chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Presyncope
Clinical narrative: Extremely nauseous; Diarrhea so bad I thought I was going to pass out; Diarrhea so bad I thought I was going to pass out; This is a spontaneous report from a contactable consumer (patient). This 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 29Mar2021 at 10:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included methadone from an unknown date for an unknown indication. The patient reported that about 36 hours after the first dose she got extremely nauseous. She stated the first time it was diarrhea so bad she thought she was going to pass out. The patient received the second dose of BNT162B2 (lot number unknown) on 19Apr2021 at 10:30. The clinical outcomes of extremely nauseous, and diarrhea so bad she thought she was going to pass out were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neuralgia, X-ray
Clinical narrative: Nerve pain down left leg; back pain that goes down left leg; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ENG6199) via an unspecified route of administration on 27Mar2021 at 10:00 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included amlodipine besilate (NORVAC), daily multivitamin, "estradiol and prog" from unspecified dates for unspecified indications. The patient previously received dose 1 of BNT162B2 (lot number ENG202) on 06Mar2021 at 10:00 as a single dose for COVID-19 immunization. On 29Mar2021, the patient started with back pain that went down the left leg; "nerve pain down left leg." The patient visited a doctor for the event. The patient underwent lab tests and procedures that included X-rays and "possible MRI." The outcomes of back pain that went down the left leg and nerve pain were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; nausea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Lot Number: ER8732) as single dose for covid-19 immunisation; amlodipine besilate (AMLODIPINE BESILATE), valsartan (VALSARTAN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  Medical history included known allergies some antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  The patient experienced tiredness,vomiting, diarrhea , nausea, joint and muscle pain on 05Apr2021 03:00 with outcome of recovered. The action taken for amlodipine besilate and valsartan was unknown. No treatment was received.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; nausea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Lot Number: ER8732) as single dose for covid-19 immunisation; amlodipine besilate (AMLODIPINE BESILATE), valsartan (VALSARTAN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  Medical history included known allergies some antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  The patient experienced tiredness,vomiting, diarrhea , nausea, joint and muscle pain on 05Apr2021 03:00 with outcome of recovered. The action taken for amlodipine besilate and valsartan was unknown. No treatment was received.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; full body ache; headache; temperature of 102 Fahrenheit; This is a spontaneous report from a contactable reporter (patient). This 22-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8736) via an unspecified route of administration in the left arm on 21Apr2021 at 18:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder, attention deficit hyperactivity disorder, major depressive disorder, and asthma, all from unknown dates and unknown if ongoing. The patient had no known allergies. Prior to vaccination the patient had not been diagnosed with COVID. Concomitant medications included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), diphenhydramine hydrochloride (BENADRYL), vortioxetine hydrobromide (TRINTELLIX) and bupropion hydrobromide (APLENZIN), all taken from unspecified dates for unspecified indications. The patient previously received the first dose of BNT162B2 (lot number ER8737) on 31Mar2021 at 06:45 (at the age of 22-years-old) for COVID-19 immunisation. On 22Apr2021 at 12:00 the patient experienced chills, full body ache, headache, and temperature of 102 Fahrenheit. It was unknown if treatment was received for the events. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of chills, full body ache, headache and temperature of 102 Fahrenheit were recovering. It was also reported that since vaccination the patient had not been tested for COVID.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from contactable consumer (patient's wife). A 80-year-old male patient received dose 1of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a little diarrhea since his first shot. The outcome of diarrhea was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual changes; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (patient, nursing student) reported that a 19-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 14Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had some menstrual changed after getting the first dose of the vaccine in Apr2021. The outcome of the event was unknown. This report was reported as non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tiredness; headache; This is a spontaneous report from a contactable consumer (reported for his wife) via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunisation. The caller was asking for his wife who got the second dose yesterday 21Apr2021 then experiencing a bit of tiredness and headache in Apr2021. The caller wanted to know if his wife can take pain reliever medication like Ibuprofen. