chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Urine odour abnormal
Clinical narrative: Sore shoulder; general malaise for the next two days; strange smelling urine; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30(at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 20:30 the patient experienced sore shoulder, general malaise for the next two days with strange smelling urine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events.  The clinical outcome of the event shoulder soreness, malaise and urine odour abnormal was recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: The aches have moved into hands; Chills; Headache; Bad body aches; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included crohns, IBD, fibromyalgia, sleep apnea, rheumatoid arthritis and juvenile idiopathic arthritis (jia). Concomitant medications included vedolizumab (ENTYVIO), duloxetine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN) and nifedipine (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously took humira and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 14:00, the patient experienced chills along with bad body aches. The chills went away but still having body aches and a headache every hour. On an unknown date in Apr2021, the aches have moved into hands. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event chills was recovered. The clinical outcome of the event bad body aches, headache and the aches have moved into hands were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastrointestinal pain, Vomiting
Clinical narrative: fatigue; still having lower intestine cramping; Votimed 3 times starting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm left on 25Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal), and diverticulitis. The patient did not receive any other medications within 2 weeks of vaccination. The patient was allergic to penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6202) via an unspecified route of administration in the arm left on 4Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25Mar2021, at 17:00 the patient experienced vomited 3 times. From 25March2021 at 17:00 to 26March2021 at 18:00, patient experienced diarrhea and again diarrhea started from 28March2021 at 18:00 to 29March2021. On 26March, the patient experienced fatigue, lower intestine cramping and still have it and forwarded on. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events diarrhea, vomited, fatigue and lower intestine cramping were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess oral, Oral candidiasis, Oral infection
Clinical narrative: large abcess in my mouth; subsequent mouth infection; subsequent mouth infection, likely thrush; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 22:30(at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included colecalciferol (VITAMIN D3), omeprazole (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, within 24 hours of the vaccine, at 12:00, the patient developed a large abscess in mouth and subsequent mouth infection, likely thrush. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of a large abscess in mouth and subsequent mouth infection, likely thrush and included antibiotics (unspecified). The clinical outcome of the event mouth abscess, infection and oral thrush was recovering at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; looked at the back and have a rash; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EpT534) via an unspecified route of administration in the left arm on 01Apr2021 at 08:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, hypertension, cholesterol high and back problems. The patient took unspecified concomitant medications. The patient did not have any known allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 12:30, the patient noticed that she was itching and when looked at her back she had a rash. On 02Apr2021, the itching was more than the previous day. The events did not result in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive any treatment for the events itching and rash. The clinical outcomes of the events itching and rash was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: low grade fever; body aches; fatigue; some nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included gout. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) 300 mg daily from an unknown date and for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6199) via an unspecified route of administration in the right arm on 10Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. 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 was not tested for COVID-19. On 01Apr2021 at 04:00, the patient experienced low grade fever for 2 days, body aches, fatigue and some nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade fever was resolved on 03Apr2021, while that of body aches, fatigue and nausea was resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Mild chills; mild to moderate body aches; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 14:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient previously took prednisone (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 01Apr2021 at 20:30, the patient experienced mild chills and mild to moderate body aches 5-6 after vaccine which lasted about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of mild chills and mild to moderate body aches was resolved on 03Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Constipation, Lymph node pain, Malaise, Pain in extremity
