chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: intense fatigue; low fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0185) via an unspecified route of administration on 18Jun2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jun2021, the patient experienced intense fatigue and low fever for over one month since second dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 23Jun2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events intense fatigue and low fever was not recovered at the time of this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pain
Clinical narrative: Area red and blotchy; Injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021 at 19:00, the patient had injection site sore, felt like right after got the first and second vaccines, area was red and blotchy.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events injection site sore and was red and blotchy were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Pain, Vaccination site pain
Clinical narrative: Painful injection site - left arm; body aches; chill; Temperature of 100.9 degrees Fahrenheit; This is a spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an intramuscular route of administration in the left arm on 20Jul2021 at 08:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from unknown date. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021 at 02:45, the patient experienced painful injection site- left arm, body aches, chill, temperature of 100.9 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  painful injection site- left arm, body aches, chill and temperature of 100.9 degrees Fahrenheit was recovering at the time of this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Have pain in right arm from injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 20Jul2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included type 2 diabetes and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Jul2021 at 02:30, the patient experienced pain in right arm from injection and reported that he had no side effects. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as the result of the event. Since the vaccination, patient had not been tested for COVID-19.  The clinical outcome of the event pain in arm was resolved on 21Jul2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nipple inflammation, Nipple pain, Pruritus, Rash
Clinical narrative: her right breast, her nipple hurts; itches; Rash on nipple; Her nipple little bit inflammed; Her nipple feels hot; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported for a 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration in Arm Right on an unspecified date (age at the time of vaccination 71-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced her right breast, her nipple hurts, itches, Rash on nipple, her nipple little bit inflamed, and Her nipple feels hot. Caller inquiring about additional information regarding the side effects of the Pfizer Covid-19 vaccine. Caller stated, on 05Aug2021 we are supposed to get the second one, I need to know how to correct this and what to do about the second shot, I need someone to tell me should she get the second one or not. The outcome for all the events was unknown.  Lot/Batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: thumb, index finger, middle finger, and fatty part of my palm started tingling as if it was going to fall asleep; my left hand asleep, particular thumb index finger, middle finger, and fatty part of palm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 17:00 (at the age of 31-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 31-years-old); both as a single dose for COVID-19 immunisation. Medical history included genital herpes and rosacea. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aciyclovir (ACYCLOVIR) for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 08:00, after patient got vaccine, patient had frequent occurrence in the mornings with left hand asleep, particular thumb, index finger, middle finger, and fatty part of palm. It happened when lying on back and hands were laying on stomach or holding up sheets. The patient slept with one pillow under head. It happened to both hands, but primarily left. This sleeping position was often used by patient (along with sleeping on side or stomach) and never had this happened as frequently as it did post vaccine. On unknown date in Jul2021, went on a hike, mowed the lawn, tidied up, then picked up some dinner. I was tired and very hungry, probably a little dehydrated too, While I was waiting in line, patient's thumb, index finger, middle finger, and fatty part of palm started tingling as if it was going to fall asleep. This was concerning as it typically only happened when patient was waking up in bed. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent COVID-19 Source NP (nasal swab) and tested negative. The clinical outcome of the event left hand asleep, particular thumb, index finger, middle finger and started tingling was not recovered at the time of this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Myalgia, Pain
