chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for Coronavirus; Tested positive for Coronavirus; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 25Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Coronavirus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Patient got the booster of Pfizer Covid Vaccine on 25Oct2021 and tested positive for Coronavirus on Monday-he did not specify which Monday/date.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Maternal exposure during pregnancy, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Mild injection site soreness; General Malaise; received both doses of the BNT162b2 SARS-CoV-2 vaccine at 29 0/7 weeks' and 32 0/7 weeks' gestation; This is a literature report.  This is a report of a 33-year-old physician who received both doses of the BNT162b2 SARS-CoV-2 vaccine at 29 0/7 weeks' and 32 0/7 weeks' gestation, respectively. She tolerated both doses well with only mild injection site soreness and general malaise with each. She had spontaneous labor at 38 5/7 weeks and delivered a healthy male infant with positive IgG SARS-CoV-2 antibodies in the umbilical vein blood sample at the time of birth. The mother also had IgG SARS-CoV-2 antibodies confirmed at the time of birth. She is healthy with no prior medical conditions and one prior term birth. There was no evidence of prior SARS-CoV-2 infection in the mother who had a negative SARS-CoV-2 IgG antibody test before vaccination, and two negative nasal swab PCR tests including one prenatally and at the time of delivery. Lab test included SARS-CoV-2 PCR (Maternal nasal swab) at 4 weeks' prenatal was negative; SARS-CoV-2 IgG (Maternal venous) at 12 weeks' gestation was negative; SARS-CoV-2 PCR (Maternal nasal swab) at 38 weeks' gestation was negative; SARS-CoV-2 IgG (Umbilical vein) at delivery was positive; SARS-CoV-2 IgG (Maternal venous) at delivery was positive.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Blood clot (DVT) in right leg; pulmonary embolism (multiple blood clots in lungs); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Aug2021 (Lot number: EWO198) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (First dose, Batch/Lot Number: EYO584), administration date: 21Jul2021, when the patient was 46 years old, for Covid-19 Immunisation. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 11Aug2021, outcome "not recovered", described as "Blood clot (DVT) in right leg"; PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening) with onset 11Aug2021, outcome "not recovered", described as "pulmonary embolism (multiple blood clots in lungs)". The patient was hospitalized for deep vein thrombosis, pulmonary embolism (hospitalization duration: 1 day(s)). The events "blood clot (dvt) in right leg" and "pulmonary embolism (multiple blood clots in lungs)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism and treatment included blood thinners. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: really bad chest pain; I was having achiness all over my body; This is a spontaneous report received from a contactable reporter (Medical assistant) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left (Lot number: 330308D) as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Medical conditions or Concomitant medications: "No, all I have is Asthma. That is all". The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "really bad chest pain"; PAIN (non-serious), outcome "unknown", described as "I was having achiness all over my body". Therapeutic measures were taken as a result of chest pain, pain.  Additional information: The patient did not receive any prior vaccinations. The patient did not had any laboratory test. The patient went to her doctor due to reaction from covid-19 vaccine. The patient was treated with Tylenol and Motrin. The doctor told her to keep drinking treatment medications and rest.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Pancreatitis acute
Clinical narrative: Lab work showing acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The consumer reported same events for himself and his brother. This case is for his brother.   A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose :1, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PANCREATITIS ACUTE (medically significant), outcome "unknown", described as "Lab work showing acute pancreatitis". The event "lab work showing acute pancreatitis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: acute pancreatitis; computerised tomogram: unknown result.  Additional information: The caller stated his brother was having the same symptoms that the caller had.  His brother's lab work was showing acute pancreatitis.  Caller states his brother was advised by the doctor to go to the Emergency Room as soon as possible for a CT Scan. The caller stated his brother had his second dose of the Covid Vaccine 3 weeks ago and was now on his way to the emergency room with pancreatitis.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721024 Same reporter, same drug, same event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in the right ear; This is a spontaneous report from a contactable reporter (other health professional). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Jan2021 at 13:15 (Lot number: EL3247) at the age of 34 years as dose 1 and bnt162b2 (BNT162B2), administered in left arm, administration date 19Feb2021 at 13:30 (Lot number: EN6201) at the age of 34 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Tonsillectomy" start date: an unknown date in 1997 (unspecified if ongoing) and "Hernia repair" start date: an unknown date in 1990 (unspecified if ongoing). There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 29Jan2021 at 18:00, outcome "unknown", described as "Tinnitus in the right ear". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: It was reported as, in the evening hours after receiving the first dose of the vaccine, the patient developed tinnitus in the right ear and only lasted a short while less than 1 hour. This was the first time ever happened to her, and happened a second time hours after receiving the second dose also. The second time it lasted a bit longer but did go away. At the time there were no reports of tinnitus side effects from the COVID vaccine but there were reports from patients who had been sick with COVID and experienced tinnitus as a result. The patient had continued to experience tinnitus sporadically since then and most recently experienced it for several hours during the night. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   Follow-up (10Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: on the third week I got positive with the COVID-19; on the third week I got positive with the COVID-19; Flu symptoms; runny nose; sneezing nonstop; getting this cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 (Lot number: FE3590) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot no: 301358A), administration date: 20Sep2021, when the patient was 49 years old, for Covid-19 Immunization. Patient had no problem and no issue. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "on the third week I got positive with the COVID-19"; INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "Flu symptoms"; RHINORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 2021, outcome "not recovered", described as "sneezing nonstop"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "getting this cold". Patient took the second shot on 14Oct2021 so 'getting' second shot two week later. Patient was feeling flu symptoms so for two weeks patient had almost like the flu and on the third week she got positive with the COVID-19 and she 'was taking' this same safety since last year nothing changes. So patient did not know how she was okay until she took the second shot of Pfizer vaccine and all of the sudden she was not that 100 percent that she used to. She was still suffering as of now, she was still having runny nose and was still sneezing nonstop, something was not right what was this way something was not right. Patient had been getting this cold this running nose. Two weeks after second vaccination, patient experienced flu symptoms had started and had tested positive, Positive for COVID. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, Vaccination failure
Clinical narrative: on the third week I got positive with the COVID-19; on the third week I got positive with the COVID-19; Flu symptoms; runny nose; sneezing nonstop; getting this cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 (Lot number: FE3590) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot no: 301358A), administration date: 20Sep2021, when the patient was 49 years old, for Covid-19 Immunization. Patient had no problem and no issue. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "on the third week I got positive with the COVID-19"; INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "Flu symptoms"; RHINORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 2021, outcome "not recovered", described as "sneezing nonstop"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "getting this cold". Patient took the second shot on 14Oct2021 so 'getting' second shot two week later. Patient was feeling flu symptoms so for two weeks patient had almost like the flu and on the third week she got positive with the COVID-19 and she 'was taking' this same safety since last year nothing changes. So patient did not know how she was okay until she took the second shot of Pfizer vaccine and all of the sudden she was not that 100 percent that she used to. She was still suffering as of now, she was still having runny nose and was still sneezing nonstop, something was not right what was this way something was not right. Patient had been getting this cold this running nose. Two weeks after second vaccination, patient experienced flu symptoms had started and had tested positive, Positive for COVID. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood phosphorus, Blood urine, C-reactive protein, Drug abuse
Clinical narrative: Uncontrolled head movement; Facial twitch/ Uncontrolled eye twitches; Headache; it feels weird. She got an unusual 'sensation'. Her head feels weird; intermittent exotropia; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant), outcome "not recovered", described as "Uncontrolled head movement"; MUSCLE TWITCHING (medically significant), outcome "not recovered", described as "Facial twitch/ Uncontrolled eye twitches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels weird. She got an unusual 'sensation'. Her head feels weird"; STRABISMUS (non-serious), outcome "unknown", described as "intermittent exotropia". The reporter stated, "the most serious one that keeps continuing she (patient) has uncontrolled head movement, twitches (voice incomprehensive) she has facial twitch and she is having some uncontrolled eye twitches." The patient underwent the following laboratory tests and procedures: blood magnesium, blood phosphorus, blood urine, notes: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; c-reactive protein, drug abuse, full blood count, metabolic function test, red blood cell sedimentation rate, toxicologic test, troponin, and urinalysis: all on (23Nov2021) results unknown. The reporter stated that the second dose was scheduled on 04Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Feeling abnormal, Full blood count, Headache, Metabolic function test