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on 05Mar2021 15:30 (at the age of 30 years old) as a 2ND DOSE, SINGLE, for COVID-19 immunisation. Medical history included COVID prior to vaccination. The patient has no allergies to medications, food or other products. Concomitant medications included prenatal vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP was on 20Jan2021. The patient experienced miscarriage on 09Apr2021. The mother was 11 Weeks pregnant (also reported as 8 weeks 1 day) at the onset of the event. The mother was due to deliver on 17Nov2021.  The event resulted in Doctor or other healthcare professional office/clinic visit. Unspecified treatment was received in response to the event. The outcome of the event was unknown. The patient has not been tested for COVID since the vaccination.   Information about lot/batch number has been requested.  Follow-up (07May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Miscarriage. 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 agency, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Breast tenderness, Menstruation irregular, Mood altered, Muscle spasms
Clinical narrative: irregular periods/period again on 31Mar2021; early PMS type symptoms; Bloating; cramping; moody; Breast tenderness; had spotting/heavy bleed; This is a spontaneous report received from contactable consumer (Patient). A 30-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient had been off birth control for over a year and have had pretty regular periods. Patient got the first dose of the vaccine on 22Mar2021.  She already had period for March. Patient been seeing an uptick of information on the vaccine and irregular periods.  She started  (period) again on 31Mar2021 and had some early PMS type symptoms. She had bloating, cramping, was moody and breast tenderness. That Wednesday (31Mar2021) thru Friday she had spotting. She  had never had that before and afterward had some heavy bleeding until Sunday when it tapered off. Then on 12Apr2021 received the second dose of the vaccine. Everything seems fine now, but she was due to have my period again pretty soon. Events outcome for all events were recovered.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual syndrome, Vaginal haemorrhage
Clinical narrative: irregular periods/period again on 31Mar2021; early PMS type symptoms; Bloating; cramping; moody; Breast tenderness; had spotting/heavy bleed; This is a spontaneous report received from contactable consumer (Patient). A 30-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient had been off birth control for over a year and have had pretty regular periods. Patient got the first dose of the vaccine on 22Mar2021.  She already had period for March. Patient been seeing an uptick of information on the vaccine and irregular periods.  She started  (period) again on 31Mar2021 and had some early PMS type symptoms. She had bloating, cramping, was moody and breast tenderness. That Wednesday (31Mar2021) thru Friday she had spotting. She  had never had that before and afterward had some heavy bleeding until Sunday when it tapered off. Then on 12Apr2021 received the second dose of the vaccine. Everything seems fine now, but she was due to have my period again pretty soon. Events outcome for all events were recovered.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Increased volume of menstrual flow after 1st dose; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in Right arm on 29Mar2021 11:00 AM (at age of 51 years old) as single dose for COVID-19 immunization. Relevant medical history included: Acid reflux, Occasional nausea, Heavy periods. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient previously took pheneticillin potassium (PENICILLIN) and had allergy. The patient experienced increased volume of menstrual flow after 1st dose on 29Mar2021 04:00 PM. No treatment received for the adverse event. The outcome of the event was Recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea exertional, Fatigue, Feeling abnormal, Heavy menstrual bleeding
Clinical narrative: joint and muscle pain; Exhaustion; earlier and increased menstrual symptoms; earlier and increased menstrual symptoms; brain fog; shortness of breath on exertion; sleep disturbances; joint and muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 11Apr2021 12:00 (Lot Number: EW0162) as single dose for COVID-19 immunisation. Medical history included wolff-parkinson-white syndrome (WPW), Atrioventricular nodal reentry tachycardia (AVNRT), anaemia, arrhythmia, psoriasis, Psoriatic arthritis, Ankylosis spondylitis, Premenstrual dysphoric disorder (PMDD), endometriosis, tinnitus, hip impingement, Raynaud's syndrome, Irritable bowel syndrome (IBS), depression, anxiety, celiac, unspecified seizure disorder and allergy to gluten. The patient received other medications within 2 weeks of vaccination. The patient previously received vancomycin, cardizem and experienced drug allergy. The patient experienced exhaustion, earlier and increased menstrual symptoms, brain fog, shortness of breath on exertion, sleep disturbances, joint and muscle pain on 13Apr2021 14:30. It started 2 days post vaccination, and has continues for 12 days, so far. It waxes and wanes. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Myalgia, Sleep disorder
