chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Feeling abnormal, Headache, Muscle spasms, Myalgia
Clinical narrative: muscles throughout body still ache; very disoriented; did not feel safe to drive.; bad headache; all over body aches,; nausea; good deal of pain in left arm; hand was cramping up (arm of injection).; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 17:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included moderate to severe asthma. The patient had no known allergies. 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 SYMBICORT taken for an unknown indication from an unknown date and unknown if ongoing. On 04Mar2021 at 23:00, the patient experienced a good deal of pain in her left arm and hand was cramping up (arm of injection). On 05Mar2021, in the next day, the patient felt very disoriented and did not feel safe to drive, bad headache, all over body aches, and nausea. She had to leave work after a couple hours in the second day and rested for the next two days bit still she had noticeable bad symptoms. After three days she was mostly felt okay. On 11Mar2021, a week later, her muscles throughout the body still ache. 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 good deal of pain in left arm, hand was cramping up (arm of injection), felt very disoriented, did not feel safe to drive, bad headache, all over body aches, nausea, and muscles throughout the body ache was resolving at the time of this report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: muscles throughout body still ache; very disoriented; did not feel safe to drive.; bad headache; all over body aches,; nausea; good deal of pain in left arm; hand was cramping up (arm of injection).; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 17:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included moderate to severe asthma. The patient had no known allergies. 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 SYMBICORT taken for an unknown indication from an unknown date and unknown if ongoing. On 04Mar2021 at 23:00, the patient experienced a good deal of pain in her left arm and hand was cramping up (arm of injection). On 05Mar2021, in the next day, the patient felt very disoriented and did not feel safe to drive, bad headache, all over body aches, and nausea. She had to leave work after a couple hours in the second day and rested for the next two days bit still she had noticeable bad symptoms. After three days she was mostly felt okay. On 11Mar2021, a week later, her muscles throughout the body still ache. 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 good deal of pain in left arm, hand was cramping up (arm of injection), felt very disoriented, did not feel safe to drive, bad headache, all over body aches, nausea, and muscles throughout the body ache was resolving at the time of this report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under left armpit, right arm pit; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm  on 10Mar2021 at 12:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to formaldehyde. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 21:30, the patient experienced swollen lymph nodes under left arm pit, right arm pit and neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures was taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes under left arm pit, right arm pit and neck was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and tenderness of left lower leg; Swelling and tenderness of left lower leg; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 20Feb2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included transient small bowel obstruction, low grade uterine cancer s/p hysterectomy and tibia/fibula rod placement in 1991 s/p MVA. 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 vaccination and did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 30Jan2021 at 15:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 08:00, the patient experienced swelling and tenderness of left lower leg, starting 3 days after second COVID vaccine was given. This was at the same site of a prior surgical rod insertion for fracture tibia/fibia which occurred in 1991. Swelling and pain have persisted over the past 3 weeks. The patient was able to ambulate and weight bear but leg continued to remain painful. There was no redness, or discharge, not had fevers, only swelling and tenderness at the surgical site. The patient had not had swelling of leg prior to this event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and tenderness of left lower leg was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; tenderness at injection sitr; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 17Feb2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. 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 10Mar2021 at 22:00, the patient experienced sore arm at injection site and tenderness at injection site. 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, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at injection site and tenderness at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disturbance in attention, Fatigue, Feeling abnormal, Pollakiuria
Clinical narrative: Within 1 hour of taking the 1st dose "I" started urinating excessively. "I" have peed 2-3 times per hour for the last 8 hours.; "I" also felt spacey and difficulty focusing; "I" also felt spacey and difficulty focusing; "I" did not feel dizzy but "I" did feel unsteady; "I" have been very tired; Within 1 hour of taking the 1st dose "I" started urinating excessively; This is a spontaneous report from a contactable consumer, the patient. A 41-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 on 12Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The medical history was 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 vaccination. The concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), lamotrigine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and fluticasone propionate/salmeterol xinafoate (ADVAIR); all for unknown indications from unknown dates and unknown if ongoing. On 12Mar2021 at 10:30, within 1 hour of taking the 1st dose, the patient started urinating excessively and had peed 2-3 times per hour for the last 8 hours, also felt spacey, difficulty focusing, the patient did not feel dizzy but did feel unsteady and had been very tired. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urinating excessively, peed 2-3 times per hour for the last 8 hours, felt spacey, difficulty focusing, felt unsteady and  very tired was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Polyuria
