chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: heart felt like it was fluttering; Had no appetite; felt like something was sitting on chest; Slept all day; felt tired; sore arm/arm hurt very badly; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received bnt162b2, intramuscular, administered in Arm Left on 12Jul2021 17:00 (Lot Number: ew0181) as DOSE 1, SINGLE at age of 12-year-old for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart felt like it was fluttering on 13Jul2021 19:00, sore arm/arm hurt very badly on 12Jul2021 19:00, felt tired on 13Jul2021, had no appetite on 13Jul2021 19:00, felt like something was sitting on chest on 13Jul2021 19:00, slept all day on 13Jul2021 19:00. Evening had sore arm. Next morning felt tired and arm hurt very badly. Had no appetite. Evening of next day felt like something was sitting on chest and heart felt like it was fluttering. Slept all day and next day woke up felt ok. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Middle ear effusion
Clinical narrative: fluid in his ears; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jul2021 08:00 (Batch/Lot Number: FA6780, does not see NDC or expiration date) as DOSE 1, SINGLE (age at vaccination 44 years old) for covid-19 immunisation.  The patient medical history included sinus problem (sinus thing is something that he has had before, he has a sinus problem before the vaccine). There were no concomitant medications.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The consumer states he is supposed to go back and take the other one, referring to the Pfizer COVID 19 vaccine. He is sick right now (from unknown date in 2021), there is fluid in his ears, so he is not going to go. He clarifies that he received the first dose of the Pfizer COVID 19 vaccine last month 03Jul2021 at 08:00AM in the left arm. He started to have the fluid in his ears about five days ago (unknown date in 2021) and he went to the doctor and took some medication and he feels by next week he can do it but he is not going to get another vaccination when he is sick. The consumer confirms he thinks he was supposed to get the second dose of the vaccination on 05Aug2021 but he is not going to get it. Sometimes the fluid in his ear goes away fast and sometimes not. He states this has nothing to do with the vaccination, it is caused from his sinuses. He is going to give the medication time to work. The events did not require a visit to the Emergency Room. The events did require a Physician Office visit- was seen at walk in clinic. Relevant tests were none. Therapeutic measures were taken as a result of fluid in his ears and feel sick. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The event fluid in ears in attributed to an intercurrent or underlying condition, and is considered unrelated to the suspect drug. A potential contributor includes history of sinus disorder. This case will be reassessed upon receipt of additional information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Cystoscopy, Haematuria, SARS-CoV-2 test, Urine analysis
Clinical narrative: Gross hematuria for 2 days after both COVID-19 vaccines given; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 09:00 (Batch/Lot Number: PAA156051) as dose 1, single (at the age of 56-years-old) and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included vitiligo, appendectomy, gall bladder removed, broken wrist and ankle; and occasional inflammatory bowel disease (IBS): Only once a year on average. Concomitant medication included amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported. The patient previously took tramadol and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Dec2020, the patient experienced gross hematuria for 2 days after both COVID-19 vaccines given. It then stopped. The patient has never had this before. The patient was now having hematuria off and on for last 8 months. The event was still happening at the time of this report. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had lab tests (urinalysis), CT urogram and cystoscopy in 2021 with unknown results. On 23Jun2021, COVID-19 nasal swab was negative. The patient has not recovered from the event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: some light bleeding; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:30 (at the age of 55 years old) (Lot Number: ER8731; Expiration Date: 31Jul2021) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included ongoing ulcerative colitis, ongoing ulcerative proctitis, ongoing Crohn's disease, ongoing rosacea (in her 20s-30s) and menopause. The patient previously took metronidazole (METROGEL) for 30 years with no issue. Patient had no Prior Vaccinations within 4 weeks. On an unspecified day in 2021, patient reported some light bleeding after the first vaccination then after the second vaccination on 11May2021, patient experienced a full blown period after menopause. The event resulted in a physician office visit. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Someone reported getting covid after being fully vaccinated; Someone  reported getting covid after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/ Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, reported getting COVID after being fully vaccinated on an unspecified date. The patient experienced positive sars-cov-2 test. The patient underwent lab tests and procedures which included sars-cov-2 test: yes on an unspecified date.  (Since the vaccination, has the patient been tested for COVID-19 Yes). The outcome of the event reported as unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Patient passed out; vomited 5 or so minutes later; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on 04Aug2021 (lot number and expiry date: unknown) at the age of 16-years-old, as dose 1, single, for COVID-19 immunization. The patient's medical history included fear of needles, has passed out 4 or so times in past from injections/needles and taking of blood at doctors' offices. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in doctor's office/urgent care. On 04Aug2021, the patient passed out and vomited 5 or so minutes later. The events were not treated. The patient recovered from the events on unspecified date in 2021. The patient has not been tested for COVID-19 since vaccination.  Information on lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Joint swelling, Pain, Pain assessment
Clinical narrative: At times it was Throbbing to Pain level 10; Swollen fingers, hands/Swollen feet; Swollen wrists/Swollen ankles; Pain in Shoulders, Hips; Could not walk for several weeks; Loss of Bladder control; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 08:30 (Lot Number: EW0169  (EW969)) at age of 71-year-old as dose 2, single for COVID-19 immunisation. The patient is not pregnant at the time of the vaccination. Medical history included seasonal allergy. Concomitant medications included atorvastatin calcium (LIPITOR); fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide; multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took potassium chloride (KDUR) and experienced allergy, took bnt162b2 dose 1 on 01Apr2021 08:30 am (lot number=EL3302) in left arm at age of 71-year-old for COVID-19 immunisation. On 25Apr2021 16:00, the patient experienced swollen fingers, hands, (At times it was Throbbing to Pain level 10) wrists ,feet, ankles, pain in shoulders, hips, the patient could not walk for several weeks, lost of bladder control. The events resulted in doctor or other healthcare professional office/clinic visit. The case was reported as non-serious. The patient received treatment for the events included medication and pain medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urinary incontinence
Clinical narrative: At times it was Throbbing to Pain level 10; Swollen fingers, hands/Swollen feet; Swollen wrists/Swollen ankles; Pain in Shoulders, Hips; Could not walk for several weeks; Loss of Bladder control; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 08:30 (Lot Number: EW0169  (EW969)) at age of 71-year-old as dose 2, single for COVID-19 immunisation. The patient is not pregnant at the time of the vaccination. Medical history included seasonal allergy. Concomitant medications included atorvastatin calcium (LIPITOR); fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide; multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took potassium chloride (KDUR) and experienced allergy, took bnt162b2 dose 1 on 01Apr2021 08:30 am (lot number=EL3302) in left arm at age of 71-year-old for COVID-19 immunisation. On 25Apr2021 16:00, the patient experienced swollen fingers, hands, (At times it was Throbbing to Pain level 10) wrists ,feet, ankles, pain in shoulders, hips, the patient could not walk for several weeks, lost of bladder control. The events resulted in doctor or other healthcare professional office/clinic visit. The case was reported as non-serious. The patient received treatment for the events included medication and pain medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Since the vaccination, the patient has been tested for COVID-19. It was reported that patient who had caught Covid after vaccination on an unspecified date also reported that several others they knew had also tested positive after vaccination (believe 2 others). It is unknown whether the vaccine they had received is the Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Also tested positive after vaccination (believe 2 others); Also tested positive after vaccination (believe 2 others); This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number: unknown), 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 underwent sars-cov-2 test and tested positive after vaccination on an unspecified date. It was unknown whether the vaccine they had received is the Pfizer vaccine. Outcome of the event covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration in Feb2021 (at unspecified age of vaccination) (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. It was unknown it the patient was diagnosed with COVID-19 prior to vaccination. On an unspecified date in Jul2021, the patient was tested positive for COVID although receiving the Pfizer vaccine in Feb with outcome of unknown. The patient went to the ER for IV fluids and was hospitalized. It was also reported the it was unknown if treatment was received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, has the patient been tested for COVID-19. The patient underwent lab tests and procedures which included: Nasal Swab (Sars-cov-2 test): positive on an unspecified date in Jul2021 (COVID test post vaccination), Nasal Swab (Sars-cov-2 test): positive an unspecified date in Jul2021 (COVID test post vaccination). The patient has been tested for COVID-19 since the vaccination.  