chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Dizziness, Fatigue
Clinical narrative: 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 17:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder (reported as heart disease) and pre-diabetic. The patient had no known allergies to any medications, food, or other products. Concomitant medications taken within two weeks prior to the vaccination included losartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. 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. From 06Apr2021 at 09:00, till three days so far at the time of report, the patient experienced 101-102 Fahrenheit fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of three days of 101-102 Fahrenheit fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea and included treatment with addition of zinc, Vitamin C, electrolytes, Vitamin D, ibuprofen. The clinical outcome of the events three days of 101-102 Fahrenheit fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain of skin, Pyrexia, Vomiting
Clinical narrative: 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; 3 days so far of 101-102f fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 17:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder (reported as heart disease) and pre-diabetic. The patient had no known allergies to any medications, food, or other products. Concomitant medications taken within two weeks prior to the vaccination included losartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. 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. From 06Apr2021 at 09:00, till three days so far at the time of report, the patient experienced 101-102 Fahrenheit fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of three days of 101-102 Fahrenheit fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea and included treatment with addition of zinc, Vitamin C, electrolytes, Vitamin D, ibuprofen. The clinical outcome of the events three days of 101-102 Fahrenheit fever, extreme bone and joint pain vomiting, dizzy, extreme fatigue, swollen glands, skin pain, nausea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Pruritus, Rash
Clinical narrative: Inflamed skin; Rash face, neck arms and ears; Itchy skin; Red skin; Rash face, neck arms and ears; Rash face, neck arms and ears; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: N6201) via an unspecified route on 26Feb2021 at 12:00 hours in left arm (at an age of 70-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history included pollen allergy. The patient received calcium (MANUFACTURER UNKNOWN), retinol (VITAMIN A), colecalciferol (VITAMIN D3) received on unknown dates within two weeks of vaccination for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route on 03Feb2021 in left arm at 10:30 hours as single dose for COVID-19 immunisation. Post the vaccination, the patient was not tested for COVID-19. On 27Feb2021, the patient experienced rash face, neck, arms and ears, itch and red or inflamed skin. 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 topical cream and a ten days course of prednisone. The clinical outcome of the events of inflamed skin, rash face, neck, arms and ears, itchy skin and red skin was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Vaccination site rash
Clinical narrative: Moderately itchy; Red rash all over neck, elbows on both arms, the back of left wrist, the upper part of abdomen, and lower right part of back.; Rash was also over the injection site on right arm; Rash did feel warmer than the surrounding skin; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and asthma. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 16:30 (at the age of 35-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 08Apr2021 at 08:00, the patient experienced red rash all over her neck, when she had looked in the mirror further the rash was also over the injection site on her right arm. At that time, the rash was not itchy or painful but did feel warmer than the surrounding skin. Throughout the day, the rash developed on other parts of her body, including the insides of her elbows on both arms, the back of her left wrist, the upper part of her abdomen and the lower right part of her back. On 09Apr2021, the rash had continued to spread to more of her abdomen and upper back and it was moderately itchy. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with oral antihistamines (fexofenadine, loratidine, and diphenhydramine) and topical cortisone cream. The clinical outcome of the events red rash all over neck, elbows on both arms, the back of left wrist, abdomen, back and over the injection site on right arm, warmer than the surrounding skin and moderately itchy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations of flutters; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) on 04Apr2021 at 17:00 (at the age of 26-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. 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 04Apr2021, after the vaccination, the patient experienced heart palpitations of flutters. They were still occurring as of 09Apr2021 (Friday). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event heart palpitations of flutters was not resolved at the time of this report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: Active "vivid" dreams. I still remember mostly what they were about. Seven days in a row. Becoming intermittent now - still having dreams but can't recall much about them.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 28Mar2021 at 08:45 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included aortic stenosis and bundle branch block left (cardiac lower left bundle block). Concomitant medications included losartan (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), finasteride (PROPECIA) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 07Mar2021 at 09:15 (at the age of 60-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 28Mar2021, the patient experienced Active "vivid" dreams. The patient still remembers mostly what they were about. Seven days in a row. Becoming intermittent - still had dreams but could not recall much about them. 