Clinical narrative: Uncontrolled head movement; Facial twitch/ Uncontrolled eye twitches; Headache; it feels weird. She got an unusual 'sensation'. Her head feels weird; intermittent exotropia; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant), outcome "not recovered", described as "Uncontrolled head movement"; MUSCLE TWITCHING (medically significant), outcome "not recovered", described as "Facial twitch/ Uncontrolled eye twitches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels weird. She got an unusual 'sensation'. Her head feels weird"; STRABISMUS (non-serious), outcome "unknown", described as "intermittent exotropia". The reporter stated, "the most serious one that keeps continuing she (patient) has uncontrolled head movement, twitches (voice incomprehensive) she has facial twitch and she is having some uncontrolled eye twitches." The patient underwent the following laboratory tests and procedures: blood magnesium, blood phosphorus, blood urine, notes: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; c-reactive protein, drug abuse, full blood count, metabolic function test, red blood cell sedimentation rate, toxicologic test, troponin, and urinalysis: all on (23Nov2021) results unknown. The reporter stated that the second dose was scheduled on 04Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Red blood cell sedimentation rate, Strabismus, Toxicologic test, Troponin
Clinical narrative: Uncontrolled head movement; Facial twitch/ Uncontrolled eye twitches; Headache; it feels weird. She got an unusual 'sensation'. Her head feels weird; intermittent exotropia; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant), outcome "not recovered", described as "Uncontrolled head movement"; MUSCLE TWITCHING (medically significant), outcome "not recovered", described as "Facial twitch/ Uncontrolled eye twitches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels weird. She got an unusual 'sensation'. Her head feels weird"; STRABISMUS (non-serious), outcome "unknown", described as "intermittent exotropia". The reporter stated, "the most serious one that keeps continuing she (patient) has uncontrolled head movement, twitches (voice incomprehensive) she has facial twitch and she is having some uncontrolled eye twitches." The patient underwent the following laboratory tests and procedures: blood magnesium, blood phosphorus, blood urine, notes: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; c-reactive protein, drug abuse, full blood count, metabolic function test, red blood cell sedimentation rate, toxicologic test, troponin, and urinalysis: all on (23Nov2021) results unknown. The reporter stated that the second dose was scheduled on 04Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Uncontrolled head movement; Facial twitch/ Uncontrolled eye twitches; Headache; it feels weird. She got an unusual 'sensation'. Her head feels weird; intermittent exotropia; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant), outcome "not recovered", described as "Uncontrolled head movement"; MUSCLE TWITCHING (medically significant), outcome "not recovered", described as "Facial twitch/ Uncontrolled eye twitches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels weird. She got an unusual 'sensation'. Her head feels weird"; STRABISMUS (non-serious), outcome "unknown", described as "intermittent exotropia". The reporter stated, "the most serious one that keeps continuing she (patient) has uncontrolled head movement, twitches (voice incomprehensive) she has facial twitch and she is having some uncontrolled eye twitches." The patient underwent the following laboratory tests and procedures: blood magnesium, blood phosphorus, blood urine, notes: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; c-reactive protein, drug abuse, full blood count, metabolic function test, red blood cell sedimentation rate, toxicologic test, troponin, and urinalysis: all on (23Nov2021) results unknown. The reporter stated that the second dose was scheduled on 04Dec2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Investigation, Skull fractured base
Clinical narrative: have a stroke; I'm partially blind; Destroyed my right occipital lobe; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on [02Dec2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "have a stroke"; BLINDNESS (medically significant) with onset 2021, outcome "not recovered", described as "I'm partially blind"; SKULL FRACTURED BASE (medically significant) with onset 2021, outcome "unknown", described as "Destroyed my right occipital lobe". The patient underwent the following laboratory tests and procedures: investigation: unknown results, notes: After months of testing with every test that modern medicine has, there's no explanation as to why it happened. Additional information: Three weeks after patient's first Pfizer shot in Sep2021, patient had a stroke that destroyed his/her right occipital lobe. After months of testing with every test that modern medicine has, there was no explanation as to why it happened. The only common denominator. Pfizer. Now patient's career was ruined because patient was partially blind.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Magnetic resonance imaging
