chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness, Tremor
Clinical narrative: body numbness/body numb and tingling; extremities cold to touch; My hands and feet are freezing; shaking/hands are shaking; body numb and tingling; This is a spontaneous report from a Pfizer sponsored program COVAX US support by a contactable consumer. This consumer(patient) reported for herself that the 42-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 at 12:45pm (Batch/Lot Number: UNK) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body numbness/body numb and tingling on an unspecified date with outcome of unknown, extremities cold to touch on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of unknown, body numb and tingling on an unspecified date with outcome of unknown, hands are shaking on an unspecified date with outcome of unknown, my hands and feet are freezing on an unspecified date with outcome of unknown.    The clinical course was reported as follows: Caller received the Pfizer vaccine yesterday, at 12:45pm.  Side effects  started this morning at 7 am. Caller states, "My hands and feet are freezing, body numb and tingling and hands are shaking. " Is this a side effect from the vaccine? Caller is going to call the Emergency Room. Spoke from EUA Fact Sheet for Healthcare Providers: LAB-1457-7.0 Revised: 06April2021: There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Caller reports extremities cold to touch, shaking and body numbness. 1st dose taken on April 19th. Transferred to MI for medical question. Caller had the first dose of the Pfizer Covid-19 vaccine yesterday (19Apr2021) and now experiencing tingling and both hands are shaking. Caller wants to know if that is the side effect of the vaccine.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This is a spontaneous report from a contactable physician. A 55-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller is a physician who states he has a patient who received his first dose of the Pfizer BioNTech COVID-19 vaccine 5 days ago (15Apr2021) and now has COVID-19 (onset date not reported). Physician would like to know if the patient were to receive monoclonal antibodies as part of his treatment, would he have to wait 90 days before receiving his second dose of the vaccine. The event was assessed as non-serious by the physician.  Information about lot/batch has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Fatigue, Headache
Clinical narrative: A blood vessel burst in my right eye; headache; tired; This is a spontaneous report from a contactable nurse.   A 43-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 08:15 (Batch/Lot Number: 20921163) as a single dose for COVID-19 immunisation   Medical history included diagnosed allergies, compromised immune status,  respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had not received any other vaccinations within 4 weeks. Concomitant medication(s) included chlorthalidone (CHLORTHALIDONE) taken for blood pressure measurement, start and stop date were not reported.  The patient reported that a blood vessel burst in her right eye on 10Apr2021 at 0600, she also reported a  headache and was  tired. The patient states that she got her first dose of the Pfizer COVID vaccine on Friday 9Apr2021. Patient states that the next day a blood vessel burst in the right eye. Patient states that at first she was thinking she didn't know what to think. Patient states that she didn't know what to do. Patient looked online to see how long the eye would take to heal. Patient states that the redness has gone away, the side part of patient's eye looked like something happened. Patient states that it was a lot when it happened. Patient states that the following morning on the 10Apr2021 she had a headache in the morning. Patient states that on or around 6:00 AM or 7:00 AM on 10Apr2021 she woke up with the headache and noticed the burst blood vessel. Patient states that the headache woke her up. Patient states that she took something for the headache but it still kind of lingered and patient felt kind of off all day long. Patient states that it lasted then kind of gradually went away and she didn't feel that way after a couple of days. Patient states that was the first vaccination and she is set to get the second vaccination on 30Apr2021. Patient states that with having that reaction of the blood vessel in the eye, she wants to get on with her life. Patient states that she wants the other portion of the vaccination but is nervous about getting it. The outcome of the events for tbe blood vessel burst in her right eye was recovering and the remaining events was recovered on 10Apr2021. The patient was not tested for COVID-19 before or after vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: had a little bit bruise; This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date as single dose, dose 2 via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a little bit bruise on first and second day. He never had any symptoms that was advertised on the CDC website. he didn't have headache, pain, or upset stomach. The patient asked if the medication in his arm was working. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: big lump on the lower side of my arm pit; Swollen lymph nodes (lymphadenopathy); This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a big lump on the lower side of his arm pit on an unspecified date. The patient wanted to know if this side effects was related to the vaccine and wanted to know if it was best to receive the second dose in the opposite arm or not since he has a big lump on one side of the arm. Response: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Outcome of the events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller received the first dose of the Covid vaccine on 07APR2021 and tested positive for the Covid virus yesterday; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age (age: 54, unit unknown) received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of the COVID vaccine on 07Apr2021 and tested positive for the COVID virus yesterday (19Apr2021). She is scheduled to receive the second dose on 28Apr2021. She asked if she is able to receive the second dose at that time. The patient underwent lab tests and procedures which included Covid 19: positive on 19Apr2021. The outcome of the event was unknown.   The following information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Feeding disorder, Nausea, Vomiting
