chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Malaise
Clinical narrative: Fever with 101.3; Shaking; Chills; Malaise; Extreme fatigue; Body aches; Booster dose; Off label use; This is a spontaneous report from a non-contactable physician, the patient. A 33-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an intramuscular route of administration in the arm left on 29Sep2021 at 10:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus and hypothyroidism on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU), pneumococcal vaccine polysacch 23v (PNEUMOVAX); both for an unknown indication on 21Sep2021; levothyroxine (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN) and unspecified probiotics (MANUFACTURER UNKNOWN); all for an unknown indication 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: EH9899) via an unspecified route of administration on 18Dec2020 as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an intramuscular route of administration on 08Jan2021 as a single dose for COVID-19 immunisation. The patient previously received azithromycin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 29Sep2021 at 22:00, the patient experienced fever (101.3), shaking, chills, malaise, extreme fatigue and body aches. On the same day at 22:00, the patient underwent body temperature monitoring and result was 101.3 (units not specified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (101.3), shaking, chills, malaise, extreme fatigue and body aches was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pyrexia, Tremor
Clinical narrative: Fever with 101.3; Shaking; Chills; Malaise; Extreme fatigue; Body aches; Booster dose; Off label use; This is a spontaneous report from a non-contactable physician, the patient. A 33-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an intramuscular route of administration in the arm left on 29Sep2021 at 10:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus and hypothyroidism on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU), pneumococcal vaccine polysacch 23v (PNEUMOVAX); both for an unknown indication on 21Sep2021; levothyroxine (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN) and unspecified probiotics (MANUFACTURER UNKNOWN); all for an unknown indication 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: EH9899) via an unspecified route of administration on 18Dec2020 as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an intramuscular route of administration on 08Jan2021 as a single dose for COVID-19 immunisation. The patient previously received azithromycin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 29Sep2021 at 22:00, the patient experienced fever (101.3), shaking, chills, malaise, extreme fatigue and body aches. On the same day at 22:00, the patient underwent body temperature monitoring and result was 101.3 (units not specified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (101.3), shaking, chills, malaise, extreme fatigue and body aches was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on palms of hands, armpits, bottom of feet and buttocks.; This is a spontaneous report from a contactable other healthcare professional. A 30-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 30Aug2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to vaccination. Concomitant medications were not reported. 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 09Aug2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. On 31Aug2021, the patient experienced a rash on palms of hands, armpits, bottom of feet and buttocks in the morning after vaccination. The event 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on palms of hands, armpits, bottom of feet and buttocks was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cold sweat, Dizziness, Dysuria, Fatigue
Clinical narrative: Nauseau; Dizziness; Severe headache; Fever; Cold sweats; Bodyaches/ horrible pain; Burning urine; Fatigue; Anxiety; Off label use; Dose received : 3; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 29Sep2021 at 10:30 (at the age of 67-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. Concomitant medications included losartan potassium (LOSARTIN), tamoxifen (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (B12), biotin (MANUFACTURER UNKNOWN), E and D; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 11Feb2021 at 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 at 01:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Sep2021 at 03:30, the patient experienced nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine followed by fatigue and anxiety aftermath. 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 ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine, fatigue and anxiety were resolved on an unknown date in 2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Nausea, Off label use, Pain
Clinical narrative: Nauseau; Dizziness; Severe headache; Fever; Cold sweats; Bodyaches/ horrible pain; Burning urine; Fatigue; Anxiety; Off label use; Dose received : 3; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 29Sep2021 at 10:30 (at the age of 67-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. Concomitant medications included losartan potassium (LOSARTIN), tamoxifen (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (B12), biotin (MANUFACTURER UNKNOWN), E and D; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 11Feb2021 at 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 at 01:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Sep2021 at 03:30, the patient experienced nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine followed by fatigue and anxiety aftermath. 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 ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine, fatigue and anxiety were resolved on an unknown date in 2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nauseau; Dizziness; Severe headache; Fever; Cold sweats; Bodyaches/ horrible pain; Burning urine; Fatigue; Anxiety; Off label use; Dose received : 3; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 29Sep2021 at 10:30 (at the age of 67-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. Concomitant medications included losartan potassium (LOSARTIN), tamoxifen (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (B12), biotin (MANUFACTURER UNKNOWN), E and D; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 11Feb2021 at 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 at 01:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Sep2021 at 03:30, the patient experienced nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine followed by fatigue and anxiety aftermath. 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 ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine, fatigue and anxiety were resolved on an unknown date in 2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Discomfort, Immunisation, Joint range of motion decreased, Lymph node pain