Clinical narrative: Major hearing loss in left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Aug2021 (Lot number: FD8448) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history (no known allergies). There were no concomitant medications. The following information was reported: DEAFNESS (medically significant) with onset 30Aug2021, outcome "not recovered", described as "Major hearing loss in left ear". The event "major hearing loss in left ear" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (2021) unknown. Therapeutic measures were taken as a result of deafness (Amoxicillin and MRI prescribed). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: the Covid 19 Vaccine killed her Aunt; This is a spontaneous report received from a non-contactable reporter (Consumer-patient's niece) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "the Covid 19 Vaccine killed her Aunt". The patient date of death was unknown. The reported cause of death was "the Covid 19 Vaccine killed her Aunt". It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: the Covid 19 Vaccine killed her Aunt
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; Symptoms similar to sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 1, single and administration date 22Mar2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "tested positive for Covid", SINUSITIS (non-serious) with onset 2021, outcome "unknown", described as "Symptoms similar to sinus infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.   No related quality issues were identified during the investigation.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infection / covid test result=Positive; Breakthrough infection / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Feb2021 (Lot number: EL3247) at the age of 41 years as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergies: Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2021, outcome "recovering" and all described as "Breakthrough infection / covid test result=Positive". The event "breakthrough infection / covid test result=positive" and "breakthrough infection / covid test result=positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional Information: if other vaccine in four weeks: No, other medications in two weeks: N/A, adverse event: Breakthrough infection, if covid prior vaccination: No, if covid tested post vaccination Yes, other medical history N/A. Dose received: 2, Most recent dose details: Product= COVID 19, Brand= Pfizer. Previous dose details: Prev dose product=COVID 19, Prev dose brand=Pfizer.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have long covid. It had improved significantly before I got the 2nd vaccine; I have long covid. It had improved significantly before I got the 2nd vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0179) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Known allergy-Not fully allergic, but intolerant to many medications and foods" (unspecified if ongoing), notes: Not fully allergic, but intolerant to many medications and foods. Concomitant medication(s) included: CLARITIN ALLERGIC. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 12Jun2021, outcome "not recovered" and all described as "I have long covid. It had improved significantly before I got the 2nd vaccine". The event "i have long covid. it had improved significantly before i got the 2nd vaccine" and "i have long covid. it had improved significantly before i got the 2nd vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: covid-19: positive, notes: I have long covid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient had long COVID. It had improved significantly before patient got the 2nd vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. patient did not received any other vaccine within 4 weeks of COVID Vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomited; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 25Nov2021 03:30, outcome "recovered" (2021), described as "vomited"; DIARRHOEA (non-serious) with onset 25Nov2021 03:30, outcome "recovered" (2021), described as "diarrhea". Therapeutic measures were not taken as a result of vomiting, diarrhoea.  Additional Information: About 42 hours after her first dose, she woke up in the night and vomited and had diarrhea. The patient didn't had any covid prior vaccination and was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Headache; Got extremely ill; His arm hurt for days; Shortness of breath; He had chills; Fever; Was sleeping like a vampire / didn't wake up until 07:00PM to 08:00PM at night; No appetite; Felt chest pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 29Oct2021 03:00 (Lot number: FD0809) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (hospitalization) with onset Oct2021, outcome "unknown", described as "His arm hurt for days"; DYSPNOEA (hospitalization) with onset Oct2021, outcome "unknown", described as "Shortness of breath"; CHILLS (hospitalization) with onset Oct2021, outcome "unknown", described as "He had chills"; PYREXIA (hospitalization) with onset Oct2021, outcome "unknown", described as "Fever"; SLEEP DISORDER (hospitalization) with onset Oct2021, outcome "unknown", described as "Was sleeping like a vampire / didn't wake up until 07:00PM to 08:00PM at night"; DECREASED APPETITE (hospitalization) with onset Oct2021, outcome "unknown", described as "No appetite"; CHEST PAIN (hospitalization) with onset Oct2021, outcome "unknown", described as "Felt chest pains"; HEADACHE (hospitalization) with onset 30Oct2021 03:00, outcome "unknown", described as "Headache"; ILLNESS (hospitalization) with onset Oct2021, outcome "unknown", described as "Got extremely ill". The patient was hospitalized for pain in extremity (start date: 31Oct2021). Therapeutic measures were taken as a result of pain in extremity, sleep disorder, headache.  