Clinical narrative: Achy; Tired; Energy levels are way down, barely had enough energy to get through workout; Tremendous joint and muscle pain; Tremendous joint and muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 20May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included spinal stenosis and degenerative disc disease. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other medications within two weeks of vaccination. The patient had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 39-years-old), as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21May2021, since receiving the second shot, the patient felt achy and tired. The energy levels were way down and as a weight lifter, patient barely had enough energy to get through workout. The patient also experienced tremendous joint and muscle pain at night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events achy, tired, energy levels were way down, barely had enough energy to get through workout, tremendous joint and muscle pain was not recovered at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Hypoaesthesia, Inappropriate schedule of product administration, Menstrual discomfort, Pain
Clinical narrative: After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; On 02Apr2021, the patient received second dose and first dose; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (age 50-year-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot Number: EW0150, age 50-year-old and non-pregnant at the time of vaccination) as DOSE 1,SINGLE for covid-19 immunisation. The medical history included allergy triggered asthma from an unknown date and unknown if ongoing. The concomitant medication included levocetirizine dihydrochloride (XYZAL, other medications taken in two weeks included Xyzal) taken for an unspecified indication, start and stop date were not reported.  The patient previously took zithromax and experienced allergies. No other vaccine taken in four weeks. On 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered). After the first dose, the patient developed slight nausea, subsided after a few hours on 23Apr2021. After second dose, solid pain in upper half of body and numbness in both arms on 23Apr2021. The discomfort lasted for 24 hours after shot. Since the shots, the patient's menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual on 23Apr2021. Considering that the patient was 50-year-old, her periods were slowing down since 2018. The patient did not receive any treatment for the adverse events. No covid happened prior to vaccination. The covid was not tested post vaccination. The outcome of the events was recovering at the time of report, while outcome of the event on 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymenorrhoea
Clinical narrative: After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; On 02Apr2021, the patient received second dose and first dose; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (age 50-year-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot Number: EW0150, age 50-year-old and non-pregnant at the time of vaccination) as DOSE 1,SINGLE for covid-19 immunisation. The medical history included allergy triggered asthma from an unknown date and unknown if ongoing. The concomitant medication included levocetirizine dihydrochloride (XYZAL, other medications taken in two weeks included Xyzal) taken for an unspecified indication, start and stop date were not reported.  The patient previously took zithromax and experienced allergies. No other vaccine taken in four weeks. On 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered). After the first dose, the patient developed slight nausea, subsided after a few hours on 23Apr2021. After second dose, solid pain in upper half of body and numbness in both arms on 23Apr2021. The discomfort lasted for 24 hours after shot. Since the shots, the patient's menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual on 23Apr2021. Considering that the patient was 50-year-old, her periods were slowing down since 2018. The patient did not receive any treatment for the adverse events. No covid happened prior to vaccination. The covid was not tested post vaccination. The outcome of the events was recovering at the time of report, while outcome of the event on 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual discomfort, Nausea, Polymenorrhoea
Clinical narrative: After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; On 02Apr2021, the patient received second dose and first dose; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (age 50-year-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot Number: EW0150, age 50-year-old and non-pregnant at the time of vaccination) as DOSE 1,SINGLE for covid-19 immunisation. The medical history included allergy triggered asthma from an unknown date and unknown if ongoing. The concomitant medication included levocetirizine dihydrochloride (XYZAL, other medications taken in two weeks included Xyzal) taken for an unspecified indication, start and stop date were not reported.  The patient previously took zithromax and experienced allergies. No other vaccine taken in four weeks. On 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered). After the first dose, the patient developed slight nausea, subsided after a few hours on 23Apr2021. After second dose, solid pain in upper half of body and numbness in both arms on 23Apr2021. The discomfort lasted for 24 hours after shot. Since the shots, the patient's menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual on 23Apr2021. Considering that the patient was 50-year-old, her periods were slowing down since 2018. The patient did not receive any treatment for the adverse events. No covid happened prior to vaccination. The covid was not tested post vaccination. The outcome of the events was recovering at the time of report, while outcome of the event on 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelids pruritus, Swelling of eyelid
