chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: bloody stool; Severe stomach pains; fever(103 degrees); diarrhea; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 (Batch/Lot Number: EN6208) at the age of 35-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications, no other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Severe stomach pains, diarrhea, fever (103 degrees), bloody stool on 24Mar2021 06:00. Adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment included Antibiotics, pain meds and colonoscopy for adverse events of Severe stomach pains, fever and bloody stool. Covid test post vaccination (Nasal Swab) on 02Apr2021: Negative. The outcome of the events was recovering. The patient received second dose of bnt162b2 (lot number: ER8737) on 02Apr2021 at Left arm for covid-19 immunisation.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event haematochezia, abdominal pain and pyrexia and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report from two contactable consumers. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Lot number was not reported) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 09Apr2021. The reporter were calling to report that there were 3 students in line behind their daughter waiting to be vaccinated on 09Apr2021. They reported that one of the students in line behind her daughter (patient) went into cardiac arrest following receiving the Covid-19 vaccine. The patient needed to be defibrillated on scene. Treatment was received for the event. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: His platelets has falling and was hospitalized; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 16Mar2021 08:30 (Lot Number: En6199), at the age of 61-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included Cancer immune compromised. The patient did not have COVID-19 prior vaccination. Historical vaccine includes first dose of BNT162B2 on 23Feb2021. Concomitant medications included aspirin; ticagrelor (BRILINTA); amlodipine besilate, ramipril (COREYRA); cetirizine hydrochloride (ZYRTEC); sacubitril valsartan sodium hydrate (ENTRESTO), all were taken for unspecified indication, start and stop date were not reported.  His platelet count on 05Feb2021 was 182. First shot on 23Feb2021. His platelet count on 05Mar2021 was 113. His 2nd shot was on 16Mar2021. His platelet count on 04Apr2021 was 47. His platelets was falling on 23Mar2021 (reported event onset) and was hospitalized for 8 days. Received platelets and waiting bone marrow biopsy results. Event required ER and physician office visit.  The patient was tested for COVID post vaccination, with unknown results. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Convulsions; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient experienced convulsions on an unspecified date with outcome of unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram, Extrasystoles, Heart rate, Palpitations
Clinical narrative: arrhythmia; Heart palpitations; additional heartbeats 10% of the time during 5 days monitor; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the first dose of bnt162b2, via an unspecified route of administration on 30Mar2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stage two kidney disease, LBBB, covid prior vaccination. Concomitant medication included metoprolol; atorvastatin. The patient experienced heart palpitations/arrhythmia did monitor for 10 days and had additional heartbeats 10% of the time during 5 days monitor. ECG and echo done and her monitor for 5 days. The events were occurred on 31Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: arrhythmia; Heart palpitations; additional heartbeats 10% of the time during 5 days monitor; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the first dose of bnt162b2, via an unspecified route of administration on 30Mar2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stage two kidney disease, LBBB, covid prior vaccination. Concomitant medication included metoprolol; atorvastatin. The patient experienced heart palpitations/arrhythmia did monitor for 10 days and had additional heartbeats 10% of the time during 5 days monitor. ECG and echo done and her monitor for 5 days. The events were occurred on 31Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Headache, Platelet count, Platelet count increased
Clinical narrative: Heavy bleeding; High platelet counts; head aches; This is a spontaneous report from a contactable consumer reporting for herself. A 38-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 16Feb2021 (lot number EN6200) at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as none. Historical Vaccine included first dose of BNT162B2 (lot number: EL3247) on 26Jan2021 on left arm for COVID-19 immunization. The patient experienced heavy bleeding, high platelet counts and headaches, all on 16Feb2021. No treatment was received for the events. The outcome of the events were not resolved.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Malaise
Clinical narrative: This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfizer sponsored program. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP534) via an unspecified route of administration, administered in Arm Left, at the age of 59-year-old, on 22Mar2021 08:30, as SINGLE DOSE for covid-19 immunization.  Medical history included three strokes, hypertension, diabetes mellitus. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect and had no prior vaccinations within the last 4 weeks. Concomitant medications included metformin taken for diabetes mellitus (has been taking for many years) and losartan taken for hypertension since 2018 (has been taking for about 3 years).  On 09Apr2021, the patient was feeling bad and went to the hospital. There he was told that he has had three strokes in the past. The patient was told that one of the strokes was about a month ago (Mar2021). He went to the hospital three days ago. He was not admitted and was sent home. He went back again and was sent home. He was started on Plavix two days ago for stroke. The events required emergency room visit. The patient right now is working and travelling and he supposed to have the 2nd dose of the vaccine on 12Apr2021. He wants to know if he can take it late or what possible that he can do. Outcome of was feeling bad was unknown while the event stroke recovered in 2021 with sequelae.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in a clinic facility on 09Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021, the patient experienced convulsions. The outcome of the event was unknown.  No follow-up attempts are completed; information about batch/lot cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Gastric haemorrhage, Rectal haemorrhage