Clinical course: Patient says his arm hurt for days after the shot and for treatment he put ice on it. He says he was put into the hospital 31Oct2021 as a result of that injection and went home a couple hours later. He says the hospital gave him meds for the headache he had had for four days. He says at first he tried to take Motrin for the headache but that didn't do nothing, and the hospital gave him something then told him to take Tylenol from now on, which he took over the counter extra strength for the dose. he was in perfect health before he got the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Headache; Got extremely ill; His arm hurt for days; Shortness of breath; He had chills; Fever; Was sleeping like a vampire / didn't wake up until 07:00PM to 08:00PM at night; No appetite; Felt chest pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 29Oct2021 03:00 (Lot number: FD0809) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (hospitalization) with onset Oct2021, outcome "unknown", described as "His arm hurt for days"; DYSPNOEA (hospitalization) with onset Oct2021, outcome "unknown", described as "Shortness of breath"; CHILLS (hospitalization) with onset Oct2021, outcome "unknown", described as "He had chills"; PYREXIA (hospitalization) with onset Oct2021, outcome "unknown", described as "Fever"; SLEEP DISORDER (hospitalization) with onset Oct2021, outcome "unknown", described as "Was sleeping like a vampire / didn't wake up until 07:00PM to 08:00PM at night"; DECREASED APPETITE (hospitalization) with onset Oct2021, outcome "unknown", described as "No appetite"; CHEST PAIN (hospitalization) with onset Oct2021, outcome "unknown", described as "Felt chest pains"; HEADACHE (hospitalization) with onset 30Oct2021 03:00, outcome "unknown", described as "Headache"; ILLNESS (hospitalization) with onset Oct2021, outcome "unknown", described as "Got extremely ill". The patient was hospitalized for pain in extremity (start date: 31Oct2021). Therapeutic measures were taken as a result of pain in extremity, sleep disorder, headache.  Clinical course: Patient says his arm hurt for days after the shot and for treatment he put ice on it. He says he was put into the hospital 31Oct2021 as a result of that injection and went home a couple hours later. He says the hospital gave him meds for the headache he had had for four days. He says at first he tried to take Motrin for the headache but that didn't do nothing, and the hospital gave him something then told him to take Tylenol from now on, which he took over the counter extra strength for the dose. he was in perfect health before he got the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Pyrexia
Clinical narrative: Fever; Bone aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Batch/Lot number: EW0175) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/lot number: Er8732, Anatomical Location: Arm Left), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "Severe headache", "fatigue", "Loss of appetite", "Body ache".  The following information was reported: PYREXIA (non-serious) with onset 23Apr2021, outcome "recovering", described as "Fever"; BONE PAIN (non-serious) with onset 23Apr2021, outcome "recovering", described as "Bone aches"; HEADACHE (non-serious) with onset 23Apr2021, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of pyrexia, bone pain, headache.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough infection/Positive PCR; breakthrough infection/Positive PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administered in arm left, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN. Patient had no relevant past drug history, no known allergies. Patient had no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Nov2021, outcome "recovering" and all described as "breakthrough infection/Positive PCR". Breakthrough infection - congestion, headache, body aches and pains, fatigue, cough. Since the vaccination, the patient had been tested for COVID-19. The event "breakthrough infection/positive pcr" and "breakthrough infection/positive pcr" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: PCR: (30Nov2021) positive, notes: Nasal Swab; Binax: (30Nov2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 with REGEN-COV.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Immunisation
Clinical narrative: Got both doses of the Pfizer Covid 19 vaccine and the booster.; Her husband did pass away from end stage dementia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (death) with onset 2021, outcome "fatal", described as "Got both doses of the Pfizer Covid 19 vaccine and the booster."; DEMENTIA (death) with onset 2021, outcome "fatal", described as "Her husband did pass away from end stage dementia". Patient was dying of end stage dementia. Consumer was taking care of him and watching him slowly die. Consumer stated her husband did pass away from end stage dementia. The patient date of death was 2021. The reported cause of death was dementia. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: husband did pass away from end stage dementia
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Immunisation, Myalgia
Clinical narrative: FEELIGN COLD; CHILLS; Fatigue; Muscle aches; Dose received: 3; This is a spontaneous report from a non-contactable pharmacist. The reporter is the patient.   A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown, Route of Administration: Unspecified, Anatomical Location: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown, Route of Administration: Unspecified, Anatomical Location: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; FEELING COLD (non-serious) with onset 09Dec2021, outcome "not recovered", described as "FEELIGN COLD"; CHILLS (non-serious) with onset 09Dec2021, outcome "not recovered", described as "CHILLS"; FATIGUE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Muscle aches". Therapeutic measures were taken as a result of feeling cold, chills, fatigue and myalgia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with OTC products- dayquill. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.