Clinical narrative: bilateral eyelids itched; Bilateral eyelids swelling; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Jul2021 at 19:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included milk allergy (Dairy allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) all from an unknown date for an unspecified indication. On 12Jul2021 at 20:00, the patient experienced eyelids itched and became swollen, bilateral within two hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures  were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events eyelids itched and became swollen, bilateral was recovered on an unspecified date in Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenitis, Pain, Tenderness
Clinical narrative: Tenderness in armpit, collarbone, and neck. All on the left side of body (the same side as the injectionsite).; It hurts when he moved/sometimes felt jabs of sharp pain on the sites mentioned.; It felt as though lymph nodes were heavily inflamed.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 18Jul2021 at 16:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 27Jun2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 19Jul2021 at 18:00, the patient experienced tenderness in armpit, collarbone, and neck, all on the left side of his body; the same side as the injection site. It hurt when he moved and sometimes felt jabs of sharp pain on the sites mentioned. It felt as though his lymph nodes were heavily inflamed. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tenderness in armpit, collarbone, and neck, all on the left side of his body, it hurt when he moved and sometimes felt jabs of sharp pain on the sites mentioned, it felt as though lymph nodes were heavily inflamed was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: bad knees; This is a spontaneous report from a contactable consumer (patient). An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ) via an unspecified route of administration on 21Jul2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient had bad knees. The patient would like to know if he can swim. When he gets cortisone shots to his knee, they tell him not to swim for 3 days. Patient mentioned he wants to make sure with the "corona" vaccine if it is safe to swim. Treatment was received for event. He stated "I just want to make sure, I don't think it affects". The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: chronic diarrhea; This is a spontaneous report from a contactable consumer (patient's grandson). A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date 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 was not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient received unspecified concomitant medications. On an unspecified date, after Pfizer COVID vaccine second shot, patient had 80+ days of chronic diarrhea. The outcome of chronic diarrhea was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Vaccination site pain
Clinical narrative: Swollen soft aching lump under left arm; Swollen soft aching lump under left arm, located below armpit, which hurt the same as the site of the shot.; Swollen soft aching lump under left arm, located below armpit, which hurt the same as the site of the shot.; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jul2021 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Jun2021 at 09:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 19Jul2021, at 03:00, the patient experienced swollen soft aching lump under left arm, that was located below armpit, which hurt the same as the site of the shot(vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen soft aching lump under left arm (below armpit), which hurt the same as the site of the shot were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: got me in a 'drug interaction'/I just got your Covid shot, the second shot and I have been on Chantix for 4 months now; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the second dose of BNT162B2 (COVID VACCINE) via an unspecified route of administration on an unspecified date (Batch/lot number: Unknown; Expiration Date: Unknown) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication was included varenicline tartrate. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient stated: "Well, I just got a phone call concerning that you guys pull Chantix from the market. I have been on Chantix for 4 months, I have had some reactions to it (Chantix) Now, I am looking online, it is all over, the news was that due to carcinogens causing cancer, it affects the brain (event captured as per verbatim). I was a little concerned, I just got your Covid shot, the second shot and I have been on Chantix for 4 months now, I basically took myself off of it (Chantix), I still had the prescription. So, I was concerned what the future holds for this drug that you have given to me to quit smoking, either I die of cancer of lungs or I die of brain aneurysm or something. So, I need to know what you put in me? I need to know what your company makes or do I get an attorney? You got me in a 'drug interaction' (not clarified), was that what cancer does, I mean I can 'shove' Pfizer and I can just drop off the prescription at the office. I am just little concerned because I don't want to die of cancer or I don't want to die of brain aneurysm from this drug that you put into me to make me quit smoking." The patient further stated, "I had called you to report side effect for this and basically you refer me, basically alert or called me back and told me that it is my doctor's problem (further clarification unknown), it was not my doctor's problem, the doctor doesn't make the drug, the doctor had put me on this drug to help me and the drug (Chantix) supposedly has done something to me that I am going to 'wear out' (not clear), that is coming up on news with brain aneurysm, cancer causing carcinogens in it and I will live it for life now because of the drug you put in me in the form of lung cancer." The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Vaccination site discolouration, Weight, Weight decreased
