chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: I am currently 26 weeks pregnant and already completed both doses; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable other health care professional(patient).    A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 06Jan2021) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 20Dec2020 09:30 as single dose for covid-19 immunisation. Medical history included Asthma, GERD, anxiety/depression.Concomitant medications included lansoprazole (PREVACID) duloxetine hydrochloride (CYMBALTA); fluticasone propionate (FLOVENT); ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT). Patient was 26 weeks pregnant and already completed both doses of COVID-19 vaccine. On 15Feb2021, patient tested positive for COVID-19 and have been sick. Patient had not covid prior vaccination, Patient had nasal swab test on 15Feb2021with positive result and had known allergies. Patient used azithromycin, zinc, steroids and melatonin as treatment.The patient delivered the pregnancy on 25May2021.  The outcome of event covid-19 and drug ineffective was recovering and exposure during pregnancy was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is a reasonable possibility of causal association between the events drug ineffective and COVID 19 and the suspect drug.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Heart rate, Hyperhidrosis, Palpitations
Clinical narrative: dizziness/dizzy/almost felt like fainting; felt like fainting; racing heart; sweating; This is a spontaneous report from contactable consumers (one is the patient). A 37-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Feb2021 13:00 [also reported as 26Feb2021 12:45 PM] (Lot Number: EL9267; Expiration Date: May2021) as a single dose for covid-19 immunisation. Medical history included drug penicillin allergies and low testosterone ongoing since 2018. Concomitant medication included testosterone cipionate (TESTOSTERONE CYPIONATE) for low testosterone, start and stop date were not reported. The patient previously took amoxicillin but had allergies. The patient reported that a few minutes after his first vaccination (19Feb2021), he experienced a racing heart, dizziness, sweating, and almost felt like fainting. A couple waves of this hit him and subsided after 10-15 minutes. The events required emergency room visit. The patient has not been covid tested post vaccination. The patient was not diagnosed with covid prior vaccination. The patient has his blood checked twice/year all normal levels (unspecified date). The patient mentioned that he became slightly dizzy after receiving his first COVID-19 vaccine and he was not nervous or scared prior to or following receiving the vaccine. He also does not have history or problems receiving other vaccines or blood draws when he received the second vaccine, he felt normal for a couple minutes although he would feel "something" thought his body immediately after the injection. A few minutes went suddenly, he became very dizzy or short of breath, EMS was on standby at this site, so they advised him to sit on the floor. They connected heart /02 monitor to him (2021), and his heart rate was very highly (around 130 BPM) or then it would swing widely to less than 50 BPM. During these swings, he would get very dizzy or faint. This happened multiple times starting from less severe to severe with fainting, to finally going away, unfortunately after 30 minutes or so when the heart rate swings were observed, EMS administered Epinephrine and Benadryl in IV form. He was taken to a hospital via ambulance where he was later discharged after no issue in observation. The events tachycardia, dizziness and fainting were considered serious with seriousness criterion of hospitalization/prolongation of hospitalization and important medical event. The outcome of the events was recovering.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: dizziness/dizzy/almost felt like fainting; felt like fainting; racing heart; sweating; This is a spontaneous report from contactable consumers (one is the patient). A 37-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Feb2021 13:00 [also reported as 26Feb2021 12:45 PM] (Lot Number: EL9267; Expiration Date: May2021) as a single dose for covid-19 immunisation. Medical history included drug penicillin allergies and low testosterone ongoing since 2018. Concomitant medication included testosterone cipionate (TESTOSTERONE CYPIONATE) for low testosterone, start and stop date were not reported. The patient previously took amoxicillin but had allergies. The patient reported that a few minutes after his first vaccination (19Feb2021), he experienced a racing heart, dizziness, sweating, and almost felt like fainting. A couple waves of this hit him and subsided after 10-15 minutes. The events required emergency room visit. The patient has not been covid tested post vaccination. The patient was not diagnosed with covid prior vaccination. The patient has his blood checked twice/year all normal levels (unspecified date). The patient mentioned that he became slightly dizzy after receiving his first COVID-19 vaccine and he was not nervous or scared prior to or following receiving the vaccine. He also does not have history or problems receiving other vaccines or blood draws when he received the second vaccine, he felt normal for a couple minutes although he would feel "something" thought his body immediately after the injection. A few minutes went suddenly, he became very dizzy or short of breath, EMS was on standby at this site, so they advised him to sit on the floor. They connected heart /02 monitor to him (2021), and his heart rate was very highly (around 130 BPM) or then it would swing widely to less than 50 BPM. During these swings, he would get very dizzy or faint. This happened multiple times starting from less severe to severe with fainting, to finally going away, unfortunately after 30 minutes or so when the heart rate swings were observed, EMS administered Epinephrine and Benadryl in IV form. He was taken to a hospital via ambulance where he was later discharged after no issue in observation. The events tachycardia, dizziness and fainting were considered serious with seriousness criterion of hospitalization/prolongation of hospitalization and important medical event. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: symptoms of covid 19 starting 07Mar2021 and tested positive for covid 19 last 11Mar2021; symptoms of covid 19 starting 07Mar2021 and tested positive for covid 19 last 11Mar2021; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 26Feb2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient had the symptoms of covid 19 starting 07Mar2021 and tested positive for covid 19 on 11Mar2021. The patient was scheduled for her second dose on 19Mar2021and wanted to know that whether she could attend her appointment for her second of the covid vaccine. The outcome of the events was unknown.  Information on about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received First dose bnt162b2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and Concomitant medication were not re-ported. On an unspecified date, patient reported that he tested positive for covid after he got the 1st dose. Outcome for events was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Breath odour, Dysgeusia, Dyspnoea