The reporter assessed events as serious with seriousness criteria of caused/prolonged hospitalization and did not result in death, life threatening, disabling or incapacitating, congenital anomaly or birth defect.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable consumer. The reporter reported reports for four patients.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive and became ill from  covid-19 on 24Jul2021 with outcome of unknown. The patient was hospitalized because of the event.  The patient underwent lab tests and procedures which included two  sars-cov-2 test: positive   on Jul2021.  Informatio about Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: rare blood cancer; This is a spontaneous report from a non-contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included autoimmune disease. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) on an unspecified date for COVID-19 immunization. The patient experienced rare blood cancer on an unspecified date after vaccination and will be starting chemotherapy soon. It was also reported that the patient's doctor wanted to give her a COVID booster shot so she wanted to be in a COVID booster trial. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Musculoskeletal chest pain
Clinical narrative: Sharp pain in my heart; ribs on my left side became sore in front and back; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: FA7484), via an unspecified route of administration, administered in right arm on 02Aug2021 15:00 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus, breast cancer on left side from 2014, high blood pressure, and known allergies to sulfa titanium. Prior to vaccination, the patient was not pregnant, did not have COVID and did not receive any other vaccines within 4 weeks. The patient had unspecified concomitant medication within 2 weeks of vaccination. On 03Aug2021 13:00, the patient reported sharp pain in her heart. Her ribs on the left side became sore in the front and back. No treatment was received for the events. Post-vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Aug2021.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Blood pressure measurement, Condition aggravated, Hypotension, Presyncope
Clinical narrative: Neurocardiogenic syncope; heart block; Worsening of symptoms with subsequent vaccination; low blood pressures (<90/50); Pre-syncope prodrome; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm right on 24Dec2020 13:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. The vaccine was administered at the workplace clinic. The patient medical history included neurocardiogenic syncope with heart block requiring pacemaker. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 24Dec2020 13:15, pre-syncope prodrome within 15 minutes of administration with low blood pressures (<90/50) for 4 days post vaccination despite hydration, salt, and compression stockings. Formal diagnosis of neurocardiogenic syncope with heart block and pacemaker prior to vaccination. No symptoms of disease prior to vaccination. Worsening of symptoms with subsequent vaccination. No treatment was provided for the events. The outcome of the events was recovered with sequel. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of Syncope, Atrioventricular block, Condition aggravated, Hypotension are assessed as possibly related to the suspect drug BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Neurocardiogenic syncope; heart block; Worsening of symptoms with subsequent vaccination; low blood pressures (<90/50); Pre-syncope prodrome; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm right on 24Dec2020 13:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. The vaccine was administered at the workplace clinic. The patient medical history included neurocardiogenic syncope with heart block requiring pacemaker. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 24Dec2020 13:15, pre-syncope prodrome within 15 minutes of administration with low blood pressures (<90/50) for 4 days post vaccination despite hydration, salt, and compression stockings. Formal diagnosis of neurocardiogenic syncope with heart block and pacemaker prior to vaccination. No symptoms of disease prior to vaccination. Worsening of symptoms with subsequent vaccination. No treatment was provided for the events. The outcome of the events was recovered with sequel. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of Syncope, Atrioventricular block, Condition aggravated, Hypotension are assessed as possibly related to the suspect drug BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Loss of consciousness, Nervous system disorder, Seizure