Clinical narrative: 2 days after - mid back ache (right shoulder blade).; Soreness under right arm; radiating into right breast; Sleep interrupted by mid back ache; mid section of body just feeling sick; Motion has not impeded; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the arm right on 28Mar2021 at 14:00 hours (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included eczema (mild), itching had subsided, now just had dull ache and was just getting over a flare on back shoulder blade pain. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergic to food, medication or other product and did not received medicine generally. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 12:00 hours, after 2 days the patient experienced mid back ache (right shoulder blade). soreness under right arm, radiating into right breast, sleep interrupted by mid back ache, mid-section of body was just feeling sick and motion had not impeded. The patient did not receive any treatment for the event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mid back ache, soreness under right arm, radiating into right breast, sleep interrupted by mid back ache, mid-section of body was just feeling sick and motion had not impeded were not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 2 days after - mid back ache (right shoulder blade).; Soreness under right arm; radiating into right breast; Sleep interrupted by mid back ache; mid section of body just feeling sick; Motion has not impeded; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the arm right on 28Mar2021 at 14:00 hours (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included eczema (mild), itching had subsided, now just had dull ache and was just getting over a flare on back shoulder blade pain. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergic to food, medication or other product and did not received medicine generally. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 12:00 hours, after 2 days the patient experienced mid back ache (right shoulder blade). soreness under right arm, radiating into right breast, sleep interrupted by mid back ache, mid-section of body was just feeling sick and motion had not impeded. The patient did not receive any treatment for the event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mid back ache, soreness under right arm, radiating into right breast, sleep interrupted by mid back ache, mid-section of body was just feeling sick and motion had not impeded were not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache; fever; chills; body ache; exhaustion/ have continued to be uncharacteristically exhausted for part of each day; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 10:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and mild heart murmer. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and pravastatin (MANUFACTURER UNKNOWN) for unknown indications from an unknown date. The patient did not have any known allergy to any medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 12Feb2021 at 10:15 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 06Mar2021, the patient had headache, fever, chills, body ache and exhaustion for about 30 hours after the shot. She had ongoing exhaustion and after recovering from the initial 30 hours of side effects from the vaccine she continued to be uncharacteristically exhausted for part of each day, especially after exercise. She was tired when she woke up in the morning, and found that after any form of activity she became physically exhausted. There were times when she could barely stay awake and had to take a nap and after which she was still very tired. This had been going on for a full four weeks after receiving the second dose, which was concerning for her. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, fever, chills, body ache and exhaustion. The clinical outcomes of the events headache, fever, chills, body ache and exhaustion were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Pain
Clinical narrative: Ball (inflamation) behin my arm.. a lot pain and inflamation its notorios; Ball (inflamation) behin my arm.. a lot pain and inflamation its notorios/he had ball behind his arm and still there; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection); Lot/batch no: ER8736) via unspecified route of administration in left arm as dose2, single on 02May2021 03:00 for COVID-19 immunization (at the age of 43-years-old). The most recent COVID-19 vaccine was administered in the pharmacy. Medical history was not reported. The patient's concomitant medications were not reported. There were no known allergies. The patient historical vaccine included first dose of BNT162B2; Lot/batch no: EW0161) via unspecified route of administration in left arm, as dose 1, single on 11Apr2021 03:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that, after 2 days 2nd dose (04May2021) he had ball behind his arm and still there. On 13May2021 patient experienced ball (inflamation) behin my arm. A lot pain and inflamation its notorios. Events resulted in physician office visit. Treatment received included steroids and Naproxen. The clinical outcome for the events was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Device use issue, Injury associated with device, Paraesthesia, Product quality issue