Clinical narrative: Bleeding from his stomach, from his anus, seriously; Bleeding from his stomach, from his anus, seriously; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) at single dose for an unspecified indication.  The patient medical history and concomitant medications were not reported.  The patient experienced having some adverse reaction on an unspecified date: He is bleeding from his stomach, from his anus, seriously. Inquiry regarding bleeding from his stomach, from his anus, seriously relative to the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Muscular weakness, Nausea, SARS-CoV-2 test
Clinical narrative: Fainted; Sudden light nausea; Full body chills; Muscle weakness in legs; Lightheadedness; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 26Feb2021 12:15 (lot number EN6203) and on 19Mar2021 12:00 (lot number EN6208), respectively, both via an unspecified route of administration in the right arm (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included: fluoxetine hydrochloride (PROZAC), lorazepam, and pantoprazole. The patient had an allergy to contrast dye. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced sudden light nausea, then full body chills, followed by muscle weakness in legs, and lightheadedness, then she fainted. Then she was fine. This whole reaction progression took place within 60 seconds, plus about 2 minutes for full leg muscle strength to return. No treatment was received for the events. The patient had a negative nasal swab COVID test on 04Mar2021. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; Sudden light nausea; Full body chills; Muscle weakness in legs; Lightheadedness; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 26Feb2021 12:15 (lot number EN6203) and on 19Mar2021 12:00 (lot number EN6208), respectively, both via an unspecified route of administration in the right arm (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included: fluoxetine hydrochloride (PROZAC), lorazepam, and pantoprazole. The patient had an allergy to contrast dye. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced sudden light nausea, then full body chills, followed by muscle weakness in legs, and lightheadedness, then she fainted. Then she was fine. This whole reaction progression took place within 60 seconds, plus about 2 minutes for full leg muscle strength to return. No treatment was received for the events. The patient had a negative nasal swab COVID test on 04Mar2021. The outcome of the events was recovered on an unspecified date.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chills, Headache, Pyrexia
Clinical narrative: troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Troponin, Troponin increased
Clinical narrative: troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: 31Jul2021), via an unspecified route of administration, on 11Apr2021 (at the age of 58 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM8727/expiration date: 31Jul2021), via an unspecified route of administration, on 21Mar2021 (at the age of 58 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension, when he was about 45, probably 10 years and was recovering from leukemia onset 2 years ago, in 2019 and he has been recovering from leukemia since about 2020; the patient had an ongoing history of being a little overweight, with onset unknown other than over 10 years ago. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) 10mg tablet taken by mouth once daily for hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, late afternoon the patient experienced swelling in his face, couldn't blink, drooping and was diagnosed with Bells Palsy which required an emergency room visit. He was not admitted to the hospital for this event, was kept under observation only in the emergency room on 12Apr2021. He was given some medication and then discharged. Bell's Palsy affected his right side of his face. The outcome was improved, the pain was a little less; but he still does not have, nothing works on the right side of his face. His right eye does not blink, eyebrow does not move, and he still can't speak very good. Treatment was received for the event. The outcome of the events Bells Palsy was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden visual loss, Visual acuity tests
Clinical narrative: Significant sudden lost of vision on left eye.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0150), via an unspecified route of administration, administered in right arm on 30Mar2021 02:30 as single dose for COVID-19 immunisation. Medical history included remitting multiple sclerosis (MS). The patient had no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), latanoprost, timolol and glatiramer acetate. On 10Apr2021 09:30, the patient experienced significant sudden lost of vision on left eye. Previous day/night vision was normal then all of the sudden, after a week and a half from first dose of Covid-19 vaccination, vision in his left eye deteriorated 90 percent. The event resulted in disability or permanent damage. The patient did not receive therapy for the event. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dizziness, Loss of consciousness
