chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Feeling abnormal, Mobility decreased
Clinical narrative: Feel pain in my heart; I have had trouble moving or moving my left arm due to the pain; Feels like heart inflammation; This is a spontaneous report from a contactable consumer (patient).    This 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Jun2021 08:30 (Lot Number: 59267-1000-02) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Jun2021, the patient experienced feel pain in my heart , I have had trouble moving or moving my left arm due to the pain, feels like heart inflammation. The outcome of the events was unknown. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysgeusia, Dyspnoea, Hypoaesthesia oral
Clinical narrative: short of breath; feeling extremely anxious; numbness around mouth; metal taste; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Rrght arm on 22Jul2021 at 10:45 (at the age of 62-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient experienced at first on 22Jul2021 at 11:54 numbness around mouth and a metal taste which lasted a couple hours. On day 3 (on 24Jul2021) started feeling extremely anxious like she could jump out of her skin and short of breath. The patient received treatment for events. It was reported that an extra Ativan was given to try to help the extreme anxiety. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. Numbness around mouth and metal taste were resolved, the other events were not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood test, Inappropriate schedule of product administration, Myalgia, Oral pain
Clinical narrative: autoimmune disorder; body pain and aches; muscular pain in my knees, hands and mouth; muscular pain in my knees, hands and mouth; 1st dose 28-APR-2021/2nd dose 07-MAY-2021; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 15:00 (Lot Number: ew0153) as single for COVID-19 immunization. Medical history included polycystic kidneys from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ew0170 on 28Apr2021 15:15 in the right arm for COVID-19 immunization. The patient has not been tested for COVID-19 post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Onset date of events reported as 26May2021 14:15. About a month and a half after receiving final covid shot (mid-late May of 2021), patient started to have a lot of body pain and aches. Still have muscular pain in my knees, hands and mouth. The patient had blood work done to try and understand what was happening and blood work indicated she now have some underlying autoimmune disorder. The patient never had an autoimmune disorder in her life. Events resulted in Doctor or other healthcare Professional office/clinic visit, Disability or permanent damage. No treatment given for events. Outcome of events was not recovered. It was also noted that patient experienced inappropriate schedule of vaccine administered as 1st dose was given 28Apr2021 and 2nd dose was given on 07May2021.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: autoimmune disorder; body pain and aches; muscular pain in my knees, hands and mouth; muscular pain in my knees, hands and mouth; 1st dose 28-APR-2021/2nd dose 07-MAY-2021; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 15:00 (Lot Number: ew0153) as single for COVID-19 immunization. Medical history included polycystic kidneys from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ew0170 on 28Apr2021 15:15 in the right arm for COVID-19 immunization. The patient has not been tested for COVID-19 post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Onset date of events reported as 26May2021 14:15. About a month and a half after receiving final covid shot (mid-late May of 2021), patient started to have a lot of body pain and aches. Still have muscular pain in my knees, hands and mouth. The patient had blood work done to try and understand what was happening and blood work indicated she now have some underlying autoimmune disorder. The patient never had an autoimmune disorder in her life. Events resulted in Doctor or other healthcare Professional office/clinic visit, Disability or permanent damage. No treatment given for events. Outcome of events was not recovered. It was also noted that patient experienced inappropriate schedule of vaccine administered as 1st dose was given 28Apr2021 and 2nd dose was given on 07May2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chest pain, Heart rate, Heart rate increased
Clinical narrative: myocarditis; chest hurt; fastheart beat; blood pressure is not stable; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, after a couple of days the patient felt side effects like myocarditis, chest hurt, fast heart beat and blood pressure was not stable. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; chest hurt; fastheart beat; blood pressure is not stable; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, after a couple of days the patient felt side effects like myocarditis, chest hurt, fast heart beat and blood pressure was not stable. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Neuralgia
Clinical narrative: Bone pain two days after vaccination that lasted a week/general bone pain; severe peripheral nerve pain; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular on Jul2021 as dose 2, single for covid-19 immunisation. Medical history included known allergies: Salmonids and known allergies: juniper. The concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination. The patient has not been tested for covid-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162b2 on 22May2021 for covid-19 immunization. On Jul2021 the patient experienced bone pain two days after vaccination that lasted a week/general bone pain and severe peripheral nerve pain. The treatment received for the adverse event was Medrol pack. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of bone pain two days after vaccination that lasted a week/general bone pain and severe peripheral nerve pain. The outcome of both the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Gastrointestinal disorder, Pyrexia, SARS-CoV-2 test
