chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms
Clinical narrative: Patient complained the next day after her shot she had Charlie horse symptoms. could not get out of bed. Patient tried taking tylenol , but did not help. Has no fever or any other adverse effects.  Patient was advised to check with her doctor if symptoms don't improve.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Feeling hot, Headache
Clinical narrative: Large red rash & body felt heated 1 hour after. Headache & upset stomach started few hours after. Starting 8 hours after dose, severe body aches & chills - lasted 8 hours after until 30 hours after. Dizzy and nauseous started 36 hours after until 38 hours after. By 48 hours after, only sore and tender arm at injection site lasting until 4 days after.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Nausea, Pain, Rash erythematous
Clinical narrative: Large red rash & body felt heated 1 hour after. Headache & upset stomach started few hours after. Starting 8 hours after dose, severe body aches & chills - lasted 8 hours after until 30 hours after. Dizzy and nauseous started 36 hours after until 38 hours after. By 48 hours after, only sore and tender arm at injection site lasting until 4 days after.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site rash, Pain, Pain in extremity
Clinical narrative: Noticed a small rash under the injection site around 4:00 a.m. after initial injection. As the day progressed the rash became larger and still remains there today.  Arm has been very sore as well. I've had severe headaches and body aches for the past three days.  The headaches have subsided today and the body aches are much less, however, I still feel tired.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Blood culture negative, Blood lactic acid normal, Chest X-ray normal
Clinical narrative: 1:22 AM:  chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance  4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER.  Patient received 500cc NS bolus IV. Labs findings unremarkable.  INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging  with Dx: reaction to COVID vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Differential white blood cell count normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: 1:22 AM:  chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance  4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER.  Patient received 500cc NS bolus IV. Labs findings unremarkable.  INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging  with Dx: reaction to COVID vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Hyperventilation, International normalised ratio increased, Metabolic function test
Clinical narrative: 1:22 AM:  chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance  4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER.  Patient received 500cc NS bolus IV. Labs findings unremarkable.  INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging  with Dx: reaction to COVID vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide, Prothrombin time prolonged, Tremor, Troponin I, Urine analysis normal
Clinical narrative: 1:22 AM:  chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance  4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER.  Patient received 500cc NS bolus IV. Labs findings unremarkable.  INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging  with Dx: reaction to COVID vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Disturbance in attention, Mental impairment, Skin haemorrhage, Skin laceration
Clinical narrative: reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; he noticed his "mental acuity [was] reduced; reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; He said he also has "drowsiness" which is getting more significant; cut his thumb while chopping asparagus He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had.; ut his thumb while chopping asparagus He added he bled terribly; This is a spontaneous report from a contactable consumer reporting for himself.   A 70-years-old male patient received  second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Mar2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer after the second vaccine doses noticed his "mental acuity [was] reduced". He also described/referred to it as: "reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness". After the second dose, this experience was "worst, more significant and continues to get more significant".  He explained he drives a large tracker truck for (Company name) and had to take days off work due to his symptoms. He specified the following details post-vaccination with his second dose: Monday night, he was preparing diner around 8 pm and cut his thumb while chopping asparagus. He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had. He then said he called his physician on Tuesday who returned his call around 5:30 that same day, and who recommended to go to the ER since stiches were needed. He added he resisted to go to the ER because of his symptoms affecting his driving but went upon his HCP's encouragement. He explained once at the ER, the doctor there said he wouldn't recommend stiches since this may seal in the bacteria from the improper dressing he had, which will affect the make the healing period and scaring.  He added they cleaned and sealed his wound nicely then they offered a tetanus shot, which he got. He described his thumb as a "flap finger". He explained when driving back home he almost had an accident due to not paying attention to details, which he wouldn't have done in his 40 years of driving experience. He said he also has "drowsiness" which is getting more significant. Events outcome was unknown.  