Clinical narrative: chalky taste in my mouth; bad breath; stuffy and thus breathing issues; This is a spontaneous report received from a contactable Consumer reporting for herself.     A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:45 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced chalky taste in my mouth on 29Mar2021 with outcome of not recovered , bad breath  on 29Mar2021 with outcome of not recovered , stuffy and thus breathing issues  on 29Mar2021 with outcome of not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site rash
Clinical narrative: had a rash underneath his injection site; experienced strong muscle aches mid-chest up, arms, back, hands, & jaw two nights in a row; This is a spontaneous report from a contactable consumer (the patient) .    A 75-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation  .  Medical history included hypertension  (Takes high blood pressure medicine).   In the past the patient received an unknown vaccine against hay fever and experienced rash. On 23Feb2021 the patient received the first dose of BNT162B2 vaccine.    The patient experienced experienced strong muscle aches mid-chest up, arms, back, hands, & jaw two nights in a row  on 18Mar2021 01:30 with outcome of not recovered , had a rash underneath his injection site  on an unspecified date with outcome of unknown.   Course of the event: After 2nd shot, the patient experienced strong muscle aches mid-chest up, arms, back, hands and jaw two nights in a row. Took Tylenol. Since then, once almost every day, usually weight training or fast walking, the patient  experienced the same ache, maybe not as severe as the first two nights but it sure does get his attention. The patient been checked out at the ER to insure it's not a heart issue per  primary care physician. The emergency room doctor told the patient his EKG was fine and his bloodwork didn't show anything.   No follow-up attempts are needed; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: a light nose bleed that lasted about 15 minutes; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient) .     A 27-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date.   The patient experienced a light nose bleed that lasted about 15 minutes on an unspecified date with outcome of recovered.    Course of the event. Caller stated one hour after receiving the second dose she experienced a light nose bleed that lasted about 15 minutes. Caller stated she just used a Kleenex and only had to switch it out once. Caller states it was not severe and she didn't have to use a washcloth or anything and has not happened since.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Night sweats
Clinical narrative: extreme tiredness; nauseated; night sweats; felt weak; light-headed; brief rapid breathing; This is a spontaneous report from a contactable consumer reported for himself.     A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30, at the age of 34 years, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to penicillin. The patient's concomitant medications were not reported. The vaccine was administered at the hospital. On 31Mar2021 17:00  the patient experienced extreme tiredness, nauseated, night sweats, felt weak, light-headed, brief rapid breathing all with outcome of recovering.  The patient didn't receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   Information on lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: extreme tiredness; nauseated; night sweats; felt weak; light-headed; brief rapid breathing; This is a spontaneous report from a contactable consumer reported for himself.     A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30, at the age of 34 years, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to penicillin. The patient's concomitant medications were not reported. The vaccine was administered at the hospital. On 31Mar2021 17:00  the patient experienced extreme tiredness, nauseated, night sweats, felt weak, light-headed, brief rapid breathing all with outcome of recovering.  The patient didn't receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: fever; body and muscle pain; headache; body and muscle pain; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Apr2021 at 7 pm after her 2nd dose, the patient experienced fever, body and muscle pain and headache. She said she still had these symptoms on the day of the report, on 03Apr2021. The patient had not recovered from the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Multiple rashes that began 24 hours later. The rash is on one lower part of arm upper area near wrist, another on leg above the knee, and on the middle area of calf.; This is a spontaneous report from a contactable consumer.   A 59-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 12:30 at the age of 59 years-old (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation  .  Medical history included an allergy to shellfish and high cholesterol.  There were no other vaccines in the past 4 weeks.    There were no concomitant medications.  On 15Apr2021, at 0700, the patient experienced multiple rashes that began 24 hours later (after vaccination received during an unspecified hospitalization). The rash was on one lower part of arm upper area near wrist, another on leg above the knee, and on the middle area of calf. The outcome of the event was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test