Clinical narrative: Triggered an auto-immune response; Triggered an auto-immune response. Had a strong fever, GI problems after the first shot; Triggered an auto-immune response. Had a strong fever, GI problems after the first shot; This is a spontaneous report from a contactable consumer. A 38-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. On 15May2021, the patient triggered an auto-immune response. He had a strong fever and GI problems after the first shot. The patient was hospitalized and received treatment of colonoscopy and prescription of anti-inflammatory. The outcome of the events was recovering. On 16Jul2021, the patient had nasal swab and showed negative result.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951006 same patient/drug, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Feeling foggy, like he had "smoked weed" but has not.; Dizziness; "bad" dose of the vaccine/Knows it should not be used after 6 hours, should be at room temperature for 30 minutes; "bad" dose of the vaccine/Knows it should not be used after 6 hours, should be at room temperature for 30 minutes; This is a spontaneous report from a contactable consumer (Patient) received from Pfizer Sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported "bad" dose of the vaccine/knows it should not be used after 6 hours, should be at room temperature for 30 minutes on an unspecified date, feeling foggy, like he had "smoked weed" but has not and dizziness. Patient reported as what to do about his side effects, thinks they are from a bad dose of the vaccine. Reported dizziness, and feeling foggy, like he had smoked weed but has not and possibly getting a bad dose of the Pfizer BioNTech Covid-19 vaccine because he saw the person at (withheld) pull it out of a box, and he thought it was supposed to come from the freezer. Knows it shouldn't be used after 6 hours, should be at room temperature for 30 minutes, and when he asked the provider about it, he was not happy with her answer. He wants to know what to do if he got a bad vaccine. Events were considered as non-serious. Outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a contactable nurse reported for a patient via a Pfizer company representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse reported "Verbatim question: for the covid vaccine, 12 and up, they encountered myocarditis. Can you please send/call her about this. She's a pediatrician. She would like more info.". The outcome of the event 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 and known drug profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and the reported event myocarditis. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: pt has been having dizziness since the first shop; The frequency and severity has gradually gotten worse, now daily, even when he wakes up; there's severe nausea at 8-9am; This is a spontaneous report from a contactable physician. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right on 13Apr2021 16:15 (Lot Number: ER8731) as dose number unknown, single (at the age of 71 years old) for COVID-19 immunization. The patient's medical history included peptic ulcer disease, penetrating atherosclerotic ulcer of aorta, hiatal hernia, colon polyp, allergic rhinitis and conjunctivitis, long covid, cubital tunnel syndrome, tachycardia, elevated blood pressure, oxygen desaturation, pollen allergy and COVID; all from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included atorvastatin; lisinopril; famotidine; fluticasone nasal spray; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in Apr2021, reported event that pt has been having dizziness since the first shop. The frequency and severity has gradually gotten worse, now daily, even when he wakes up. There's severe nausea at 8-9am and he would need to sit down for an hour before it gets better. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on May2021 (Covid test post vaccination via nasal swab: Negative on May2021). No treatment given for adverse event (AE). The outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Dizziness and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: starting the day after 2nd shot I had nosebleeds on and off all day and night for 10 days.; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection. Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:30 as dose 2, single (at the age of 67-years-old) as dose 2, single for COVID-19 immunization. Medical history included allergic to asprin sulfa barium and cancer. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection. Lot Number EN6202) via an unspecified route of administration, administered in Arm Left on 09Mar2021 08:30 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior the vaccination patient did not diagnosed with COVID-19. The patient experienced starting the day after second shot she had nosebleeds on and off all day and night for 10 days on 31Mar2021 06:00. The adverse event result in Emergency room visits and doctor or other healthcare professional office/clinic visit. Therapeutic measures cauterized and given afrin spray were taken as a result of nosebleeds. Since the vaccination patient did not diagnosed with COVID-19. The outcome of the event reported as unknown.  No follow-up attempts are possible. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; Vomiting within 72 hours of the shot; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Jul2021 14:15 (at the age of 43 years) (Batch/Lot Number: FA6780) as a single dose for COVID-19 immunization. Medical history included hypertension. Patient is not pregnant at the time of vaccination. Concomitant medications included losartan; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC); and omeprazole magnesium (PRILOSEC). On 18Jul2021 14:00 , the patient experienced diarrhea with outcome of recovered with sequelae and nausea and vomiting within 72 hours of the shot with outcome of recovered in Jul2021. Nausea and vomiting lasted around 18 hours. Diarrhea continued but is not as frequent as onset. No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: small rash on back of right thigh. similar to psoriasis; small rash on back of right thigh. similar to psoriasis; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0183), via an unspecified route of administration, administered in right arm on 13Jul2021 16:45 as single dose for COVID-19 immunization. The patient's medical history included hypothyroidism. The patient had no known allergies. The patient's concomitant medications included estrogens conjugated (PREMARIN) and levothyroxine sodium (LEVOTHYROXIN). Facility where the most recent COVID-19 vaccine was administered was other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small rash on back of right thigh, similar to psoriasis on 16Jul2021 at 12:00. No treatment was received for the event. 