Clinical narrative: nausea; vomiting; couldn't get out of bed; couldn't eat; diarrhea; This is a spontaneous report from a contactable physician.   A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EL9263) as SINGLE DOSE for covid-19 immunisation  .  Medical history included huntington's disease since 1995  Relevant medical history and concurrent conditions:  Structured information(Patient episode name): Huntington's disease  Patient Medical comments: Verbatim: Huntington's Disease.     The patient's concomitant medications were not reported.  The patient received the vaccine 24 FEB 2021, she had 4 days of severe nausea, vomiting and couldn't get out of bed. this patient has Huntington's disease. she was told it was safe, but I don't think they took into consideration that it's a genetic modification and she has Huntington's which is also the genetic modification. The outcome of the events was not reported.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: pain and itching to affected arm; pain and itching to affected arm; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported for herself that a female patient of unspecified age received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was complaining of pain and itching to affected arm, wanted to know what do about it. Patient stated was unpleasant from the beginning, and sounded upset. She expressed frustration over the long hold wait. She became more upset when informed of the common side effects and did not want to hear explanation of how long symptoms may last. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Myalgia, Pain in extremity, Palpitations
Clinical narrative: severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; heart palpitation for 6 hours; muscle pain; light headiness; chills; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. Medical history included she had COVID-19 in the past and thyroid. Concomitant medications included she was also taking medications for the thyroid. Patient stated that she had already reported her symptoms with Pfizer COVID-19 vaccine she received on 09Mar2021 and a week after she experienced severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen, had heart palpitation for 6 hours, light headiness, chills, she was wearing a heart monitor now, she still had the muscle pain. Patient wanted to know if with second dose she would have more sever side effects, should she take or not take the second dose. She was scheduled to take it this Thursday. Patient also wanted to know how she would know if she was allergic to the vaccine/ingredient. Outcome of the event severe pain in the leg was not recovered while of remain was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; heart palpitation for 6 hours; muscle pain; light headiness; chills; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. Medical history included she had COVID-19 in the past and thyroid. Concomitant medications included she was also taking medications for the thyroid. Patient stated that she had already reported her symptoms with Pfizer COVID-19 vaccine she received on 09Mar2021 and a week after she experienced severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen, had heart palpitation for 6 hours, light headiness, chills, she was wearing a heart monitor now, she still had the muscle pain. Patient wanted to know if with second dose she would have more sever side effects, should she take or not take the second dose. She was scheduled to take it this Thursday. Patient also wanted to know how she would know if she was allergic to the vaccine/ingredient. Outcome of the event severe pain in the leg was not recovered while of remain was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriospasm coronary, Chills, Contusion, Diarrhoea, Dizziness
Clinical narrative: severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; heart palpitation for 6 hours; muscle pain; light headiness; chills; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. Medical history included she had COVID-19 in the past and thyroid. Concomitant medications included she was also taking medications for the thyroid. Patient stated that she had already reported her symptoms with Pfizer COVID-19 vaccine she received on 09Mar2021 and a week after she experienced severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen, had heart palpitation for 6 hours, light headiness, chills, she was wearing a heart monitor now, she still had the muscle pain. Patient wanted to know if with second dose she would have more sever side effects, should she take or not take the second dose. She was scheduled to take it this Thursday. Patient also wanted to know how she would know if she was allergic to the vaccine/ingredient. Outcome of the event severe pain in the leg was not recovered while of remain was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Palpitations, Phlebitis, Ultrasound scan
Clinical narrative: severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen; heart palpitation for 6 hours; muscle pain; light headiness; chills; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. Medical history included she had COVID-19 in the past and thyroid. Concomitant medications included she was also taking medications for the thyroid. Patient stated that she had already reported her symptoms with Pfizer COVID-19 vaccine she received on 09Mar2021 and a week after she experienced severe pain in the leg, it got worse, checked for clot, pain was from inner thigh to calf, it was swollen, had heart palpitation for 6 hours, light headiness, chills, she was wearing a heart monitor now, she still had the muscle pain. Patient wanted to know if with second dose she would have more sever side effects, should she take or not take the second dose. She was scheduled to take it this Thursday. Patient also wanted to know how she would know if she was allergic to the vaccine/ingredient. Outcome of the event severe pain in the leg was not recovered while of remain was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles broke out on me; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported that a 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said shingles broke out on her. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Weight