Clinical narrative: rubbing his chest at boobs and went down to his knees. He said it was hurting bad; rubbing his chest at boobs and went down to his knees. He said it was hurting bad; has a brown oval spot at the injection site of both arms.  It is not black and blue.; has lost weight because of pain; This is a spontaneous report from a contactable consumer (Patient wife). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 16:30 (at the age of 66 year) as dose 2, single for COVID-19 immunisation at Hospital. Medical history included Leukemia (Diagnosed about 5 years ago). Concomitant medication(s) included ongoing nilotinib hydrochloride (TASIGNA) taken for leukaemia. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 25Mar2021 (at the age of 66 year) for COVID-19 immunisation and experienced brown oval spot at injection site from first dose right arm. On an unspecified date in Jul2021, a week ago consumer stated that patient started rubbing his chest at boobs and went down to his knees. It was hurting bad. This has happened several times in the last 2 weeks. On an unspecified date in 2021, Patient has lost weight because of pain. They saw the doctor the other day and didn't know what to do. The doctor said he would give him some Tramadol. Patient (reporter husband) said he would get it for her (reporter) if she had pain because it doesn't do anything for him. Patient started having this pain about three weeks ago. Patient has leukemia. Patient was diagnosed prior to getting the vaccine. His numbers are going down. Patient arm was black and blue and was still there. Then clarified, on 19Apr2021 that patient has a brown oval spot at the injection site of both arms. It was not black and blue. Tramadol doesn't work for patient. The patient underwent lab tests and procedures on an unknown date in 2021 which included weight: lost weight. AE(s) require a visit to Physician Office. The outcome of event weight decrease was unknown while for rest events was not recovered.  Information about lot/batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Cough, Fatigue, Headache
Clinical narrative: Stomach cramps; nausea; headaches; chest heavy; sore throat; some swolling; body aches; coughing; tingling sensation on hands, feet and ankles; Moody tired feeling; Like I'm comin down with the flu; Puking; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 09Jul2021 (at the age of 52-year-old)as a single dose for COVID-19 immunisation. Medical history included celiac disease, IBS bipolar, major depression, gastritis and hiatal hernia . The patient previously took paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN), celecoxib(CELEBREX), amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient has known allergy to penicillin, wheat, barley, rye, jalapeno and mesquite. The patient received other vaccine within four weeks prior to the vaccination. The patient received shingles shot (MANUFACTURER UNKNOWN) on 21Jun2021. On 16Jul2021 at 12:00 the patient experienced stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu was not recovered at the time of report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Oropharyngeal pain, Pain, Paraesthesia
Clinical narrative: Stomach cramps; nausea; headaches; chest heavy; sore throat; some swolling; body aches; coughing; tingling sensation on hands, feet and ankles; Moody tired feeling; Like I'm comin down with the flu; Puking; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 09Jul2021 (at the age of 52-year-old)as a single dose for COVID-19 immunisation. Medical history included celiac disease, IBS bipolar, major depression, gastritis and hiatal hernia . The patient previously took paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN), celecoxib(CELEBREX), amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient has known allergy to penicillin, wheat, barley, rye, jalapeno and mesquite. The patient received other vaccine within four weeks prior to the vaccination. The patient received shingles shot (MANUFACTURER UNKNOWN) on 21Jun2021. On 16Jul2021 at 12:00 the patient experienced stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu was not recovered at the time of report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vomiting
Clinical narrative: Stomach cramps; nausea; headaches; chest heavy; sore throat; some swolling; body aches; coughing; tingling sensation on hands, feet and ankles; Moody tired feeling; Like I'm comin down with the flu; Puking; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 09Jul2021 (at the age of 52-year-old)as a single dose for COVID-19 immunisation. Medical history included celiac disease, IBS bipolar, major depression, gastritis and hiatal hernia . The patient previously took paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN), celecoxib(CELEBREX), amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient has known allergy to penicillin, wheat, barley, rye, jalapeno and mesquite. The patient received other vaccine within four weeks prior to the vaccination. The patient received shingles shot (MANUFACTURER UNKNOWN) on 21Jun2021. On 16Jul2021 at 12:00 the patient experienced stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu was not recovered at the time of report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: has a brown oval spot at the injection site of both arms.  