An autopsy was not performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: blood clot to the brain; This is a spontaneous report from a contactable consumer (patient's relative). A female patient (mother-in-law) of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient died from a blood clot to the brain on an unspecified date. The reporter personally think that it was from the Pfizer shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Reported Cause(s) of Death: blood clot to the brain
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Condition aggravated, Death
Clinical narrative: 2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine; One person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart.; One person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart.; This is a spontaneous report from a Non-contactable consumer. This consumer reported for 2 other patients that a patient of unspecified age and gender received bnt162b2 (BNT162B2), 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. Medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced 2 family's members of hers died after receiving the pfizer biontech covid 19 vaccine on an unspecified date , one person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart on an unspecified date with outcome of unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: Caller stated common knowledge that your vaccine and moderna create spike protein within the body, how do you as a company plan to fix that? It doesn't stay in the arm, the spike protein is whats causing the excess problems. Caller reported 2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine. One person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart. She also reports various adverse events...damage to the heart , Guillen barre, women miscarrying their babies, other women starting periods after menopause. Caller stated that creator of the mRNA stated that its going to kill people within 3 years. Caller also states that white coat summit states its dangerous and unsafe. How you plan on helping theses people who have financial responsibility who can no longer work, care for their families, no longer here for their families or the Comirnaty vaccine damaged them unrecognizably. Caller states that the Comirnaty vaccine is not preventing or saving anybody from the covid 19 infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: 2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: a 19 year old female is dead from second dose of Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. This report reported similar events for two patients. This is the second of two reports. A female patient of 19-years-old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 19-years-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. A 19 years old female is dead from second dose of Pfizer Covid 19 vaccine. Both had no prior conditions with the heart and now are dead. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101091051 same report/drug/AE, different patients; Reported Cause(s) of Death: a 19 year old female is dead from second dose of Pfizer Covid 19 vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac failure congestive, Cardiac monitoring, Cough, Dyspnoea
Clinical narrative: shortness of breath; coughing; Congestive heart failure; her heart had a virus; fluid under lungs and heart; fluid under lungs and heart; had a skipping heart beat; very weak; low pulse rate; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158) at the age of 63-years, via an unspecified route of administration, administered in right arm on 12Apr2021 at 12:00 at single dose for covid-19 immunisation, at pharmacy or drug store. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not pregnant at time of vaccination. There were other medications the patient received within 2 weeks of vaccination. On 09Aug2021 she had shortness of breath and coughing. Thought she had COVID again but got tested and was negative. Went to ER. Congestive heart failure. Never had a past history of any type of heart problems. After a 4 day hospital stay, she was told her heart had a virus. Still taking furosemide (LASIX) and Beta blocker to remove fluid from her under her lungs and heart. She was currently wearing a heart monitor and had a skipping heart beat. Will be seeing a EP cardiologist once reports are all in to monitor her heart. Very weak and low pulse rate. These adverse events started on 09Aug2021 at 10:00, result in emergency room/department or urgent care. The patient underwent lab tests and procedures, which included test for COVID was negative. Outcome of the events was not recovered/not resolved. The events were reported as life-threatening and hospitalization for 3 days.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Heart rate decreased, Pericardial effusion, Pleural effusion, SARS-CoV-2 test
Clinical narrative: shortness of breath; coughing; Congestive heart failure; her heart had a virus; fluid under lungs and heart; fluid under lungs and heart; had a skipping heart beat; very weak; low pulse rate; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158) at the age of 63-years, via an unspecified route of administration, administered in right arm on 12Apr2021 at 12:00 at single dose for covid-19 immunisation, at pharmacy or drug store. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not pregnant at time of vaccination. There were other medications the patient received within 2 weeks of vaccination. On 09Aug2021 she had shortness of breath and coughing. Thought she had COVID again but got tested and was negative. Went to ER. Congestive heart failure. Never had a past history of any type of heart problems. After a 4 day hospital stay, she was told her heart had a virus. Still taking furosemide (LASIX) and Beta blocker to remove fluid from her under her lungs and heart. She was currently wearing a heart monitor and had a skipping heart beat. Will be seeing a EP cardiologist once reports are all in to monitor her heart. Very weak and low pulse rate. These adverse events started on 09Aug2021 at 10:00, result in emergency room/department or urgent care. The patient underwent lab tests and procedures, which included test for COVID was negative. Outcome of the events was not recovered/not resolved. The events were reported as life-threatening and hospitalization for 3 days.   Follow-up attempts are completed. No further information is expected.