chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: generalized pruritic urticarial rash; This is a spontaneous report from a Contactable Physician. An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EL3247), intramuscularly in left arm on 28Jan2021 10:00, as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination: 80-years-old). The patient medical history includes hypertension. The patient did not have COVID prior vaccination neither covid tested post vaccination. Patient did not reported any allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took lisinopril within 2 weeks of vaccination. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EL9263), on 18Feb2021, via an unspecified route of administration as DOSE 2, SINGLE for covid-19 immunization. The patient confirms there was no expiration listed for both doses. The patient mentioned that he had received two doses of the Pfizer vaccine. During the period of time, after starting the vaccine, (exact date not provided), he developed a generalized pruritic urticarial rash. He has gone to the Dermatologist and has an appointment again today. He has tried changing his deter-gents, re-washed all his clothing, changed health care products (deodorants and soaps) but the rash was still persistent in fact it has gone to other sites. The patient treatment includes systemic prednisone, and steroid ointments, which stopped the itching but has-n't helped relieved the rash. The steroid ointments have not helped either to relive the rash. He stated to consider the possibility of this being a side of effect of the vaccine since the time frame was suggestive. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastroenteritis viral, Pyrexia
Clinical narrative: severe diarrhea; had a virus in his stomach that caused the diarrhea; fatigue; fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6207 and expiry date was not reported), via an unspecified route of administration, on 13Mar2021, as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked can he get his second injection of the Pfizer covid-19 injection since he had a side effect after the first injection and can it cause diarrhea. The patient received the first injection of the Pfizer covid-19 vaccine about a month ago. About 3 days later, he experienced severe diarrhea. The severe diarrhea lasted 3 days and then he was recovered. He had a test done with a nasal swab for COVID-19 a week or two later and it was negative. His physician told him he had a virus in his stomach that caused the diarrhea. The patient had fever for couple a days and fatigue but it went in three days. He was scheduled to get his second injection of Pfizer covid-19 vaccine this Saturday and wanted to know was this safe to get it the secondary vaccine. The patient underwent lab test and procedure included SARS-Cov-2 with negative result on an unspecified date. Outcome of the events fatigue and fever was recovered on an unspecified date and for all other events it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Hypoaesthesia, Hypoaesthesia oral, Lip disorder
Clinical narrative: mouth tingling; swelling of tongue with her mouth and lips feeling numb and thick; swelling of tongue with her mouth and lips feeling numb and thick; swelling of tongue with her mouth and lips feeling numb and thick; light headed; couldn't swallow; numbness; then inside of my mouth and my tongue they started to swell; everything felt very sick like inside in my mouth, everything just felt like moving very slowly; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).    A 28-years-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), (at age of 28-years-old) via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient reported adverse reactions for her first dose of Pfizer covid vaccine received on 01Apr2021 and states immediately (after about one minute) after receiving the shot, she experienced mouth tingling, swelling of tongue with her mouth and lips feeling numb and thick. She also experienced dizziness which took rest of day for it to wear off. Customer stated that she had reactions when she got vaccine, the first dose about one minute after she got the shot, the back of her mouth started to tingle, then inside of her mouth and her tongue they started to swell, her mouth was going numb, her lips were going numb, she felt very lightheaded. she couldn't swallow and everything felt very sick like inside in her mouth, everything just felt like moving very slowly, when she woke up next morning everything was fine next day but throughout the day it slowly wore off, she just wants to know if she should be getting the second dose after having those reactions and stated to note on there she had numbness on there. The outcome of the events was unknown.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oral disorder, Paraesthesia oral, Swollen tongue
Clinical narrative: mouth tingling; swelling of tongue with her mouth and lips feeling numb and thick; swelling of tongue with her mouth and lips feeling numb and thick; swelling of tongue with her mouth and lips feeling numb and thick; light headed; couldn't swallow; numbness; then inside of my mouth and my tongue they started to swell; everything felt very sick like inside in my mouth, everything just felt like moving very slowly; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).    A 28-years-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), (at age of 28-years-old) via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient reported adverse reactions for her first dose of Pfizer covid vaccine received on 01Apr2021 and states immediately (after about one minute) after receiving the shot, she experienced mouth tingling, swelling of tongue with her mouth and lips feeling numb and thick. She also experienced dizziness which took rest of day for it to wear off. Customer stated that she had reactions when she got vaccine, the first dose about one minute after she got the shot, the back of her mouth started to tingle, then inside of her mouth and her tongue they started to swell, her mouth was going numb, her lips were going numb, she felt very lightheaded. she couldn't swallow and everything felt very sick like inside in her mouth, everything just felt like moving very slowly, when she woke up next morning everything was fine next day but throughout the day it slowly wore off, she just wants to know if she should be getting the second dose after having those reactions and stated to note on there she had numbness on there. The outcome of the events was unknown.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Rash, Swelling face