Clinical narrative: Within 1 hour of taking the 1st dose "I" started urinating excessively. "I" have peed 2-3 times per hour for the last 8 hours.; "I" also felt spacey and difficulty focusing; "I" also felt spacey and difficulty focusing; "I" did not feel dizzy but "I" did feel unsteady; "I" have been very tired; Within 1 hour of taking the 1st dose "I" started urinating excessively; This is a spontaneous report from a contactable consumer, the patient. A 41-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 on 12Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The medical history was 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 vaccination. The concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), lamotrigine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and fluticasone propionate/salmeterol xinafoate (ADVAIR); all for unknown indications from unknown dates and unknown if ongoing. On 12Mar2021 at 10:30, within 1 hour of taking the 1st dose, the patient started urinating excessively and had peed 2-3 times per hour for the last 8 hours, also felt spacey, difficulty focusing, the patient did not feel dizzy but did feel unsteady and had been very tired. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urinating excessively, peed 2-3 times per hour for the last 8 hours, felt spacey, difficulty focusing, felt unsteady and  very tired was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache; body aches; Chills; This is a spontaneous report from a non contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications was 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 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 18Feb2021 at 12:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. On 10Mar2021 at 22:00, the patient experienced headache, body aches and chills. 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, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache, body aches and chills was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Moderate Headache; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of 63 years of age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 09Mar2021 at 11:00 (at the age of 63-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 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 on an unknown date as a single dose for COVID-19 immunisation. On 10Mar2021, the patient experienced moderate headache and was tired. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events moderate headache and tired was resolved an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL3247), at the age of 41, via an unspecified route of administration, in the right arm, on Mar 10, 2021, at 10:30, single dose, for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 11, 2021, patient experienced slight soreness in right deltoid and very mild fatigue. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of slight soreness in right deltoid and very mild fatigue: resolving (at the time of this report). No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Approximately 20 hours after took 2nd vaccine, I was lighheaded. This was approx. 9AM on 02/28/21.  I continue to be lightheaded when get up every morning.  One morning around March 2nd was also a little Dizzy.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left on arm 27Feb2021 at 12:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo from 2009 and labyrinthitis from 2018. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926S) via an unspecified route of administration in the left arm 03Feb2021 at 10:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 09:00, approximately 20 hours after the vaccination, the patient was light headed, he continued to be lightheaded when he get up every morning, one morning around 02Mar2021, the patient was also a little dizzy. The patient had less lightheaded as day goes on. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with special exercise to improve. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light headed/dizzy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Skin exfoliation, Vaccination site pain
Clinical narrative: severe pain at shot site close to kidney stone level.; skin started pealing in 1" wide patch about 1/2" ofeach eye brow across the center of the forehead.; Patch peal every dayfor a couple of weeks leaving the skin deep dark red.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. The patient had no known allergies. 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 POTASSIUM CITRATE and ALLOPURINOL, all for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 09:00, about 25th hour after vaccination, the patient experienced severe pain at shot site which was close to kidney stone level. On an unknown date in Feb2021, a few days after vaccination, the patient experienced skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead. Patch peal every day for a couple of weeks leaving the skin-deep dark red. Pealing subsided and redness was waning. 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 severe pain at shot site close to kidney stone level was resolved on 19Feb2021 at 11:00, after the duration of 2 hours whereas the events skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead and patch peal every day for a couple of weeks leaving the skin deep dark red was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody increased, Burning sensation, C-reactive protein increased, Erythema, Fatigue
