chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Right arm, it's been 10 days now and full neck is stiff, both right and left side of the neck is impacted; Motion of the next obstructed and painful movement; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not take any concomitant medications. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 10May2021 at 10:30 (at the age of 54-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 COVID vaccine. On 07May2021, at 12:00 the patient experienced stiffness in the neck (left side), motion of the next obstructed and painful movement. It was continuing after 10 days of second vaccination. The patient experienced the neck was impacted from both right and left side. 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 which included treatment with pain killer medication (self-prescribed) but now does not help. The clinical outcome of the events of stiffness in the neck and motion of the next obstructed and painful movement were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash of sores the size of a small eraser head located on arm and trunk; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179) via an unspecified route of administration in the left arm on 17May2021 at 18:00 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history included rash, eczema, penicillin allergy, and COVID-19 from an unknown date. 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 COVID vaccine. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date and unknown if ongoing. On 18May2021 at 08:00, the patient experienced a rash of sores the size of a small eraser head located on the arm and trunk. The patient did have eczema but this was unlike any flare that patient experienced. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the event. The clinical outcome of the event rash of sores the size of a small eraser head located on arm and trunk was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0179) via an unspecified route of administration in the left arm on 07May2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. She previously took azithromycin (ZITHROMAX) on unknown date for an unspecified indication and experienced drug allergy. 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 COVID vaccine. On 17May2021 at 06:00, the patient experienced vertigo. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of vertigo was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Lymph nodes under right armpit tender; Lymph nodes under right armpit swollen; Continues Throbbing; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 19May2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, fruit allergy and honey allergy. Patient received no medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 28Apr2021 at 16:45 (at the age of 46-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 20May2021 at 16:00, the patient experienced lymph nodes under right armpit swollen and tender. Continues throbbing. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lymph nodes under right armpit swollen and tender, continues throbbing was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Fever; Chills; Exhaustion; Weakness; Headache; insomnia; weak and painful left arm; weak and painful left arm; Joint pain; Muscle pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0186) via an unspecified route of administration in the left arm on 20May2021 at 14:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0171 ), via an unspecified route of administration in the right arm on 27Apr2021 at 12:30 (at the age of 36-years-old), as a single dose 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. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient had no known allergies to medications, food or other products. On 20May2021 at 20:00, the patient had fever, chills, joint and muscle pain, exhaustion, weakness, headache, weak and painful left arm and insomnia. 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 fever, chills, joint and muscle pain, exhaustion, weakness, headache, weak and painful left arm and insomnia were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscular weakness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Exhaustion; Weakness; Headache; insomnia; weak and painful left arm; weak and painful left arm; Joint pain; Muscle pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0186) via an unspecified route of administration in the left arm on 20May2021 at 14:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0171 ), via an unspecified route of administration in the right arm on 27Apr2021 at 12:30 (at the age of 36-years-old), as a single dose 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. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient had no known allergies to medications, food or other products. On 20May2021 at 20:00, the patient had fever, chills, joint and muscle pain, exhaustion, weakness, headache, weak and painful left arm and insomnia. 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 fever, chills, joint and muscle pain, exhaustion, weakness, headache, weak and painful left arm and insomnia were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Lymphadenopathy, Menstrual disorder
Clinical narrative: Extreme muscle soreness and Weakness in legs (thigh muscles, Calves, hips, knees, feet and bottom of Feet) that is still on-going that started Day after 1st shot and progressed Greatly after second shot; Menstruated in April and May even though past menopause for more than 2 years; Headaches; swollen glands in neck and armpits; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (at the age of 49-years-old) as dose 2, single for covid-19 immunization. Medical history included blood pressure, allergic to Latex, allergic to shellfish, allergic to sulfa drugs. The patient had received BNT162B2 dose 1 (Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 16Mar2021 as dose 1, single for covid-19 immunization and had experienced Menstruated in April and May even though past menopause for more than 2 years, extreme muscle soreness, weakness in legs (thigh muscles, calves, hips, knees, feet and bottom of feet), Headaches and swollen glands in neck and armpits. The patient received no other vaccine in four weeks. Concomitant medication included metoprolol succinate (TOPROL XL); olmesartan medoxomil (BENICAR); escitalopram oxalate (LEXAPRO).  