Clinical narrative: stroke-like symptoms; episodes of passing out/seizure like reaction; episodes of passing out/seizure like reaction; experiencing prolonged neurological issues; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), tow doses both via an unspecified route of administration, administered in right arm on an unspecified date (at 28-year-old, not pregnant at time of vaccination) as single dose, for COVID-19 immunization. Medical history included allergies: amide, PCOS (polycystic ovarian syndrome). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin (METFORMIN) taken for PCOS, thyroid medication. On 01Aug2021 the patient was experiencing prolonged neurological issues. She had multiple episodes of passing out/seizure like reaction. Presenting at hospital with stroke-like symptoms. Nearly a week later she still had dizziness and neurological issues. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Pending additional testing. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Cerebrovascular accident, Loss of consciousness, Seizure cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was diagnosed with COVID-19 after being fully vaccinated; was diagnosed with COVID-19 after being fully vaccinated; This is a spontaneous report from a non-contactable consumer. A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There is unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient on 04Aug2021 was diagnosed with covid-19 via SARS-COV-2 test (nasal swab) after being fully vaccinated. The outcome of the events was not recovered.  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: Cellulitis, Deep vein thrombosis, Erythema, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: early DVT; cellulitis; Presumed superficial phlebitis; moderate swelling; severe erythema; tenderness to left lower leg radiating to groin.; D Dimer mildly elevated along with white blood cell count; D Dimer mildly elevated along with white blood cell count; This is a spontaneous report from a contactable physician. A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) intramuscularly in the left arm on 03Aug2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were reported as None. Patient did not have any known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications within 2 weeks of vaccination as received by patient was reported as None.  On 04Aug2021 (1 day after vaccination), patient had early DVT (deep vein thrombosis), cellulitis, presumed superficial phlebitis and developed moderate swelling with severe erythema and tenderness to left lower leg radiating to groin and D-Dimer mildly elevated along with white blood cell count. No preceding injury or explanation. The adverse events were DVT and Cellulitis were reported to be serious. The adverse events result in visit to emergency room. Treatment received were antibiotics, steroids and anticoagulation. Lab test included ultrasound scan and evaluation showed no evidence of DVT, D Dimer test shows mildly elevated along with elevated white blood cell count, on 04Aug2021. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis and cellulitis cannot be totally 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Phlebitis superficial, Swelling, Ultrasound scan, White blood cell count
Clinical narrative: early DVT; cellulitis; Presumed superficial phlebitis; moderate swelling; severe erythema; tenderness to left lower leg radiating to groin.; D Dimer mildly elevated along with white blood cell count; D Dimer mildly elevated along with white blood cell count; This is a spontaneous report from a contactable physician. A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) intramuscularly in the left arm on 03Aug2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were reported as None. Patient did not have any known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications within 2 weeks of vaccination as received by patient was reported as None.  On 04Aug2021 (1 day after vaccination), patient had early DVT (deep vein thrombosis), cellulitis, presumed superficial phlebitis and developed moderate swelling with severe erythema and tenderness to left lower leg radiating to groin and D-Dimer mildly elevated along with white blood cell count. No preceding injury or explanation. The adverse events were DVT and Cellulitis were reported to be serious. The adverse events result in visit to emergency room. Treatment received were antibiotics, steroids and anticoagulation. Lab test included ultrasound scan and evaluation showed no evidence of DVT, D Dimer test shows mildly elevated along with elevated white blood cell count, on 04Aug2021. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis and cellulitis cannot be totally 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: early DVT; cellulitis; Presumed superficial phlebitis; moderate swelling; severe erythema; tenderness to left lower leg radiating to groin.; D Dimer mildly elevated along with white blood cell count; D Dimer mildly elevated along with white blood cell count; This is a spontaneous report from a contactable physician. A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) intramuscularly in the left arm on 03Aug2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were reported as None. Patient did not have any known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications within 2 weeks of vaccination as received by patient was reported as None.  On 04Aug2021 (1 day after vaccination), patient had early DVT (deep vein thrombosis), cellulitis, presumed superficial phlebitis and developed moderate swelling with severe erythema and tenderness to left lower leg radiating to groin and D-Dimer mildly elevated along with white blood cell count. No preceding injury or explanation. The adverse events were DVT and Cellulitis were reported to be serious. The adverse events result in visit to emergency room. Treatment received were antibiotics, steroids and anticoagulation. Lab test included ultrasound scan and evaluation showed no evidence of DVT, D Dimer test shows mildly elevated along with elevated white blood cell count, on 04Aug2021. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis and cellulitis cannot be totally 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.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after getting vaccinated and a week later he was buried; This is a spontaneous report from a contactable consumer. This consumer (patient's friend) reported for a male patient (reporter's friend). A male patient of an unspecified age 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. The patient's medical history and concomitant medications were not reported. The patient got sick after getting vaccinated and a week later he was buried on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: got sick after getting vaccinated and a week later he was buried
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity, SARS-CoV-1 test, Sinusitis, Vaccination failure
Clinical narrative: Caller states she had fluid behind her ears and the doctor said it was probably from the typical sinus infection she gets from allergies.; Caller states she had fluid behind her ears and the doctor said it was probably from the typical sinus infection she gets from allergies.; Tested positive for Covid 19, after receiving both doses of the Covid vaccine.; Tested positive for Covid 19, after receiving both doses of the Covid vaccine.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EN6201) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 21Jan2021 (at the age of 68-years-old) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reports her and her male friend were vaccinated in Jan2021 and Feb2021 and her friend was recently diagnosed with Covid and she said this makes her nervous. The patient states actually, yesterday she was diagnosed with Covid as well (medically significant) on 04Aug2021 17:30, and it freaked her out. She states she wears a mask and she got the shots at , and just to find out had she has Covid, she couldn't believe it. She states she hope y'all give us a booster soon. she started with a little cough on Saturday on 31Jul2021 and she went to the doctor on Monday. She states she had fluid behind her ears and the doctor said it was probably from the typical sinus infection she gets from allergies. Patient states the antibiotic he prescribed she was allergic to, so she didn't take it. She states while she was waiting from them to change it, in the meantime, she went to take her friend to get tested and she was tested as well. She states he had bad chills, and all this stuff. She states all she had was a bad cough. Bad headache on 04Aug2021. She did let everyone know that she had been around that she got Covid. She states she was freaking out and she wears masks. She states this makes her think the Delta variant was dangerous. She states now she had a bad headache, she had intermittent spurts of the cough and headache. She states she will have her friend call and report for himself. She states he got a lot sicker than she did. She asks, does call handler think they are going to get a booster for us. She was going to go take some Advil because she has a bad headache. Headache and cough was not recovered. The patient underwent lab test and procedure included Covid-19 test with positive result on 04Aug2021 17:30. The outcome of all events outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He got COVID; He got COVID; This is a spontaneous report from a contactable consumer(patient).  A 78-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiration dates were unknown), first dose on 31Jan2021 and second dose on 21Feb2021, both via unspecified route of administration at single doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient reported that he was diagnosed with COVID almost exactly 6 months from the first dose of vaccination, 5 months from the second one. At the time of report, he was waiting to get an infusion. The patient underwent lab tests and procedures which included rapid BD Veritor COV-2 Rapid antigen swab on 04Aug2021, and the results showed he had COVID.  The outcome of the events were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: he did not had a temperature but today I took it like four or five times and it started to go up/fever; allergy; lot of congestion / very congestive; difficulty in breathing / hard time breathing; chest hurt a little bit; arms were sore and may be his lymph nodes a little; arms were sore and may be his lymph nodes a little; tired; slept a little more than normal; does not feel well / he just not feel right; achy; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 12:00 (Batch/Lot Number: EW0181) (at the age of 13 years old) as single dose for covid-19 immunisation. Medical history included: he was born with cleft palate, he also has a lot of nasal congestion and a deviated septum, somewhat of compromised he could have a little bit of compromised system, and had several surgeries over the years. The patient's concomitant medications were not reported. The patient received the vaccine last 29Jul2021 at 12:00, and he just didn't had any side effect other than his arms was sore and may be his lymph