Clinical narrative: she is in a prolonged flare up, and it has gotten worse; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8730), via an unspecified route of administration on 23Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunization. Medical history included ulcerative colitis from an unspecified date, ongoing ulcerative colitis flare-up from Jan2020 and lost weight because of the flare-up. Concomitant medications were not reported. On an unspecified date, the patient experienced a worsening of her prolonged ulcerative colitis flare-up. She had been advised by her doctor to start a high dose of prednisone (40 mg), one week from now, for her condition. The doctor did not want or feel comfortable with the patient waiting for 2 weeks after the shot to start the prednisone, her condition necessitated she take the prednisone now. She had not previously gone on higher doses of prednisone for more than 10 days due to the virus. She was due for the second dose of the vaccine and queried whether a moderate to high level of prednisone will interfere with the vaccine. The clinical outcome of "she is in a prolonged flare up, and it has gotten worse" was not resolved.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: INR was 3.7; was up/ went up; The initial case was missing the following minimum criteria: no indication that the patient experienced an event under suspect product BNT162B2. Upon receipt of follow-up information on 20Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm right on 14Apr2021 20:00 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included leukaemia, and covid. Concomitant medication included warfarin. The patient stated that she took Covid shot on 14Apr2021 and was on Warfarin blood thinner. Her INR was 3.7 yesterday (20Apr2021). Stated that it had went up/ it was up and event onset time was reported as 19Apr2021 16:00. Wanted to double check and make sure everything was alright. Stated she was not having any symptoms and felt fine. Stated that she had leukemia before she started warfarin and COVID shot. She had Covid in January and went ahead and got the shot. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First shot arm hurt for days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced first shot arm hurt for days and mild symptoms. Second shot nothing. No symptoms. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Echocardiogram, SARS-CoV-2 test, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic PAC/PVCs); This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 20-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on 06Jan2021 at 12:00 (at the age of 20-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included known allergy to tree nuts from an unspecified date and unspecified if ongoing. Other medical history was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 the patient experienced cardiac dysrhythmia development (Symptomatic PAC/PVCs). The event resulted in an Emergency Room visit and required treatment with a Holter monitor, echocardiogram and cardiologist. The clinical outcome of the event cardiac dysrhythmia development (Symptomatic PAC/PVCs) was recovering/resolving. Since the vaccination, the patient tested positive for COVID-19 via a nasal swab on 13Apr2021 (captured in AER: 2021456226).   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and known product profile, the causal relationship  between the reported cardiac dysrhythmia development (Symptomatic PAC/PVCs) and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) at the vaccinate age of 36 years old, as single dose for covid-19 immunisation. Patient received the first dose on Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced muscle aches on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: weakness; dizziness; This is a spontaneous report from a contactable consumer (patient's wife). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 01:30 as single dose for covid-19 immunisation. Medical history included diabetes. The patient's concomitant medications were not reported.  The patient had started to feel weakness and dizziness on 20Apr2021. The outcomes of events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Myalgia, Sensory loss, Vaccination site pain
Clinical narrative: Having pain in left shoulder, same site where the Pfizer Covid Vaccination was given; hardly feel hand; its stiff; can hardly move her shoulder; she can feel it in the muscle; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported she received the Pfizer Covid Vaccine on 31Mar2021. Patient was having pain in the left shoulder, same site where the vaccination was given. Patient could hardly feel her hand. Stated it goes and comes. 15Apr2021morning when patient woke up it was worse, it was stiff and patient could hardly move her shoulder. She could feel it in the muscle, since receiving the vaccination. Patient stated she needed help and was in pain. Patient asked what should be used for pain. Weight was 168 or 170, in between. Patient stated she wanted to call her doctor before it is too late. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Nasal congestion, Pain