On an unspecified date, the patient experienced extreme muscle soreness, weakness in legs, progressed greatly after second shot (condition worsened), menstruated in april and may even though past menopause for more than 2 years, headaches, swollen glands in neck and armpits. Treatment was given for the events with Tylenol and was asked to rest. Extreme muscle soreness and Weakness in legs (thigh muscles, Calves, hips, knees, feet and bottom of Feet) that was still on-going that started Day after 1st shot and progressed greatly after second shot. Patient was not covid prior vaccination. Patient did not test for covid post vaccination. Outcome of the events were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Extreme fatigue; Leg cramps; Headache; Vision changes; Joint pain; Anemia; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 07Apr2021 at 18:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer, diabetic, asthma, anemia, and allergy to IVP dye. The patient previously took avelox, morphine, benadryl and compazine on unknown dates and for unknown indications and experienced drug allergy. Concomitant medications included cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D), insulin aspart (NOVOLOG), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), insulin detemir (LEVEMIR) and gabapentin (GAPATIN); all for unspecified indications and since unknown dates. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 62-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 20:00 the patient experienced dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain and anemia. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain, anemia and included treatment with meclizine (MANUFACTURER UNKNOWN) and MRI on an unknown date. On 14Apr2021, the patient underwent COVID 19 test (nasal swab) and the result was negative. The clinical outcome of the events dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain and anemia were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, SARS-CoV-2 test, Visual impairment
Clinical narrative: Dizziness; Extreme fatigue; Leg cramps; Headache; Vision changes; Joint pain; Anemia; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 07Apr2021 at 18:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer, diabetic, asthma, anemia, and allergy to IVP dye. The patient previously took avelox, morphine, benadryl and compazine on unknown dates and for unknown indications and experienced drug allergy. Concomitant medications included cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D), insulin aspart (NOVOLOG), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), insulin detemir (LEVEMIR) and gabapentin (GAPATIN); all for unspecified indications and since unknown dates. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 62-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 20:00 the patient experienced dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain and anemia. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain, anemia and included treatment with meclizine (MANUFACTURER UNKNOWN) and MRI on an unknown date. On 14Apr2021, the patient underwent COVID 19 test (nasal swab) and the result was negative. The clinical outcome of the events dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain and anemia were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Dose was given to patient before patient turned 12 years old.; This is a spontaneous report from a contactable pharmacist. An 11-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via intramuscular route in the left arm on 21May2021 at 17:00 (at the age of 11-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known drug allergy. It was unknown whether the patient received medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 17:00, first dose of vaccine was given to the patient before patient turned 12 years old (product used in unapproved population). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. No follow-up attempts are needed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine before turning 12 years old; This is a spontaneous report from a contactable pharmacist. A 11-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via intramuscular route of administration in the arm left on 21May2021 at 17:00 (at the age of 11-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. It was unknown, whether the patient received any Concomitant medications within two of vaccination. The patient had no known allergies to medications, food or other products. It was unknown, whether the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown, whether the patient had been tested for COVID-19, since the vaccination.  The patient did not receive any vaccination within four weeks prior to the COVID vaccine. On 21May2021 at 17:00, the patient received vaccine before turning 12 years old (product administered to patient of inappropriate age). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the product administered to patient of inappropriate age was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Product administered at inappropriate site, Pyrexia, Sleep disorder
Clinical narrative: Cannot sleep (20 hours); Joint pain; Fever; Dose 1: 21May2021 05:00; Dose 2: 21May2021 17:00; BNT162b2 received in the right leg; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right leg on 21May2021 at 05:00 (at the age of 47-year-old) as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 21May2021 at 17:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021 at 01:00, the patient could not sleep (20 hours) until she received the 2 doses and had fever and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events cannot sleep (20 hours), Joint pain and fever were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Nausea, Pain
Clinical narrative: Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; This is a spontaneous report from a contactable consumer, the parent. A 13-year-old male patient 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 14May2021 at 15:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as no. The patient was allergic to chemicals (reported as red dye allergy). Concomitant medications taken within two weeks of vaccination 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 16May2021 at 08:00, starting two days after the vaccine, the reporters son, the patient experienced abdominal pain, nausea, aches and chills for seven days. The events resulted in doctor or other healthcare professional office/clinic visit. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events starting two days after the vaccine the patient experienced abdominal pain, nausea, aches and chills for seven days was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Severe headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 19May2021 at 15:00 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 09:00, the patient experienced severe headache and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events severe headache and extreme fatigue was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen axillary lymph nodes; moderate to severe pain radiating; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the left arm on 20May2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, narcolepsy and anxiety. The patient had no known allergies.Concomitant medications included escitalopram oxalate (LEXAPRO), medroxyprogesterone (MANUFACTURER UNKNOWN) and modafinil 300 (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the left arm on 30Apr2021 at 17:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, the patient experienced swollen axillary lymph nodes with moderate to severe pain radiating. 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, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome for the events swollen axillary lymph nodes and moderate to severe pain radiating were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Chromaturia, Decreased appetite, Dysuria