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 events was not recovered. The events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She had the best two weeks she has had in the last 10 years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age and gender received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiry dates were not reported), via unspecified routes of administration on unspecified dates at single doses for COVID-19 immunization. Medical history included ongoing trouble hearing and Dercums. Concomitant medication was not reported. The patient reported that she had a rare autoimmune disease called Dercums which affected all the systems. She was told by the CDC that it was safe to take the Pfizer COVID shot with her disease. She has had both COVID shots and everything went perfect, her reaction to the shot was amazing. She had the best two weeks she has had in the last 10 years, did not know why or how. Everything worked, all the broken parts worked. Every week, someone with Dercum would also inform her that they felt so good after the Pfizer COVID vaccine. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Digestive enzyme abnormal, Feeling abnormal, Pain
Clinical narrative: She had the best two weeks she has had in the last 10 years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age and gender received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiry dates were not reported), via unspecified routes of administration on unspecified dates at single doses for COVID-19 immunization. Medical history included ongoing trouble hearing and Dercums. Concomitant medication was not reported. The patient reported that she had a rare autoimmune disease called Dercums which affected all the systems. She was told by the CDC that it was safe to take the Pfizer COVID shot with her disease. She has had both COVID shots and everything went perfect, her reaction to the shot was amazing. She had the best two weeks she has had in the last 10 years, did not know why or how. Everything worked, all the broken parts worked. Every week, someone with Dercum would also inform her that they felt so good after the Pfizer COVID vaccine. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Claustrophobia, Confusional state, Disorientation, Dizziness
Clinical narrative: fainting sensation; disoriented; haziness in vision; anxiety; claustrophobia; light-headedness; headaches; cloudiness; cold; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a male patient (colleague's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fainting sensation, disoriented, haziness in vision, anxiety, claustrophobia, light-headedness, headaches, cloudiness, cold. In line with this, reporter would like to know if this side effects were reported and if it will go away. Outcome of all the events was not resolved.  Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951344 Same reporter/ drug/ AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Syncope, Vision blurred
Clinical narrative: fainting sensation; disoriented; haziness in vision; anxiety; claustrophobia; light-headedness; headaches; cloudiness; cold; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a male patient (colleague's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fainting sensation, disoriented, haziness in vision, anxiety, claustrophobia, light-headedness, headaches, cloudiness, cold. In line with this, reporter would like to know if this side effects were reported and if it will go away. Outcome of all the events was not resolved.  Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951344 Same reporter/ drug/ AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This is a spontaneous report from a contactable consumer (reported for herself).   A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Jul2021, as DOSE 1, SINGLE for Covid-19 immunization. Medical history and concomitant medications were not provided. It was stated that had she received first shot a day prior to this report (reported as yesterday), her first vaccine and then she fell asleep and she woke up and she was hungry and tried to eat something. She felt nauseous, it made her nauseous and, what else. That's it, now she wanted to know if this was, because that's one of the symptoms that's on the papers that they gave. The patient stated, "was there something for her to worry about". The outcome of the event was unknown.   The lot number for the vaccine was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She has picked up a cold in the last few days; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional reported for herself. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid019 immunization. She got her Pfizer shot and is due for second one tomorrow. She has picked up a cold in the last few days. She thinks it is a cold. She wonders if they will give it to her tomorrow. She is not sure if she should show up and infect everyone.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: . severely heavy menstrual bleeding; This is a spontaneous report from a non-contactable consumer (patient). A 33-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 29May2021 14:00 (Batch/lot number unknown), at age 33 years old, as dose number unknown, single, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Jun2021, the patient experienced severely heavy menstrual bleeding. The patient stated that it was at least double of what she has ever bled for one cycle in her life. No treatment was taken for the event. The patient recovered from the event in on an unspecified date in Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Since being fully vaccinated in April 2021, I noticed my known condition (Vitiligo) spread a lot quicker within the past 3 months then prior months/years; his is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) (at the age of 36 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing vitiligo. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient received the first dose of BNT162B2 in left arm on COVID-19 immunization on 02Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, since being fully vaccinated in Apr2021 patient noticed known condition vitiligo spread a lot quicker within the past 3 months than prior months/years. No treatment for the events. The outcome of the event was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder
Clinical narrative: Started having an altered taste for some foods and drinks; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  Historical Vaccine includes bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced started having an altered taste for some foods and drinks on an unspecified date. It was reported that Patient had the Pfizer two shots vaccine for Covid-19 and patient had it for a while but about a month ago, started having an altered taste for some foods and drinks, patient haven't lost any smell or anything and patient had a Covid test recently just to see if there is anything going on with that but patient just can't figure out, patient talked to some doctors about why having an altered taste on some foods and drinks and I was just wondering, do you know of any cases or is there any information regarding people having that side effect. When probed if the result of Covid test that consumer had was negative, consumer stated, Correct. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of event was Unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angular cheilitis, Glossitis, SARS-CoV-2 test
Clinical narrative: angular cheilitis; tongue inflammation; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number and expiry date was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 29Apr2021 (lot number and expiry date was not reported) as dose 2, single for COVID-19 immunization. Medical history included allergy to gluten on an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient underwent an RT PCR nasal swab COVID test with an unknown result. It was reported that on an unknown date in 2021, two weeks plus one day after each vaccination, the patient developed angular cheilitis and tongue inflammation. After the first vaccination, the symptoms resolved within a few days. After the second vaccination, the symptoms wax and wane but have not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: I received the second shot on Thursday 2:30 pm. At 3:00 AM on Sunday, July 25, my heart started beating irregularly. My heart rate was extremely unstable and was fluctuating erratically from 60 to 130; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for himself that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0181), via an unspecified route of administration, administered in Arm Left on 22Jul2021 14:45 (Age at vaccination 50 years) as dose 2, single for covid-19 immunisation. Patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : EW0181), via an unknown route of administration on 01Jul2021 in left arm at 02:45PM (Age at vaccination 50 years) as dose 1, single for covid-19 immunisation. On 25Jul2021 at 3:00 am on sunday, the patient stated that heart started beating irregularly. heart rate was extremely unstable and was fluctuating erratically from 60 to 130 for around 5 hours. Patient received no treatment for event. The patient underwent lab tests and procedures which included heart rate: 60 to 130 bpm on 25Jul2021 heart started beating irregularly. No prolonged hospitalization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Patient was not received any other medications within 2 weeks of vaccination. The clinical outcome of event was recovered on unspecified date in Jul2021.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: The pain varies in location over my heart and chest.; chest pain; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24May2021 15:00 (Batch/Lot Number: EW0183) as dose 2, single for covid-19 immunisation at a hospital. Medical history included known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW1075) on 28Apr2021 15:30 in the left arm for Covid-19 immunization. The patient began having chest pain 3-4 days after his 2nd covid vaccine and this has continued since then. The pain occurs sometimes when resting but at all times when getting up and moving around.  For example, he has chest pain when he walks down the stairs and even when he was standing up and washing the dishes. The pain sometimes lasts for 5 minutes but at other times it lasts for hours. The pain varies in location over his heart and chest. No SOB. He had to take an LOA from his job because of the continued chest pain which would last for hours while he was at work. The events started on 28May2021 and resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were not treated. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Hyperhidrosis
Clinical narrative: sweating; couldn't stand; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced activities of daily living impaired, fever and headache. After the second shot, the patient was sweating and couldn't stand for 4 days. The wife wanted to take the patient to the hospital because he looked like he was dying. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: he was bleeding; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 25Jul2021 (Batch/Lot Number: FA7484) as dose number unknown, single for covid-19 immunisation. Medical history included Crohn's disease. Concomitant medication included adalimumab (HUMIRA) taken for Crohn's disease, start and stop date were not reported. In Jul2021, it was reported that the patient received a vaccine of Pfizer and when he got the shot he bleed a lot, "a lot and we had to get tissues, we had to get gauze, he was bleeding". It was stated that it was unknown if that's a side effect. No treatment was received. The patient recovered from the event in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection, Vaccination site erythema, Vaccination site pain