Clinical narrative: she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:45 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, atrial fibrillation from Aug2020 and ongoing , cystitis. Concomitant medications included sulfamethoxazole, trimethoprim taken for cystitis from 27Mar2021 to 02Apr2021; apixaban (ELIQUIS) taken for atrial fibrillation from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for Blood pressure from an unspecified start date and ongoing. The patient received first dose of bnt162b2 for COVID-19 immunization on 15Mar2021 lot number: EN6202, Expiry date: 30Jun2021. The patient received the second dose of the Covid vaccine around 8:45 a.m. and states that she "felt fabulous." On 06Apr2021 she felt fabulous. She said that she had a doctors appointment at 1200 06Apr2021 and her blood pressure was good. She said that she was also taking an antibiotic prior to that week. She asked the doctors about taking vaccines after taking the antibiotic since the medication said that you should avoid vaccines while taking the antibiotic, and they all said that it was fine. She came home about 1330 06Apr2021 and she passed out while making her lunch. She hurt her ankle from it and she is not a happy camper.  She said that all her vitals were good and her blood was good. That was all taken 2 hours before she passed out. The weird thing was she never felt better that day after she passed out. She said that she had no reaction after the first shot. Prior to this she felt good and there was no warning, she just felt dizzy so fast and passed out. Caller said that her ankle is getting better and she hurt her toe too, but it is getting better. She treated the ankle with ice. She said that it could have been worse. She said that she did not understand this and had no side effects previously. The event passed out was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: good on an unspecified date her blood was good. Therapeutic measures were taken as a result of she hurt her ankle from it (arthralgia). The outcome of the event passed out was recovered with sequel on 06Apr2021, unknown for the other events.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness, X-ray
Clinical narrative: it made her sick/got horrible sick; This is a spontaneous report from a contactable consumer (patient).   An 84-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 11Mar2021 (Lot Number: EN6206), at the age of 84-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing (stated that she had Covid, she was in the hospital for 35 days). There were no concomitant medications.  The patient stated she got one shot of the Pfizer Covid 19 vaccine and it made her sick on 12Mar2021. The patient said her HCP said not to get another one. The patient stated her health department told her she had no coverage at all. She wants to know if that is true. The patient said she had Covid and asked would not she have antibodies from that. The patient stated that she had one shot and got horrible sick and ended up in the hospital. She stated that it was like she got Covid again. Stated that they took X-rays of her chest and did blood work the same day she went to the hospital and told her that everything was good. The outcome of the event was recovered on 15Mar2021.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Right side of face freezes (possible Bell's palsy) upon awakening from sleep; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER20150), via an unspecified route of administration in right arm, on 12Apr2021 at 07:00 PM (19:00), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccine was administered in four weeks. On 13Apr2021 at 06:30 AM, the patient's right side of face freezes (possible Bell's palsy) upon awakening from sleep. No treatment was administered for the event. The patient has not been tested for COVID-19 post-vaccination. The outcome of the event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), administered on the left arm on 03Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 05Mar2021, the patient had pericarditis; assessed as serious (medically significant). The event had resulted into an emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient had received bisoprolol as treatment for pericarditis. The patient had a negative nasal swab COVID-19 test on 10Mar2021. The outcome of the events was recovering. The patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 post-vaccination. The event occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: Heavy menstrual bleeding with clots; Heavy menstrual bleeding with clots; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 08Apr2021 13:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant and had no other vaccine in 4 weeks. On 08Apr2021 13:30, the patient experienced heavy menstrual bleeding with clots. There was no therapy for the events. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Outcome of events was recovered on an unspecified date.  Information about Lot/Batch number is requested.; Sender's Comments: Based on the available information the reported events were attributed to  an underlying or  an intercurrent medical condition and  it is assessed as unrelated to the  suspect drug bnt162b2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Psoriatic arthropathy
Clinical narrative: A flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis; A flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8734) via an unspecified route of administration in the right arm on 09Apr2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medial history included HTN (hypertension), high cholesterol, CAD (coronary artery disease), depression, allergic rhinitis, all from unspecified dates and unspecified if ongoing and ongoing psoriasis and psoriatic arthritis from unspecified dates. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included apremilast (OTEZLA) taken for psoriasis and psoriatic arthritis from an unspecified date and unspecified if ongoing. It was reported that no other vaccine was received in four weeks prior to the COVID-19 vaccine and it was also reported that another vaccine was reported in two weeks prior to the COVID-19 vaccine. The patient previously received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration in the right arm on 19Mar2021 at 09:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. On 11Apr2021 the patient experienced a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis. The clinical course was reported as follows: "I take Otezla for Psoriasis and Psoriatic Arthritis. I have been well controlled for over a year. On the 3rd day following the vaccine I developed a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis." Treatment was not received for the events. The clinical outcomes of the events a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis were both recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: she passed out after taking her second dose yesterday; This is a spontaneous report from Pfizer-sponsored program. A non-contactable female consumer (patient) of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on Apr2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient passed out after taking her second dose yesterday (Apr2021). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fall
Clinical narrative: still real weak, like a real bad flu; still real weak, like a real bad flu; cannot hear really well; really frustrated; Diarrhea; major chills; my whole body was shaking; Dizzy; almost fell twice; really sick; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 as single for covid-19 immunisation. Patient medical history included bone graft on18Mar2021. Patient concomitant medication included amoxicillin (500mg) taken for bone graft from 19Mar2021. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on 05Mar2021 as single for covid-19 immunisation. On 30Mar2021 patient experienced It was not until few hours later got severe diarrhea it was like pure water and then like 6 hours after that started having major chills, whole body was shaking and nurse had to get up to go the bathroom and patient was so dizzy, holding on to bed and she  almost fell twice, she had been holding on but she was really sick and she couldn't take temperature because she afraid coming downstairs and then the next day she was still real weak, like a real bad flu and she had no idea that If could took up the temperature because she couldn't come downstairs to take temperature. Nurse stated really frustrated, she cannot hear well. The patient reported that she just had dental surgery. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Hypoacusis, Illness, Influenza, Tremor
Clinical narrative: still real weak, like a real bad flu; still real weak, like a real bad flu; cannot hear really well; really frustrated; Diarrhea; major chills; my whole body was shaking; Dizzy; almost fell twice; really sick; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 as single for covid-19 immunisation. Patient medical history included bone graft on18Mar2021. Patient concomitant medication included amoxicillin (500mg) taken for bone graft from 19Mar2021. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on 05Mar2021 as single for covid-19 immunisation. On 30Mar2021 patient experienced It was not until few hours later got severe diarrhea it was like pure water and then like 6 hours after that started having major chills, whole body was shaking and nurse had to get up to go the bathroom and patient was so dizzy, holding on to bed and she  almost fell twice, she had been holding on but she was really sick and she couldn't take temperature because she afraid coming downstairs and then the next day she was still real weak, like a real bad flu and she had no idea that If could took up the temperature because she couldn't come downstairs to take temperature. Nurse stated really frustrated, she cannot hear well. The patient reported that she just had dental surgery. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Pain, SARS-CoV-2 test
Clinical narrative: Aches and pains; this morning I went and I had a rapid COVID test and it says it tested positive; this morning I went and I had a rapid COVID test and it says it tested positive; still felt like had some flu; This is a spontaneous report from a contactable consumer or other non-HCP. A 59-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. Concomitant medications included Aimovig sureclick 70 mg once every 30 days for migraine. Historical vaccine included BNT162B2 (Batch no. EN6208, expiry date Jun2021) on 24Mar2021 for Covid-19 Immunization. Patient stated that he received both doses of Pfizer vaccine shot and about week before of the second shot he started having a aches and pains like a mild flu on 01Apr2021 and so this last, so on Sunday he got the second dose and then still felt like had some flu, aches, and pains. The events were considered non serious. Patient received Tylenol, Every 4 hour twice a day as a treatment of the events. In morning on 13Apr2021, he went and had a rapid COVID test (RT PCR test) which tested positive which was considered serious as medically significant event. Patient had not yet recovered from the events aches and pains like a mild flu and outcome of event, this morning patient went and had a rapid COVID test and it says it tested positive was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: she had a stroke after the vaccine; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   The consumer reported that his wife got the vaccine and about three weeks later she had a stroke after the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Erythema, Headache, Sinusitis