Clinical narrative: severe pain at shot site close to kidney stone level.; skin started pealing in 1" wide patch about 1/2" ofeach eye brow across the center of the forehead.; Patch peal every dayfor a couple of weeks leaving the skin deep dark red.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. The patient had no known allergies. 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 POTASSIUM CITRATE and ALLOPURINOL, all for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 09:00, about 25th hour after vaccination, the patient experienced severe pain at shot site which was close to kidney stone level. On an unknown date in Feb2021, a few days after vaccination, the patient experienced skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead. Patch peal every day for a couple of weeks leaving the skin-deep dark red. Pealing subsided and redness was waning. 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 severe pain at shot site close to kidney stone level was resolved on 19Feb2021 at 11:00, after the duration of 2 hours whereas the events skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead and patch peal every day for a couple of weeks leaving the skin deep dark red was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Heart rate increased, Immature granulocyte count increased, Injection site pain, Joint range of motion decreased
Clinical narrative: severe pain at shot site close to kidney stone level.; skin started pealing in 1" wide patch about 1/2" ofeach eye brow across the center of the forehead.; Patch peal every dayfor a couple of weeks leaving the skin deep dark red.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. The patient had no known allergies. 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 POTASSIUM CITRATE and ALLOPURINOL, all for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 09:00, about 25th hour after vaccination, the patient experienced severe pain at shot site which was close to kidney stone level. On an unknown date in Feb2021, a few days after vaccination, the patient experienced skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead. Patch peal every day for a couple of weeks leaving the skin-deep dark red. Pealing subsided and redness was waning. 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 severe pain at shot site close to kidney stone level was resolved on 19Feb2021 at 11:00, after the duration of 2 hours whereas the events skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead and patch peal every day for a couple of weeks leaving the skin deep dark red was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, Ligament pain, Magnetic resonance imaging abnormal, Pain, Rash erythematous
Clinical narrative: severe pain at shot site close to kidney stone level.; skin started pealing in 1" wide patch about 1/2" ofeach eye brow across the center of the forehead.; Patch peal every dayfor a couple of weeks leaving the skin deep dark red.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. The patient had no known allergies. 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 POTASSIUM CITRATE and ALLOPURINOL, all for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 09:00, about 25th hour after vaccination, the patient experienced severe pain at shot site which was close to kidney stone level. On an unknown date in Feb2021, a few days after vaccination, the patient experienced skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead. Patch peal every day for a couple of weeks leaving the skin-deep dark red. Pealing subsided and redness was waning. 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 severe pain at shot site close to kidney stone level was resolved on 19Feb2021 at 11:00, after the duration of 2 hours whereas the events skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead and patch peal every day for a couple of weeks leaving the skin deep dark red was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash pruritic, Scar, Skin exfoliation
Clinical narrative: severe pain at shot site close to kidney stone level.; skin started pealing in 1" wide patch about 1/2" ofeach eye brow across the center of the forehead.; Patch peal every dayfor a couple of weeks leaving the skin deep dark red.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. The patient had no known allergies. 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 POTASSIUM CITRATE and ALLOPURINOL, all for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 09:00, about 25th hour after vaccination, the patient experienced severe pain at shot site which was close to kidney stone level. On an unknown date in Feb2021, a few days after vaccination, the patient experienced skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead. Patch peal every day for a couple of weeks leaving the skin-deep dark red. Pealing subsided and redness was waning. 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 severe pain at shot site close to kidney stone level was resolved on 19Feb2021 at 11:00, after the duration of 2 hours whereas the events skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead and patch peal every day for a couple of weeks leaving the skin deep dark red was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe migraine after first dose. Started approx. 24 hours after injection and lasted one day.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and allergy to tree nuts. Concomitant medications taken within two weeks of vaccination 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 vaccination. On an unknown date the patient experienced severe migraine after first dose. It started approximately 24 hours after injection and lasted one day. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe migraine after first dose, it started approximately 24 hours after injection was resolved on an unknown date after the duration of one day. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 immunisation and experienced no side effects.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Upper respiratory tract congestion
