chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, SARS-CoV-2 test, Wheezing
Clinical narrative: Coughing; wheezing; shortness of breath; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 90 years, first dose on 19Jan2021 09:00 (lot number: EK4176) and second dose on 09Feb2021 (lot number EL9261); via unspecified routes of administration on the left arm at single doses for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included losartan, terazosin, melatonin, glipizide, linagliptin (TRAJENTA), clopidogrel bisulfate (PLAVIX), clopidogrel bisulfate, citalopram, zinc, famotidine, amino acids nos (PROTINEX) and colecalciferol (VITAMIN D). On 20Jan2021, the patient experienced coughing, wheezing and shortness of breath. The patient was taken to the ER and put in the hospital for five days (date of hospitalization was unknown). Treatment received by the patient was unknown. Lab data includes COVID test: Unknown results on an unspecified date. The outcome of the events was recovered with sequelae on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Platelet count, Platelet count decreased
Clinical narrative: acute myeloid leukemia; her platelets were below 30,000; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Feb2021 at single dose for COVID-19 immunization. Medical history included ongoing immunodeficiency (reported as immunocompromised). Concomitant medications were not reported. The patient had an acute myeloid leukemia and her platelets were below 30,000 on an unspecified date. Clinical outcome of the events was unknown.  Information on about lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Optic neuritis
Clinical narrative: optic neuritis; This is a spontaneous report from a contactable physician. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included lost vision in one eye on unspecified date, 20 years ago in the military. Concomitant medications were not reported. After 2 days, on 06Feb2021, the patient developed severe optic neuritis in one eye. Event was assessed as serious, medically significant. The patient is getting a fairly extensive workup. He was getting labs (unspecified) and will get 1 gram a day of Solumedrol for three days followed by oral Prednisone. He was going to get the typical. Outcome of the event was unknown.  Information on Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Illness, Myalgia, Nausea
Clinical narrative: Became unresponsive for a short period on the way to the ER after vomiting; Became so sick and weak within 2 hours needed to seek medical help at the ER; Became so sick and weak within 2 hours needed to seek medical help at the ER; Uncontrollable cough; low grade fever; muscle aches; nausea; violent projectile vomiting; This is a spontaneous report from a contactable consumer (patient)   A 75 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Feb2021 at 14:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included lung cancer on 2007, Covid 19 infection on an unspecified date prior vaccination. The patient received first dose of BNT162B2 on 21Jan2021 at 15:00 in left arm. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and pravastin. On 13Feb2021 at 13:00 the patient started experiencing  uncontrollable cough, low grade fever, muscle aches, nausea, violent projectile vomiting. He became so sick and weak within 2 hours needed to seek medical help at the ER. It was also informed that patient became unresponsive for a short period on the way to the ER after vomiting. Treatment received included Zofran, LR (IV fluids).  The patient recovered from became unresponsive on 13Feb2021. At the time of the reporting the patient was recovering from the events.    Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Unresponsive to stimuli, Vomiting projectile
Clinical narrative: Became unresponsive for a short period on the way to the ER after vomiting; Became so sick and weak within 2 hours needed to seek medical help at the ER; Became so sick and weak within 2 hours needed to seek medical help at the ER; Uncontrollable cough; low grade fever; muscle aches; nausea; violent projectile vomiting; This is a spontaneous report from a contactable consumer (patient)   A 75 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Feb2021 at 14:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included lung cancer on 2007, Covid 19 infection on an unspecified date prior vaccination. The patient received first dose of BNT162B2 on 21Jan2021 at 15:00 in left arm. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and pravastin. On 13Feb2021 at 13:00 the patient started experiencing  uncontrollable cough, low grade fever, muscle aches, nausea, violent projectile vomiting. He became so sick and weak within 2 hours needed to seek medical help at the ER. It was also informed that patient became unresponsive for a short period on the way to the ER after vomiting. Treatment received included Zofran, LR (IV fluids).  The patient recovered from became unresponsive on 13Feb2021. At the time of the reporting the patient was recovering from the events.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Fatigue, Hallucination, auditory, Loss of consciousness
Clinical narrative: heard a loud bang in my brain; blacked out for an instant; tired and wobbly; Did not get my balance/wobbly; 1,Day after the vaccine, I had violent projectile diarrhea; This is a spontaneous report from a contactable consumer (patient). An 83 year-old elderly female patient received first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration from 20Jan2021 20:30 at single dose in the right arm for COVID-19 immunisation. Medical history included small cell lung, 2cm, no follow -up treatment necessary. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), and losartan potassium. One day after the vaccine administration on 21Jan2021 10:00, the patient had violent projectile diarrhea. Two days after the vaccine, she blacked out for an instant and heard a loud bang in her brain. She was tired and wobbly for over one week. She did not get her balance back for nearly 3 weeks. The events resulted in Disability or permanent damage. Treatment for the events was unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Headache, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paralysis
Clinical narrative: hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillan Barre Syndrome; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A male patient of an unspecified age received pneumococcal 13 valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunisation and influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took  atorvastatin (LIPITOR) in which his doctor overdosed him with, so he developed a liver problem. It was reported that the patient was planning on receiving the Pfizer-BioNTech Covid-19 Vaccine. However, he said he was concerned about getting it since he had a history of having a reaction with the flu and pneumonia shot. He said his doctor overdosed him with LIPITOR so he developed a liver problem. So when his doctor gave him the flu and pneumonia shot, he ended up getting Guillan Barre Syndrome on an unspecified date with unknown outcome. He wanted to know if it would still be safe for him to receive the vaccine considering this, and his weakened immune system.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Dysgeusia, Full blood count, Metabolic function test
