chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: Light headed, dizzy; Sick feeling; This is a spontaneous report from a non-contactable pharmacist. A 67-year-old male patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: EW0151) via an intramuscular route of administration in the left arm on 06May2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 06May2021, the patient felt light headed, dizzy and sick feeling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had not been tested for COVID-19. The clinical outcome of the events light headed, dizzy and sick feeling was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever; Body ache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Sep2021 (at the age of 49-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. On 27Sep2021, the patient experienced fever, body ache and nausea. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, body ache and nausea was not resolved 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears; This is a spontaneous report from a non-contactable nurse, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Sep2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021 the patient experienced ringing in ears. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears 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.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Fatigue, Palpitations, SARS-CoV-2 test
Clinical narrative: Pounding heart; Fatigue; Poor circulation on left side of body; This is a spontaneous report from a contactable consumer, the patient. A 22-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 an unknown date in 2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included Urinary tract infection and 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 COVID-19 vaccine. Concomitant medications included unspecified antibiotics for urinary tract infection (UTI) from an unknown date and unknown if ongoing. 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 10Jun2021 at 16:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 12Sep2021, the patient experienced pounding heart, fatigue and poor circulation on left side of body. 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 been tested for COVID-19. On 04Aug2021, the patient underwent amazon test via nasal swab and the result was negative. The clinical outcome of the events pounding heart, fatigue and poor circulation on left side of body was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Pain in arms; Stomach ache; Stuffy nose; This is a spontaneous report from a non-contactable consumer, the patient.  A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 05May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced fever, chills, pain in arms, stomach ache and stuffy nose. 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 fever, chills, pain in arms, stomach ache and stuffy nose was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Erythema, Pain, Pruritus
Clinical narrative: Old BCG scar tender to the touch; Old BCG scar red; Old BCG scar itchy; Left armpit to breast is painful to raise or move arm; Left armpit is painful; Breast is painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old 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 25Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and migraine. 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 topiramate (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and unknown if ongoing. 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 arm left on 04Sep2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 27Sep2021 at 04:00, the patient reported that her old BCG scar was red, itchy and tender to the touch. Scar was located same arm had Pfizer injection. Also, left armpit to breast was painful to raise or move arm. Both things occurred 2 days after injection. The patient was unable to use left arm without pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with cetirizine hydrochloride (ZYRTEC) and cortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events old BCG scar was red, itchy and tender to the touch, left armpit to breast was painful to raise or move arm/unable to use left arm without pain were not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Scar pain
Clinical narrative: Old BCG scar tender to the touch; Old BCG scar red; Old BCG scar itchy; Left armpit to breast is painful to raise or move arm; Left armpit is painful; Breast is painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old 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 25Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and migraine. 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 topiramate (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and unknown if ongoing. 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 arm left on 04Sep2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 27Sep2021 at 04:00, the patient reported that her old BCG scar was red, itchy and tender to the touch. Scar was located same arm had Pfizer injection. Also, left armpit to breast was painful to raise or move arm. Both things occurred 2 days after injection. The patient was unable to use left arm without pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with cetirizine hydrochloride (ZYRTEC) and cortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events old BCG scar was red, itchy and tender to the touch, left armpit to breast was painful to raise or move arm/unable to use left arm without pain were not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Phantosmia - since the 2nd shot I have smelled smoke all of the time; This is a spontaneous report from a non-contactable nurse, the patient. A 49-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 14Sep2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known drug allergies. Concomitant medications taken within two weeks of vaccination included celecoxib (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. 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: EW0186) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 15Sep2021 at 06:00, the patient experienced phantosmia. Since the second shot she had smelled smoke all of the time. 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event phantosmia; since the second shot she had smelled smoke all of the time was not resolved 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Gastrointestinal sounds abnormal, Headache
Clinical narrative: Sore arm; Intense headache; Chills; Sweating; Throwing up; Diarrhea; Rumbling stomach; A lot of tension; Tightness from the middle of my head; Lightheaded; Tightness from the middle of my head down to my upper back and shoulder area.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 19:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Sep2021 at 07:00, the patient experienced sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach, also and still had a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded often. Reactions lasted for 3.5 days. 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 sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach was resolved on 27Sep2021; while that of a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscle tightness, Pain in extremity, Tension, Tension headache