Clinical narrative: pain all over her body; nasal congestion; cough; feeling chills that night; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration on 11Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation. The patient mentioned that aside feeling chills that night (11Apr2021), everything was normal. Eight days later (19Apr2021), she woke up feeling chills, pain all over her body, nasal congestion and today she wakes up having cough. The outcomes of events were unknown.   No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported same event for two patients. This is the first of two reports.  A 21-year-old female patient received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer Covid vaccine in Jan2021 (reported as "Jan2020") and recently tested positive for Covid on 14Apr2021 and has had a severe case of Covid. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021444196 same reporter/drug/event, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Soreness in Vaccination Arm (left Arm).  Painful and unable to move the arm; Soreness in Vaccination Arm (left Arm).  Painful and unable to move the arm; This is a spontaneous report from a contactable consumer.  A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Apr2021 17:00 (Batch/Lot number was not reported) (at age of 49-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced soreness in vaccination arm (left arm).  painful and unable to move the arm on 15Apr2021 23:30. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. There was no COVID prior vaccination or no COVID tested post vaccination.  The outcome of events was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a Pfizer-sponsored program Eliquis patient Ambassador Program from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021 (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 previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 24Mar2021 for covid-19 immunisation. The patient experienced migraine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mildly sore arm for 12 hours; This is a spontaneous report received from a contactable consumer. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 experienced mildly sore arm for 12 hours on 15Apr2021 with outcome of recovered.  No treatment for the mildly sore arm.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable pharmacist (reporting for a family member) .  A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced showed symptoms of Covid and tested positive   (medically significant) on Apr2021. It was reported  the patient received the first dose of the Pfizer COVID on 01Apr2021 and about 10 days out they showed symptoms of COVID and tested positive.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on Apr2021  Caller is asking how long he has to wait to get the 2nd dose. Caller refused to provide details of the patient. The clinical outcome of the events was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Oropharyngeal pain
Clinical narrative: joint pain; throat hurts; has moved to his chest & back pain; has moved to his chest & back pain; This is a spontaneous report received from a contactable consumer (patient himself). This male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. Patient medical history included arthritis and concomitant medications were not reported. On an unspecified date, the patient experienced joint pain, that has moved to his chest, back pain and throat hurts. Caller stated that "it feels like I been working out, kind of like I've been in a fight". Caller also voiced that his throat hurts as well. Caller was seen in his local ER and told he had arthritis and needed to take Tylenol. He seen his PCP who ran test and diagnosed him with increased inflammation that may have been from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Thermal burn
Clinical narrative: Burn; This is a spontaneous report from a contactable consumer(patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  He got his first dose on 18Mar2021 and got a burn last week in Apr2021, and was prescribed with antibiotics for the next 7 days and he was scheduled to receive the 2nd dose on Thursday, and wanted to know if the antibiotic would affect the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vomiting
Clinical narrative: headache; throwing up; chills; Tiredness and being worn out; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Apr2021 11:30 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose on 27Mar2021. The patient just finished his 2-dose series of the PFIZER-BIONTECH COVID-19 VACCINE on 17Apr2021 and the first one on 27Mar2021. He wanted to confirm if the side effects that he is experiencing is normal. Side effects that he was experiencing were feeling of tiredness and being worn out from 17Apr2021, he also felt sick since 19Apr2021, by sick he meant he have been throwing up. Also he had chills for 19Apr2021 night and experienced headache. No emergency room or physician office visit. The outcome tiredness was recovered on 18Apr2021, throwing up was not recovered, chills recovered on 20Apr2021, outcome of headache was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ears; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ringing in her ears. It started happening right after the second shot which was a week and a half now. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seasonal allergy
Clinical narrative: pollen allergy; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). This consumer reported similar events for two patients (son and self). This is the first of two report.  A 70 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pollen allergies started yesterday 19Apr2021, and his son's pollen allergy symptoms started on 18Apr2021. It only happened when smelling pollen from flowers. They do not have this allergy before and was only developed after taking the vaccine. He also mentioned that his wife has taken the vaccine but there was no allergy. Second doses are scheduled for 30Apr2021. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021448825 same reporter, drug, event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypoaesthesia, Pain in extremity, Thrombosis