Clinical narrative: Tingling sensation; device use issue; accidental needle stick; product quality issue; This is a spontaneous report from a contactable consumer (reported for her husband). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 27Feb2021 (at the age of 71-years-old) as dose 2, single for covid-19 immunisation, co-suspect drug HUMIRA (adalimumab) via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at a dose of 1gm 1in2 week (40mg/0.4ml (40 milligram, solution for injection in pre-filled pen)) for psoriatic arthropathy. Medical history included alcoholic from an unknown date and unknown if ongoing occasional drinker one bottle of beer (started 1967) non-smoker. Concomitant medication(s) included aspirin (ACETYLSALICYLIC ACID) taken for cardiac disorder, lisinopril (LISINOPRIL) taken for blood pressure measurement, simethicone (SIMETHICONE) taken for dementia alzheimer's type, sulfasalazine (SULFASALAZINE) taken for arthritis, memantine (MEMANTINE) taken for dementia alzheimer's type and mirtazapine (MIRTAZAPINE) taken for depression. The patient previously received tamsulosin for product used for unknown indication and experienced drug hypersensitivity (Tamsulosin allergy manifested by hypotensive/tachycardia the patient's past medications include: tamsulosin for unknown indication), ENBREL for product used for unknown indication and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 (at the age of 71-years-old) as dose 1, single for covid-19 immunisation. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 06May2021, the patient's wife accidentally punctured her right thumb while injecting her husband/felt tingling sensation and product quality issue with Humira 40mg/0.4ml (adalimumab). On 06May2021, the patient experienced tingling sensation, device use issue, accidental needle stick and product quality issue. The events assessed as non-serious. The outcome of the events was resolved on 06May2021. The reporter's causality for the event(s) of patient's wife accidentally punctured her right thumb while injecting her husband/felt tingling sensation onset 06May2021 and patient's wife accidentally punctured her right thumb while injecting her husband/felt tingling sensation onset 06May2021 with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of patient's wife accidentally punctured her right thumb while injecting her husband/felt tingling sensation onset 06May2021 and product quality issue was not provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: soreness; The dose 0.3ml dose diluted with 0.8ml instead of 1.8ml; Patient got a super concentrated dose of the vaccine; This is a spontaneous report from a contactable pharmacist. An 84-years-old male patient received bnt62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0178; Expiration Date: Aug2021), dose 1 via an Intramuscular route of administration at Right Deltoid on 25May2021 at 07:24 (at the age of 84 years) as dose 1, single for COVID-19 immunization. Dose: 2 (batch number and expiry date was not reported) via intramuscular at right deltoid on 15Jun2021 09:58 as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported on 25May2021 at 07:00 in morning, the pharmacist gave a patient the dose 0.3ml dose diluted with 0.8ml instead of 1.8ml. The patient received a super concentrated dose. Pharmacist wanted to know whether to revaccinate or how it will affect the patient. It was confirmed that no other patient received product from this vial. On 26May2021, the patient experienced soreness. Outcome of the event soreness was recovered 16Jun2021 and unknown for other events.  Follow up (12Jul2021): Added new event soreness.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Head discomfort, Hypertension, Nasal congestion
Clinical narrative: had a flare that cause pain in left shoulder lower back, left hip and left leg; had a flare that cause pain in left shoulder lower back, left hip and left leg; had a flare that cause pain in left shoulder lower back, left hip and left leg; had 2 instances of a sinus infections; sore throat; stuffy nose, head; stuffy nose, head; small amount of drainage; current high blood pressure; This is a spontaneous report from a contactable nurse and a contactable consumer (patient) via Pfizer-sponsored program.  A 56-year-old female consumer received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) for covid-19 immunisation and oral tofacitinib citrate (XELJANZ XR) at 11mg daily for rheumatoid arthritis. Medical history included high blood pressure. The patient was not pregnant. The patient reported she stopped taking XELJANZ XR due to covid vaccine doses, during this time she had a flare that caused pain in left shoulder lower back, left hip and left leg. The patient took steroid to help with pain. The patient had 2 instances of a sinus infections with sore throat, stuffy nose, head and small amount of drainage. MD aware. During time with sinus infections advised multiple doses missed. The action taken with XELJANZ XR was unknown. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Sinusitis
