chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Malaise, Pyrexia
Clinical narrative: started running a fever of 102 by 10 pm; flu - pure poison; feel like crap; This is a spontaneous report from a contactable consumer. A 54 year old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 10Jun2021 (at the age of 54 year old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and COVID-19. The patient received an unspecified medication within two weeks of vaccination which was unspecified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 20May2021 (at the age of 54 year old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. On 10Jun2021 at 22:00, the patient had running a fever of 102 by 10 pm, like had the flu, pure poison and missed another day of work and had been in bed for 24 hours and still felt like crap. The patient hope by next day that would pass. On 10Jun2021, the patient checked body temperature and the result was 102(unspecified units). The clinical outcome of the events were unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Influenza like illness
Clinical narrative: flu like symptoms with increased bruising all over body; flu like symptoms with increased bruising all over body; This is a spontaneous report from a contactable nurse, patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24May2021 at 14:30(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypothyroidism, and hypertension. Patient had several unspecified allergies. The patient received unspecified other medications within two weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26May2021 at 02:00, the patient experienced flu like symptoms with increased bruising all over body. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event flu like symptoms with increased bruising all over body was recovered with sequelae on an unknown date in 2021, at the time of this report.   Information about lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sneezing
Clinical narrative: Tired; Headache; Sneezing; This is a spontaneous report from a contactable consumer, the patient. A 21-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 right arm on 01Jun2021 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes type one and known allergy to gluten. Concomitant medications were not reported. 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 did not receive any other vaccines within four weeks prior to the vaccination. On  02Jun2021, the patient was very tired a day after getting vaccine, had a few headaches and had been sneezing for the last few days. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of very tired a day after getting vaccine, had a few headaches and had been sneezing for the last few days were recovered on unknown date in Jun2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms. Mostly headache, nausea, and feeling hot; Flu like symptoms. Mostly headache, nausea, and feeling hot.; Flu like symptoms. Mostly headache, nausea, and feeling hot.; Flu like symptoms. Mostly headache, nausea, and feeling hot.; This is a spontaneous report from a non-contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 12Jun2021 at 08:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in May2021 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021 at 08:00, the patient experienced flu like symptoms, mostly headache, nausea, and feeling hot. 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 flu like symptoms, mostly headache, nausea, and feeling hot 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Headache; Nausea; Feeling hot; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 12Jun2021 at 08:00 (at the age of 16-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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date (at an unknown age) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Jun2021, the patient experienced flu like symptoms, mostly headache, nausea and feeling hot. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, headache, nausea and feeling hot were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Palpitations, Tachycardia
Clinical narrative: Heart palpitations; Dizzy/Light headed; Blood pressure dropped; Tachycardia; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: ER8727; expiration date: 30Jun2021), intramuscularly administered in the left arm on 28Mar2021 15:15 (at the age of 65-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypothyroidism, sensitivity to cold medicines, and atrioventricular nodal reentrant tachycardia (AVRNT) from 2015 to 20Apr2021 (ablation done on 20Apr2021). Concomitant medications included thyroid (ARMOUR THYROID) and levothyroxine sodium (SYNTHROID). The patient previously took guaifenesin/phenylephrine hydrochloride (ENTEX) and sulindac (CLINORIL) and experienced drug allergy with both drugs. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205; expiration date: 30Jun2021) intramuscularly administered in the upper arm (unspecified which side) on 07Mar2021 15:00 (at the age of 65-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccinations within 4 weeks of the COVID vaccine. On 28Mar2021, the patient experienced heart palpitations, tachycardia, dizzy/light headed, and blood pressure dropped approximately 1 and a half to 2 hours after the vaccination. The heart palpitations and tachycardia lasted for 15 minutes. Therapeutic measures were not taken as result of the events. The outcome of events palpitations and tachycardia was recovered on 28Mar2021. The outcome of event dizziness was recovered on an unspecified date while the outcome of event blood pressure dropped was unknown. The event palpitations was reported as serious (important medical event).  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling arm around injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the arm on 09Jun2021 at 10:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and other medication received within two weeks of vaccination was not reported. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021, the patient experienced swelling arm around injection site. The event 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 event. The clinical outcome of the event swelling arm around injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: Fever; chills; body ache; chest pain while breathing in; Dose number=1 27May2021/ Dose number=2 10Jun2021; Dose number=1 27May2021/ Dose number=2 10Jun2021; This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female non-pregnant the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection)via an unspecified route of administration, administered in Arm Left on 27May2021 at 03:00 PM (Batch/Lot number was not reported) as a Dose 1, Single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 10Jun2021 at 14:00 (at the age of 41-years-old) as a Dose 2,Single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication in two weeks included, birth control medications. Other vaccine received in four weeks was none. It was unknown whether the patient had covid prior vaccination. The patient was not tested for covid post vaccination. The patient had Dose number=1 27May2021/ Dose number=2 10Jun2021 (off label use and inappropriate schedule of product administration). On 11Jun2021 at 04:00, patient experienced fever, chills, body ache and chest pain while breathing in. Therapeutic measures were taken as a result of the events which included Anti-inflammatory medications. Events resulted in the Emergency room/department or urgent care. Outcome of off label use and inappropriate schedule of product administration were unknown whereas, rest of the events were recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; body ache; chest pain while breathing in; Dose number=1 27May2021/ Dose number=2 10Jun2021; Dose number=1 27May2021/ Dose number=2 10Jun2021; This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female non-pregnant the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection)via an unspecified route of administration, administered in Arm Left on 27May2021 at 03:00 PM (Batch/Lot number was not reported) as a Dose 1, Single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 10Jun2021 at 14:00 (at the age of 41-years-old) as a Dose 2,Single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication in two weeks included, birth control medications. Other vaccine received in four weeks was none. It was unknown whether the patient had covid prior vaccination. The patient was not tested for covid post vaccination. The patient had Dose number=1 27May2021/ Dose number=2 10Jun2021 (off label use and inappropriate schedule of product administration). On 11Jun2021 at 04:00, patient experienced fever, chills, body ache and chest pain while breathing in. Therapeutic measures were taken as a result of the events which included Anti-inflammatory medications. Events resulted in the Emergency room/department or urgent care. Outcome of off label use and inappropriate schedule of product administration were unknown whereas, rest of the events were recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Incontinence, Nasal congestion
Clinical narrative: Congestion; dizziness; headaches; incontinence; severe lower leg pain; numbness in feet; tingling on face; This is a spontaneous report from a contactable consumer, the patient. A 68-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 right arm on 07Jun2021 at 13:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included 2 heart mitral valve surgeries, Raynaud's disease, deviated septum and arthritis. The patient had allergies to sulfa drugs. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 the patient experienced congestion, dizziness, headaches, incontinence, severe lower leg pain, numbness in feet and tingling on face. It happened within an hour of vaccine. Got better 2 days in between and on 3rd now having same side effects as the first day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events congestion, dizziness, headaches, incontinence, severe lower leg pain, numbness in feet and tingling on face were not recovered 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Congestion; dizziness; headaches; incontinence; severe lower leg pain; numbness in feet; tingling on face; This is a spontaneous report from a contactable consumer, the patient. A 68-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 right arm on 07Jun2021 at 13:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included 2 heart mitral valve surgeries, Raynaud's disease, deviated septum and arthritis. The patient had allergies to sulfa drugs. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 the patient experienced congestion, dizziness, headaches, incontinence, severe lower leg pain, numbness in feet and tingling on face. It happened within an hour of vaccine. Got better 2 days in between and on 3rd now having same side effects as the first day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events congestion, dizziness, headaches, incontinence, severe lower leg pain, numbness in feet and tingling on face were not recovered 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fatigue; Severe body aches; Headache; Severe injection site pain; Chills; High fever (101 degrees Fahrenheit); This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 20May2021 at 12:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. 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: ER8735) via an unspecified route of administration in the left arm on 29Apr2021 at 12:15 (at the age of 34-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 vaccination. On 21May2021 at 00:30, the patient experienced fatigue, severe body aches, headache, severe injection site pain, chills and high fever (101 degrees Fahrenheit). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, severe body aches, headache, severe injection site pain, chills and high fever (101 degrees Fahrenheit) were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fatigue; Severe body aches; Headache; Severe injection site pain; Chills; High fever (101 degrees Fahrenheit); This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 20May2021 at 12:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. 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: ER8735) via an unspecified route of administration in the left arm on 29Apr2021 at 12:15 (at the age of 34-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 vaccination. On 21May2021 at 00:30, the patient experienced fatigue, severe body aches, headache, severe injection site pain, chills and high fever (101 degrees Fahrenheit). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, severe body aches, headache, severe injection site pain, chills and high fever (101 degrees Fahrenheit) were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland in neck still there after almost 4 weeks; This is a spontaneous report from a contactable healthcare professional. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0162) via an unspecified route of administration in the arm left on 18May2021 at 10:15(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the arm left on an unknown date in Apr2021 at 10:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021, the patient experienced swollen gland in neck still there after almost 4 weeks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event swollen gland in neck still there after almost 4 weeks was not recovered at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: immediate muscle and joint stiffness that was almost paralyzing and extremely painful; immediate muscle and joint stiffness that was almost paralyzing and extremely painful; muscle pain; barely walk,or stand; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 10Apr2021 at 10:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammation. The patient had no allergies to any food or medications or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 02:30, the patient experienced immediate muscle stiffness and joint stiffness after second shot that was almost paralyzing and extremely painful. The patient could not get out of bed for several hours. And was informed at emergency room muscle pain was normal and should go away. Pain and stiffness increased. The patient was back at the doctor who treated inflammation and recommended orthopedic. Pained increased and was given pain medications. On an unknown date in 2021, the patient at the time of this report, the events were going on 3 months and could barely walk or stand. Doctors are still trying to identify the illness. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measured were taken for the events which included unspecified inflammation meds and pain medications. The clinical outcome of the events barely walk,or stand, immediate muscle and joint stiffness that was almost paralyzing and extremely painful, muscle pain were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Pain in extremity
Clinical narrative: Pain in my arm, by my arm pit/chest, shoulder and back by my arm pit; Pain in my arm, by my arm pit/chest, shoulder and back by my arm pit; Pain in my arm, by my arm pit/chest, shoulder and back by my arm pit; Pain in my arm, by my arm pit/chest, shoulder and back by my arm pit; This is a spontaneous report from a contactable consumer, the patient. A 80-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 right arm on 11Jan2021 at 00:00 (at the age of 80-years-old) as a single dose and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Feb2021 at 10:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included tocopherol (VITAMIN E), fish oil (MANUFACTURER UNKNOWN), lorazepam 1 milligram (MANUFACTURER UNKNOWN) and ascorbic acid, vitamin d nos (ASCORBIC ACID; VITAMIN D NOS) (reported as vitamin C with D), all taken for unknown indication from unknown date and unknown if ongoing. 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 did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021, the patient experienced pain in arm, by her arm pit/chest, shoulder and back by her arm pit. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events pain in arm, by her arm pit/chest, shoulder and back by her arm pit was not resolved, at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches starting 1 day after and continuing into the 2nd day after the vaccination and treated with tylenol and Ibuprofen.; Fever starting 1 day after and continuing into the 2nd day after the vaccination and treated with tylenol and Ibuprofen.; Chills starting 1 day after and continuing into the 2nd day after the vaccination and treated with tylenol and Ibuprofen.; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via intramuscular route of administration in the right arm on 12Jun2021 as a single dose for COVID-19 immunisation. Medical history was unknown. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via intramuscular route of administration in the right arm on 17May2021 as a single dose for COVID-19 immunisation. On 13Jun2021, the patient experienced body aches, fever and chills starting one day after and continuing into the second day after the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events, body aches, fever and chills which included treatment with Tylenol and ibuprofen. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events body aches, fever and chills was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Malaise
Clinical narrative: Extreme fatigue/gets tired easily; night sweats; 8 weeks of low grade fevers; malaise; headache; chills; body aches; cough; elevated sed rate; c reactive protein; URI; This is a spontaneous report from a contactable consumer (Patient) reported for himself that.  A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 (Batch/Lot Number: EW0151) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient past  Medical history included hypertension from 2016 and ongoing , Mitral valve prolapse from an unknown date and unknown if ongoing , cardiac murmur from 2018 and ongoing Echo- 2019  Echo- 09Apr2021, inflammatory bowel disease from 2016 and ongoing , acute endocarditis from 18Jun2021 and ongoing 17Jun2021- Echocardiogram  14Jun2021- Blood Cultures , hypertension from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , insomnia from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide, lisinopril (PRINZIDE) taken for hypertension from 13May2019 to 02Jun2021; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF) taken for an unspecified indication, sertraline hydrochloride (ZOLOFT) taken for depression, anxiety from 21Jun2021 and ongoing; trazodone hydrochloride (DESYREL) taken for insomnia from 21Jun2021 and ongoing; losartan potassium (COZAAR) taken for hypertension from 02Jun2021 and ongoing. facility type vaccine- Doctor's office/urgent care. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Apr2021, The patient experienced 8 weeks of low grade fevers, malaise, headache, chills, body aches, cough, with elevated sed rate, C reactive protein Improved with steroids returned when steroids stopped. On an unspecified date the patient experienced extreme fatigue" gets tired easily, Cough, night sweats and headache. No fever or shortness of breath. Referred to Urgent Care to be elevated said they could not be due to putting their boat in the water. Did go to Urgent Care later that day. The patient underwent lab tests and procedures which included blood culture: positive On 14Jun2021 Streptococcus mitis/oralis, C-reactive protein: 3.7 mg/dl on 02Jun2021, C-reactive protein: 7.2 mg/dl on 14Jun2021, echocardiogram: unknown results on 15Jun2021 No changes from previous , epstein-barr virus antibody: positive on 02Jun2021 Previous infection of EBV, Red blood cell sedimentation rate increased: 46 on 02Jun2021, Sars-cov-2 test: negative on 07May2021, Sars-cov-2 test: negative on 30May2021 and Sars-cov-2 test: negative on 15Jun2021. The event outcome was Not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dyspnoea, Fatigue, Hypersensitivity, Pulmonary pain