Clinical narrative: Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (Lot Number: EN6198) at a single dose, and the second dose via an unspecified route of administration in left arm on 19Mar2021 13:30 (Lot Number: EN6199) at a single dose for covid-19 immunization at the age of 53 years old. Medical history included hypertension and known allergies to sulfa, both from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included irbesartan taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden hearing loss in right ear on 10Apr2021 12:00.  The event resulted in doctor or other healthcare professional office/clinic visit, and cased disability or permanent damage. The patient underwent lab tests and procedures which included covid-19 virus test (nasal swab): negative on 14Apr2021. Therapeutic measures were taken as a result of sudden hearing loss in right ear included steroid injection series into eardrum. The outcome of the event was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: appendicitis/had his appendix removed; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 25Jan2021 (lot number: EL3249) at the age of 35 years old, as single dose for COVID-19 immunisation. Medical history reported as none. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. No other vaccines received in four weeks. No other medications taken in two weeks. On unspecified date, after first vaccination, the patient had appendicitis and had his appendix removed. The event resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative. The patient was given dose 2 of BNT162b2 on 15Feb2021 (lot number: EL9267), administered in left arm. Outcome of the event appendicitis was recovered with sequelae.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Cervical incompetence
Clinical narrative: Cervical insufficiency in pregnancy resulting in loss of pregnancy; Cervical insufficiency in pregnancy resulting in loss of pregnancy; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) at the age of 31-years-old, via an unspecified route of administration in left arm on 23Feb2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. She has no COVID prior to vaccination, no other vaccines in four weeks, and no other medications in two weeks. The patient was pregnant. Her last menstrual date was on 11Oct2020. Her delivery date is on 18Jul2021. The patient received her COVID-19 vaccine in a hospital. She experienced cervical insufficiency in pregnancy resulting in loss of pregnancy on 03Mar2021 at 15:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization from 2021 to 2021 for 1 day. There was no treatment given in response to the events. She was not tested got COVID post vaccination. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 31-years-old, via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The outcome of the events was unknown.; Sender's Comments: The information available is limited. The etiology for the reported events could be multifactorial in nature. However  until more information is available the contributory role of the suspect product BNT162B2 cannot be completely ruled out based on the potential temporal association noted. This case will be updated when more information is 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Confusional state, Dysarthria, Electrocardiogram
Clinical narrative: left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Headache, Laboratory test, Magnetic resonance imaging, Somnolence
Clinical narrative: left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Vision blurred
Clinical narrative: left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: TIA ( mini stroke) on fourth day after dose two.; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208 and expiration date not provided), via an unspecified route of administration, administered in Arm Right second dose on 25Mar2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included Hypertension and Penicillin allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) and bupropion hydrochloride (WELLBUTRIN). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201 and expiration date not provided) via an unspecified route of administration administered in Arm Right first dose on 04Mar2021 administration time: 04:00 PM for covid-19 immunisation. On 29Mar2021 10:00, the patient experienced TIA (mini stroke) on fourth day after dose two. The event resulted in physician office visit, Emergency room visit, and hospitalization for 1 day. The patient was treated and was placed on three medication (unspecified). The patient underwent lab tests and procedures which included Spectrum DNA test: negative on 15Apr2021.  The outcome of the event was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vitreous detachment
Clinical narrative: posterior vitreous detachment; This is a spontaneous report from a contactable physician. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL-3302), intramuscular, administered in Arm Right on 18Dec2020 08:00 (at 50-years-old) as single dose for COVID-19 immunization. Medical history included HTN (hypertension). Patient had no known allergies. Facility type vaccine was Hospital. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included amlodipine; chlorthalidone. The patient experienced posterior vitreous detachment on 20Dec2020 with outcome of not recovered. Ae resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of posterior vitreous detachment (also reported that "treatment: exam, there is no treatment", pending confirmation).; Sender's Comments: Based on the information provided, the event "Posterior vitreous detachment" is likely to be an intercurrent event unrelated to the use of suspect product bnt162b2 in this 50-year-old male patient. This case will be reassessed should additional information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature increased, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypertension, Musculoskeletal stiffness, Oropharyngeal discomfort, Palpitations
Clinical narrative: light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for SARs-COV-2; Positive for SARs-COV-2; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, expiry date and lot number not reported), via an unspecified route of administration On an unknown date in Apr2021(reported as last Wednesday), as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021(reported as last Wednesday), patient received first dose and tested positive for SARs-COV-2. The event was considered serious (medically significant). It was reported that the patient had scheduled for second dose. The outcome of the event was unknown.  Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Rash, Tremor, Vomiting