Clinical narrative: had a flare that cause pain in left shoulder lower back, left hip and left leg; had a flare that cause pain in left shoulder lower back, left hip and left leg; had a flare that cause pain in left shoulder lower back, left hip and left leg; had 2 instances of a sinus infections; sore throat; stuffy nose, head; stuffy nose, head; small amount of drainage; current high blood pressure; This is a spontaneous report from a contactable nurse and a contactable consumer (patient) via Pfizer-sponsored program.  A 56-year-old female consumer received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) for covid-19 immunisation and oral tofacitinib citrate (XELJANZ XR) at 11mg daily for rheumatoid arthritis. Medical history included high blood pressure. The patient was not pregnant. The patient reported she stopped taking XELJANZ XR due to covid vaccine doses, during this time she had a flare that caused pain in left shoulder lower back, left hip and left leg. The patient took steroid to help with pain. The patient had 2 instances of a sinus infections with sore throat, stuffy nose, head and small amount of drainage. MD aware. During time with sinus infections advised multiple doses missed. The action taken with XELJANZ XR was unknown. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Arrhythmia
Clinical narrative: heart arrhythmia; This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Right arm on 29Dec2020 08:00 (Lot Number: EK9231) at age of 47-year-old as dose 1, single for COVID-19 immunization.  Medical history included hypertension (HTN). The patient's concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medication the patient received within 2 weeks of vaccination.  The patient previously took amoxicillin and experienced Known allergies:Amoxicillin. Almost exactly four hours of receiving vaccine, both times, she had heart arrhythmia (29Dec2020 12:00 for first dose). She had never had arrhythmias before. Arrhythmias have continued intermittently since but was getting less as times went by.  Additionally, after being in the hospital in Mar for condition (unrelated) she was diagnosed with a positive C-ANCA blood test. Her primary MD also agreed that she was "most likely" having a parasympathetic reaction to the vaccine. She was not sure if the C-ANCA was related to the vaccine or not - however- she was highly suspicious it might be. She was nurse practitioner and she could tell unequivocally she was certain she had some sort of reaction to this vaccine. She had never had issues with any vaccines before and obviously based on her profession was required to be vaccinated for all. There was no treatment for the event. No covid prior vaccination and no covid tested post vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Arrhythmia and the suspect drug BNT162B2. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood test, Dizziness, Dyskinesia, Eyelid function disorder
Clinical narrative: my throat became tight; my entire body went limp; could barely move my mouth to talk; within 25 minutes, i became extremely cold, dizzy, and then my entire body went limp; within 25 minutes, i became extremely cold, dizzy, and then my entire body went limp; I couldn't talk or move my neck or open my eyes, but I could hear; I couldn't move any part of my body except neck; I couldn't talk or move my neck or open my eyes, but I could hear; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hemiplegic migraines, sjogren's syndrome, hashimoto's hypothyroidism, hypothyroidism, allergies: penicillin, wheat, and peanuts. Patient is not pregnant at time of vaccination. Concomitant medications included levothyroxine; erenumab aooe (AIMOVIG); and ubrogepant (UBRELVY) and OTC vitamins. The patient previously took verapamil, and acetazolamide and experienced allergy. Patient previously received Flu shot for immunisation and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 25 minutes, patient became extremely cold, dizzy, and then her entire body went limp. Patient couldn't move any part of her body except neck, and could barely move her mouth to talk. Within a minute, she couldn't talk or move her neck or open her eyes, but she could hear. An Epi-pen was administered into her right thigh and she was whisked off to ER on a gurney, where steroids and benadryl were also given through IV when her throat became tight. Adverse event start date was 20Mar2021 11:30 AM. Adverse events result in Emergency room/department or urgent care. Treatment Epi-Pen, steroids, Benadryl were received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included covid test type post vaccination (Blood test): positive on 22Apr2021, Covid test type post vaccination (Nasal Swab): negative on 22Apr2021. The outcomes of events were recovered on unspecified date. Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Gait disturbance, Movement disorder, SARS-CoV-2 test, Throat tightness
Clinical narrative: my throat became tight; my entire body went limp; could barely move my mouth to talk; within 25 minutes, i became extremely cold, dizzy, and then my entire body went limp; within 25 minutes, i became extremely cold, dizzy, and then my entire body went limp; I couldn't talk or move my neck or open my eyes, but I could hear; I couldn't move any part of my body except neck; I couldn't talk or move my neck or open my eyes, but I could hear; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hemiplegic migraines, sjogren's syndrome, hashimoto's hypothyroidism, hypothyroidism, allergies: penicillin, wheat, and peanuts. Patient is not pregnant at time of vaccination. Concomitant medications included levothyroxine; erenumab aooe (AIMOVIG); and ubrogepant (UBRELVY) and OTC vitamins. The patient previously took verapamil, and