Clinical narrative: The pain I feel, Could be due to a blood clot?; pain on my arm; felt numbness in my arm; now I feel it on the inside, like if it was in the bone.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the arm on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient received the Pfizer Covid 19 vaccine on Friday, since then she felt pain on her arm, it got stronger in the afternoon, she couldn't lift anything or move that arm. On Saturday, the pain diminished. On the day of the report, the patient still feel pain, but now is like an internal ache, like if it is in the bone. She had trouble getting dressed, specially putting on t-shirts, when she goes to sleep, she cannot lay on that arm. It was reportedly very painful, and she was feeling as if it has moved to the other arm. On the day of the report, she applied heat on her arm and took Tylenol on Friday and Saturday. On Friday, she couldn't do anything, she felt numbness in her arm. Initially the pain was external, now she feels it on the inside, like if it was in the bone. The patient also asked if the pain she feel could be due to a blood clot. The event pain on my arm resolved on an unknown date in 2021, while the outcome of the rest of the events was unknown.   Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: fever reaching 104 F; chills; headache; severe body aches; joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 23:45 (Lot Number: ew0162) as SINGLE DOSE (at the age of 34 years old) for covid-19 immunisation.  Medical history included chronic kidney disease from an unknown date and unknown if ongoing , bipolar disorder from an unknown date and unknown if ongoing , migraines from an unknown date and unknown if ongoing.Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took augmentin [amoxicillin sodium;clavulanate potassium] and experienced Known allergies: augmentin, vancomycin and experienced Known allergies: vancomycin, lamictal and experienced Known allergies: lamictal,  Historical vaccine information included BNT162B2 Pfizer, Lot number er8730, Administration date 28Mar2021 03:00 am in the Left arm, Dose number: 1 for covid-19 immunisation at 34 years old.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 19Apr2021 12:00 pm, the patient experienced fever reaching 104 F, chills, headache, severe body aches and joint pain. No treatment was received for the events. Outcome of events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever reaching 104 F; chills; headache; severe body aches; joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 23:45 (Lot Number: ew0162) as SINGLE DOSE (at the age of 34 years old) for covid-19 immunisation.  Medical history included chronic kidney disease from an unknown date and unknown if ongoing , bipolar disorder from an unknown date and unknown if ongoing , migraines from an unknown date and unknown if ongoing.Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took augmentin [amoxicillin sodium;clavulanate potassium] and experienced Known allergies: augmentin, vancomycin and experienced Known allergies: vancomycin, lamictal and experienced Known allergies: lamictal,  Historical vaccine information included BNT162B2 Pfizer, Lot number er8730, Administration date 28Mar2021 03:00 am in the Left arm, Dose number: 1 for covid-19 immunisation at 34 years old.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 19Apr2021 12:00 pm, the patient experienced fever reaching 104 F, chills, headache, severe body aches and joint pain. No treatment was received for the events. Outcome of events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Myalgia, Neck pain, Pain in extremity
Clinical narrative: having aches in my right shoulder, neck, and leg/shoulder pain/joint pain; having aches in my right shoulder, neck, and leg/neck pain; having aches in my right shoulder, neck, and leg/her right leg from her feet to her thigh, it feels like a muscle ache or a little pain; muscle aches; arthritis has gotten worse; muscle pain; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that the 63-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced having aches in my right shoulder, neck, and leg/shoulder pain on an unspecified date with outcome of unknown, having aches in my right shoulder, neck, and leg/neck pain on an unspecified date with outcome of unknown, having aches in my right shoulder, neck, and leg/her right leg from her feet to her thigh, it feels like a muscle ache or a little pain on an unspecified date with outcome of unknown, muscle aches on an unspecified date with outcome of unknown, arthritis has gotten worse on an unspecified date with outcome of unknown, joint pain on an unspecified date with outcome of unknown, muscle pain on an unspecified date with outcome of unknown.    The clinical course was reported as follows: I had the first shot either March 1st or the next Monday nd my last one was on the 29th of March. In between I didn't think nothing about it but I've been having aches in my right shoulder, neck, and leg. It's mostly at night. I put cream on it for muscle aches but this is not going away. It's not all the time just mostly at night. She was having symptoms after getting the Covid 19 vaccine and she is asking if anyone else is having these symptoms. She has neck pain and shoulder pain and her right leg from her feet to her thigh, it feels like a muscle ache or a little pain. She puts some cream on it and it goes away. It doesn't hurt all the time, mostly at night. She told the lady yesterday that she spoke with she had these symptoms. She does report she has arthritis but it has never affected her every day. She thinks maybe her arthritis has gotten worse. She was reading over the paper that has side effects from the Covid 19 vaccine and it talks about muscle pain and joint pain. She has questions. She reports the facility kept her vaccine card after she received her second dose. She thinks she received her first dose on 01Mar2021 or 08Mar2021 and she received her second dose on 29Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.