Information about lot/batch has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; he noticed his "mental acuity [was] reduced; reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; He said he also has "drowsiness" which is getting more significant; cut his thumb while chopping asparagus He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had.; ut his thumb while chopping asparagus He added he bled terribly; This is a spontaneous report from a contactable consumer reporting for himself.   A 70-years-old male patient received  second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Mar2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer after the second vaccine doses noticed his "mental acuity [was] reduced". He also described/referred to it as: "reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness". After the second dose, this experience was "worst, more significant and continues to get more significant".  He explained he drives a large tracker truck for (Company name) and had to take days off work due to his symptoms. He specified the following details post-vaccination with his second dose: Monday night, he was preparing diner around 8 pm and cut his thumb while chopping asparagus. He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had. He then said he called his physician on Tuesday who returned his call around 5:30 that same day, and who recommended to go to the ER since stiches were needed. He added he resisted to go to the ER because of his symptoms affecting his driving but went upon his HCP's encouragement. He explained once at the ER, the doctor there said he wouldn't recommend stiches since this may seal in the bacteria from the improper dressing he had, which will affect the make the healing period and scaring.  He added they cleaned and sealed his wound nicely then they offered a tetanus shot, which he got. He described his thumb as a "flap finger". He explained when driving back home he almost had an accident due to not paying attention to details, which he wouldn't have done in his 40 years of driving experience. He said he also has "drowsiness" which is getting more significant. Events outcome was unknown.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: acute hearing loss in the left ear; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced acute hearing loss in the left ear about ten days after getting the vaccine. The physician was wondering how common this was and if there was any advice for re-treatment or further testing. Outcome of the event was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event hearing loss 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.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: facial paralysis on right side; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 33-year-old male patient (reporter's son) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on Mar2021, four hours after the vaccine was received, the patient experienced facial paralysis on the right side. The patient went to the hospital and the side effects subsided. The outcome of the event was unknown.   Information about Lot/Batch number is requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Feeling abnormal, Pain
Clinical narrative: tested positive for covid; body aches; not feeling well; weakness; low grade fever; This is a spontaneous report received from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the BNT162B2 vaccine on 23Feb2021 and day later she had symptoms of covid, body aches, not feeling well, weakness, low grade fever, tested positive for covid. In the second week she had to go to hospital for few days and was very week and still covid positive. Reporter wanted to know can patient take her second dose or if she needs to redo her series. The outcome of the events was unknown.  information about lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for covid; body aches; not feeling well; weakness; low grade fever; This is a spontaneous report received from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the BNT162B2 vaccine on 23Feb2021 and day later she had symptoms of covid, body aches, not feeling well, weakness, low grade fever, tested positive for covid. In the second week she had to go to hospital for few days and was very week and still covid positive. Reporter wanted to know can patient take her second dose or if she needs to redo her series. The outcome of the events was unknown.  information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sickle cell anaemia with crisis
Clinical narrative: sickle cell crisis; This is a spontaneous report received from a contactable consumer (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 6 or 7 days later after receiving the first dose of the Pfizer Covid vaccine, the patient started to experience a sickle cell crisis which was continuing and had not resolved. The patient wanted guidance and also wanted to know if she should get the second dose. Outcome of the event was not recovered.  Information related to the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Cardiac stress test, Electroencephalogram, Headache, Hot flush
Clinical narrative: sickle cell crisis; This is a spontaneous report received from a contactable consumer (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 6 or 7 days later after receiving the first dose of the Pfizer Covid vaccine, the patient started to experience a sickle cell crisis which was continuing and had not resolved. The patient wanted guidance and also wanted to know if she should get the second dose. Outcome of the event was not recovered.  Information related to the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Sickle cell anaemia with crisis