acetazolamide and experienced allergy. Patient previously received Flu shot for immunisation and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 25 minutes, patient became extremely cold, dizzy, and then her entire body went limp. Patient couldn't move any part of her body except neck, and could barely move her mouth to talk. Within a minute, she couldn't talk or move her neck or open her eyes, but she could hear. An Epi-pen was administered into her right thigh and she was whisked off to ER on a gurney, where steroids and benadryl were also given through IV when her throat became tight. Adverse event start date was 20Mar2021 11:30 AM. Adverse events result in Emergency room/department or urgent care. Treatment Epi-Pen, steroids, Benadryl were received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included covid test type post vaccination (Blood test): positive on 22Apr2021, Covid test type post vaccination (Nasal Swab): negative on 22Apr2021. The outcomes of events were recovered on unspecified date. Information on lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 15Apr2021 at 13:45 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE (at the age of 74-years-old) for COVID-19 immunisation. Medical history included Type 2 diabetes mellitus and Chronic Obstructive Pulmonary Disease (COPD), high blood pressure (BP) and Covid-19 from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received several normal prescriptions and supplements within 2 weeks of vaccination. The patient had unspecified concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had a stroke on 05May2021 at 13:30 and was ambulanced to the hospital where he had vascular carotid artery surgery. The patient was hospitalized from 05May2021 to an unknown date for 9 days. The second dose was set for 06May2021. The event resolved with sequel. The event resolved with sequel on an unspecified date in 2021. This report is serious (caused / prolonged hospitalization, disabling / incapacitating). The event required Emergency room/department or urgent care.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Lymphadenopathy, Lymphatic disorder, Pruritus
Clinical narrative: Itching; Inflammation of the face with small bumps, painless but itchy; Inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw; Swollen lymph nodes; Rash; Hives; Swelling of the face; acute allergic reaction; lymphopathy; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Jun2021 18:00 (Batch/Lot Number: EW0196) at age of 69-years-old as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. No known allergy. Concomitant medication included metoprolol received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient experienced swollen lymph nodes, rash, hives and swelling of the face on 25Jun2021 with outcome of unknown, inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw on 25Jun2021 07:00 with outcome of not recovered, itching on 25Jun2021 07:00 with outcome of recovered in 2021, all reported as medically significant. AE resulted in Emergency or urgency room/department. Treatment to against allergy was received. Clinical course reported as follow: Patient received the first shot of the Pfizer Covid-19 vaccine on 24Jun2021 and the next day he had an allergic reaction. He went to withheld Hospital in withheld to the emergency room because his face was swollen and he had some lumps/"bumps" on his face on his cheeks and under his jaw. The treatment he received was diphenhydramine (BENADRYL) 25 mg oral capsules, oral tablets (2 tablets a day for 4 days); Prednisone 20 mg oral tablets, and Hydrocortisone topical 0.1% cream. He had to take 2 tablets of Prednisone 20 mg for 4 days. He took the treatment for 3 days and now has stopped it. He no longer has the itching he previously had. He had internal swelling on the face, like if the swelling was coming from his glands. He currently has no itchiness swelling was internal, like lymph nodes. The diagnosis the doctor gave him was acute allergic reaction (2021) and they described it as itching on the face and swelling. He was due to get his second dose of the COVID-19 vaccine on 15Jul2021. He needed to explain that the swelling on his face was supposed to be on his neck but because of an allergic reaction, he got this on his face. It was called lymphopathy (2021). The lymph nodes were supposed to come out on his neck but nothing came out on his neck, they came out on his face was what the doctor were informed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Swelling face, Urticaria
Clinical narrative: Itching; Inflammation of the face with small bumps, painless but itchy; Inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw; Swollen lymph nodes; Rash; Hives; Swelling of the face; acute allergic reaction; lymphopathy; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Jun2021 18:00 (Batch/Lot Number: EW0196) at age of 69-years-old as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. No known allergy. Concomitant medication included metoprolol received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient experienced swollen lymph nodes, rash, hives and swelling of the face on 25Jun2021 with outcome of unknown, inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw on 25Jun2021 07:00 with outcome of not recovered, itching on 25Jun2021 07:00 with outcome of recovered in 2021, all reported as medically significant. AE resulted in Emergency or urgency