chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis, like his arthritis more severe; his arm was swollen, his hands were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 14Mar2021 (lot number not reported), at the age of 57-years-old, at single dose for COVID-19 immunization. Patient medical history included ongoing rheumatoid arthritis. Concomitant medications were not reported. The patient had his first vaccine on 14Mar2021 and he started experiencing (probably 4 or 5 days later) unspecified date in Mar2021, like almost to rheumatoid arthritis, like his arthritis more severe. It was reported that he had before feels like joints were swollen and painful but it wasn't very reoccurring and then it seems like after the vaccine it was very, constantly the joints were inflamed, he couldn't close his hands because you know his arm was swollen, his hands were swollen and you know then he didn't take the second dose because he had to travel as far the country and his second dose was 2 days ago which was 40 days from the first dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Miliaria
Clinical narrative: 1st day a lil out of breath if doing chores had to relax.; Heat rash under right boob showed up today; Just feel warm; This is a spontaneous report from a contactable consumer. This 38-year-old female (patient) reported herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04May2021 11:30 AM at left arm for COVID-19 immunization. Medical history included anxiety and overweight. The patient had no history of COVID-19 and did not have test for COVID-19. Concomitant drugs included alprazolam for anxiety (patient was naturally high anxiety if did not take alprazolam). On 06May2021 17:45 PM, the patient had heat rash under right boob. The patient was a lil out of breath if doing chores had to relax. Just feel warm. No treatment was received for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 test, Tonsillitis
Clinical narrative: Within 6 hours of receiving the vaccine, my throat started swelling up; I could feel my tonsils touching the back of my throat; This is a spontaneous report from a contactable health professional (patient). A 47-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 26Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included hydrocortisone, calcium carbonate/colecalciferol (VITAMIN D 2000), levothyroxine, and cabergoline (CABERGOL). Within 6 hours of receiving the vaccine, her throat started swelling up. She could feel her tonsils touching the back of her throat and had to be given diphenhydramine hydrochloride (BENADRYL) in ER. She had an issue with her throat swelling off and on for 2 weeks after the shot. It was the only new thing that was in her life. Adverse events start date was 27Jan2021. AE resulted in emergency room/department or urgent care. Covid test (nasal swab) was negative. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Throat swelling,Tonsillitis. The case will be reassessed once new 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
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 58-years-old-male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 27Mar2021 10:00 for Covid-19 immunization. Medical history included hypertension, hairy cell leukemia, and high cholesterol. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included simvastatin, lisinopril, doxazosin, and acetylsalicylic acid (ASPIRIN 81mg). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced atrial fibrillation on 14Apr2021 23:45 requiring cardioversion. The event was assessed as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Gait disturbance, Inappropriate schedule of product administration, Joint swelling
Clinical narrative: His whole body ache, the spinal cord is he can't even get up; His whole body ache, the spinal cord is he can't even get up; His whole body ache, the spinal cord is he can't even get up; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; he had swollen arm, hand and wrist; he had swollen arm, hand and wrist; first dose was administered on 14Mar2021 and the second dose was on 03May2021; first dose was administered on 14Mar2021 and the second dose was on 03May2021; This is a spontaneous report from two contactable consumers (patient and patient's wife). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03May2021 (at the age of 57-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 (at the age of 57-year-old) for COVID-19 immunization and experienced rheumatoid arthritis, like his arthritis more severe, Joints were swollen; painful; the joints were inflamed and his arm was swollen, his hands were swollen. It was reported that the patient's first dose was administered on 14Mar2021 he was unable to take the second dose because he had to travel far from the country, and the second dose was administered on 03May2021. It was reported that his "whole body ache, the spinal cord is he can't even get up", he was in lot of pain with his knee, the both knees; can hardly walk because his knees are very weak and he had swollen arm, hand and wrist on an unspecified date. The patient took anti-inflammatory and  pain medication for the event "he was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak". Outcome of events was unknown.  Information on Lot/Batch number was not available. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Off label use, Pain, Peripheral swelling, Spinal cord disorder