Clinical narrative: I had a rash; my cheeks were just beet reddish blue looking; my face was swelled, it's kind of like a rash; low grade fever; 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), via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) (at the age of 73 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes, blood pressure high and arthritis. Concomitant medications included metformin, taken for diabetes, start and stop dates were not reported. The patient experienced rash, her cheeks were just beet reddish blue looking, her face was swelled, it was kind of like a rash and low grade fever on an unspecified date in 2021. The patient received no treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in the right arm on 21Feb2021 (at the age of 73 years old) as dose 2, single for COVID-19 immunisation. The patient has no medical history. The patient reported that he takes about 4-5 other medications. On 28Feb2021, the patient developed a rash after he got the vaccination. He said he couldn't just scratch so he went to a doctor. The doctor said it was possibly from the Pfizer shot. The patient was given prednisone to see if it would deal with the rash, and still not had deal with the rash. The patient also stated that he only took 5 pills of prednisone, but it still did not get rid of the rash. The patient has not recovered from the event.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Mass, Pruritus, Skin swelling
Clinical narrative: I got a circle around the arm like if I am allergic to needle or something and that was itchy, Wasn't a rash but it was like my skin had puffed up; I got a circle around the arm like if I am allergic to needle or something and that was itchy, Wasn't a rash but it was like my skin had puffed up; I got a circle around the arm like if I am allergic to needle or something and that was itchy, Wasn't a rash but it was like my skin had puffed up; I got a circle around the arm like if I am allergic to needle or something and that was itchy, Wasn't a rash but it was like my skin had puffed up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (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, the patient experienced got a circle around the arm like if I am allergic to needle or something and that was itchy, wasn't a rash but it was like my skin had puffed up. The patient stated that, "I just want to know if my arm is, if I am okay, if my arm was okay. When you get a needle on the bandage you notice a little blood, and there was no blood on my bandage. I didn't feel like they inject a needle in my arm." The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Pyrexia, Somnolence
Clinical narrative: Vomiting; Weakness; He had a small fever (99.4); Sleepy; Fatigue; This is a spontaneous report from a contactable consumer(Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 06Apr2021 02:45 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. On 06Apr2021 06:00 the patient experienced he had a small fever (99.4), sleepy, fatigue, vomiting, weakness. Patient reported also vomited like 5 times now. The patient underwent lab tests and procedures which included body temperature was 99.4 on 06Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Weakness; He had a small fever (99.4); Sleepy; Fatigue; This is a spontaneous report from a contactable consumer(Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 06Apr2021 02:45 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. On 06Apr2021 06:00 the patient experienced he had a small fever (99.4), sleepy, fatigue, vomiting, weakness. Patient reported also vomited like 5 times now. The patient underwent lab tests and procedures which included body temperature was 99.4 on 06Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hypersomnia, Pain
Clinical narrative: He reports that she had been having a fever ranging from 100.4F to 101.2F or 101.4F.; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Fever is accompanied by chills that present how they'll just affect just one arm or leg at a time; This is a spontaneous report from a contactable consumer (patient's husband). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. It was not reported if the patient was pregnant at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced that she had been having a fever ranging from 100.4f to 101.2f or 101.4f, fever is accompanied by chills that present how they'll just affect just one arm or leg at a time (chills), caller states his wife also has a headache, body aches, and has been "sleeping alot" on an unspecified date with outcome of unknown. It was also reported that the fever is accompanied by chills that present how they'll just affect just one arm or leg at a time. The patient underwent lab tests and procedures which included body temperature: 100.4f to 101.2f or 101.4f fahrenheit on an unknown date. The action taken in response to the events for bnt162b2 were not applicable. Therapeutic measures Tylenol and stuff were taken as a result of events. The clinical course of the outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He reports that she had been having a fever ranging from 100.4F to 101.2F or 101.4F.; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Fever is accompanied by chills that present how they'll just affect just one arm or leg at a time; This is a spontaneous report from a contactable consumer (patient's husband). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. It was not reported if the patient was pregnant at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced that she had been having a fever ranging from 100.4f to 101.2f or 101.4f, fever is accompanied by chills that present how they'll just affect just one arm or leg at a time (chills), caller states his wife also has a headache, body aches, and has been "sleeping alot" on an unspecified date with outcome of unknown. It was also reported that the fever is accompanied by chills that present how they'll just affect just one arm or leg at a time. The patient underwent lab tests and procedures which included body temperature: 100.4f to 101.2f or 101.4f fahrenheit on an unknown date. The action taken in response to the events for bnt162b2 were not applicable. Therapeutic measures Tylenol and stuff were taken as a result of events. The clinical course of the outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chills, Diarrhoea, Fatigue
