chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site rash
Clinical narrative: Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site; Left underarm swollen; Severe headache; Jaw pain; Body aches; Chills; 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 58-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified antibiotic (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 14Jan2021 at 13:00 (at the age of 57-years-old) and also 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 04Feb2021 at 08:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 23:45, the patient experienced severe headache, jaw pain, body aches and chills, till the half of 09Oct2021. On 09Oct2021, the patient noticed rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots and left underarm swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 08Sep2021, the patient underwent SARS-COV-2 test (Polymerase Chain Reaction (PCR)) through nasal swab and the result was negative. The clinical outcome of the events severe headache, jaw pain, body aches and chills were resolved on 09Oct2021 while rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots, left underarm swollen was resolving at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pharyngeal swelling, Rash
Clinical narrative: Fuzzy head; Hives; Rash; Throat swelling; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05Oct2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took codeine (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (VICODIN) and doxycycline (MANUFACTURER UNKNOWN); all for unknown indications and experienced drug allergy. On 05Oct2021, the patient immediately had fuzzy head, hives, rash, throat swelling, thereafter fatigue and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fuzzy head, hives, rash, throat swelling, fatigue and nausea was resolved on an unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fuzzy head; Hives; Rash; Throat swelling; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05Oct2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took codeine (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (VICODIN) and doxycycline (MANUFACTURER UNKNOWN); all for unknown indications and experienced drug allergy. On 05Oct2021, the patient immediately had fuzzy head, hives, rash, throat swelling, thereafter fatigue and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fuzzy head, hives, rash, throat swelling, fatigue and nausea was resolved on an unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain in extremity, Pollakiuria
Clinical narrative: 24 hours later extreme leg and feet cramps for 9 hours; Frequent urination every 30 minutes all night; Headache; Arm ache; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358A) via an unspecified route of administration in the left arm on 28Sep2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 26Aug2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 29Sep2021 at 21:00, 24 hours after the vaccination, the patient experienced extreme leg and feet cramps for 9 hours, frequent urination every 30 minutes all night, headache and arm ache. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme leg and feet cramps for 9 hours was resolved on 30Sep2021 at 06:00 while frequent urination every 30 minutes all night, headache and arm ache was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphoedema
Clinical narrative: Right underarm lymphadema; Dose 3 administration: 07Oct2021; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received the third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 07Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the right arm on 14Dec2020 (at the age of 26-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 01Jan2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 07Oct2021, the patient experienced right underarm lymphadema less than 24 hours after getting the third vaccine. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right underarm lymphadema was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: Swelling of lymph nodes in armpit, groin and neck; Joint pain; Fever over 100 degrees; Off label use; Booster/ Dose received : 3; This is a spontaneous report from a non-contactable consumer, the patient. 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 unspecified route of administration in the right arm on 08Oct2021 at 10:15 (at the age of 38-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 meloxicam (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN); both from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines 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 08Oct2021 at 22:00, the patient experienced swelling of lymph nodes in armpit, groin and neck, joint pain and fever over 100 degrees. 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 event. On same day, the patient underwent body temperature and the result was over 100 degrees. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of lymph nodes in armpit, swelling of groin and neck, joint pain and fever over 100 degrees was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Limb discomfort, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Booster; Significant lower body discomfort to the point; Significant impact on ability to sleep; localized leg pain; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Oct2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included blood pressure high and abnormal blood cholesterol (borderline). The patient did not have 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 amlodipine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). 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 06Oct2021 the patient experienced significant lower body discomfort to the point that had a significant impact on his ability to sleep. On the same day, the patient felt localized leg pain just the entire lower body. On 07Oct2021, the patient underwent a SARS-CoV-2 test (Abbott) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) 900mg every 8-12 hours from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events significant lower body discomfort, significant impact on ability to sleep and localized leg pain just the entire lower body were recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head titubation, Muscle spasms, Muscle twitching, Pain of skin
Clinical narrative: Paresthesia (numbness/tingling) of face, arms, legs, chest, randomly throughout the day in different locations,; tremors of head and hands; tremors of hands; Twitches and spasm of head and extremities; spasm of head and extremities; dizziness, light headedness; dermatomal pains; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration on 28Aug2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation .Medical History included COVID-19. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) and calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin sodium phosphate, thiamine hydrochloride (VITAMIN B COMPLEX) taken for an unknown indication and unknown if ongoing.   On 01Sep2021, a few days after the vaccination, the patient experienced paresthesia (numbness/tingling) of face, arms, legs, chest, randomly throughout the day in different locations, tremors of head and hands, twitches and spasms of head and extremities, dizziness, light-headedness, dermatomal pains randomly throughout the day and had lasted about 6-7 weeks. The events resulted in doctor or other healthcare professional office/clinic. No therapeutic measures were taken as a result of the events. Since the vaccination the patient was not tested for COVID-19. The clinical outcome of the events paresthesia, tremors of head and hand, twitches and spasms of head and extremities, dizziness dermatomal pains were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Paresthesia (numbness/tingling) of face, arms, legs, chest, randomly throughout the day in different locations,; tremors of head and hands; tremors of hands; Twitches and spasm of head and extremities; spasm of head and extremities; dizziness, light headedness; dermatomal pains; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration on 28Aug2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation .Medical History included COVID-19. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) and calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin sodium phosphate, thiamine hydrochloride (VITAMIN B COMPLEX) taken for an unknown indication and unknown if ongoing.   On 01Sep2021, a few days after the vaccination, the patient experienced paresthesia (numbness/tingling) of face, arms, legs, chest, randomly throughout the day in different locations, tremors of head and hands, twitches and spasms of head and extremities, dizziness, light-headedness, dermatomal pains randomly throughout the day and had lasted about 6-7 weeks. The events resulted in doctor or other healthcare professional office/clinic. No therapeutic measures were taken as a result of the events. Since the vaccination the patient was not tested for COVID-19. The clinical outcome of the events paresthesia, tremors of head and hand, twitches and spasms of head and extremities, dizziness dermatomal pains were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: debilitating pain in left arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 66-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 66-year-old); both as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, high blood pressure and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously took bee pollen (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On an unknown date in Jan2021, the patient experienced debilitating pain in her left arm and wanted to get booster but was concerned about it making the pain worse. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event debilitating pain in left arm was not resolved at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pollakiuria, Pyrexia, Somnolence
Clinical narrative: Slight fever; Excessive tiredness; Slept for most of 24 hours; Frequent urinating waking up from sleep; Head stuffiness behind the eyes and nose; Booster dose\dose 3 received; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Oct2021 at 10:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication. 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 right arm on 16Mar2021 at 12:00 (at the age of 64-year-old) 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: UNKNOWN) via an unspecified route of administration in the right arm on 06Apr2021 at 17:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 13:00, the patient experienced a slight fever, excessive tiredness and slept for most of 24 hours, frequent urination for which the patient woke up from sleep which the patient would rarely do and head stuffiness behind the eyes and nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight fever, excessive tiredness, frequent urinating waking up from sleep and head stuffiness behind the eyes and nose was recovered on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Slight fever; Excessive tiredness; Slept for most of 24 hours; Frequent urinating waking up from sleep; Head stuffiness behind the eyes and nose; Booster dose\dose 3 received; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Oct2021 at 10:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication. 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 right arm on 16Mar2021 at 12:00 (at the age of 64-year-old) 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: UNKNOWN) via an unspecified route of administration in the right arm on 06Apr2021 at 17:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 13:00, the patient experienced a slight fever, excessive tiredness and slept for most of 24 hours, frequent urination for which the patient woke up from sleep which the patient would rarely do and head stuffiness behind the eyes and nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight fever, excessive tiredness, frequent urinating waking up from sleep and head stuffiness behind the eyes and nose was recovered on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling and pain in left arm; Severe swelling and pain in left arm; Severe swelling and pain in left arm & armpit (assume it is a very swollen lymph node).; Severe swelling and pain in left arm & armpit (assume it is a very swollen lymph node).; 3rd booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included cold. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and lansoprazole (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 07Mar2021 and 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 28Mar2021 as a single dose for COVID-19 immunisation. On 08Oct2021 at 20:00, the patient experienced severe swelling and pain in left arm & armpit (assume it was a very swollen lymph node). On 04Oct2021, the patient underwent PCR test via nasal swab and the result was negative. 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 been tested for COVID-19. The clinical outcome of the events severe swelling and pain in left arm & armpit (assume it was a very swollen lymph node) was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe swelling and pain in left arm; Severe swelling and pain in left arm; Severe swelling and pain in left arm & armpit (assume it is a very swollen lymph node).; Severe swelling and pain in left arm & armpit (assume it is a very swollen lymph node).; 3rd booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included cold. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and lansoprazole (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 07Mar2021 and 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 28Mar2021 as a single dose for COVID-19 immunisation. On 08Oct2021 at 20:00, the patient experienced severe swelling and pain in left arm & armpit (assume it was a very swollen lymph node). On 04Oct2021, the patient underwent PCR test via nasal swab and the result was negative. 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 been tested for COVID-19. The clinical outcome of the events severe swelling and pain in left arm & armpit (assume it was a very swollen lymph node) was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Immunisation
Clinical narrative: Administration date unknown, dose number=3; Headache; Chills; Sweat; This is a spontaneous report from a non-contactable consumer, the patient. A 37-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 an unknown date (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa. 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 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 on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On an unknown date, the patient had "administration date unknown, dose number=3". On 07Oct2021, the patient experienced headache, chills and sweat. Therapeutic measures were not taken as a result of the events headache, chills and sweat. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of headache, chills and sweat was recovered on an unknown date in Oct2021. The clinical outcome of the event "administration date unknown, dose number=3" 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation, Lymphadenopathy
Clinical narrative: Warm uncomfortable left armpit lymph node; Warm uncomfortable left armpit lymph node; third booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, NDC:59267-1000-01) via an unspecified route of administration in the left arm on 05Oct2021 at 15:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified proton pump inhibitors(PPI), unspecified hydrochloride, acetylsalicylic acid (ASPIRIN) and atorvastatin calcium (LIPITOR); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines 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: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 66-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021, the patient experienced warm uncomfortable, left armpit, lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events warm uncomfortable left armpit lymph node was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation
Clinical narrative: Headache which lasted four or five days; Administration date 27Sep2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 79-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 27Sep2021 at 11:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); both 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 an unspecified route of administration in the left arm on 09Feb2021 at 11:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation 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 02Mar2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 27Sep2021 at 11:00, the patient had "administration date 27Sep2021, dose number=3". On 28Sep2021, the patient experienced headache which lasted four or five days. Therapeutic measures were not taken as a result of the event headache which lasted four or five days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache which lasted four or five days was recovered on an unknown date in Oct2021. The clinical outcome of the event "administration date 27Sep2021, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Period has been delayed for a week; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 11:00 (at the age of 35-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 in the left arm on 02Oct2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included pulmonary stenosis, mitral valve prolapse and hypothyroidism. 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 medication included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 01Oct2021 at 15:45, the patient had her period been delayed for a week now (at the time of this report) and had timely periods for the past 5 years. 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 event. Since the vaccination, the patient had been tested for COVID-19. On 05Oct2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event period had been delayed for a week 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Off label use, Pain
Clinical narrative: Off-label use; Booster; Extreme whole body aches; Headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration on 05Oct2021 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), valsartan, amlodipine besilate (AMLODIPINE/VALSARTAN) and metoprolol (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9263) via an unspecified route of administration on 21Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration on 30Jan2021, as a single dose for COVID-19 immunisation.  On an unknown date in Oct2021, the patient experienced extreme whole body aches, headache and chills. Therapeutic measures were not taken as a result of the event. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme whole body aches, headache and chills was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warm to touch at injection site; Burning at injection site; Mouth tingling; Facial and neck paresthesia (burning, itching, tingling); Facial and neck paresthesia (burning, itching, tingling), scalp itching; This is a spontaneous report from a non-contactable nurse, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3102) via an unspecified route of administration in the left arm on 24Sep2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Sep2021, the patient experienced warm to touch at injection site, burning at the injection site, mouth tingling, facial and neck paresthesia (burning, itching, tingling) and scalp itching. 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 warm to touch at injection site, burning at injection site, mouth tingling, facial and neck paresthesia (burning, itching, tingling) and scalp itching was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Myalgia
Clinical narrative: Severe myalgia both shoulders; This is a spontaneous report from a contactable physician. A 72-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), hypertension (HTN), history of autoimmune hemolytic anemia in the past, sinusitis, osteoarthritis, acute onset polymyalgia and diagnosis of polymyalgia rheumatica (PMR) on 09Jan. 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 prednisone (MANUFACTURER UNKNOWN) started at least for 1.5 years for polymyalgia rheumatica (PMR). 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 as a single dose for COVID-19 immunisation. The patient had acute onset polymyalgia and was diagnosed with polymyalgia rheumatica (PMR) by the reporter who was a treating rheumatologist on 09Jan2021. On 14Jan2021, after the second dose, the patient saw ortho for severe myalgia of both shoulders, and underwent C-reactive protein (CRP) and the results was 62 (unspecified units). She responded greatly to steroids with normalization of CRP and the diagnosis was being treated for at least one year five months with prednisone. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe myalgia both shoulders was resolved with lasting effects on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Malaise, Muscle spasms, Nausea
Clinical narrative: Feeling like I might vomit; Dry heaving; Cramping; Stomach ache; Headache; Generally feeling sick.; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 08Oct2021 at 13:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included leg ulcer, cellulitis, high blood pressure, high cholesterol, overweight and mersa (infection MRSA - methicillin-resistant Staphylococcus aureus). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included about 14 prescriptions, high blood pressure medications (unspecified) from unknown dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 at 13:00, the patient was feeling like she might vomit, dry heaving, cramping, stomach ache, headache and generally feeling sick. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events feeling like she might vomit, dry heaving, cramping, stomach ache, headache and generally feeling sick was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Feeling like I might vomit; Dry heaving; Cramping; Stomach ache; Headache; Generally feeling sick.; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 08Oct2021 at 13:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included leg ulcer, cellulitis, high blood pressure, high cholesterol, overweight and mersa (infection MRSA - methicillin-resistant Staphylococcus aureus). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included about 14 prescriptions, high blood pressure medications (unspecified) from unknown dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 at 13:00, the patient was feeling like she might vomit, dry heaving, cramping, stomach ache, headache and generally feeling sick. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events feeling like she might vomit, dry heaving, cramping, stomach ache, headache and generally feeling sick was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Myalgia
Clinical narrative: Recurring chills; Back muscular aches; The patient received booster dose; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the 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 13:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to yeast, sulfa and air borne allergens. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 24Feb2021 at 19:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation and 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 17Mar2021 at 19:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient had received other vaccines within four weeks prior to the vaccination and included influenza vaccine (MANUFACTURER UNKNOWN) (reported as senior flu) via unspecified route of administration in the left arm on 23Sep2021 for immunisation. On 08Oct2021 at 09:00, the patient experienced recurring chills and back muscular aches. 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 recurring chills and back muscular aches were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.