Clinical narrative: His whole body ache, the spinal cord is he can't even get up; His whole body ache, the spinal cord is he can't even get up; His whole body ache, the spinal cord is he can't even get up; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; he had swollen arm, hand and wrist; he had swollen arm, hand and wrist; first dose was administered on 14Mar2021 and the second dose was on 03May2021; first dose was administered on 14Mar2021 and the second dose was on 03May2021; This is a spontaneous report from two contactable consumers (patient and patient's wife). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03May2021 (at the age of 57-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 (at the age of 57-year-old) for COVID-19 immunization and experienced rheumatoid arthritis, like his arthritis more severe, Joints were swollen; painful; the joints were inflamed and his arm was swollen, his hands were swollen. It was reported that the patient's first dose was administered on 14Mar2021 he was unable to take the second dose because he had to travel far from the country, and the second dose was administered on 03May2021. It was reported that his "whole body ache, the spinal cord is he can't even get up", he was in lot of pain with his knee, the both knees; can hardly walk because his knees are very weak and he had swollen arm, hand and wrist on an unspecified date. The patient took anti-inflammatory and  pain medication for the event "he was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak". Outcome of events was unknown.  Information on Lot/Batch number was not available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Discomfort, Heart rate
Clinical narrative: BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; This is a spontaneous report from a non-contactable pharmacist.   A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), at the age of 60 years-old, dose 2 intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: ER8733) as a single dose for covid-19 immunisation. And dose 1 Lot number: ER8727Administration route: Intramuscular, Administration Date: 24Mar2021, Vaccine location: Left arm. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination was given in a hospital. on 14Apr2021, at 1557: Pt went up to nursing staff 15minutes after vaccine administration to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care. Pt received diphenhydramine 50 mg PO and methylprednisolone 125 mg IV in the ED as well as cardioversion (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, nor was tested after vaccination. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oxygen saturation, Throat irritation, Tongue pruritus
Clinical narrative: BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; This is a spontaneous report from a non-contactable pharmacist.   A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), at the age of 60 years-old, dose 2 intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: ER8733) as a single dose for covid-19 immunisation. And dose 1 Lot number: ER8727Administration route: Intramuscular, Administration Date: 24Mar2021, Vaccine location: Left arm. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination was given in a hospital. on 14Apr2021, at 1557: Pt went up to nursing staff 15minutes after vaccine administration to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care. Pt received diphenhydramine 50 mg PO and methylprednisolone 125 mg IV in the ED as well as cardioversion (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, nor was tested after vaccination. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Condition aggravated, Peripheral swelling
Clinical narrative: caller states it has worsened.; swelling and pain near arm pit; swelling and pain near arm pit; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 11:29 (Batch/Lot Number: EW0153, vaccinated at the age of 46 years old) as single dose for covid-19 immunisation. The patient received the first dose on 13Apr2021. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced swelling near her arm pit, under the arm. It was pain and swelling and the patient thought it was near a duct or lymph node, but wasn't sure. The caller states that the patient had that vaccine on Tuesday and this is Thursday. Swelling started yesterday but he not sure on that. It is ongoing and that the caller states it has worsened. Outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available,  the reported events of peripheral swelling and axillary pain and of the suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 3 days after the shot he had a  grand mal seizure lasting 3 minutes; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation. Medical history included seizure and epilepsy. The patient's concomitant medications were not reported. An adverse reaction happened with her disabled son and she can't complete the report now because she has to go to the doctors. She wants to know if she could call back. He lives upstate in a residential home, one of the first places to give vaccines and she called them several times to say they needed to report it. He has epilepsy and 3 days after the shot he had a grand mal seizure lasting 3 minutes, he has not had a seizure that long in over 2 years. He has not had a seizure since then. She stated it was the pfizer covid 19 vaccine. She spoke with his neurologist and he said it probably triggered it. If he was to get vaccinated again like if he needed a booster. This happened on the second dose. She told them that it was considered an adverse event. If he ever needed to go for a booster since he has epilepsy she would go to his doctor and make sure his medication was at a higher level so maybe he would not have a seizure the second time. No further information provided. People with seizures should know this could give you a seizure. He usually has 30 second seizures, last year he had 2 seizures in the whole year both 30 seconds. The event outcome was unknown.  