Clinical narrative: Upper respiratory congestion; Productive cough white phlegm.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-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 arm right on 10Mar2021 at 14:00(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chest heaviness and peanut 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 vaccination. Concomitant medications included paracetamol (TYLENOL), gliclazide (CLARITIN) and multivitamin(MANUFACTURER UNKNOWN). On 10Mar2021, the patient experienced upper respiratory congestion, productive cough white phlegm. 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 upper respiratory congestion, productive cough white phlegm were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore arm at site of injection; Minor headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 11:30 (at the age of 37-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 vaccination. On 10Mar2021 at 16:00, the patient experienced sore arm at site of injection and minor headache. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm at site of injection and minor headache were recovered with sequelae on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Somnolence
Clinical narrative: Aches; Headache; Tired/fatigued; Sleepy; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. It was unknown if the patient had known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the day after the vaccine, the patient experienced aches and headache which minimized during the day. On the same day, the patient also experienced tired, sleepy and fatigued. The patient was feeling much better on the second day after the shot. The patient had no aches and had "normal" tired feeling. 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 aches, headache, tired, sleepy and fatigued were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: Had a headache in the evening, but ithad passed in the morning.; lack of sleep; This is a spontaneous report from a non-contactable pharmacist. An elderly male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 14Mar2021 as a single dose for COVID-19 immunisation. It was unknown if the patient had any relevant medical history. It was unknown if the patient had any known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any concomitant medications within two weeks of 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 on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 14Mar2021, the patient experienced headache in the evening, but it had passed in the morning. He also mentioned that it could be also been from lack of sleep on an unknown date in 2021. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event headache was recovered on an unknown date in 2021, while the event lack of sleep was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I was in the bathroom all night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 73; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported by the patient that she was about to go in about an hour for her second shot and stated that last night on 15Mar2021 she did not know if it was because she ate something, but she was in the bathroom all night. She mentioned that feel a little better today. She wanted to ask if it will affect her getting second shot. She thought she just ate too much fruit yesterday and it had to come out. As a treatment she took Pepto-Bismol and drinking electrolyte water. The patient was recovering from the event at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: Tired; Not Well; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old 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 right arm on 10Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history included blood pressure. The patient had no known allergies. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 08Dec2020, the patient underwent nasal swab test and the result was positive. On 10Mar2021 at 16:00 the patient experienced tired, not well and nausea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events tired, not well and nausea was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, in the left arm, on an unknown date in Mar 2021, at 15:45, single dose, for COVID-19 immunisation. Medical history included asthma and had a mini-stroke 30 years ago in 1991. The patient did not have any known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medication not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On Mar 6, 2021, at 17:00, patient experienced mono effects, leg/arm pain and significant fatigue. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has tested for COVID-19. On Mar 8, 2021, patient underwent a SARS-CoV-2 test (nasal swab test and the result: negative). The outcome of leg/arm pain and significant fatigue: recovering (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Feeling abnormal, Neck pain
Clinical narrative: Balance problem; Some foot drop; Brain fog; Neck pains; Extreme weakness; Some dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis on an unknown date. 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. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. On 26Feb2021, the patient experienced extreme weakness, some dizziness, balance problem, neck pains, brain fog and some foot drop. 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 balance problem, some foot drop, brain fog, neck pains, extreme weakness and some dizziness were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peroneal nerve palsy
Clinical narrative: Balance problem; Some foot drop; Brain fog; Neck pains; Extreme weakness; Some dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis on an unknown date. 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. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. On 26Feb2021, the patient experienced extreme weakness, some dizziness, balance problem, neck pains, brain fog and some foot drop. 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 balance problem, some foot drop, brain fog, neck pains, extreme weakness and some dizziness were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.