Clinical narrative: elevated blood pressure; dizziness; headache; redness of either side of her nose; sinus infection; This is a spontaneous report from a contactable consumer (reported for herself).  An 84-year-old female patient received second of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 07Mar2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. She received historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 14Feb2021, as a single dose for Covid-19 immunization. The next day of second dose on 08Mar2021, she began experiencing dizziness and a headache (for the whole day and it was still there at the time of this report) and redness of either side of her nose. She was treated for a sinus infection with Sumatriptan 50 mg, 5 days of prednisone 20mg, Amoxicillin 175mg. She also reportedly went to the hospital for an elevated blood pressure where she received nitroglycerine. The outcome of the events of elevated blood pressure, dizziness, headache, redness of either side of her nose and sinus infection was not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: who received Pfizer COVID vaccine first dose on 20Jan2021 and then on 29Jan2021, He tested positive for COVID-19; This is a spontaneous report from a contactable nurse other Healthcare Professional. A 73-year-old male patient received first dose  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: Not provided) via an unspecified route of administration, in Arm Left, on 20Jan2021, as a single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included monoclonal antibody Bamlanivimab. On 29Jan2021,tested positive for COVID-19.On 31Jan2021 started treatment with monoclonal antibody Bamlanivimab. It will be 90 days (from his first dose of the vaccine) till 31Apr2021. Patient didn't get his second dose. Further stated there will be a hub in their hospital this coming Wednesday and they wanted to know the guidance/clinical considerations for this patient's case. Patient underwent lab test and procedures with Covid-19 (Positive) on 29Jan2021.The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The association between the event COVID-19 with BNT162b2 can not be fully 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: F
Vaccine: COVID19
Symptoms: Feeling hot, Food allergy, Pruritus, Urticaria
Clinical narrative: severe allergic reaction to mango fruit after receiving the vaccine; hives all over her body; severe itching; entire body turned hot; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 14Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed a severe allergic reaction to mango fruit after receiving the vaccine. She has eaten mangos all her life. In fact she has mango products at home at all times. She had taken both doses of the Pfizer vaccine. She had a small piece of a mango several weeks ago on an unknown date in 2021 and developed hives all over her body, severe itching and entire body turned hot. nitially patient didn't realize the allergic reaction was due to the mango. On Saturday night 17Apr2021 she had a small piece of a Mango and immediately had a severe allergic reaction and that is when we realized she had developed an allergic reaction to the mango. She took 2 zyrtecs and her Symbicort inhaler to relive symptoms. Symptoms subsided after 4 hours. Reporter strongly believe the allergy to mangos was a newly developed allergy associated with the vaccine as mango has been a staple in our diet and never experienced any issues before. Adverse event resulted in: [Life threatening illness (immediate risk of death from the event)]. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Apr2021. Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Auricular swelling, Eye swelling, Lip swelling, Pruritus, Rash
Clinical narrative: I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Facility type vaccine was Pharmacy or Drug Store. There was no other vaccine in four weeks nor other medications in two weeks. The patient broke out in a rash (chest - neck - arms - legs - back) with extreme itching, face was swollen (eyes - lips - ears). Patient went to the hospital and was given IV drip with Benadryl - steroids for treatment. Patient was then sent home but the rash and itching still persist. He then went to my doctor and was given 2 shots of steroids and Prednisone 10mg. The events onset date was reported as 16Apr2021 16:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of events was recovering. Patient had no COVID prior vaccination nor tested COVID post vaccination. No known allergies.  Information on the lot/ batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Facility type vaccine was Pharmacy or Drug Store. There was no other vaccine in four weeks nor other medications in two weeks. The patient broke out in a rash (chest - neck - arms - legs - back) with extreme itching, face was swollen (eyes - lips - ears). Patient went to the hospital and was given IV drip with Benadryl - steroids for treatment. Patient was then sent home but the rash and itching still persist. He then went to my doctor and was given 2 shots of steroids and Prednisone 10mg. The events onset date was reported as 16Apr2021 16:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of events was recovering. Patient had no COVID prior vaccination nor tested COVID post vaccination. No known allergies.  Information on the lot/ batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Portal vein thrombosis, SARS-CoV-2 test
Clinical narrative: Portal Vein Thrombosis; This is a spontaneous report from a contactable consumer (the patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 9809), via an unspecified route of administration in left arm on 10Feb2021 at age of 47-year-old at single dose for COVID-19 immunisation. Medical history included back pain/stenosis and high cholesterol. No known allergies. The patient did not have COVID prior vaccination. Concomitant medications (Other medications in two weeks) included oxycodone taken for an unspecified indication from an unspecified date; docusate sodium (COLACE) taken for an unspecified indication from an unspecified date; pregabalin (LYRICA) taken for an unspecified indication from an unspecified date; atorvastatin calcium (LIPITOR ORIFARM) taken for an unspecified indication from an unspecified date; naloxegol oxalate (MOVANTIK) taken for an unspecified indication from an unspecified date. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247) via an unspecified route of administration in left arm on 20Jan2021 08:00AM for COVID-19 immunisation. The patient experienced portal vein thrombosis on 26Mar2021. The event resulted in: Emergency room/department or urgent care, Hospitalization (for 3 days), Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the event included treated with Anti Coagulation. Nasal Swab test was done on 02Apr2021 with result of "negative". The outcome of the event was recovering.