room/department. Treatment to against allergy was received. Clinical course reported as follow: Patient received the first shot of the Pfizer Covid-19 vaccine on 24Jun2021 and the next day he had an allergic reaction. He went to withheld Hospital in withheld to the emergency room because his face was swollen and he had some lumps/"bumps" on his face on his cheeks and under his jaw. The treatment he received was diphenhydramine (BENADRYL) 25 mg oral capsules, oral tablets (2 tablets a day for 4 days); Prednisone 20 mg oral tablets, and Hydrocortisone topical 0.1% cream. He had to take 2 tablets of Prednisone 20 mg for 4 days. He took the treatment for 3 days and now has stopped it. He no longer has the itching he previously had. He had internal swelling on the face, like if the swelling was coming from his glands. He currently has no itchiness swelling was internal, like lymph nodes. The diagnosis the doctor gave him was acute allergic reaction (2021) and they described it as itching on the face and swelling. He was due to get his second dose of the COVID-19 vaccine on 15Jul2021. He needed to explain that the swelling on his face was supposed to be on his neck but because of an allergic reaction, he got this on his face. It was called lymphopathy (2021). The lymph nodes were supposed to come out on his neck but nothing came out on his neck, they came out on his face was what the doctor were informed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lower limb fracture, Mouth swelling, Plantar fasciitis, Stomatitis
Clinical narrative: broke her leg and then that went to plantar fasciitis; broke her leg and then that went to plantar fasciitis; cant close her mouth all the way since it is swollen; piece of meat on the top of her mouth behind the two front teeth have been inflamed/ experiencing inflammation of the meat behind her front two teeth; cannot swallow; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11Mar2021 for COVID-19 immunisation. After the second dose of the vaccine, patient reported that the "piece of meat on the top of her mouth behind the two front teeth have been inflamed." Ever since the second shot, the patient has been experiencing inflammation of the meat behind her front two teeth. Every morning the patient wakes up with it. The patient went to the doctor, her dentist, and the endodontist. She ended up getting steroids for a different reason. The patient had to get on steroids because she broke her leg and then that went to plantar fasciitis. She thought the steroids would help with the inflammation of the meat behind her front two teeth and it didn't. Then she tried the mouth wash that you take for thrush and that didn't do anything either. She added that she had a crown put on her bottom molar because she can't close her mouth all the way since it was swollen and she also cannot swallow. She had been to the dentist, pharmacist and health care provider. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Swelling face
Clinical narrative: under her chin, a lump about the size of a golf ball; face really swollen; Huge painful; This is a spontaneous report from a contactable consumer (patient's husband) and contactable nurse (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jul2021 (Batch/Lot number was not reported) at the age of 66 years old as dose 1, single for COVID-19 immunization. Medical history included Blood pressure high, Heart disease, Diabetes, Thyroid diseases, Crohn's disease and swollen lymph nodes, all from unknown dates and unknown if ongoing.  Concomitant medications included taking medicine for high blood pressure, heart, thyroid and diabetes and has Crohn's diseases. No prior vaccination (within 4 weeks). As reported, patient received vaccine 5 days ago (Jul2021) and on 07Jul2021 ("this morning"), she got up with her face really swollen and right under her chin, a lump about the size of a golf ball. Further stated that she's had swollen lymph nodes before but nothing like this. It's huge. None of her other lymph nodes seems to be tendered and nowhere under her arm so it's just a lump under a chin. Further stated that, patient woke up and there was a huge painful (incomplete sentence) on Jul2021. Outcome of events were unknown.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Broke out in a full body rash; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; This is a spontaneous report from a contactable consumer reported (reporter's son). A 12-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:00 (Batch/Lot number was not reported) as dose 2, single (at age of 12-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Concomitant medications included ascorbic acid (VITAMIN C); vitamin d nos (VITAMIN D). Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18May2021 09:00 administered in left arm (at age of 12-years-old) for COVID-19 immunisation. The patient broke out in a full body rash starting 2 days after the 2nd shot on 10Jun2021. Started on top of his feet and spots on his leg and by the 3rd day, was covering most of his body up to his neck. Red, warm to touch, itchy, it was not too raised, just slightly swollen on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Used Zyrtec and Benadryl per advise of doctor. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No Hospitalization Prolonged. Outcome of the events was recovered/resolved.  Information on the lot/batch number has been requested.