chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Oropharyngeal pain, Pain
Clinical narrative: Headaches; Dizziness; Fatigue; Sweating; Chills; Joint pain; Body aches; Sore throat; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 06Oct2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic and osteoarthritis, spondylosis, migraines. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included trazodone hydrochloride (DEPRAX) 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-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA8780) via an unspecified route of administration in the right arm on 15Sep2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient previously also received pneumococcal 13 valent vaccine (PVC-13 PNEUMONIA VACCINE) for unknown indication from an unknown date and experienced allergy to vaccine and triamcinolone acetonide (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. On 06Oct2021 at 23:00, the patient experienced chills, joint pain, body aches, sore throat and coughing. On 07Oct2021 at 22:00, the patient experienced sweating. On 08Oct2021 at 21:00, the patient experienced headaches, dizziness and fatigue. 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 reported events. The clinical outcome of the events chills, joint pain, body aches, sore throat and coughing was resolved on 07Oct2021 at 19:00, sweating was resolved on 08Oct2021 at 21:00 while headaches, dizziness and fatigue was resolved on 15Oct2021 at 08:00.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Malaise, Pyrexia
Clinical narrative: 3rd booster dose; Fever; Malaise; Headache; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Oct2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of this report. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, the patient experienced fever, malaise and headache. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever, malaise and headache was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching, no rash; This is a spontaneous report from a contactable consumer. An unspecified aged adult female patient received 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. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown, if the patient received any other vaccine within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced itching, no rash. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event itching, no rash 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use
Clinical narrative: Extreme tiredness; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 49-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 in the right arm on 08Oct2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide/telmisartan (TELMISARTAN HCTZ) from an unknown date for an 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 intramuscular route of administration in the right arm on 15Jan2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Feb2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Oct2021 at 21:00, the patient experienced extreme tiredness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tiredness 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Dyspnoea, Hyperhidrosis
Clinical narrative: difficulty breathing; Swelling of lymph node under left armpit and left jaw.; Metal taste in mouth; fever (99.6 F); chills; sweats; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number was FH8027,e xpiry date was not reported), via an unspecified route of administration, administered in Arm Left on 15Oct2021 12:45 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included,drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EN6207, Expiry date was not reported) via an unspecified route of administration on 14Mar2021 08:00AM, administered in Left arm as dose 1, single for covid-19 immunisation and on 04Apr2021 08:00AM patient had received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was ER8733, Expiry date was not reported) via an unspecified route of administration, administered in Left arm as dose 2, single for covid-19 immunisation. On 15Oct2021 21:00 the patient experienced difficulty breathing, swelling of lymph node under left armpit and left jaw, metal taste in mouth, fever (99.6 f), chills, sweats, muscle aches. On 15Oct2021 the patient underwent lab tests and procedures which included body temperature was 99.6 fahrenheit. Events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of difficulty breathing, swelling of lymph node under left armpit and left jaw, metal taste in mouth,fever (99.6 f),chills, sweats,muscle aches included Advil and drink water. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: difficulty breathing; Swelling of lymph node under left armpit and left jaw.; Metal taste in mouth; fever (99.6 F); chills; sweats; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number was FH8027,e xpiry date was not reported), via an unspecified route of administration, administered in Arm Left on 15Oct2021 12:45 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included,drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EN6207, Expiry date was not reported) via an unspecified route of administration on 14Mar2021 08:00AM, administered in Left arm as dose 1, single for covid-19 immunisation and on 04Apr2021 08:00AM patient had received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was ER8733, Expiry date was not reported) via an unspecified route of administration, administered in Left arm as dose 2, single for covid-19 immunisation. On 15Oct2021 21:00 the patient experienced difficulty breathing, swelling of lymph node under left armpit and left jaw, metal taste in mouth, fever (99.6 f), chills, sweats, muscle aches. On 15Oct2021 the patient underwent lab tests and procedures which included body temperature was 99.6 fahrenheit. Events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of difficulty breathing, swelling of lymph node under left armpit and left jaw, metal taste in mouth,fever (99.6 f),chills, sweats,muscle aches included Advil and drink water. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Product administration error, Vaccination site rash
Clinical narrative: Administrative error by the staff where she had her shot; Only a slight rash on the vaccination site; Fatigue; headache that started from mouth then jaw; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: not reported) dose 3 via an unspecified route of administration on 13Oct2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1 and dose 2 single for covid-19 immunization. On an unspecified date in Oct2021, it was reported that patient had administrative error by the staff where she had her shot. The staff encoded the wrong date of birth, patient had no major side effects, only a slight rash on the vaccination site, fatigue, and headache that started from the mouth then jaw. It was reported that patient realized about the administrative error after visiting her gynecologist. The outcome of events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gingival swelling, Myalgia, Night sweats