nodes a little and he was tired, like he slept a little more than normal but today (04Aug2021) and yesterday (03Aug2021), the parent didn't know if it has anything to do with vaccine or not, the patient has been experiencing with lot of congestion, difficulty in breathing and his chest hurt a little bit. Yesterday (03Aug2021), the parent took his (patient) temperature twice and he did not have a temperature but today (04Aug2021) the parent took it like four or five times and it started to go up/fever at 10 in the morning it's 99.5 and then it went up after 11 o'clock at 99.6, 1:30 at 99.7 then the parent just did it again at 6:30 it was 100.7 and in between patient was given Claritin because the parent thought it was allergy related and then also the parent had just given him some Ibuprofen too to try to get the fever down. The patient was very congestive the last two days and he has hard time breathing. On an unknown date in 2021, he does not feel well and he was saying he was achy, he was saying that he just not feel right but the parent didn't know if it's allergy related or if it's around somebody after or before the shot if it has anything to do with the shot. The parent stated that the patient can't get a doctor's appointment tomorrow however he/she wants to know if he/she should be concerned because the patient did not seem well and did not want him to suffer in any way. The patient underwent lab tests which included body temperature: he did not have a temperature on 03Aug2021, he did not have a temperature on 03Aug2021, 99.5 on 04Aug2021 at 10 in the morning, 99.6 on 04Aug2021 (it went up after 11 o'clock), 99.7 on 04Aug2021 at 1:30, 100.7 on 04Aug2021 at 6:30. The adverse events were considered important medical events and resulted in physician's office visit. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: it sounded like she was dying.3 people she knows that have this.; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A contactable consumer reported similar events for 4 patients. This is 1 of 4 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer reported that her friend got vaccinated, and it sounded like the patient was dying. 3 people, the consumer knew that had this (from Withheld), and she thinks that maybe (Withheld) were getting worse effects. The consumer wanted to know anyone have these same symptoms and if we knew anything about that. The reporter was provided information from the attached document and referred to HCP for further guidance, symptom management and treatment recommendations. Also spoke from the no information section of the attached VR regarding knowing if the information on side effects was broken down by race. The reporter replied, stating that 3 of them (her and some friends from Withheld) have this. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-202101007383 same reporter, same drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: It sounded like she was dying; This is a spontaneous report. A contactable consumer reported for a female patient (reporter's friend).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The consumer reported it sounded like she was dying in 2021, went to 4 or 5 doctors and didn't do anything. The patient was ready to go see a different doctor somewhere there. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunosuppression
Clinical narrative: I am immunosuppressed; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that "I am immunosuppressed and I want to participate in your booster trial if you have one. I have already taken both of my Pfizer Covid shots." The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Full body excruciating pain/Paralyzing pain in the evenings from chin down; Hips killing him/Knee pain; Get so bad in evenings cannot walk, legs lock up, fingers, and toes hurt; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jun2021 14:45 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation at the age of 41-year-old. Medical history included ongoing crohn's disease that diagnosed about 9 years ago. Concomitant medicationt included azathioprine (IMURAN [AZATHIOPRINE]) taken for crohn's disease from an unspecified start date and ongoing. The patient previously took remicade 3 weeks prior to his Covid Vaccine, the doctor discontinued it to put him on a different medication at that time. The patient received bnt162b2 dose 1 administered in Arm Left on 27May2021 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation at the age of 41-year-old. On 23Jun2021, the patient experienced Full body excruciating pain, the patient states pain is excruciating from his chin down. States it could be called paralyzing, especially in the evenings.  Says it gets so bad in the evenings that he cannot walk, his legs lock up, his hips are killing him, his fingers and toes are hurting, his knees are hurting.  Patient states it has not improved, only gotten worse. The events resulted in visit of Emergency Room and Physician Office. The doctors are not able to diagnose what is going on, some of them will say its the vaccine but will not verify it or put it on paper. The patient thinks his reaction may have to do with his underlying condition of Crohn's disease. The outcome of event was Not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101009308 same product/event, different patient