It is not black and blue.; This is a spontaneous report from a contactable consumer or other non hcp (Patients wife).  A 66-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Mar2021 16:30 (Age at vaccination: 66-years-old) as single dose for covid-19 immunization. Vaccination Facility was Hospital. Medical history included leukaemia (Diagnosed about 5 years ago). Concomitant medication included nilotinib hydrochloride (TASIGNA) taken for leukaemia from an unspecified start date and ongoing (Started taking 4-5 years ago). Patient did not receive Additional Vaccines on Same Date of the Pfizer Suspect. Prior vaccinations within 4 weeks was reported as none. It was reported that caller is speaking on behalf of her husband. Her husband received the Pfizer vaccine. On 25Mar2021 patient experienced has a brown oval spot at the injection site of both arms. It is not black and blue. It was reported that a week ago he started rubbing his chest at boobs and went down to his knees. He said it was hurting bad. This has happened several times in the last 2 weeks. caller looked online and saw that this could be side effects. When providing weight caller adds that her husband has lost weight because of pain. They saw the doctor the other day and didn't know what to do. The doctor said he would give him some Tramadol. Her husband said he would get it for her if she had pain because it doesn't do anything for him. Caller thinks he started having this pain about three weeks ago. Adds that her husband has leukaemia. He was diagnosed prior to getting the vaccine. His numbers are going down. He received the second dose on 19Apr2021. It was given in his left arm. Caller does not have the vaccine card to provide NDC, Lot or Expiry. Caller asked if the second dose was scheduled for 26 days later after the first dose. stated that her husbands arm was black and blue and is still there. Then clarified that he has a brown oval spot at the injection site of both arms. It is not black and blue. Adverse event resulted in physician office visit. The outcome for he event was reported as not resolved at the time of this report.   Information about lot/batch has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eyelids pruritus, Swelling of eyelid
Clinical narrative: eye lids are swollen and very itchygetting Worsen; eye lids are swollen and very itchygetting Worsen; eye lids are swollen and very itchygetting Worsen; This is a spontaneous report from a contactable Pharmacist reported that.  A 51- years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 50 years). The patient medical history was not reported Concomitant medication(s) included loratadine (CLARITINE strength 10mg once a day) taken for an unspecified indication. The patient is reported that he has had a reaction that is lasted several months, stating this is been longer than 6 months and it's gotten worse. He is stating that his eye lids are swollen and very itchy and getting Worsen on an unspecified date. Well, they are exactly worsened in the last probably 2 months, it was like pretty mild all way up from February all way up to April or May and then started getting Worsen, worsen and now it's swollen every day. No treatment was reported. The event outcome was Unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Soft, apple sized swelling in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 20Jul2021 at 10:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL) and gabapentin (MANUFACTURER UNKNOWN); all from an unknown date, for an unknown indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 29Jun2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Jul2021 at 21:00, the patient experienced soft, apple sized swelling in left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soft, apple sized swelling in left armpit was not recovered at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: After 1st shot, 2 days later swollen gland in left armpit, it went away in 8 days. after the second shot it took 3 days and both armpits are swollen; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 26Jun2021 at 11:00 (at the age of 45-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 17Jul2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included otc allergy medications. The patient previously took neomycin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication and experienced drug allergy. On 28Jun2021, after first shot, two days later, the patient experienced swollen gland in left armpit, it went away in 8 days. After the second shot it took 3 days and both armpits were swollen, went to doctor and they said to check back in 3 weeks with them and to report to Pfizer. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen gland in left armpit, it went away in 8 days. After the second shot it took 3 days and both armpits were swollen was unknown at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration on an unknown date (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date the patient experienced rash on arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on arms and legs was recovering.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: I got terrible migraines; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified allergy medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Jul2021 at 01:00, the patient experienced terrible migraines after he got the second vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of event terrible migraines was unknown at the time of this report.    The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.