Information on the lot/ batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: rhabdomyolysis; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated, "These symptoms could be unrelated to the vaccine, but I believe they are worth reporting as they occurred after the vaccination." On 16Apr2021, the patient experienced rhabdomyolysis and currently have ongoing muscle pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and hospitalization for 1 day. The outcome of the events was not recovered. No treatment was given to the patient for the events.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Loss of consciousness, Nausea
Clinical narrative: Blacking out (everything went black I thought I was going to pass out); Fever; Headache; Body aches; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 16:00 (Lot Number: EW0167) as single dose at 30 year old for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included allergies to Penicillin. No covid prior vaccination and Covid was not tested post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose on 14Apr2021 16:45 (lot number: EW0164) at 30 year old in the Left arm at single dose for covid-19 immunization, cipro [ciprofloxacin] and experienced allergies. Day after shot on 06May2021 10:45 AM, the patient experienced a Fever, headache, body aches, chills, nausea, blacking out (everything went black the patient thought she was going to pass out). No treatment received. The patient was recovering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Blacking out (everything went black I thought I was going to pass out); Fever; Headache; Body aches; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 16:00 (Lot Number: EW0167) as single dose at 30 year old for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included allergies to Penicillin. No covid prior vaccination and Covid was not tested post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose on 14Apr2021 16:45 (lot number: EW0164) at 30 year old in the Left arm at single dose for covid-19 immunization, cipro [ciprofloxacin] and experienced allergies. Day after shot on 06May2021 10:45 AM, the patient experienced a Fever, headache, body aches, chills, nausea, blacking out (everything went black the patient thought she was going to pass out). No treatment received. The patient was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myelitis transverse, Paralysis
Clinical narrative: Transverse myelitis; Paralyzed; A young pregnant woman (Patient); 6 months pregnant; This is a spontaneous report from a contactable consumer. This is the second of 2 reports for the second dose. A 37-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation and experienced myelitis transverse. The patient received the second dose of bnt162b2 on 01Apr2021 and by 03Apr2021 she was "paralyzed". The patient was 6 months pregnant and had a "transverse myelitis" attack after the vaccine. Events outcome was unknown.  Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Legally blind; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 14Apr2021 (Batch/Lot number was not reported) (at age of 68-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included type 2 diabetes.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2 on 24Mar2021 (at age of 68-year-old) for COVID-19 immunisation. The patient experienced legally blind on 30Apr2021. Consumer stated, 'I just wanted to know I have type 2 diabetes (Intent: History) and I wanted to know if anybody else has reported any adverse reaction to the vaccine? I have a very bad reaction (Clarification unknown) with Pfizer COVID Vaccine and I wondered if other people has same reaction, people with type 2 diabetes if they have a trouble with the Vaccine'. Date of adverse event: 30Apr (Consumer was unsure). LOT#: Consumer stated, 'I have no idea. There is no bar code. It was from (Pharmacy name). I am also legally blind so, this is very difficult to see it'. Due to network issue call handler voice did not get through to the consumer. Call back was done to gather more information but was not successful.  Limited information was available over the call. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Multiple sclerosis
Clinical narrative: Multiple sclerosis; Tired; Out of sorts; This is a spontaneous report from a non-contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced multiple sclerosis, tired and was out of sorts. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying, Maternal exposure during pregnancy, Monoplegia, Muscle spasms, Myelitis transverse