Clinical narrative: joint and muscle pain; Exhaustion; earlier and increased menstrual symptoms; earlier and increased menstrual symptoms; brain fog; shortness of breath on exertion; sleep disturbances; joint and muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 11Apr2021 12:00 (Lot Number: EW0162) as single dose for COVID-19 immunisation. Medical history included wolff-parkinson-white syndrome (WPW), Atrioventricular nodal reentry tachycardia (AVNRT), anaemia, arrhythmia, psoriasis, Psoriatic arthritis, Ankylosis spondylitis, Premenstrual dysphoric disorder (PMDD), endometriosis, tinnitus, hip impingement, Raynaud's syndrome, Irritable bowel syndrome (IBS), depression, anxiety, celiac, unspecified seizure disorder and allergy to gluten. The patient received other medications within 2 weeks of vaccination. The patient previously received vancomycin, cardizem and experienced drug allergy. The patient experienced exhaustion, earlier and increased menstrual symptoms, brain fog, shortness of breath on exertion, sleep disturbances, joint and muscle pain on 13Apr2021 14:30. It started 2 days post vaccination, and has continues for 12 days, so far. It waxes and wanes. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a non-contactable consumer (patient's sister). A female 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 unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was calling on behalf of her sister.  She stated her sister got the Covid vaccine yesterday and had had dizziness and nausea all day today. She wanted to know what to do to stop this. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed period; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  There was no relevant medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date for covid-19 immunisation. The patient stated she has not missed a menses since 13 years old and "on BC". She missed period after second shot of COVID vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report received from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache the day after second dose. The outcome of the event was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I did the second Covid vaccine and I have not gotten my periods; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated "I did the second Covid vaccine on the 5th and I have not gotten my periods, I am "93" (not clarified)." The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Scab
Clinical narrative: White papule; Scab; This is a spontaneous report from a contactable other hcp (patient's mother). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0162), dose 2 intramuscular, administered in right arm on 19Apr2021 09:15 as 2nd dose, single for covid-19 immunisation. Medical history included vaso vagal syncope. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733,) intramuscular administered in right arm on 29Mar2021 16:00 for COVID-19 Immunization. On 26Apr2021, the patient developed white papule which turned into a scab approximately 1 week following second injection, roughly three inches below injection site. Seriousness criteria-Congenital anomaly/birth defect: Yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination, no known Allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the vents was resolved with sequel.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Immobile, Spinal stenosis
Clinical narrative: Spinal stenosis became so bad that I rapidly became immobile; TSH went up; Spinal stenosis became so bad that I rapidly became immobile; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Mar2021 as 2nd dose, single for covid-19 immunisation. Medical history included spinal stenosis from 2009,  thyroid cancer from 2013. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 Immunization. The patient stated, he did not know if there is direct relationship or coincidence. But right after second shot, his TSH went up on 01Apr2021 and he needed to increase his synthroid dose. And his spinal stenosis became so bad that he rapidly became immobile on 01Apr2021. There is no other vaccine in four weeks, no known no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Started developing chest pain a week after taking the first dose. Progressively worsened since then till present/had bouts of sharp chest pain/CP; X-Ray showed pleural effusion and slight fullness of main pulmonary artery.; pleural effusion; Fatigue/tiredness/High fatigue and tiredness persisted from right after the vaccine till present; diarrhea; tiredness; high fever; chills; nausea; brain