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Feeling unwell; Nausea; Vomiting; Diarrhea; Severe radiating stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the arm left on 05Mar2021 at 16:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, shellfish allergy and bee sting hypersensitivity (bee venom). It was reported that the patient was in good health and was working on lifestyle changes. 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. Concomitant medications included minerals nos (MINERALS), ademetionine (SAME) and Multivitamins (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received formaldehyde (MANUFACTURER UNKNOWN), ethanol (MANUFACTURER UNKNOWN) and xylitol (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 06Mar2021 at 01:00, the patient experienced tiredness, headache, muscle pain, chills. On the same day at the same time the patient also experienced feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day. The events resulted in doctor or other healthcare professional office/clinic visits. The events resulted in the emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with unspecified medications. On an unknown date in 2021, the patient underwent a blood test and ultrasound abdomen (reported as ultrasound R quad abdomen) and both the results were not reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, tiredness, headache and muscle pain was recovered on 07Mar2021, after the duration of 36 hours. The clinical outcome of the event chills was recovered on 07Mar2021, after the duration of 24 hours while that of the events, feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Ultrasound abdomen
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Feeling unwell; Nausea; Vomiting; Diarrhea; Severe radiating stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the arm left on 05Mar2021 at 16:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, shellfish allergy and bee sting hypersensitivity (bee venom). It was reported that the patient was in good health and was working on lifestyle changes. 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. Concomitant medications included minerals nos (MINERALS), ademetionine (SAME) and Multivitamins (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received formaldehyde (MANUFACTURER UNKNOWN), ethanol (MANUFACTURER UNKNOWN) and xylitol (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 06Mar2021 at 01:00, the patient experienced tiredness, headache, muscle pain, chills. On the same day at the same time the patient also experienced feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day. The events resulted in doctor or other healthcare professional office/clinic visits. The events resulted in the emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with unspecified medications. On an unknown date in 2021, the patient underwent a blood test and ultrasound abdomen (reported as ultrasound R quad abdomen) and both the results were not reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, tiredness, headache and muscle pain was recovered on 07Mar2021, after the duration of 36 hours. The clinical outcome of the event chills was recovered on 07Mar2021, after the duration of 24 hours while that of the events, feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Feeling unwell; Nausea; Vomiting; Diarrhea; Severe radiating stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the arm left on 05Mar2021 at 16:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, shellfish allergy and bee sting hypersensitivity (bee venom). It was reported that the patient was in good health and was working on lifestyle changes. 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. Concomitant medications included minerals nos (MINERALS), ademetionine (SAME) and Multivitamins (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received formaldehyde (MANUFACTURER UNKNOWN), ethanol (MANUFACTURER UNKNOWN) and xylitol (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 06Mar2021 at 01:00, the patient experienced tiredness, headache, muscle pain, chills. On the same day at the same time the patient also experienced feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day. The events resulted in doctor or other healthcare professional office/clinic visits. The events resulted in the emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with unspecified medications. On an unknown date in 2021, the patient underwent a blood test and ultrasound abdomen (reported as ultrasound R quad abdomen) and both the results were not reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, tiredness, headache and muscle pain was recovered on 07Mar2021, after the duration of 36 hours. The clinical outcome of the event chills was recovered on 07Mar2021, after the duration of 24 hours while that of the events, feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Tinnitus; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, discoid lupus erythematosus, allergy to gluten and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included colestipol (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), vitamin d not other specified (VITAMIN D), cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. On 24Mar2021 at 06:00, the patient experienced tinnitus and vertigo. The events resulted in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported events and included an ongoing treatment still with steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus and vertigo was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: extreme fatigue; sharp pains; extremely painful muscles; extremely painful joints; nausea; slight fever; injection site red; second injection site  broken out in spots/rash; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 19:30 (Batch/Lot Number: ER8730) as dose 2, single (at the age of 40 years old) for COVID-19 immunisation.  Medical history included asthma, endometriosis, hypothyroidism, PCOS, latex allergy, shellfish allergy, seasonal allergy and cats allergy. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 07:30 (Batch/Lot Number: EN6206) for COVID-19 immunisation and experienced fatigue, nausea, flu-like chills/aches - lasted 3 days, injection site still red 3 weeks later. The patient experienced extreme fatigue, sharp pains, extremely painful muscles and joints, nausea, slight fever - lasted two and a half days, (I slept a full 24 hours on day three), second injection site red and broken out in spots/rash on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: extreme fatigue; sharp pains; extremely painful muscles; extremely painful joints; nausea; slight fever; injection site red; second injection site  broken out in spots/rash; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 19:30 (Batch/Lot Number: ER8730) as dose 2, single (at the age of 40 years old) for COVID-19 immunisation.  Medical history included asthma, endometriosis, hypothyroidism, PCOS, latex allergy, shellfish allergy, seasonal allergy and cats allergy. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 07:30 (Batch/Lot Number: EN6206) for COVID-19 immunisation and experienced fatigue, nausea, flu-like chills/aches - lasted 3 days, injection site still red 3 weeks later. The patient experienced extreme fatigue, sharp pains, extremely painful muscles and joints, nausea, slight fever - lasted two and a half days, (I slept a full 24 hours on day three), second injection site red and broken out in spots/rash on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Flushing, Headache
Clinical narrative: Nausea; dizziness; Headache; muscle pain from shoulder to hand; fast heart beat; shortness of breath; feeling flushed/hot; tired; not feeling well in general; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 31-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EIU6202, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (age at vaccination was 31 years) as dose 1, single for COVID-19 immunization. The patient's medical history included, food allergy and drug hypersensitivity (Allergy to Sulfamethoxazole) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took trimethoprim, azithromycin. Patient took allergy medicine as other medications in two weeks. Patient received second dose of BNT162B2 on 26Apr2021 at 14:30. On 07Apr2021 at 14:00 the patient experienced nausea, dizziness, headache, muscle pain from shoulder to hand, fast heart beat, shortness of breath, feeling flushed/hot, tired and not feeling well in general. The patient underwent lab tests and procedures which included nucleic acid test which showed negative result on 19Apr2021. No treatment was received for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Nausea, Nucleic acid test
Clinical narrative: Nausea; dizziness; Headache; muscle pain from shoulder to hand; fast heart beat; shortness of breath; feeling flushed/hot; tired; not feeling well in general; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 31-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EIU6202, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (age at vaccination was 31 years) as dose 1, single for COVID-19 immunization. The patient's medical history included, food allergy and drug hypersensitivity (Allergy to Sulfamethoxazole) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took trimethoprim, azithromycin. Patient took allergy medicine as other medications in two weeks. Patient received second dose of BNT162B2 on 26Apr2021 at 14:30. On 07Apr2021 at 14:00 the patient experienced nausea, dizziness, headache, muscle pain from shoulder to hand, fast heart beat, shortness of breath, feeling flushed/hot, tired and not feeling well in general. The patient underwent lab tests and procedures which included nucleic acid test which showed negative result on 19Apr2021. No treatment was received for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hot flush, Hyperhidrosis
Clinical narrative: fever; Headache; sweats; chills; nausea; weakness; aches; heat flashes; This is a spontaneous report from a contactable consumer or other non hcp.  A 20-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number ER8729 and expiration date: unknown)  via an unspecified route of administration on 06Apr2021  (at age of vaccination 20-years-old) as dose 1 Single for covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient had covid prior vaccination and covid tested post vaccination was unknown. On 07Apr2021 patient experienced headache, sweats, chills, nausea, weakness, aches, heat flashes/fever. The outcome of event was unknown.  Follow-up #1 (09Apr2021): No significant information.   No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever; Headache; sweats; chills; nausea; weakness; aches; heat flashes; This is a spontaneous report from a contactable consumer or other non hcp.  A 20-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number ER8729 and expiration date: unknown)  via an unspecified route of administration on 06Apr2021  (at age of vaccination 20-years-old) as dose 1 Single for covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient had covid prior vaccination and covid tested post vaccination was unknown. On 07Apr2021 patient experienced headache, sweats, chills, nausea, weakness, aches, heat flashes/fever. The outcome of event was unknown.  Follow-up #1 (09Apr2021): No significant information.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Malaise