Clinical narrative: Sore arm; Intense headache; Chills; Sweating; Throwing up; Diarrhea; Rumbling stomach; A lot of tension; Tightness from the middle of my head; Lightheaded; Tightness from the middle of my head down to my upper back and shoulder area.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 19:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Sep2021 at 07:00, the patient experienced sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach, also and still had a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded often. Reactions lasted for 3.5 days. 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 sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach was resolved on 27Sep2021; while that of a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sore arm; Intense headache; Chills; Sweating; Throwing up; Diarrhea; Rumbling stomach; A lot of tension; Tightness from the middle of my head; Lightheaded; Tightness from the middle of my head down to my upper back and shoulder area.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 19:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Sep2021 at 07:00, the patient experienced sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach, also and still had a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded often. Reactions lasted for 3.5 days. 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 sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach was resolved on 27Sep2021; while that of a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pain in jaw, SARS-CoV-2 test
Clinical narrative: Bad pain in right jaw area when open mouth, chew, or sneeze a day after vaccine given; Pain in right pinky finger; Dull headache on right side; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC2588) via an unspecified route of administration in the right arm on 13Sep2021 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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 COVID vaccine. On 14Sep2021 at 15:00, the patient experienced bad pain in right jaw area when open mouth, chew, or sneeze a day after vaccine was given. She also experienced pain in right pinky finger and dull headache on right side. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified anti-inflammatory prescription medications. On 27Sep2021, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event bad pain in right jaw area when open mouth, chew, or sneeze a day after vaccine given, pain in right pinky finger and dull headache on right side was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Headache, Nasal congestion
Clinical narrative: Congestion; Body aches; Fever; Headache; Chills; Loss of taste; Loss of smell; Coughing up phlegm; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 27Sep2021 at 15:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Sep2021, the patient experienced congestion, body aches, fever, headache, chills, loss of taste, loss of smell and coughing up phlegm. 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 congestion, body aches, fever, headache, chills, loss of taste, loss of smell and coughing up phlegm was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Productive cough, Pyrexia
Clinical narrative: Congestion; Body aches; Fever; Headache; Chills; Loss of taste; Loss of smell; Coughing up phlegm; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 27Sep2021 at 15:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Sep2021, the patient experienced congestion, body aches, fever, headache, chills, loss of taste, loss of smell and coughing up phlegm. 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 congestion, body aches, fever, headache, chills, loss of taste, loss of smell and coughing up phlegm was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Sore arm for 24 hours.; Off label use; Booster 3 rd dose; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Sep2021 at 12:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension and known allergy to poison ivy. 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 COVID-19 vaccine. On 26Sep2021 at 16:00, the patient experienced sore arm for 24 hours. Therapeutic measures were not 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 sore arm for 24 hours was resolved on 26sep2021 at 16:00, after the duration of 24 hours.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing of the ears constantly; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 at 13:00 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulpha drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 31Aug2021, the patient experienced ringing of the ears constantly. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included appointment with ear specialist. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing of the ears constantly was not resolved 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump under his armpit; This is a spontaneous report from a contactable consumer. A 16-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 23Aug2021 (Lot Number: FD8448) as DOSE 1, SINGLE, dose 2 intramuscular on 13Sep2021 (Lot Number: EW0191) (at the age of 16-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lump under his armpit on an unspecified date in 2021. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pain, Pyrexia
Clinical narrative: Slight fever; Chills; Body aches; Rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Sep2021 at 09:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on 22Sep2021 for an unknown indication, estrogens conjugated (PREMARIN), cyanocobalamin (VITAMIN B12), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), tocopherol (VITAMIN E), calcium (MANUFACTURER UNKNOWN) and pro (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient received other vaccines within four weeks prior to the COVID-19 vaccine. On 29Sep2021 at 21:00, the patient experienced slight fever, chills, body aches and rapid heartbeat. 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 slight fever, chills, body aches and rapid heartbeat was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Nausea
Clinical narrative: Feeling tired; Nausea; Fatigue; Fever (100.4); Chills; Cough; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via intramuscular route of administration in the left arm on 27Sep2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and shellfish 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 levothyroxine sodium (LEVOTHYROXIN), taken for an unspecified indication from an unknown date and unknown if ongoing. On 27Sep2021 at 23:00, the patient experienced feeling tired, nausea, fatigue, fever (100.4), chills and cough. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 27Sep2021 at 23:00, the patient underwent body temperature test and the result was 100.4 (unspecified units). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events feeling tired, nausea, fatigue, fever (100.4), chills and cough was resolving at the time of this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling tired; Nausea; Fatigue; Fever (100.4); Chills; Cough; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via intramuscular route of administration in the left arm on 27Sep2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and shellfish 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 levothyroxine sodium (LEVOTHYROXIN), taken for an unspecified indication from an unknown date and unknown if ongoing. On 27Sep2021 at 23:00, the patient experienced feeling tired, nausea, fatigue, fever (100.4), chills and cough. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 27Sep2021 at 23:00, the patient underwent body temperature test and the result was 100.4 (unspecified units). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events feeling tired, nausea, fatigue, fever (100.4), chills and cough was resolving at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Acne; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 40-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 11Sep2021 at 01:00, the patient experienced acne. The event acne did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event acne was not resolved 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left underarm; Dose 1: 05Mar2021Dose 2: 27Sep2021; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 27Sep2021 at 17:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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. The patient's concomitant medications were reported as not applicable. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 30Sep2021 at 06:00, the patient experienced swollen lymph nodes in left underarm. The adverse event 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in left underarm was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Influenza like illness, Nausea