Clinical narrative: sickle cell crisis; This is a spontaneous report received from a contactable consumer (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 6 or 7 days later after receiving the first dose of the Pfizer Covid vaccine, the patient started to experience a sickle cell crisis which was continuing and had not resolved. The patient wanted guidance and also wanted to know if she should get the second dose. Outcome of the event was not recovered.  Information related to the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: staph infection; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient is scheduled to get the second dose of the Pfizer COVID-19 vaccine tomorrow (26Mar2021). However, he had been on antibiotics for a month and a half and he wants to know if there would be any potential interaction with antibiotics and the vaccine. He said he had a staph infection (medically significant) and he had taken antibiotics intravenously for 3 weeks (on an IV line) and he is supposed to take oral antibiotics for 2 more weeks. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Lymphadenopathy, Malaise, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Pulmonary congestion, Respiratory tract congestion, Speech disorder
Clinical narrative: she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (wife) reported for a male patient reported that, A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 23Mar2021 at a SINGLE DOSE for covid-19 immunization. Patient had a medical history of cough and his ears were plugged and he was dizzy. The patient's concomitant medications were not reported. On 25Mar2021 patient visited urgent care and was performed COVID-19 virus test resulted as positive. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: She experienced 3 strokes; This is a spontaneous report from a contactable consumer.  A female patient of unspecified age received BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration  on 12Mar2021 (lot number and expiry date not reported) as a single dose for COVID-19 immunization. The patient's medical history included severe Factor 7 deficiency. Concomitant medications were not reported. On 12Mar2021, 50 minutes following the injection, the patient experienced 3 strokes. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 antibody test, Syncope
Clinical narrative: lost consciousness and fainted two times; lost consciousness and fainted two times; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 21-year-old female received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 15:00 (Lot Number: 10350) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Bipolar II and post-traumatic stress disorder (PTSD). Prior to vaccination, patient was diagnosed with COVID-19 on an unknown date. No allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE), methylphenidate hydrochloride (CONCERTA), aripiprazole (ABILIFY) and escitalopram oxalate (LEXAPRO). On 25Mar2021 15:00, the patient lost consciousness and fainted two times. Paramedics were called and she was released. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 06Jan2021. The outcome of the events was recovered in Mar2021.  The events lost consciousness and fainted 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Erythema, Feeling hot, Gait inability, Muscle tightness
Clinical narrative: could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation.  Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night.  The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, Ultrasound scan
Clinical narrative: could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation.  Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night.  The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: stools that appear to be what she described as "coffee grounds; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age also reported 71 (unit of measurement not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 24Mar2021, as SINGLE DOSE for covid-19 immunisation; apixaban (ELIQUIS), via an unspecified route of administration, from Sep2020 and ongoing, at 5 mg, 2x/day for an unspecified indication; iron via an unspecified route of administration, from an unspecified date, at unspecified dose and frequency, for an unspecified indication.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was concerned about the information she received to report if she was taking a blood thinner. The patient didn't read the information prior to receiving the vaccine to inform the clinic. She has been taking ELIQUIS 5mg twice daily since Sep2020. The patient experienced stools that appear to be what she described as "coffee grounds" on 25Mar2021 (the next day). Action taken with apixaban and iron was unknown. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Lyme disease
Clinical narrative: Lyme disease; Patient has no appetite after 2nd shot; This is a spontaneous report received from a contactable Non-healthcare Professional on behalf of a patient. A non-pregnant adult female patient received bnt162b2 (Pfizer, Solution for injection), dose 2 via an unspecified route of administration on Mar2021 as single dose, via an unspecified route of administration on Mar2021 to Mar2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation first dose. The patient experienced lyme disease (Medically significant) and has no appetite after 2nd shot on Mar2021. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Headache, Hyperhidrosis
Clinical narrative: very high blood pressure; shortness of breath; his arm redness; sweating; dizziness; his head was pounding; weakness in his legs; This is a spontaneous report received from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at an unspecified age on 15Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included allergic to penicillin and iodine, when he took what he was allergic to he broke out in rash, hives. Concomitant medications were not reported. The patient had side effects: shortness of breath, very high blood pressure, his arm redness, sweating, dizziness, his head was pounding, weakness in his legs and dizzy. The patient was treated and was taken to the hospital till his blood pressure went down and they gave him some diphenhydramine hydrochloride (BENADRYL) for his side effects. They were looking the answer for if he can take a second shot or not. Since he went through all of these side effects. The patient did not want to take a second shot after what he has experienced after the first shot. He was doing ok right now. The patient did not have COVID. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Muscular weakness