Clinical narrative: Severe rash; Tiredness; Muscle soreness; Swelling of gums; Hives; Chills; Night sweats; Poor sleep; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male 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 06Oct2021 at 09:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had medical history and any 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 vaccination. On 09Oct2021, the patient experienced severe rash, tiredness, muscle soreness, swelling of gums, hives, chills, night sweats and poor sleep. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether 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 events severe rash, tiredness, muscle soreness, swelling of gums, hives, chills, night sweats and poor sleep 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Rash, Urticaria
Clinical narrative: Severe rash; Tiredness; Muscle soreness; Swelling of gums; Hives; Chills; Night sweats; Poor sleep; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male 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 06Oct2021 at 09:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had medical history and any 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 vaccination. On 09Oct2021, the patient experienced severe rash, tiredness, muscle soreness, swelling of gums, hives, chills, night sweats and poor sleep. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether 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 events severe rash, tiredness, muscle soreness, swelling of gums, hives, chills, night sweats and poor sleep 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immunisation, Off label use
Clinical narrative: Numbness in lips; Numbness in lips and extremities; The patient received third/booster dose; The patient received third/booster dose; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. 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 vaccination. Concomitant medications included unspecified blood pressure medicines from an unknown date and unknown if ongoing. The patient previously received 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 a 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. On 07Oct2021, the patient experienced numbness in lips and extremities that lasted 4 days post third dose. 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 numbness in lips and extremities was resolved on 11Oct2021, after the duration of 4 days. The events numbness in lips and extremities occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 12-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 12, via an unspecified route of administration, on Oct 17, 2021, at 11:45, in the left arm, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. No medical history or allergies reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other concomitant medications within two weeks prior to the vaccination. On Oct 19, 2021, at 22:30, patient experienced rashes on the whole arm. No therapeutic measures taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of rashes on the whole arm: unknown (at the time of this report). The lot number for  BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: severely immunocompromised; This is a spontaneous report received from a contactable consumer (patient's neighbor). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had COVID-19 before vaccination. The reporter stated that he/she was on her/him neigborhood homeowner association (HOA) and someone applied to install a fence. When we set up the walkthrough, they volunteered that they hoped everyone was vaccinated since they had a major adverse medical event following the first of the Pfizer vaccine last Mar2021. They indicated they could not receive a second dose and he/she was now severely immunocompromised. The event was reported as non-serious, and it was unknown if treatment was received. It was unknown if patient was tested for COVID-19 since vaccination. The outcome of the event was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Heart rate increased, Hypoaesthesia oral, Peripheral coldness
Clinical narrative: Left forehead feeling different; Heart beat feeling fast; tongue and jaw numb feels like dental anesthesia; My left hand feel cold; This is a spontaneous report from contactable other healthcare professional. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an intramuscular route of administration in the left arm on 19Oct2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not provided and the patient was allergic to unspecified antibiotic and developed a rash. It was unknown whether the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not provided. On 19Oct2021 at 15:24 via phone call, notified by an employee that the patient had gradually had symptoms after the first dose of COVID-19 vaccine, which was administered on 19Oct2021 at 14:00, symptoms tongue and jaw numb, felt like dental anaesthesia and also felt left hand cold. On the same day, at 16:00 the patient experienced a heartbeat felt fast and left forehead felt different and the patient denies of breathing difficulty or swelling of mouth or tongue. The patient was advised to be immediately evaluated at the nearest emergency room or urgent care. The events resulted in the emergency room/department or urgent care. It was unknown any, 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 events tongue and jaw numb felt like dental anaesthesia, left hand felt cold, left forehead felt different and the heartbeat felt fast were unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: A fast heart beat; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on unknown date as a single dose for COVID-19 immunisation. The patient had unspecified medical history and 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 received medications (unspecified) within two weeks of vaccination. On 11Apr2021, the patient experienced a fast heart beat. The event resulted in doctor or other healthcare professional office/clinic visit. On 11Apr2021, the patient underwent heart rate test and the result was fast heart beat. 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 a fast heart beat was resolved with sequelae on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER873) via an unspecified route of administration in the right arm on 22Apr2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Swelling of eyelid, Urticaria