Clinical narrative: Leg spasms; She has a patient who is pregnant with her first child. She had the second dose of the vaccine on April 1st.; Just 2 days after she had leg spasms then it led to being paralized; she had leg spasms then it led to being paralized. It spread through her whole body, even her stomach; She is now a transverse/ have Transverse mylighttis as well; she had leg spasms then it led to being paralized. It spread through her whole body, even her stomach; This is a spontaneous report from a Pfizer sponsored program  support from a non contactable consumer.  A 37-year-old female patient received 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. The patient previously received first dose of BNT162B2 on unknown date. The patient was pregnant with her first child. She had the second dose of the vaccine on 01Apr2021. Just 2 days after she had leg spasms then it led to being paralized. It spread through her whole body, even her stomach. She was put into the hospital and she was now a transverse and was going to hospice. She was only 37 years old and the caller wanted to know what happened to other people who have transverse mylighttis as well. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Leg spasms; She has a patient who is pregnant with her first child. She had the second dose of the vaccine on April 1st.; Just 2 days after she had leg spasms then it led to being paralized; she had leg spasms then it led to being paralized. It spread through her whole body, even her stomach; She is now a transverse/ have Transverse mylighttis as well; she had leg spasms then it led to being paralized. It spread through her whole body, even her stomach; This is a spontaneous report from a Pfizer sponsored program  support from a non contactable consumer.  A 37-year-old female patient received 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. The patient previously received first dose of BNT162B2 on unknown date. The patient was pregnant with her first child. She had the second dose of the vaccine on 01Apr2021. Just 2 days after she had leg spasms then it led to being paralized. It spread through her whole body, even her stomach. She was put into the hospital and she was now a transverse and was going to hospice. She was only 37 years old and the caller wanted to know what happened to other people who have transverse mylighttis as well. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction that she had after the first dose; Hives; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), dose 1, via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction of hives after the first dose, which lasted for more than 6 weeks. The patient mentioned she called the hotline for medical assistance and is awaiting a call back. Clinical outcome of the events allergic reaction of hives was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: fully vaccinated and they still got sick/COVID vaccine inefficacy; fully vaccinated and they still got sick/COVID vaccine inefficacy; This is a spontaneous report from a contactable other HCP. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported.  The patient was fully vaccinated and still got sick/COVID vaccine inefficacy (medically significant) on 04May2021 with outcome of unknown. Causality was reported as Related.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  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.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Lot Number: ER8734) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose on 08Apr2021 but he missed the second dose which was supposed to be on 29Apr2021 because he had a heart attack after the first dose or in between the doses he did not get the second dose in Apr2021. The patient stated that he needed to set up his 2nd shot. The event outcome was unknown.  Information on Lot/Batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: Blood clot in leg; This is a spontaneous report from a contactable consumer (patient). A 66 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 at 12:45 (Batch/Lot Number: EN6198) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Nov2020 to an unknown date: came down with COVID virus in November and it felt like mild flu symptoms. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 08Mar2021 at 12:45 (Batch/Lot Number: EN6198) as a single dose in the right shoulder for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any adverse events following prior vaccinations. The patient's medical history included: father had a blood clot in his 50s. Concomitant medication (other medications taken in two weeks) were none.   On an unspecified date in Apr2021, the patient experienced blood clot in leg. Relevant test included: ultrasound on 15Apr2021 showed blood clot. The clinical course was as follows: On 04Apr2021 or 05Apr2021 he started to notice a problem on his right leg. He went to see the doctor and it was determined he has a vascular problem. This problem got worse and ended up in the emergency room and was informed he had a blood clot in his leg. The clot started down by his ankle and had moved up towards half way to knee. Then moved up higher. He went to the emergency room on 15Apr2021and was diagnosed with a blood clot with an ultrasound scan that was done. He was then prescribed a blood thinner. He was informed it is a superficial thrombosis. The patient clarified the problem he started to notice with his right leg as it was like a bump, and sore. He was not sure what it was. He thought at first he may have banged his leg. Then he noticed it was sore and getting higher. He went to see his physician who referred him to a vascular surgeon. It took a while to get in to be seen by the vascular surgeon because so busy. A few days after that he went to the hospital, the emergency room because he was not getting better. That is when he found out he had a blood clot. Treatment for the blood clot in leg included, patient was prescribed rivaroxaban (XARELTO) 10mg once a day. The patient confirmed the blood clot was getting better. The outcome of the event blood clot was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion
Clinical narrative: Pleural effusion; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient stated he went on 02Apr2021 to get the first COVID vaccine and he got Pfizer. He stated he had to go to hospital as he had a problem and had a pleural effusion. The patient was hospitalized for pleural effusion from 02May2021 to 05May2021. The doctor at the hospital that was now checking him did not want to let him go back until he got all the liquid from the pleural effusion and the doctor did not want to let the patient go before the problem was gone. The patient stated the doctor had him at the hospital with the treatment and the treatment still had not finished. He stated yesterday the doctor told him 10 days more and he was supposed to get the second vaccine on 23Apr2021 so what he wanted to know was how long can he wait for this to finish to go and get the second vaccine and what will happen. He stated he had done his research and it showed that he could get the second vaccine six weeks since the first vaccine. He stated but if he was not finished with his treatment and asked what will happen if he gets the second dose in more than 6 weeks. He clarified he was not in the hospital now but the doctor was checking on him. He stated the doctor he saw in the hospital sent him home with treatment and did not want to let him go until he finishes the treatment and can prove that he was better.  The outcome of the event pleural effusion was unknown.  The event pleural effusion occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Respiratory disorder, Thrombocytopenic purpura
Clinical narrative: developed a worsening of their ITP/ Idiopathic thrombocytopenic purpura; complained of upper respiratory symptoms; This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: not provided) as 2nd dose single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. The patient experienced developed a worsening of their idiopathic thrombocytopenic purpura (ITP), It was thought that the worsening of this condition is attributed to the vaccine. On 07Apr2021, 10 days later, the patient presented to urgent care with a bruise on her hip and also complained of upper respiratory symptoms. It was unknown if the patient was experiencing shortness of breath or what. The patient's platelet count drop at 34,000. Her count was repeated two days later and was found to be below 30,000, clarified as 21,000. The patient was started on a steroid, clarified as dexamethasone 40mg, orally, daily for 4 days. This treatment was completed on 22Apr2021. She got labs drawn again on 22Apr2021 and her platelet count was back up to 173,000. The patient recovered from the event platelet count low on 22Apr2021. The outcome of other events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. Case will be reassessed upon receipt of follow-up 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Bone pain, Breast pain, Ear congestion, Ear discomfort
Clinical narrative: pain reached her neck; had sore throat; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; the inflammation/pressure grew to my right year and all over my head; it felt very swollen; pain in my arm; pain grew to my armpit; side of the left breast, and up to the clavicle; side of the left breast, and up to the clavicle; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 1 via an unspecified route of administration in left arm on 01May2021 at 11:00 as 1st dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamin d nos, iron, vitamins nos, thyroid. No other vaccine in 4 week, no prior vaccination Covid testing and no post vaccination Covid tested. On 03May2021, the patient experienced pain in my arm, pain grew to my armpit, side of the left breast and up to the clavicle, it felt very swollen and on 05May2021 experienced feeling congestion/inflammation/pressure in my left ear, the inflammation/pressure grew to my right year and all over my head and pain reached her neck and had sore throat. As resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the event pain in my arm, pain grew to my armpit, side of the left breast, and up to the clavicle recovered on 07May2021 and feeling congestion/inflammation/pressure in my left ear the inflammation/pressure grew to my right year and all over my head, it felt very swollen, pain reached her neck and had sore throat were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Head discomfort, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: pain reached her neck; had sore throat; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; the inflammation/pressure grew to my right year and all over my head; it felt very swollen; pain in my arm; pain grew to my armpit; side of the left breast, and up to the clavicle; side of the left breast, and up to the clavicle; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 1 via an unspecified route of administration in left arm on 01May2021 at 11:00 as 1st dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamin d nos, iron, vitamins nos, thyroid. No other vaccine in 4 week, no prior vaccination Covid testing and no post vaccination Covid tested. On 03May2021, the patient experienced pain in my arm, pain grew to my armpit, side of the left breast and up to the clavicle, it felt very swollen and on 05May2021 experienced feeling congestion/inflammation/pressure in my left ear, the inflammation/pressure grew to my right year and all over my head and pain reached her neck and had sore throat. As resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the event pain in my arm, pain grew to my armpit, side of the left breast, and up to