Clinical narrative: Had difficulty and pain with urination; Urine color brown/reddish; Klebsiella infection; Fever of 100 degrees; Chills; Nausea; Loss of appetite; Fatigue; Lethargy; This is a spontaneous report from a non contactable Nurse.  A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 06Mar2021 09:30 (Batch/Lot Number: EN6199) age at vaccination of 71-years-old, as single dose, for covid-19 immunisation. Medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tamsulosin and experienced drug hypersensitivity, silodosin and experienced drug hypersensitivity.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 (evening) the patient experienced a fever of 100 degrees Fahrenheit, chills, nausea, loss of appetite, fatigue and lethargy. On 07Mar2021 the patient had difficulty and pain with urination, urine color brown/reddish. The events resulted in doctor or other healthcare professional office/clinic visit. Antibiotics were given for Klebsiela infection. 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 recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The association between the event Klebsiella infection with BNT162b2 can not be fully excluded based on temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Klebsiella infection, Lethargy, Nausea, Pyrexia
Clinical narrative: Had difficulty and pain with urination; Urine color brown/reddish; Klebsiella infection; Fever of 100 degrees; Chills; Nausea; Loss of appetite; Fatigue; Lethargy; This is a spontaneous report from a non contactable Nurse.  A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 06Mar2021 09:30 (Batch/Lot Number: EN6199) age at vaccination of 71-years-old, as single dose, for covid-19 immunisation. Medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tamsulosin and experienced drug hypersensitivity, silodosin and experienced drug hypersensitivity.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 (evening) the patient experienced a fever of 100 degrees Fahrenheit, chills, nausea, loss of appetite, fatigue and lethargy. On 07Mar2021 the patient had difficulty and pain with urination, urine color brown/reddish. The events resulted in doctor or other healthcare professional office/clinic visit. Antibiotics were given for Klebsiela infection. 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 recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The association between the event Klebsiella infection with BNT162b2 can not be fully excluded based on temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Bruise about the size of a quarter at injection site; Bruise about the size of a quarter at injection site and very painful still after 4 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration in the right arm on 18May2021 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included GERD (Gastroesophageal reflux disease) and gastritis. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included lansoprazole (PREVACID), diphenhydramine hydrochloride (BENADRYL) and vitamins nos (DAILY VITAMIN) all for an unknown indication from an unknown date. 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 19May2021, the patient experienced bruise about the size of a quarter at injection site and very painful still after 4 days. 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, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events bruise about the size of a quarter at injection site and very painful still after 4 days was not recovered 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: Headache, Inappropriate schedule of product administration, Oropharyngeal discomfort, Pain, Rash pruritic
Clinical narrative: Rash that looked like scalded skin with blisters; Rash itched but, burnt intensely; Blinding headache; Body aches; Tickle in throat; Wheezing; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 41-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 16May2021 at 11:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation Medical history included Sjogren's and penicillin allergy. The patient previously took CIPRO and experienced allergy. The patient received other unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 02May2021 at 11:00 (at the age of 41-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 16May2021 at 15:00, the patient experienced rash that looked like scalded skin with blisters, rash itched but, burnt intensely, blinding headache, body aches, tickle in throat and wheezing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with BENADRYL. The clinical outcome of the event rash that looked like scalded skin with blisters, rash itched but, burnt intensely, blinding headache, body aches, tickle in throat and wheezing were recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular, Wheezing
Clinical narrative: Rash that looked like scalded skin with blisters; Rash itched but, burnt intensely; Blinding headache; Body aches; Tickle in throat; Wheezing; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 41-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 16May2021 at 11:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation Medical history included Sjogren's and penicillin allergy. The patient previously took CIPRO and experienced allergy. The patient received other unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 02May2021 at 11:00 (at the age of 41-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 16May2021 at 15:00, the patient experienced rash that looked like scalded skin with blisters, rash itched but, burnt intensely, blinding headache, body aches, tickle in throat and wheezing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with BENADRYL. The clinical outcome of the event rash that looked like scalded skin with blisters, rash itched but, burnt intensely, blinding headache, body aches, tickle in throat and wheezing were recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Herpes zoster, Pyrexia