Clinical narrative: Nausea; Hives; Headache; Swollen eye lids; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 11Oct2021 at 09:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy seizure disorder. 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 lamotrigine (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and cyanocobalamin (VIT B12); all for unknown indication from an unknown date and unknown if ongoing. On 11Oct2021 at 09:30, the patient experienced nausea, hives, headache, bodyaches and swollen eyelids. 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 reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen eye lids, nausea, hives, headache and body aches was resolved with sequelae on an unknown date in Oct2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Dyspnoea, Fatigue
Clinical narrative: hands numb; Unable to use due to pain; Difficult to breathe; kidney spasm; Dizzy off balance; sick throbbing headache; Nauseous; All joints painful; Lymph swell in chest and breast; Fatigue; off balance; kidney spasms; eyes out of focus; Booster dose / Dose 3; Off label use; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 11:00 (at the age of 69-years-old) as a single dose. Medical history included cryptogenic organizing pneumonia and rheumatoid arthritis. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 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 in the left arm on 22Mar2021 at 10:00 (at the age of 69-years-old) 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 in the left arm on 01Mar2021 at 10:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. On 18Oct2021 at 11:00, the patient experienced dizzy off balance, sick throbbing headache, nauseous, hands numb, unable to use due to pain, all joints painful, difficult to breathe, lymph swell in chest breast, eyes out of focus, fatigue and kidney spasm. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy off balance, sick throbbing headache, nauseous, hands numb, unable to use due to pain, all joints painful, difficult to breathe, lymph swell in chest breast, eyes out of focus, fatigue and kidney spasm 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: Headache, Hypoaesthesia, Immunisation, Lymphadenopathy, Muscle spasms
Clinical narrative: hands numb; Unable to use due to pain; Difficult to breathe; kidney spasm; Dizzy off balance; sick throbbing headache; Nauseous; All joints painful; Lymph swell in chest and breast; Fatigue; off balance; kidney spasms; eyes out of focus; Booster dose / Dose 3; Off label use; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 11:00 (at the age of 69-years-old) as a single dose. Medical history included cryptogenic organizing pneumonia and rheumatoid arthritis. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 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 in the left arm on 22Mar2021 at 10:00 (at the age of 69-years-old) 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 in the left arm on 01Mar2021 at 10:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. On 18Oct2021 at 11:00, the patient experienced dizzy off balance, sick throbbing headache, nauseous, hands numb, unable to use due to pain, all joints painful, difficult to breathe, lymph swell in chest breast, eyes out of focus, fatigue and kidney spasm. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy off balance, sick throbbing headache, nauseous, hands numb, unable to use due to pain, all joints painful, difficult to breathe, lymph swell in chest breast, eyes out of focus, fatigue and kidney spasm 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: Nausea, Off label use, Pain in extremity, Renal colic, Vision blurred
Clinical narrative: hands numb; Unable to use due to pain; Difficult to breathe; kidney spasm; Dizzy off balance; sick throbbing headache; Nauseous; All joints painful; Lymph swell in chest and breast; Fatigue; off balance; kidney spasms; eyes out of focus; Booster dose / Dose 3; Off label use; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 11:00 (at the age of 69-years-old) as a single dose. Medical history included cryptogenic organizing pneumonia and rheumatoid arthritis. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 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 in the left arm on 22Mar2021 at 10:00 (at the age of 69-years-old) 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 in the left arm on 01Mar2021 at 10:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. On 18Oct2021 at 11:00, the patient experienced dizzy off balance, sick throbbing headache, nauseous, hands numb, unable to use due to pain, all joints painful, difficult to breathe, lymph swell in chest breast, eyes out of focus, fatigue and kidney spasm. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy off balance, sick throbbing headache, nauseous, hands numb, unable to use due to pain, all joints painful, difficult to breathe, lymph swell in chest breast, eyes out of focus, fatigue and kidney spasm was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Back pain, Diarrhoea, Nausea
Clinical narrative: Back muscle aches; Abdominal Pain; Lower back pain; Nausea; Diarrhea; Upset stomach; Full body aches; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30125BA) via an unspecified route of administration in the left arm on 17Oct2021 at 12:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and allergy to penicillin. 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. The patient received unspecified medications (reported as "Too many to name") within 2 weeks of vaccination. The patient previously received amoxicillin; clavulanate potassium (AUGMENTIN) for unspecified indication from unknown date and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 17Sep2021 at 12:00 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. On 19Oct2021 at 16:00, the patient experienced back muscle aches, abdominal pain, lower back pain, nausea, diarrhea, upset stomach and full body aches. 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 back muscle aches, abdominal pain, lower back pain, nausea, diarrhea, upset stomach and full body aches was not resolved at the time of the report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Back muscle aches; Abdominal Pain; Lower back pain; Nausea; Diarrhea; Upset stomach; Full body aches; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30125BA) via an unspecified route of administration in the left arm on 17Oct2021 at 12:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and allergy to penicillin. 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. The patient received unspecified medications (reported as "Too many to name") within 2 weeks of vaccination. The patient previously received amoxicillin; clavulanate potassium (AUGMENTIN) for unspecified indication from unknown date and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 17Sep2021 at 12:00 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. On 19Oct2021 at 16:00, the patient experienced back muscle aches, abdominal pain, lower back pain, nausea, diarrhea, upset stomach and full body aches. 