Clinical narrative: Severe vomiting, diarrhea, chills, nausea, muscle pain, joint pain, weakness and feeling unwell the day after still; Diarrhea; Chills; Nausea; Muscle pain; Joint pain; Weakness; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 07Apr2021 at 12:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and osteoporosis, beginning stage  The patient had no known 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 COVID vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), alendronate sodium (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. On 07Apr2021 at 17:00, the patient experienced severe vomiting, diarrhea, chills, nausea, muscle pain, joint pain, weakness and feeling unwell the day after still. 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 events severe vomiting, diarrhea, chills, nausea, muscle pain, joint pain, weakness and feeling unwell the day after still were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Severe vomiting, diarrhea, chills, nausea, muscle pain, joint pain, weakness and feeling unwell the day after still; Diarrhea; Chills; Nausea; Muscle pain; Joint pain; Weakness; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 07Apr2021 at 12:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and osteoporosis, beginning stage  The patient had no known 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 COVID vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), alendronate sodium (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. On 07Apr2021 at 17:00, the patient experienced severe vomiting, diarrhea, chills, nausea, muscle pain, joint pain, weakness and feeling unwell the day after still. 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 events severe vomiting, diarrhea, chills, nausea, muscle pain, joint pain, weakness and feeling unwell the day after still were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Pyrexia
Clinical narrative: After 5 days, her father had a fever, not feeling great and loss of energy but feeling fine now; After 5 days, her father had a fever, not feeling great and loss of energy but feeling fine now; After 5 days, her father had a fever, not feeling great and loss of energy but feeling fine now; This is a spontaneous report from a contactable consumer (reported for father) from Regulatory Authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced after 5 days, patient had a fever, not feeling great and loss of energy but feeling fine now on 21Mar2021. Reporter asked if patient (her father) could take the 2nd dose. Customer and/or medical inquiry forwarded or referred. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Joint pain; hurting under her arm; swelling in the lymph nodes; top part of the arm was swollen; problems in breathing; problems with breathing; heart was beating very fast; fast heart rate; chest pain; legs were just trembling; legs trembling; Dizzy; chest was a little tight; Arm was really hurting; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Mar2021 (Lot Number: EN6206) (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included hysterectomy on an unspecified date and limitations on the left arm (several tests and MRI conducted; patient went to physical therapy). The patient had a test before and everything shows well. The patient did not have diabetes and was not overweight. Concomitant medications included estradiol (0.1 mg patch) for estrogen (as reported). The patient previously received a flu shot and vaccine for hepatitis B for unspecified indications. On unspecified dates in Mar2021, the patient experienced a little bit of joint pain. An hour after the vaccination, she experienced hurting under her arm and also had swelling in the lymph nodes. The top part of the arm was swollen for like two days. Within an hour and a half to get home, the patient started having problems in breathing and claimed that her heart was beating very fast and felt like chest pain. The patient laid on the couch, and when she stood up, her legs were just trembling and even a slight walk to the bathroom was scary for the patient because and claims that her legs almost felt like she did not have control and they were just trembling for no reason. The patient felt dizzy and was afraid to go to sleep. The patient experienced problems with breathing, fast heart rate, and legs trembling for about 3 days. The next morning, her heart was not racing but still had some problem with breathing. She added that her chest was a little tight. She also added that her arm was really hurting when she was working and could not even take her clothes off when she got home. The patient has seen her doctor for a lab test. The patient was upset and was afraid of getting the second dose. The patient recovered from "top part of the arm was swollen", legs trembling, and fast heart rate on unspecified dates in 2021 while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Investigation, Lymphadenopathy, Pain in extremity
Clinical narrative: Joint pain; hurting under her arm; swelling in the lymph nodes; top part of the arm was swollen; problems in breathing; problems with breathing; heart was beating very fast; fast heart rate; chest pain; legs were just trembling; legs trembling; Dizzy; chest was a little tight; Arm was really hurting; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Mar2021 (Lot Number: EN6206) (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included hysterectomy on an unspecified date and limitations on the left arm (several tests and MRI conducted; patient went to physical therapy). The patient had a test before and everything shows well. The patient did not have diabetes and was not overweight. Concomitant medications included estradiol (0.1 mg patch) for estrogen (as reported). The patient previously received a flu shot and vaccine for hepatitis B for unspecified indications. On unspecified dates in Mar2021, the patient experienced a little bit of joint pain. An hour after the vaccination, she experienced hurting under her arm and also had swelling in the lymph nodes. The top part of the arm was swollen for like two days. Within an hour and a half to get home, the patient started having problems in breathing and claimed that her heart was beating very fast and felt like chest pain. The patient laid on the couch, and when she stood up, her legs were just trembling and even a slight walk to the bathroom was scary for the patient because and claims that her legs almost felt like she did not have control and they were just trembling for no reason. The patient felt dizzy and was afraid to go to sleep. The patient experienced problems with breathing, fast heart rate, and legs trembling for about 3 days. The next morning, her heart was not racing but still had some problem with breathing. She added that her chest was a little tight. She also added that her arm was really hurting when she was working and could not even take her clothes off when she got home. The patient has seen her doctor for a lab test. The patient was upset and was afraid of getting the second dose. The patient recovered from "top part of the arm was swollen", legs trembling, and fast heart rate on unspecified dates in 2021 while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.