Clinical narrative: had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets counts drop; metallic taste; Potassium level went down; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) first dose on 12Feb2021 on Deltoid Left at single dose for covid-19 immunisation. Medical history included Covid-19 and High cholesterol. Concomitant medications were not reported. He said that he was 60 days post COVID and his doctor advised him to get vaccinated. He was feeling fine, but after 10 minutes into the shot, he had a metallic taste in the mouth. After 12-13 minutes, he had a feeling of impending death and thought he was gonna die. It freaked him out. He was rushed to the ER and had a complete blood count (CBC) and Basic Metabolic Panel (BMP) test run on him. It was that his Potassium level went down to 3.3 and his platelets dropped to 141. He had tests on 28Jan2021 and mentioned that his Potassium levels were normal and had a platelet count of 181. He mentioned that there was no other way but the vaccine that could have caused this. He is if he would already have passed away from the shot from his opinion. Patient had a Syncopal episode of some type. He had an intended feeling like he was going to die after the shot, he was 60 days post Covid when he get that shot, he was getting over Covid and he was 60 days and he didn't wait the 90 days his primary doctor care told me that he can get it too because he was feeling better which he was feeling better but since then he have gotten that shot, he went to the doctor on the 28Jan2021 and he had CBC drawn on him and he went for his regular physical and Covid follow-up at his doctor, his platelets counts drop since he have had shot struck at 40 points, feels concerning. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "feeling of impending death and Syncopal episode " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.  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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Near death experience, Platelet count, Platelet count decreased, Syncope
Clinical narrative: had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets counts drop; metallic taste; Potassium level went down; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) first dose on 12Feb2021 on Deltoid Left at single dose for covid-19 immunisation. Medical history included Covid-19 and High cholesterol. Concomitant medications were not reported. He said that he was 60 days post COVID and his doctor advised him to get vaccinated. He was feeling fine, but after 10 minutes into the shot, he had a metallic taste in the mouth. After 12-13 minutes, he had a feeling of impending death and thought he was gonna die. It freaked him out. He was rushed to the ER and had a complete blood count (CBC) and Basic Metabolic Panel (BMP) test run on him. It was that his Potassium level went down to 3.3 and his platelets dropped to 141. He had tests on 28Jan2021 and mentioned that his Potassium levels were normal and had a platelet count of 181. He mentioned that there was no other way but the vaccine that could have caused this. He is if he would already have passed away from the shot from his opinion. Patient had a Syncopal episode of some type. He had an intended feeling like he was going to die after the shot, he was 60 days post Covid when he get that shot, he was getting over Covid and he was 60 days and he didn't wait the 90 days his primary doctor care told me that he can get it too because he was feeling better which he was feeling better but since then he have gotten that shot, he went to the doctor on the 28Jan2021 and he had CBC drawn on him and he went for his regular physical and Covid follow-up at his doctor, his platelets counts drop since he have had shot struck at 40 points, feels concerning. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "feeling of impending death and Syncopal episode " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.  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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2.  The mother was 11 weeks pregnant at the onset of the event.  The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC).  Information of lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarriage' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information.  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: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fall; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261) via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunisation. There were no relevant medical history or concomitant medications (it was also reported that the patient was on a lot of different medications). The patient experienced fall on 16Feb2021. The patient was then "hospitalized for a fall" and might not be attend her second vaccination appointment. Her second dose was scheduled on 24Feb2021. The hospitalization had nothing to do with vaccine. The outcome of event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Dizziness, Epistaxis, Loss of consciousness
Clinical narrative: I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Stomatitis
Clinical narrative: nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the  second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain, Vomiting
Clinical narrative: nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the  second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hiccups
Clinical narrative: feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal disorder, Nausea, Oropharyngeal pain, Respiratory tract infection, SARS-CoV-2 test
Clinical narrative: feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion, Vaccination site pain
Clinical narrative: feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Paranasal sinus discomfort, Vaccination site pain
Clinical narrative: severe sinus pressure; severe chills; nausea; pain at injection site; This is a spontaneous report from a contactable consumer(Patient). A 25-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and known allergies reported as none. The patient's concomitant medications were not reported. The patient experienced severe sinus pressure, nausea, severe chills, pain at injection site on 16Feb2021. No treatment received. The outcome of the events were recovering. There was no Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: developed pneumonia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first Pfizer vaccine shot on 03Feb2021 and was due to receive 2nd dose on 24Feb2021. 2 weeks after receiving his 1st vaccine dose, patient developed pneumonia and is currently in the hospital. Patient was hospitalized. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Upper limb fracture, Wrist fracture