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 back muscle aches, abdominal pain, lower back pain, nausea, diarrhea, upset stomach and full body aches was not resolved at the time of the report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he was fully vaccinated, he got his 2nd dose in February; a high profile figure, died of the covid-19 virus; This is a spontaneous report from contactable consumers. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included multiple myeloma - a type of blood cancer that can limit the body's ability to fight infection and Parkinson's disease. The patient's concomitant medications were not reported. The patient who was a high-profile figure, died of the covid-19 virus. He had received the vaccine. From what the reporter had heard, he may have been battling cancer and so was autoimmune compromised. The patient received his second dose of the Pfizer-BioNTech vaccine in February, said his longtime aide. He had been scheduled for a booster last week but before he received it, she said (as reported). The patient died Monday as a result of complications from COVID-19, his family said. He was fully vaccinated against the virus but had been treated over the past few years for multiple myeloma - a type of blood cancer that can limit the body's ability to fight infection, according to his longtime aide. The patient died on 18Oct2021 due to drug ineffective and suspected COVID-19. It was unknown if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up; Reported Cause(s) of Death: he was fully vaccinated, he got his 2nd dose in February; (Name), a high profile figure, died of the covid-19 virus
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Depressed mood, Insomnia, Micturition urgency
Clinical narrative: severe dehydration; can't sleep; going to the bathroom so frequently; Getting upset; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN8733 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0161 and expiry date was not reported), via an unspecified route of administration, on an unspecified date in Apr2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included Severe anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced severe dehydration, she could not sleep, was going to the bathroom so frequently and she got upset. Outcome of the events was unknown.  Follow-Up (22Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cartilage injury, Chest pain, Dyspnoea, Ear pain
Clinical narrative: rash; constant runny nose; pain in the ear; shortness of breath; torn labrum; clicking sound in the hip joint; chest pain; cold infection; This is a spontaneous report from a contactable other HCP and a consumer. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Ibrance 125mg tablet by mouth daily for 21 days on and 7 days off in conjunction with femara (letrozole) as prescribed by MD. Patient reported after the start of therapy patient received covid 19 vaccination. Second dose was received in Apr2021. Since vaccination patient has been experiencing a rash, constant runny nose, pain in the ear and shortness of breath (date of onset not provided). Reported on an unknown date in May2021 patient was seen by an orthopedic specialist for a torn labrum and clicking sound in the hip joint. An unknown injection was given to help with symptoms. Symptoms have now resolved. MD aware. Patient was seen in the emergency room "about 2 and a half months ago" due to shortness of breath and chest pain (date of onset unknown). Patient received multiple tests - chest x-ray and covid 19, which all came back unremarkable. Patient was diagnosed with a cold infection and was placed on prednisone, doxycyline, and cough syrup with codeine. Therapy was placed on hold "about one month". Symptoms still persist and MD was aware. The events reported as other serious (Important Medical Events). The outcome of the events rash, constant runny nose, pain in the ear, shortness of breath, chest pain, cold infection was not recovered, of other events was recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events rash, constant runny nose, pain in the ear and shortness of breath, chest pain are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. However, The event s torn labrum, joint clicking and cold infection are most likely related to inter-current condition, thus unrelated to the suspect drug.  This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Joint noise, Nasopharyngitis, Rash, Rhinorrhoea, X-ray
Clinical narrative: rash; constant runny nose; pain in the ear; shortness of breath; torn labrum; clicking sound in the hip joint; chest pain; cold infection; This is a spontaneous report from a contactable other HCP and a consumer. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Ibrance 125mg tablet by mouth daily for 21 days on and 7 days off in conjunction with femara (letrozole) as prescribed by MD. Patient reported after the start of therapy patient received covid 19 vaccination. Second dose was received in Apr2021. Since vaccination patient has been experiencing a rash, constant runny nose, pain in the ear and shortness of breath (date of onset not provided). Reported on an unknown date in May2021 patient was seen by an orthopedic specialist for a torn labrum and clicking sound in the hip joint. An unknown injection was given to help with symptoms. Symptoms have now resolved. MD aware. Patient was seen in the emergency room "about 2 and a half months ago" due to shortness of breath and chest pain (date of onset unknown). Patient received multiple tests - chest x-ray and covid 19, which all came back unremarkable. Patient was diagnosed with a cold infection and was placed on prednisone, doxycyline, and cough syrup with codeine. Therapy was placed on hold "about one month". Symptoms still persist and MD was aware. The events reported as other serious (Important Medical Events). The outcome of the events rash, constant runny nose, pain in the ear, shortness of breath, chest pain, cold infection was not recovered, of other events was recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events rash, constant runny nose, pain in the ear and shortness of breath, chest pain are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. However, The event s torn labrum, joint clicking and cold infection are most likely related to inter-current condition, thus unrelated to the suspect drug.  This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report from a contactable consumer who reported for a female patient (reporter's wife). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient  diagnosed with COVID on 07Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with COVID on 07Oct2021.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.