Clinical narrative: little shingles outbreak; "Normal Side effects the first evening (fever & chills)"; "Normal Side effects the first evening (fever & chills)"; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 07May2021 at 11:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 25-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 07May2021, the patient experienced "normal side effects the first evening (fever & chills)". On 15May2021, the patient experienced little shingles and was specifically writing about the little shingles outbreak which the patient was having, likely due to the vaccine. It was reported that the patient was 25 years old and an active individual and have never had a shingles outbreak previously. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the events "normal side effects the first evening (fever & chills)" and little shingles outbreak were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: felt a sharp pain in chest; This is a spontaneous report received  from a non-contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 06May2021 at 17:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to dairy. Concomitant medications included prazosin (MANUFACTURER UNKNOWN) and buspirone hydrochloride (BUSPAR) and hydroxyzine (MANUFACTURER UNKNOWN); all taken for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 06May2021 at 17:15,10 minutes post injection, the patient felt a sharp pain in chest that lasted for 2 hours before fading out. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event  felt a sharp pain in chest was recovered on unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Hypoaesthesia, Lymph node pain, Paraesthesia
Clinical narrative: painful lymph nodes all on left side esp in neck area which started within the first minute of receiving vaccine.; spleen pain; joint pain in hips, knees, ankles, under left shoulder blade pain; numbness in hands and feet which now is just in fingertips b/l of hands.; tingling; abnormal vaginal bleeding; This is a spontaneous report from a non-contactable nurse, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0108) via an unspecified route of administration in the arm left on 15May2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD (Attention deficit hyperactivity disorder). The patient had no known drug allergies. Concomitant medications included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (ADDERALL) and multivitamin all from an unknown date for an unknown indication and was 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 15May2021 the patient experienced spleen pain, painful lymph nodes all on the left side especially in the neck area which started within the first minute of receiving the vaccine, joint pain in hips, knees, ankles, under left shoulder blade pain, numbness and tingling in hands and feet which now is just in fingertips b/l of hands, abnormal vaginal bleeding. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events spleen pain, painful lymph nodes all on left side especially in neck area which started within the first minute of receiving the vaccine, joint pain in hips, knees, ankles, under left shoulder blade pain, numbness and tingling in hands and feet which now is just in fingertips b/l of hands, abnormal vaginal bleeding were not recovered at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: painful lymph nodes all on left side esp in neck area which started within the first minute of receiving vaccine.; spleen pain; joint pain in hips, knees, ankles, under left shoulder blade pain; numbness in hands and feet which now is just in fingertips b/l of hands.; tingling; abnormal vaginal bleeding; This is a spontaneous report from a non-contactable nurse, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0108) via an unspecified route of administration in the arm left on 15May2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD (Attention deficit hyperactivity disorder). The patient had no known drug allergies. Concomitant medications included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (ADDERALL) and multivitamin all from an unknown date for an unknown indication and was 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 15May2021 the patient experienced spleen pain, painful lymph nodes all on the left side especially in the neck area which started within the first minute of receiving the vaccine, joint pain in hips, knees, ankles, under left shoulder blade pain, numbness and tingling in hands and feet which now is just in fingertips b/l of hands, abnormal vaginal bleeding. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events spleen pain, painful lymph nodes all on left side especially in neck area which started within the first minute of receiving the vaccine, joint pain in hips, knees, ankles, under left shoulder blade pain, numbness and tingling in hands and feet which now is just in fingertips b/l of hands, abnormal vaginal bleeding were not recovered at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Axillary pain, Diarrhoea, Hypoaesthesia
Clinical narrative: Abnormal vaginal bleeding; Pain in hips, knees, ankles; Painful lymph nodes on left side especially neck area; Spleen pain; Painful armpit left side; Diarrhea; Numbness and tingling in hands and feet; Numbness and tingling in hands and feet; This is a spontaneous report from a non-contactable nurse, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), via an unspecified route of administration in the left arm on 15May2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date. The patient did not have any history of allergies to any food or medications or other products. Concomitant medication included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for an unknown indication from an 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 15May2021, the patient experienced abnormal vaginal bleeding, pain in hips, knees, ankles, painful lymph nodes on left side especially neck area, spleen pain, painful armpit left side, diarrhea first 2 days, numbness and tingling in hands and feet and then only tingling in fingertips of both hands. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the event diarrhea was resolved on an unknown date in May2021. The clinical outcome of the events abnormal vaginal bleeding, pain in hips, knees, ankles, painful lymph nodes on left side especially neck area, spleen pain, painful armpit left side, numbness and tingling in hands and feet were not resolved at the time of report.    No follow-up attempts are possible. No further information is expected.