Clinical narrative: I have got my first shot, I am supposed to get the second one and I am in the hospital because I have UTI (Urinary tract Infection); My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included open heart surgery; patient fell and got 2 titanium screws in her neck and three screws in her hip; she also had got venous stasis in the leg where the blood goes down but won't go back up. The patient had a whole list of concomitant medications (unspecified). It was reported that the patient was in the hospital. She got her first shot and she was supposed to get the second one, but she was in the hospital because she has UTI (Urinary tract Infection). So, she was just asking what to do as she does not want them to come to her home since she was not there. She asked whether she would just call when she gets out of the hospital. She confirmed that it was the first dose of Pfizer covid-19 vaccine. She got the first dose of the vaccine on 07Jul2021 and was supposed to get the second one on 28Jul2021, but she was still in the hospital. When probed about the side effects, she mentioned her arms was just little sore, but no she didn't have any side effects. She just wanted to know what she should do, if she should call when she gets out of the hospital to get her second shot. She commented that she wanted to get the second shot. She added that she read in the paper she was given about smell and taste and shortness of breath, and she read all that. She added no it did not swell up. It was just in the spot where she got the injection, just was red and sore but it went away right away. No side effects. The UTI, vaccination site pain and vaccination site erythema started in Jul2021. The outcome of urinary tract infection was unknown while vaccination site pain and vaccination site erythema was recovered in Jul2021.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Urinary tract infection
Clinical narrative: I have got my first shot, I am supposed to get the second one and I am in the hospital because I have UTI (Urinary tract Infection); My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included open heart surgery; patient fell and got 2 titanium screws in her neck and three screws in her hip; she also had got venous stasis in the leg where the blood goes down but won't go back up. The patient had a whole list of concomitant medications (unspecified). It was reported that the patient was in the hospital. She got her first shot and she was supposed to get the second one, but she was in the hospital because she has UTI (Urinary tract Infection). So, she was just asking what to do as she does not want them to come to her home since she was not there. She asked whether she would just call when she gets out of the hospital. She confirmed that it was the first dose of Pfizer covid-19 vaccine. She got the first dose of the vaccine on 07Jul2021 and was supposed to get the second one on 28Jul2021, but she was still in the hospital. When probed about the side effects, she mentioned her arms was just little sore, but no she didn't have any side effects. She just wanted to know what she should do, if she should call when she gets out of the hospital to get her second shot. She commented that she wanted to get the second shot. She added that she read in the paper she was given about smell and taste and shortness of breath, and she read all that. She added no it did not swell up. It was just in the spot where she got the injection, just was red and sore but it went away right away. No side effects. The UTI, vaccination site pain and vaccination site erythema started in Jul2021. The outcome of urinary tract infection was unknown while vaccination site pain and vaccination site erythema was recovered in Jul2021.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Echocardiogram, Heart rate
Clinical narrative: Developed Atrial Flutter.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 01Mar2021 (Batch/Lot number was not reported) (at the age of 71-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Medical history included high blood pressure and acid stomach (waiting for consultation with cardiologist). The patient had no known allergies. Concomitant medications included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and amlodipine besilate (NORVASC). On 10Jun2021 16:00, the patient developed atrial flutter. The patient never had this problem prior to covid-19 vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included echocardiogram: unknown results and heart monitor: unknown results. Therapeutic measures were taken as a result of the event which also includes echocardiogram and heart monitor. The patient had not yet recovered from the event. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenopia, Eye pain, Vision blurred
Clinical narrative: Blurred vision; Tension/eye strain; Tension/eye strain; This is a spontaneous report from a contactable consumer (caregiver) received via a Regulatory Authority.  An elderly, 70 to 80-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date 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), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. After the 2nd dose of vaccine, the patient experienced blurred vision and tension/eye strain on an unspecified date.  The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lupus-like syndrome
Clinical narrative: drug induced lupus; This is a spontaneous report from a non-contactable consumer (the patient) A 38-years-old female patient received bnt162b2 (BNT162B2) unknown dose number, 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 drug induced lupus  (medically significant) on an unspecified date with outcome of unknown.    Course of the event. The patient started experiencing lupus-like  symptoms within weeks of taking the Pfizer COVID-19 vaccine. Rheumatologist suggested it might be drug induced lupus and is running more tests  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.