fog; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started developing chest pain a week after taking the first dose (13Apr2021). Progressively worsened since then till present. At present also have fatigue, diarrhea and tiredness. Yesterday, had bouts of sharp chest pain so got an X-Ray from ED which showed pleural effusion and slight fullness of main pulmonary artery. Doctor stated it was indicative of CP. In the initial few days after the first dose, had high fever, chills, nausea and brain fog. High fatigue and tiredness persisted from right after the vaccine till present. The patient was very healthy and have never had a heart complication before. The timing might be indicative of a causation between the vaccine and the present medical condition. Ae resulted in doctor or other healthcare professional office/clinic visit. There is no other vaccine in four weeks, no other medications in two weeks, no treatment for ae, no covid prior vaccination. The patient tested covid post vaccination (RT-PCR) with Nasal Swab on 03May2021, covid test result was Negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient did not receive within 2 weeks of vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pleural effusion, Pyrexia, SARS-CoV-2 test, X-ray
Clinical narrative: Started developing chest pain a week after taking the first dose. Progressively worsened since then till present/had bouts of sharp chest pain/CP; X-Ray showed pleural effusion and slight fullness of main pulmonary artery.; pleural effusion; Fatigue/tiredness/High fatigue and tiredness persisted from right after the vaccine till present; diarrhea; tiredness; high fever; chills; nausea; brain fog; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started developing chest pain a week after taking the first dose (13Apr2021). Progressively worsened since then till present. At present also have fatigue, diarrhea and tiredness. Yesterday, had bouts of sharp chest pain so got an X-Ray from ED which showed pleural effusion and slight fullness of main pulmonary artery. Doctor stated it was indicative of CP. In the initial few days after the first dose, had high fever, chills, nausea and brain fog. High fatigue and tiredness persisted from right after the vaccine till present. The patient was very healthy and have never had a heart complication before. The timing might be indicative of a causation between the vaccine and the present medical condition. Ae resulted in doctor or other healthcare professional office/clinic visit. There is no other vaccine in four weeks, no other medications in two weeks, no treatment for ae, no covid prior vaccination. The patient tested covid post vaccination (RT-PCR) with Nasal Swab on 03May2021, covid test result was Negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient did not receive within 2 weeks of vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray abnormal
Clinical narrative: Started developing chest pain a week after taking the first dose. Progressively worsened since then till present/had bouts of sharp chest pain/CP; X-Ray showed pleural effusion and slight fullness of main pulmonary artery.; pleural effusion; Fatigue/tiredness/High fatigue and tiredness persisted from right after the vaccine till present; diarrhea; tiredness; high fever; chills; nausea; brain fog; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started developing chest pain a week after taking the first dose (13Apr2021). Progressively worsened since then till present. At present also have fatigue, diarrhea and tiredness. Yesterday, had bouts of sharp chest pain so got an X-Ray from ED which showed pleural effusion and slight fullness of main pulmonary artery. Doctor stated it was indicative of CP. In the initial few days after the first dose, had high fever, chills, nausea and brain fog. High fatigue and tiredness persisted from right after the vaccine till present. The patient was very healthy and have never had a heart complication before. The timing might be indicative of a causation between the vaccine and the present medical condition. Ae resulted in doctor or other healthcare professional office/clinic visit. There is no other vaccine in four weeks, no other medications in two weeks, no treatment for ae, no covid prior vaccination. The patient tested covid post vaccination (RT-PCR) with Nasal Swab on 03May2021, covid test result was Negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient did not receive within 2 weeks of vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disorientation, Heart rate, Heart rate increased, Hypertension