Clinical narrative: very high blood pressure; shortness of breath; his arm redness; sweating; dizziness; his head was pounding; weakness in his legs; This is a spontaneous report received from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at an unspecified age on 15Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included allergic to penicillin and iodine, when he took what he was allergic to he broke out in rash, hives. Concomitant medications were not reported. The patient had side effects: shortness of breath, very high blood pressure, his arm redness, sweating, dizziness, his head was pounding, weakness in his legs and dizzy. The patient was treated and was taken to the hospital till his blood pressure went down and they gave him some diphenhydramine hydrochloride (BENADRYL) for his side effects. They were looking the answer for if he can take a second shot or not. Since he went through all of these side effects. The patient did not want to take a second shot after what he has experienced after the first shot. He was doing ok right now. The patient did not have COVID. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Information on the batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Woke up the following morning after the injection with Vertigo and dizziness. Attempted to get out of bed and the room was spinning. Have never had Vertigo before.; Woke up the following morning after the injection with Vertigo and dizziness. Attempted to get out of bed and the room was spinning. Have never had Vertigo before.; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation.  Medical history included Diabetes, high blood pressure, tinnitus, drusen of the optic nerve. 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.Concomitant medication(s) included insulin glargine (TOUJEO) taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; pravastatin taken for an unspecified indication, start and stop date were not reported; carvedilol taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported.  At 05:30 AM of 16Mar2021,Woke up the following morning after the injection with Vertigo and dizziness. Attempted to get out of bed and the room was spinning. Have never had Vertigo before. This side effect has now continued for close to 2 weeks now, however, it has subsided as time progresses. Outcome of events was not recovered. No treatment received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Tetanus
Clinical narrative: ache in the arm with first dose; felt like mild tetanus; stiff arm for a couple of hours; s is a spontaneous report from a contactable consumer.   A 68-years-old male patient received bnt162b2 (BNT162B2), at the age of 68 years old, dose 1 via an unspecified route of administration, in left arm on 02Mar2021 at 14:30 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation  .  Medical history included ongoing type 2 diabetes mellitus he was diagnosed almost 30 years ago , plague plague shot a long time ago the black plague shots, states it kicked the heck out of him, had a low grade case of the black plague and it made him feel pretty miserable. He got it over seas, when he went to Africa. It was so long ago, over 15 years ago. Concomitant medication(s) included insulin degludec (TRESIBA) taken for type 2 diabetes mellitus from 2015 and ongoing; semaglutide (OZEMPIC) taken for type 2 diabetes mellitus from 2017 and ongoing; dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication from an unspecified start date about 5 years agoand ongoing.  Patient states that after his first shot he felt pretty good, it didn't bother him, felt like mild tetanus and a stiff arm for a couple of hours. Ache in his arm with the first dose, patient confirms started the day after he got the first dose, but only lasted a few hours. Patient clarifies his muscles aches recovered 80-90%, states it is fading away, it is more like he is just worn out. Patient states that his hips were aching, but that is gone now. The outcome of the remaining events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Iridocyclitis
Clinical narrative: anterior uveitis / can't see well enough; it was getting better, but it was not happy; This is a spontaneous report from a contactable physician reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, deltoid right on 10Mar2021 (batch/lot number EN6208 and expiry date not reported) at 66 years of age as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included some over the counter B12 (unspecified). The patient informed that she developed an anterior uveitis which started 2 days post her COVID injection (12Mar2021). The patient informed that she will be reporting online but she can't see well enough (Mar2021) to report online. The patient informed that "it was getting better, but it was not happy". The patient informed that in response to the vaccine she was on Prednisolone 1 percent ophthalmic eye drops. The patient confirmed that she was taking Prednisolone as a treatment (for the events) and was still on it. The outcome of the event anterior uveitis was not recovered, while unknown for the other event. The physician informed that causality was "yes".; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event iridocyclitis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Investigation
Clinical narrative: weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.