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 event active vivid dreams was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Thirst, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site soreness; Slight swelling at injection site; Headache; Tiredness; Increased thrist; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP0955) via an unspecified route of administration in the left arm on 06Apr2021 at 09:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) probiotics nos (MANUFACTURER UNKNOWN) and vitamin (MANUFACTURER UNKNOWN) all taken from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 12:30 (at the age of 47-year-old) as single dose for COVID-19 immunisation. 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 07Apr2021 at 06:00 the patient experienced soreness and slight swelling at injection site, headache (lasted ca 8 hours), tiredness/fatigue, increased thirst. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness and slight swelling at injection site, headache (lasted ca 8 hours), tiredness/fatigue, increased thirst were recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash under both arms, April3-5. Itchy red rash on throat, April 6 tocurrent.; Itchy red rash under both arms, April3-5. Itchy red rash on throat, April 6 tocurrent.; slight headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 15:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included valacyclovir 1gm (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN). 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 31Mar2021 and on 01Apr2021, the patient experienced slight headache. On 03Apr2021, the patient experienced itchy red rash under both arms and itchy red rash on throat. Therapeutic measures were not taken as a result of the events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event slight headache, itchy red rash under both arms and itchy red rash on throat was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: Headache; injection side pain; tiredness; feeling unwell; This is a spontaneous report from a non-contactable physician, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included factor V Leiden mutation (reported as Modification of Factor 5 Type Leiden). Concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 62-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 08Apr2021, the patient experienced headache, injection side pain, tiredness and the patient was feeling unwell. 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 headache, injection side pain, tiredness and feeling unwell was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; Severe dizziness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 06Apr2021 at 02:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included no other health issues. The patient had no known allergies to food, medications or other products. Concomitant medications included ibuprofen 200 mg (MANUFACTURER UNKNOWN) after second vaccination for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 31-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 09Apr2021 at 07:00 the patient experienced severe dizziness and vertigo. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events severe dizziness and vertigo was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash vesicular, SARS-CoV-2 test
Clinical narrative: Rash on arms both; popular and small vesicular rash; popular and small vesicular rash; This is a spontaneous report from a contactable physician. A 47-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 on 30Mar2021(at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products.  The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 09Mar2021 (at the age of 47-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient underwent PCR (nasal swab) and the result was Negative. On 04Apr2021 four days after the second vaccination, the patient experienced rash on both arms, popular and small vesicular rash. 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 triamcinolone. The clinical outcome of the events rash on arms both, papular and small vesicular rash were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vertigo
Clinical narrative: Low grade fever; Felt unwell; Vertigo episode; This is a spontaneous report from a non-contactable consumer, the patient. A 49-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 an unknown date in Jan2021 at 14:30 (at the age of 49-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. 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 the vaccination. On an unknown date in Jan2021, at 07:00, first day after shot the patient experienced low grade fever and felt unwell for 3 days. On an unknown date in 2021, 5 days after shot the patient had a vertigo episode that lasted for over 2 months. 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 low grade fever, felt unwell and vertigo episode were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: Inappropriate schedule of vaccine administered; Rash developed on the arm where the injection was received; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 15Mar2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 04Apr2021 at 14:00, i.e., 8 days after injection the patient experienced rash developed on the arm where the injection was received. The patient had no known allergies. The adverse events did not result in doctor/other health care 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 rash developed on the arm where the injection was received was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower back pain; This is a spontaneous report from a non-contactable consumer, the patient. A 21-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 07Apr2021 at 14:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date 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. On 08Apr2021 the patient experienced severe lower back pain. 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 event. The clinical outcome of the event severe lower back pain was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Decreased appetite, Disturbance in attention, Headache