Clinical narrative: feverish; hypertension; heart palpitations; increased heart rate; hypotension; injection site swollen about 4 inch diameter and bright red and warm; injection site swollen about 4 inch diameter and bright red and warm; loss of appetite; nausea; swollen throat; injection site swollen about 4 inch diameter and bright red and warm; lymph nodes in armpits swollen/painful; lymph nodes in armpits swollen/painful; lethargic; disoriented; unable to speak or think coherently; unable to speak or think coherently; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 12:30 (Lot Number: EW0170) as single dose for covid-19 immunisation.  Medical history included Polycystic Ovarian Syndrome.The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 lot_number EP6955 on 13Apr2021,01:30 PM,at Left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 05May2021 15:00 she started to notice lymph nodes in armpits swollen/painful. Around 3 pm incredibly lethargic, disoriented, unable to speak or think coherently. Around 05May2021 18:00  loss of appetite, slight nausea, swollen throat, worsening pain in armpit lymph nodes, injection site swollen about 4 inch diameter and bright red and warm. Around 19:00 began to experience severe hypotension even when trying to move around to get blood flow. About 1.5 hours later 20:30 she began to experience severe hypertension, increased heart rate, heart palpitations, etc. All symptoms noticed from earlier in the afternoon had become worse at this point so went to bed.The patient did not received any treatment. As of 06May2021 the patient was still very disoriented, feverish, lack of appetite. The outcome of the events disoriented, loss of appetite and feverish was not resolved and for other events was resolving.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Committees, and Investigators, as appropriate
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Lethargy, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: feverish; hypertension; heart palpitations; increased heart rate; hypotension; injection site swollen about 4 inch diameter and bright red and warm; injection site swollen about 4 inch diameter and bright red and warm; loss of appetite; nausea; swollen throat; injection site swollen about 4 inch diameter and bright red and warm; lymph nodes in armpits swollen/painful; lymph nodes in armpits swollen/painful; lethargic; disoriented; unable to speak or think coherently; unable to speak or think coherently; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 12:30 (Lot Number: EW0170) as single dose for covid-19 immunisation.  Medical history included Polycystic Ovarian Syndrome.The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 lot_number EP6955 on 13Apr2021,01:30 PM,at Left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 05May2021 15:00 she started to notice lymph nodes in armpits swollen/painful. Around 3 pm incredibly lethargic, disoriented, unable to speak or think coherently. Around 05May2021 18:00  loss of appetite, slight nausea, swollen throat, worsening pain in armpit lymph nodes, injection site swollen about 4 inch diameter and bright red and warm. Around 19:00 began to experience severe hypotension even when trying to move around to get blood flow. About 1.5 hours later 20:30 she began to experience severe hypertension, increased heart rate, heart palpitations, etc. All symptoms noticed from earlier in the afternoon had become worse at this point so went to bed.The patient did not received any treatment. As of 06May2021 the patient was still very disoriented, feverish, lack of appetite. The outcome of the events disoriented, loss of appetite and feverish was not resolved and for other events was resolving.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Committees, and Investigators, as appropriate
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngeal swelling, Pyrexia, Speech disorder, Thinking abnormal
Clinical narrative: feverish; hypertension; heart palpitations; increased heart rate; hypotension; injection site swollen about 4 inch diameter and bright red and warm; injection site swollen about 4 inch diameter and bright red and warm; loss of appetite; nausea; swollen throat; injection site swollen about 4 inch diameter and bright red and warm; lymph nodes in armpits swollen/painful; lymph nodes in armpits swollen/painful; lethargic; disoriented; unable to speak or think coherently; unable to speak or think coherently; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 12:30 (Lot Number: EW0170) as single dose for covid-19 immunisation.  Medical history included Polycystic Ovarian Syndrome.The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 lot_number EP6955 on 13Apr2021,01:30 PM,at Left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 05May2021 15:00 she started to notice lymph nodes in armpits swollen/painful. Around 3 pm incredibly lethargic, disoriented, unable to speak or think coherently. Around 05May2021 18:00  loss of appetite, slight nausea, swollen throat, worsening pain in armpit lymph nodes, injection site swollen about 4 inch diameter and bright red and warm. Around 19:00 began to experience severe hypotension even when trying to move around to get blood flow. About 1.5 hours later 20:30 she began to experience severe hypertension, increased heart rate, heart palpitations, etc. All symptoms noticed from earlier in the afternoon had become worse at this point so went to bed.The patient did not received any treatment. As of 06May2021 the patient was still very disoriented, feverish, lack of appetite. The outcome of the events disoriented, loss of appetite and feverish was not resolved and for other events was resolving.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Committees, and Investigators, as appropriate