Clinical narrative: Moderate pain in lymphnodes; Moderate discomfort from in side elbow all the way to left flank/ Discomfort; Pain felt like severe bruising; Limited range of motion; Off-label use; Dose received: 3; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the deltoid left on 27Sep2021 (at the age of 57-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 other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously 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 as a single dose for COVID-19 immunisation and 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 29Sep2021 at 09:00, the patient experienced moderate pain in lymph nodes, moderate discomfort from in side elbow all the way to left flank, pain felt like severe bruising with limited range of motion. The events did not result in doctor/other health care 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 event moderate discomfort from in side elbow all the way to left flank were resolved on an unknown date in Oct2021 and moderate pain in lymph nodes, pain felt like severe bruising with limited range of motion were resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Moderate pain in lymphnodes; Moderate discomfort from in side elbow all the way to left flank/ Discomfort; Pain felt like severe bruising; Limited range of motion; Off-label use; Dose received: 3; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the deltoid left on 27Sep2021 (at the age of 57-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 other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously 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 as a single dose for COVID-19 immunisation and 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 29Sep2021 at 09:00, the patient experienced moderate pain in lymph nodes, moderate discomfort from in side elbow all the way to left flank, pain felt like severe bruising with limited range of motion. The events did not result in doctor/other health care 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 event moderate discomfort from in side elbow all the way to left flank were resolved on an unknown date in Oct2021 and moderate pain in lymph nodes, pain felt like severe bruising with limited range of motion were resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness; Extreme fatigue; Weakness; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age received the first dose of 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, the patient was not diagnosed with COVID -19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 02Oct2021, the patient experienced dizziness, extreme fatigue and weakness. The event resulted in 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 been tested for COVID-19. The clinical outcome of the events dizziness, extreme fatigue and weakness 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Nausea, Pain
Clinical narrative: Nausea; Shivers; Body ache; Booster; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the arm right on 05Oct2021 at 09:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN) taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. 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 and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration both as a single dose for COVID-19 immunisation. On 05Oct2021 at 18:00 the patient experienced nausea, shivers and body ache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events nausea, shivers and body ache were recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting projectile
Clinical narrative: Severe projectile vomiting; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 16-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 right arm on 05Oct2021 (at the age of 16-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of 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 09Sep2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021, the patient experienced severe projectile vomiting and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vomiting projectile and nausea and included treatment with prochlorperazine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting projectile and nausea was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: very bad case of shingles 7 months after; This is a spontaneous report from a contactable nurse. This 40-year-old female nurse (patient) re-ported for herself that:  A 40-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration, administered in right arm (reported as right arm) on 01Jan2021 14:00 (at the age of 40-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type Vaccine: Hospital. Patient relevant medical history included multiple sclerosis, gluten allergy and dairy allergy from an unknown date and unknown if ongoing. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Ek5730) via an unspecified route of administration, administered in right arm on 12Dec2020 14:00 (at the age of 40-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was not tested for covid-19. The patient did not receive any other vaccine in four weeks and the patient did not receive any other medications in two weeks. On 22Aug2021, patient developed very bad case of shingles 7 months after. Patient reported that patient was reading more and more online that patients with auto immune diseases may develop shingles afterwards. So patient reported her case as a possible link and would like to share the possibility. Patient received creams and pills as treatment. Outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via intramuscular route of administration in the left arm on 06Oct2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via intramuscular route of administration in the left arm on 28Jan2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via intramuscular route of administration in the left arm on 18Feb2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient previously also received influenza vaccine (FLU SHOT) via an unspecified route of administration on 22Sep2021 (at the age of 36-years-old) within four weeks prior to the COVID-19 vaccine. On 06Oct2021 at 21:30, starting about 12 hours after administration, the patient experienced fever, chills, and muscle ache. 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 event fever, chills and muscle ache was resolved on an unknown date in Oct2021.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Dizziness/Lightheadedness; Weakness; Headache; Chest discomfort; Fever; Injection site pain; Feeling as though head is altered/drugged; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 62-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 left arm on 03Oct2021(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Oct2021 at 18:00, the patient experienced chest discomfort, dizziness/lightheadedness, weakness/tiredness, headache, fever, injection site pain and feeling as though head is altered/drugged. 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 discomfort, dizziness/lightheadedness, weakness/tiredness, headache, fever, injection site pain, feeling as though head is altered/drugged was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Dizziness/Lightheadedness; Weakness; Headache; Chest discomfort; Fever; Injection site pain; Feeling as though head is altered/drugged; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 62-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 left arm on 03Oct2021(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Oct2021 at 18:00, the patient experienced chest discomfort, dizziness/lightheadedness, weakness/tiredness, headache, fever, injection site pain and feeling as though head is altered/drugged. 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 discomfort, dizziness/lightheadedness, weakness/tiredness, headache, fever, injection site pain, feeling as though head is altered/drugged was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration
Clinical narrative: Dose 1 given on 26Aug2021 and Dose 2 on 9Sep2021 which is less that 19 days; My mensural cycle began 9/29/21 and has not stopped as of today 10/7/21 and I am worried.; This is a spontaneous report from a contactable consumer, the patient. A 44-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 09Sep2021 at 18:45 (at the age of 44-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 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 vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Aug2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 29Sep2021, the patient experienced menstrual cycle which began and had not stopped as of the day of report, 07Oct2021, and was worried. 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event menstrual cycle began on 29Sep2021 and had not stopped as of the day of report, 07Oct2021 was not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Tiredness; Chills; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Decreased appetite; Diarrhoea; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male 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 05Oct2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, high blood pressure (HBP), back surgery, cancer, arthritis and chronic pain. 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 hydrochlorothiazide (HTZ) (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously took pethidine hydrochloride (DEMEROL) and experienced drug allergy. 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 an unknown date at 08:00 and also 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 12Feb2021 at 08:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 19:00, the patient experienced tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite and diarrhea. 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. The clinical outcome of the events tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite, and diarrhea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Malaise, Myalgia, Nausea
Clinical narrative: Tiredness; Chills; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Decreased appetite; Diarrhoea; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male 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 05Oct2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, high blood pressure (HBP), back surgery, cancer, arthritis and chronic pain. 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 hydrochlorothiazide (HTZ) (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously took pethidine hydrochloride (DEMEROL) and experienced drug allergy. 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 an unknown date at 08:00 and also 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 12Feb2021 at 08:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 19:00, the patient experienced tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite and diarrhea. 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. The clinical outcome of the events tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite, and diarrhea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pyrexia
Clinical narrative: Tiredness; Chills; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Decreased appetite; Diarrhoea; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male 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 05Oct2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, high blood pressure (HBP), back surgery, cancer, arthritis and chronic pain. 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 hydrochlorothiazide (HTZ) (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously took pethidine hydrochloride (DEMEROL) and experienced drug allergy. 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 an unknown date at 08:00 and also 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 12Feb2021 at 08:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 19:00, the patient experienced tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite and diarrhea. 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. The clinical outcome of the events tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite, and diarrhea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Immunisation, Pyrexia
Clinical narrative: Fever; Chills; Headache; Vomiting; Diarrhea; Third (booster) dose administered; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Oct2021 at 14:00 (at the age of 69-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 taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 69-years-old) and also a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Oct2021 at 00:00, the patient experienced fever, chills, headache, vomiting and diarrhea. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, vomiting and diarrhea were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Chills; Headache; Vomiting; Diarrhea; Third (booster) dose administered; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Oct2021 at 14:00 (at the age of 69-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 taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 69-years-old) and also a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Oct2021 at 00:00, the patient experienced fever, chills, headache, vomiting and diarrhea. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, vomiting and diarrhea were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Immunisation, Musculoskeletal discomfort
Clinical narrative: Have been feeling dizzy; Constant mild headache; Heaviness in neck; Blood pressure has been high; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-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 on 01Oct2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. 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 magnesium (MANUFACTURER UNKNOWN), riboflavin (VITAMIN B2) and sumatriptan (MANUFACTURER UNKNOWN), all taken for an unspecified indication 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 on 17Dec2020 (at the age of 44-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 00:15, the patient had been feeling dizzy and constant mild headache with heaviness in neck. Blood pressure had been high although the patient was not a hypertensive (HTN) patient. 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 acetylsalicylic acid (ASPIRIN). The clinical outcome of the events had been feeling dizzy, constant mild headache with heaviness in neck and blood pressure had been high was not resolved at the time of this report.    The lot number for the vaccine for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Have been feeling dizzy; Constant mild headache; Heaviness in neck; Blood pressure has been high; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-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 on 01Oct2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. 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 magnesium (MANUFACTURER UNKNOWN), riboflavin (VITAMIN B2) and sumatriptan (MANUFACTURER UNKNOWN), all taken for an unspecified indication 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 on 17Dec2020 (at the age of 44-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 00:15, the patient had been feeling dizzy and constant mild headache with heaviness in neck. Blood pressure had been high although the patient was not a hypertensive (HTN) patient. 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 acetylsalicylic acid (ASPIRIN). The clinical outcome of the events had been feeling dizzy, constant mild headache with heaviness in neck and blood pressure had been high was not resolved at the time of this report.    The lot number for the vaccine for BNT162b2 was not provided and will be requested during follow up.