Clinical narrative: fell on the ice; broke hip, arm and her wrists; broke hip, arm and her wrists; broke hip, arm and her wrists; This is a spontaneous report from a contactable consumer report for self from a Pfizer Sponsored Program . This 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. None medical history nor other products. The patient received the first vaccine on the 03Feb and she is scheduled to get the second one on 24Feb and about a week after the first dose she fell on the ice at her house and broke hip, arm and her wrists and had to have surgery. Her admission into the hospital was 09Feb2021. She had surgery on the 10Feb. She was discharged home 13Feb2021. She lost enough blood in surgery that she had to have 2 units of blood transfusion, she said the blood transfusions on 11Feb2021. She wanted to know is it safe to get the second vaccine after having those transfusions.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (reporting for son). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's son (the patient) received the first dose of the Pfizer-BioNtech COVID-19 vaccine on an unknown date. Two (2) days later he wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat. About 8 days after the shot, he tested positive to COVID-19. He was asked to quarantine for 10 days and will have a second COVID-19 test then. His breathing was ok. He will probably have to wait 3 months for his second shot. The doctor told him it might be a false read.  The event was reported as non-serious. The outcome of the event "tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat" was uknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling, Vaccination site pain
Clinical narrative: pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EM9810) via intramuscular in the left arm on 10Feb2021 13:15 at single dose for covid-19 immunisation. Medical history included hypothyroid. Known- allergies included sulfamethoxazole; trimethoprim (BACTRIM). Concomitant medication included levothyroxine, tramadol, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced pain at injection site, swelling, warmth, redness; all on 12Feb2021 08:00. The events resulted in physician office visit. The patient was hospitalized from Feb2021 for the events. Treatment received for the events included cefalexin (CEPHALEXIN) orally; methylprednisolone (MEDROL) dose pack; famotidine; and cetirizine hydrochloride (ZYRTEC). The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Dyspnoea exertional, Muscular weakness, Paraesthesia
Clinical narrative: Tingling burning in all extremities, trunk and face; Tingling burning in all extremities, trunk and face; weakness in all extremities; Shortness of breath with after completing one flight of stair.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included high blood pressure (BP), ocular migraine. Concomitant medication included amitriptyline, amlodipine. The patient received first dose of BNT162B2 on 02Jan2021 4:00PM for Covid-19 immunization and expedited tingling in right 15 days first dosage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Tingling burning in all extremities, trunk and face after second dosage. Tingling and burning was followed by weakness in all extremities including Shortness of breath with after completing one flight of stair. Visited primary care physician and blood work results were not significant for any abnormalities. Visited emergency room (ER) and was seen by neurologist who did think symptoms were severe. Awaiting EMG scheduled for 24Mar2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Headache
Clinical narrative: severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), on 15Feb2021 at 09:30 AM (at the age of 73-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was reported as none including no known allergies and no covid prior vaccination. The patient's concomitant medications included simvastatin (ZOCOR). The patient previously received the first dose of BNT162B2 (lot number EL1283), on 25Jan2021 09:30 AM (at the age of 73-year-old) on left arm for COVID-19 immunization, no other vaccines were administered in four weeks prior to vaccination. On 16Feb2021 at 10:00 AM the patient experienced mild headache severe cramps and lower abdominal pain across lower abdomen. The event "severe cramps" was reported as serious with criteria medically significant while the other events were reported as non-serious. No treatment for the events was received. No covid test was performed post vaccination. The outcome of the events was not resolved.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives on thighs, arms and stomach; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 36-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9266), via an unspecified route of administration on 19Feb2021 18:00 on Right arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9269) , via an unspecified route of administration on 29Jan2021 08.30 AM on Right arm at single dose for covid-19 immunization. The patient experienced hives on thighs, arms and stomach on 19Feb2021 19:30 with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered at School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hives on thighs, arms and stomach within 45 minutes of injection. Hives subsided within a few hours. No treatment was received for the adverse event. The event was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Lymph node pain
Clinical narrative: Hives on thighs, arms and stomach; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 36-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9266), via an unspecified route of administration on 19Feb2021 18:00 on Right arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9269) , via an unspecified route of administration on 29Jan2021 08.30 AM on Right arm at single dose for covid-19 immunization. The patient experienced hives on thighs, arms and stomach on 19Feb2021 19:30 with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered at School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hives on thighs, arms and stomach within 45 minutes of injection. Hives subsided within a few hours. No treatment was received for the adverse event. The event was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nasal congestion, Palpitations
Clinical narrative: Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262)  via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Coagulopathy, Myocardial infarction, Thrombosis, Troponin
Clinical narrative: very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself).  A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks.  Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received.  The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, and concomitant medications. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.