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: feverish; hypertension; heart palpitations; increased heart rate; hypotension; injection site swollen about 4 inch diameter and bright red and warm; injection site swollen about 4 inch diameter and bright red and warm; loss of appetite; nausea; swollen throat; injection site swollen about 4 inch diameter and bright red and warm; lymph nodes in armpits swollen/painful; lymph nodes in armpits swollen/painful; lethargic; disoriented; unable to speak or think coherently; unable to speak or think coherently; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 12:30 (Lot Number: EW0170) as single dose for covid-19 immunisation.  Medical history included Polycystic Ovarian Syndrome.The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 lot_number EP6955 on 13Apr2021,01:30 PM,at Left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 05May2021 15:00 she started to notice lymph nodes in armpits swollen/painful. Around 3 pm incredibly lethargic, disoriented, unable to speak or think coherently. Around 05May2021 18:00  loss of appetite, slight nausea, swollen throat, worsening pain in armpit lymph nodes, injection site swollen about 4 inch diameter and bright red and warm. Around 19:00 began to experience severe hypotension even when trying to move around to get blood flow. About 1.5 hours later 20:30 she began to experience severe hypertension, increased heart rate, heart palpitations, etc. All symptoms noticed from earlier in the afternoon had become worse at this point so went to bed.The patient did not received any treatment. As of 06May2021 the patient was still very disoriented, feverish, lack of appetite. The outcome of the events disoriented, loss of appetite and feverish was not resolved and for other events was resolving.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Committees, and Investigators, as appropriate
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Nasal congestion, Pulmonary congestion, Respiratory tract oedema, Vocal cord inflammation
Clinical narrative: Airway edema; Lungs start feeling gooey and congested; Vocal chord swelling; Stuffy nose; Lost my voice; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 (Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included migraine diagnosed 30 years ago, cholesterol a little bit high diagnosed about 10 years ago, slightly high, patient didn't have to take statins or anything; reactive airway diagnosed at least 15 years ago. The was no concomitant medications. Patient received the first dose of the Pfizer Covid 19 vaccine on 19Mar2021. She had a history of being very reactive respiratory wise to irritants in the air. 45 minutes after first dose, patient experienced vocal chord swelling, stuffy nose, lost her voice, lungs start feeling gooey and congested on 19Mar2021. And 45 minutes after receiving the vaccine she had airway edema on 19Mar2021, which was not uncommon for her as she had a very reactive airway. The patient usually had airway edema when she was around any sort of latex, perfumes, chemicals, things like that. She took meds (levosalbutamol hydrochloride (XOPENEX), fluticasone propionate, salmeterol xinafoate (ADVAIR), levocetirizine dihydrochloride (XYZAL), diphenhydramine hydrochloride (BENADRYL), 5mg prednisone) immediately, inhalers and everything was fine 45 minutes to hour later. The airway edema subsided in 1.5 hours. She never went into respiratory distress. The patient took daily medications but declined to provide details on them, she did not believe this event was from them as she had been taking these medications for years. Reporter seriousness for airway edema was medically significant. Outcome of airway edema was recovered on 19Mar2021, and outcome of other events was recovered in Mar2021.; Sender's Comments: Based on a strong temporal relationship, A possible causal relationship between events Respiratory tract oedema, Pulmonary congestion, Vocal cord inflammation, Nasal congestion ,Aphonia and suspect drug BNT162B2 cannot be excluded    "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate."
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Hepatic enzyme, Hepatic enzyme increased, Suspected COVID-19, White blood cell count
Clinical narrative: increased liver enzymes and white count; increased liver enzymes and white count; They didn't rule out Covid illness; They didn't rule out Covid illness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (Age at vaccination: 67-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. About 3 weeks after her dose she ended up being transported by ambulance (for the first time in her life) to the hospital. She reported increased liver enzymes and white count. They didn't rule out Covid illness. Caller has an opportunity to receive her second dose this Saturday, but doesn't know if she should? After returning from hold and providing information to caller, she indicated she would forgo a second dose. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.