the clavicle recovered on 07May2021 and feeling congestion/inflammation/pressure in my left ear the inflammation/pressure grew to my right year and all over my head, it felt very swollen, pain reached her neck and had sore throat were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: pain reached her neck; had sore throat; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; feeling congestion/inflammation/pressure in my left ear; the inflammation/pressure grew to my right year and all over my head; it felt very swollen; pain in my arm; pain grew to my armpit; side of the left breast, and up to the clavicle; side of the left breast, and up to the clavicle; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 1 via an unspecified route of administration in left arm on 01May2021 at 11:00 as 1st dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamin d nos, iron, vitamins nos, thyroid. No other vaccine in 4 week, no prior vaccination Covid testing and no post vaccination Covid tested. On 03May2021, the patient experienced pain in my arm, pain grew to my armpit, side of the left breast and up to the clavicle, it felt very swollen and on 05May2021 experienced feeling congestion/inflammation/pressure in my left ear, the inflammation/pressure grew to my right year and all over my head and pain reached her neck and had sore throat. As resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the event pain in my arm, pain grew to my armpit, side of the left breast, and up to the clavicle recovered on 07May2021 and feeling congestion/inflammation/pressure in my left ear the inflammation/pressure grew to my right year and all over my head, it felt very swollen, pain reached her neck and had sore throat were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Periorbital swelling, Pruritus, Rash
Clinical narrative: Increasing the itchiness. now in my legs too/itchiness in my skin; Rash in my left side of my face, neck , ears, arms and chest; My under left eye was swollen & redness; My under left eye was swollen & redness; It's very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 22Apr2021 12:15 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, depression and known allergies: yes from an unknown date and unknown if ongoing. Concomitant medications included losartan; escitalopram oxalate (LEXAPRO); bupropion; hydrochlorothiazide all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old, via an unspecified routed of administration administered in left arm on 01Apr2021 12:15 (lot number was not reported) for covid-19 immunization. The patient reported 2 days after her second vaccine, she was with rash in the left side of her face, neck , ears, arms and chest. Her under left eye was swollen & redness. Increasing the itchiness now in her legs too. It's very uncomfortable. The events occurred on 24Apr2021 06:00. She have been using several products over the counter such as Zyrtec, Benadryl cream, Caladryl, Hydrocortisone, Aveeno body wash and Curel lotion. But still suffering of the itchiness in her skin. The patient did not recover from the events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast discomfort, Chest pain, Cyanosis, Hyperhidrosis
Clinical narrative: thought she was having a heart attack; cramping in abdominal area; finger went blue; sweating; chest pain/pain in chest; pressure near breast; back cramping/severe cramping; left pupil dilated; arm went numb; turned pale; Veins popping out of skin; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that an adult female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as 1 st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 48 hours after first dose of bnt162b2 (unspecified date), the patient felt side effects of cramping in abdominal area, finger went blue, sweating, chest pain and pressure near breast (has been receiving episodes of this pressure and pain for a week after dose), back cramping and left pupil dilated. Stated that side effects were only for left side of body, none on the right. Also reported pain in chest, arm went numb, sweating, turned pale, thought she was having a heart attack and left pupil larger, severe cramping and veins popping out of skin. The patient was supposed to get 2 nd vaccine yesterday wanted to know what to do. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Mydriasis, Myocardial infarction, Pallor
Clinical narrative: thought she was having a heart attack; cramping in abdominal area; finger went blue; sweating; chest pain/pain in chest; pressure near breast; back cramping/severe cramping; left pupil dilated; arm went numb; turned pale; Veins popping out of skin; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that an adult female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as 1 st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 48 hours after first dose of bnt162b2 (unspecified date), the patient felt side effects of cramping in abdominal area, finger went blue, sweating, chest pain and pressure near breast (has been receiving episodes of this pressure and pain for a week after dose), back cramping and left pupil dilated. Stated that side effects were only for left side of body, none on the right. Also reported pain in chest, arm went numb, sweating, turned pale, thought she was having a heart attack and left pupil larger, severe cramping and veins popping out of skin. The patient was supposed to get 2 nd vaccine yesterday wanted to know what to do. The outcome of the events was unknown.  Information on the lot/batch number has been requested.