Clinical narrative: Chest pain; Shortness of breath; Flu like symptoms; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Sep2021 at 12:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Sep2021 at 22:00, the patient experienced chest pain, nausea, shortness of breath and flu like symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, shortness of breath, flu like symptoms and nausea were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Late menstural period by over a week; This is a spontaneous report from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an intramuscular route of administration in the left arm on 16Sep2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included "hypothyroid". The patient has known allergies to penicillins. Prior to 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 levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) and had drug allergy. On 21Sep2021, the patient had late menstrual period by over a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 late period was unknown at the time of this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood glucose, Blood glucose increased, Thyroid function test, Thyroid hormones increased
Clinical narrative: Approx. 5 months after my 2nd Pfizer Covid-19 vaccination, I started losing my hair; After 1 month after the 2nd dose, my blood glucose & thyroid levels rose; After 1 month after the 2nd dose, my blood glucose & thyroid levels rose; This is a spontaneous report from a non-contactable consumer, the patient. A 69-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 30Jan2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included multivitamins, colecalciferol (VITAMIN D3), zinc (MANUFACTURER UNKNOWN), imipramine (MANUFACTURER UNKNOWN) and probiotics nos (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously took chlorhexidine gluconate (SURGILUBE) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, after one month after the second dose, the patients blood glucose and thyroid levels rose. On 01Jul2021 at 08:00, approximately five months after second Pfizer COVID-19 vaccination, she started losing her hair. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events after one month after the second dose, blood glucose and thyroid levels rose and approximately five months after her second Pfizer COVID-19 vaccination, she started losing her hair was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Rash
Clinical narrative: Fatigue; Chills/shivering; Headache; Body rash; Off label use; A third (booster) dose was administered.; This is a spontaneous report from a non-contactable pharmacist. A 77-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 28Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Sep2021, the patient experienced fatigue, chills/shivering, headache and body rash. 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 fatigue, chills/shivering, headache and body rash was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, Muscle spasms
Clinical narrative: Menstrual cycle is abnormal; Amount of blood is sparse, looks like spotting; Painful cramps; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Sep2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included unspecified iron supplement and fibre supplement; both from unknown dates for unknown indications and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (SEPTRA) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Sep2021, the patient experienced menstrual cycle was abnormal, amount of blood was sparse, looked like spotting and painful cramps. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle was abnormal, amount of blood was sparse, looked like spotting and painful cramps was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Influenza, Myalgia
Clinical narrative: Having a hard time focusing on tasks; Muscle pain; Extreme fatigue; It's like a very bad flu.; This is a spontaneous report from a contactable consumer. A patient of an unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 30Sep2021 the patient experienced having a hard time focusing on tasks due to muscle pain and extreme fatigue, it was like a very bad flu. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events having a hard time focusing on tasks, muscle pain, extreme fatigue and it was like a very bad flu was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Lymphadenopathy; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Sep2021 at 08:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) taken 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 30Sep2021, the patient experienced lymphadenopathy. 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 been tested for COVID-19. On 30Sep2021, the patient underwent COVID-19 test via nasal swab test and the result was negative. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event lymphadenopathy was not resolved 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Maternal exposure during pregnancy, Off label use, Pyrexia
Clinical narrative: Twelve hours after administration of booster; Twelve hours after administration of booster, rigoring and fever occurred.  Symptoms persisted for 24 hours after onset.  Symptoms were alleviated with oral acetaminophen.; Fever occurred; Maternal Exposure During Pregnancy, second trimester; Off label use; This is a spontaneous report from a contactable consumer. A 35-year-old pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 28Sep2021 at 12:00(at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. The patient's last menstrual date was on an unknown date in May2021. The patient was due in Mar2022. 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 COVID vaccine. On 29Sep2021 at 00:15,  twelve hours after administration of booster, the patient experienced rigoring and fever occurred. The symptoms persisted for 24 hours after onset and symptoms were alleviated with oral acetaminophen. Therapeutic measures were taken as a result of the events and included treatment with oral acetaminophen (MANUFACTURER UNKNOWN). 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 events rigoring and fever was recovered 30Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dysgeusia, Fatigue, Headache
Clinical narrative: Chills; Nausea; Fatigue; Headache; Bitter taste in mouth; Cough; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 28Sep2021 at 14:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and contrast dye. 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 metoprolol (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN) and assorted vitamins (unspecified); all for an unknown indication on an unknown date and unknown if ongoing. On 28Sep2021 at 17:00, the patient experienced chills, nausea, fatigue, headache, bitter taste in mouth and cough. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, nausea, fatigue, headache, bitter taste in mouth and cough was resolving at the time of this report.