Clinical narrative: I don't feel good; rash all over the body, spots, in a couple of spots; shaking; throwing up; sick; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunisation. Relevant medical history included that she had Stevens-Johnson syndrome and was in the hospital for a month because she had a reaction to vancomycin and almost had a liver transplant. Concomitant medications were not reported. The patient reported that on an unspecified date she did not feel good, woke up with breaking a rash all over the body, spots, in a couple of spots, shaking, throwing up, sick. She have been through urgent care and nobody had any idea. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis
Clinical narrative: acute appendicitis; I had severe abdominal pain beginning on 02Apr; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 43 years, on 30Mar2021 10:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 03Apr2021 to an unknown date. Concomitant medications included paracetamol (TYLENOL) and nystatin (STATIN [NYSTATIN]), both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2, at the age of 43 years, on 09Mar2021 in the left arm at single dose for COVID-19 immunization. The patient stated, "I had severe abdominal pain beginning on 02Apr2021; I went to the emergency room at 3am on 03Apr2021 and was diagnosed with acute appendicitis". The patient was hospitalized for the events. The outcome of the events was recovered on an unspecified date.   Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: with right leg, severe pain and had DVT diagnosed/ diagnose with DVT (deep vein blood clot) in my leg; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 60; Unit: Unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included COVID-19 from 02Oct2020 to an unknown date. Concomitant medications were not reported. The patient experienced with right leg, severe pain and had dvt diagnosed/ diagnose with dvt (deep vein blood clot) in my leg on an unspecified date in 2021 with outcome of unknown. Patient states she had COVID-19 on 02Oct2020. She received her first Pfizer vaccine dose in her left arm on 17Mar2021. On 01Apr2021, she went to the hospital ED with right leg, severe pain and had DVT diagnosed. She was sent home from the ED with Xarelto. On 07Apr2021, 2nd vaccine dose received by patient. Consumer stated, "I called the health department and I just wanted you to record that I called you guys back on 17Mar I've had my first COVID shot and then 01Apr, I went to the hospital (further details for the hospitalization not available hence not checked as seriousness criteria) and diagnose with DVT (deep vein blood clot) in my leg. I just felt, I just know that what going on right now with Johnson and Johnson but I am just trying to kind of understand that  2 weeks to the day that I had my first COVID shot I came down with the blood clot in my leg. So I just wanted to see if that's anything that I need to concerned, it's very painful, fortunately I have been able to work from home but it's very painful and I did get my second round because level one I need to think about it. So, with everything going on. I never had blood clot now before that I have now."  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, General physical health deterioration, Immobile, Inappropriate schedule of product administration, Joint range of motion decreased
Clinical narrative: the muscle pain and weakness has worsened to the point of near immobility; muscle pain; weakness; in constant pain; cannot raise my arms above shoulder height/knees and other joints do not want to bend; in the worst condition of my life; first dose in Feb2021/second dose on 05Feb2021; first dose in Feb2021/second dose on 05Feb2021; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported as Misplaced/discarded), via an unspecified route of administration on 05Feb2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. For the past 10 weeks, since the second dose of vaccination, the muscle pain and weakness had worsened to the point of near immobility. It took both hands to lift a half full coffee cup, and patient could barely manage that. Patient could not raise his arms above shoulder height, his knees and other joints did not want to bend, and he was in constant pain. Patient had had to receive five (5) steroid shots in an attempt to counteract this, and the doctor had stated he could receive no more. Patient contacted his doctor's office and local health department, but neither could help me. Patient was healthy and had no such issues before the shot, and now he was in the worst condition of my life. All these events with start date 09Mar2021, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and received treatment Steroid Shots. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Pain
Clinical narrative: the muscle pain and weakness has worsened to the point of near immobility; muscle pain; weakness; in constant pain; cannot raise my arms above shoulder height/knees and other joints do not want to bend; in the worst condition of my life; first dose in Feb2021/second dose on 05Feb2021; first dose in Feb2021/second dose on 05Feb2021; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported as Misplaced/discarded), via an unspecified route of administration on 05Feb2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. For the past 10 weeks, since the second dose of vaccination, the muscle pain and weakness had worsened to the point of near immobility. It took both hands to lift a half full coffee cup, and patient could barely manage that. Patient could not raise his arms above shoulder height, his knees and other joints did not want to bend, and he was in constant pain. Patient had had to receive five (5) steroid shots in an attempt to counteract this, and the doctor had stated he could receive no more. Patient contacted his doctor's office and local health department, but neither could help me. Patient was healthy and had no such issues before the shot, and now he was in the worst condition of my life. All these events with start date 09Mar2021, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and received treatment Steroid Shots. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: bloody stools; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bloody stools in Apr2021. Caller is a consumer, asking if bloody stools are a common occurrence after getting the vaccine and should he be worried. Caller reported that he received his first vaccine dose yesterday (18Apr2021) and afterwards he had had bloody stools 3 times (in Apr2021). He reported never experiencing anything like this before. The outcome of the event was unknown.  Information about lot/batch number has been requested.