Clinical narrative: I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I have been exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 11:45 (at the age of 32-year-old) at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 15Apr2021 12:30 the patient experienced i suffered from severe allergies, i am suffering from bone pain and my lungs hurt, it is hard to breathe, i have been exhausted, there are times when i can't breathe. Adverse events resulted in Emergency room visit. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 03May2021 Nasal Swab (Covid tested post vaccination: Yes). Patient received treatment for the adverse events. Outcome of the events was not resolved.   Follow-up attempts are needed; information about lot/batch number requested.  Follow up (19Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Swelling
Clinical narrative: Armpit has swollen up; Arm is now feeling pain not directly on the injection site. but, it feels like bruising all over arm that was injected in.; Arm is now feeling pain not directly on the injection site. but, it feels like bruising all over arm that was injected in.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 09Jun2021 at 12:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jun2021 at 16:00 the patient experienced armpit had swollen up and arm was now feeling pain not directly on the injection site. but it feels like bruising all over her arm that she had injected in. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events armpit had swollen up and arm was now feeling pain not directly on the injection site, but it felt like bruising all over arm that was injected in were resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Extreme fatigue; Severe headache; Neck / arm pain; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Jun2021 at 14:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included blood pressure (MANUFACTURER UNKNOWN) and PREMARIN taken for unknown indication from an unknown start date. The patient had no known allergies. 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 20May2021 at 13:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021, the patient experienced extreme fatigue lasting 3+ days, severe headache and neck / arm pain. 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 these events.  The clinical outcome of the events extreme fatigue, severe headache and neck / arm pain was recovering at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: 48 hours headache; lethargy; This is a spontaneous report from a contactable consumer. A (non-pregnant) female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:  Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks and COVID prior vaccination were unknown. On an unspecified date the patient experienced 48 hours headache, lethargy. It was unknown whether patient tested for COVID post vaccination. The outcome of event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain and a little throbbing after 4 weeks from the 2nd vaccine; This is a spontaneous report from a contactable other hcp (patient, self-reporting). A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), dose 2 via intramuscular route of administration in arm left on 13May2021 at 17:00 as single dose (age at vaccination 57-year-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number EWO172), 1st dose (age at vaccination 57-year-old) on 22Apr2021 at 04:30 PM administration site left arm for COVID -19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. other medication includes VITAMINS. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced pain and a little throbbing after 4 weeks from the 2nd vaccine on 14May2021. No treatment was given for events. The outcome for event was not recovered.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on the finger tips; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient had not received any concomitant medications within two weeks of the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29May2021, the patient experienced numbness on the finger tips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event numbness on the finger tips was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Peripheral swelling, Vaccination site pain
Clinical narrative: Pain was felt time the needle entered  upper arm and when it was taken out; Lost some mobility in arm; Swelling is there and arm is a half inch larger than left.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient 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 12Mar2021 at 13:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and latex tape. 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 12Mar2021, the patient felt vaccine was administered into the nerve of the right arm and the patient experienced pain when the needle entered upper arm and when it was taken out, to date patient was in pain. The patient lost some mobility in the arm and swelling was there in the arm. The patient stated the arm was a half inch larger than the left arm and the patient was unable to raise arm to full capacity or reach back. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with orthopaedic doctor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain was felt when the needle entered upper arm and when it was taken out, lost some mobility in arm and swelling was there in the arm was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Injection site pain, Injection site swelling, Joint range of motion decreased, Mobility decreased
Clinical narrative: Pain was felt time the needle entered  upper arm and when it was taken out; Lost some mobility in arm; Swelling is there and arm is a half inch larger than left.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient 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 12Mar2021 at 13:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and latex tape. 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 12Mar2021, the patient felt vaccine was administered into the nerve of the right arm and the patient experienced pain when the needle entered upper arm and when it was taken out, to date patient was in pain. The patient lost some mobility in the arm and swelling was there in the arm. The patient stated the arm was a half inch larger than the left arm and the patient was unable to raise arm to full capacity or reach back. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with orthopaedic doctor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain was felt when the needle entered upper arm and when it was taken out, lost some mobility in arm and swelling was there in the arm was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.