Clinical narrative: Inappropriate schedule of vaccine administeredDose 1 on 23Mar2021 and Dose 2 on 01Apr2021; Headache; Muscle pain; Bone pain; Chills; Nausea; Loss appetite; Swollen lymph glands; Brain fade; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm right on 23Mar2021 at 19:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Apr2021 at 19:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation (described as inappropriate schedule of vaccine administered). Medical history included osteoporosis and chronic obstructive pulmonary disease (COPD). Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; budesonide; formoterol fumarate (SYMBICORT) from an unspecified date in 2021 (3 days before vaccine) for an unknown indication. The patient previously took Augmentin and experienced drug allergy (allergies to medications, food, or other products: allergic to Augmentin). 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 25Mar2021 at 09:00, the patient experienced headache, muscle pain, bone pain, chills, nausea, loss appetite, swollen lymph glands and brain fade. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event inappropriate schedule of vaccine administered was unknown; while that of the events headache, muscle pain, bone pain, chills, nausea, loss appetite, swollen lymph glands and brain fade were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Inappropriate schedule of vaccine administeredDose 1 on 23Mar2021 and Dose 2 on 01Apr2021; Headache; Muscle pain; Bone pain; Chills; Nausea; Loss appetite; Swollen lymph glands; Brain fade; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm right on 23Mar2021 at 19:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Apr2021 at 19:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation (described as inappropriate schedule of vaccine administered). Medical history included osteoporosis and chronic obstructive pulmonary disease (COPD). Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; budesonide; formoterol fumarate (SYMBICORT) from an unspecified date in 2021 (3 days before vaccine) for an unknown indication. The patient previously took Augmentin and experienced drug allergy (allergies to medications, food, or other products: allergic to Augmentin). 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 25Mar2021 at 09:00, the patient experienced headache, muscle pain, bone pain, chills, nausea, loss appetite, swollen lymph glands and brain fade. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event inappropriate schedule of vaccine administered was unknown; while that of the events headache, muscle pain, bone pain, chills, nausea, loss appetite, swollen lymph glands and brain fade were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Facial twitching on ride side of face for 3+ hours straight; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via unspecified route of administration in the left arm on 07Apr2021 at 13:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. 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 07Apr2021 at 20:30, the patient experienced facial twitching on ride side of face for 3+ hours straight. The adverse event did not result in a visit to the doctors 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 event. The clinical outcome of facial twitching was recovered on 07Apr2021 at 23.30.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness grade 1; Vertigo grade 1; This is a spontaneous report from a contactable physician, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the left arm on 14Mar2021 at 16:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had a known allergy to iodine contrast. The patient did not receive any medication within two weeks of the vaccination. Prior to the vaccination, it was unknown whether 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 COVID-19 vaccination. On 14Mar2021 at 16:30, the patient experienced vertigo (CTCAE v 4.03 grade 1) and dizziness (CTCAE v 4.03 grade 1). 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 vertigo (CTCAE v 4.03 grade 1) and dizziness (CTCAE v 4.03 grade 1) was resolved on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling abnormal, Headache
Clinical narrative: Woke up sweaty; Achy head; Feeling off; Temperature was around 101/ My temp was 101.7 at the highest I took.; Felt fatigued; Felt some weakness; Achy; Felt some nausea; Hives on left lower arm; Hives on temple area; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age 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 15Mar2021 as single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the 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 COVID-19 vaccination. The patient reported that "it was similar to the first dose, just not quite as bad". The time frame was very similar. On 06Apr2021 at 07:45, the patient woke up feeling off and then in another 6 hours she felt worse. Her temperature was around 101 (unspecified units), she felt fatigued, achy and felt some weakness. She napped for some time that afternoon. She felt some nausea. The patient went to bed at 18:30 and slept off and on all night. Her temperature was 101.7 (unspecified units) at the highest she took. On 07Apr2021, the next morning she could tell that she felt better although she had an achy head and felt off, but could continue some of the normal activities. She did not nap and went to bed at 22:00 and slept all night. On 08Apr2021, the patient woke up sweaty and changed tops. On 09Apr2021 in the morning, the patient felt better but still noticed an achiness in her head. The patient also had hives on her left lower arm "during this time" on an unspecified date in Apr2021 and during the first time on an unspecified date in 2021, they were on her temple area. The adverse event 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 for the events feeling off, fever, felt fatigued, achy, felt some weakness, felt some nausea, achy head, sweaty and hives on the left lower arm and hives on the temple region were recovered with sequelae.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: Woke up sweaty; Achy head; Feeling off; Temperature was around 101/ My temp was 101.7 at the highest I took.; Felt fatigued; Felt some weakness; Achy; Felt some nausea; Hives on left lower arm; Hives on temple area; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age 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 15Mar2021 as single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the 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 COVID-19 vaccination. The patient reported that "it was similar to the first dose, just not quite as bad". The time frame was very similar. On 06Apr2021 at 07:45, the patient woke up feeling off and then in another 6 hours she felt worse. Her temperature was around 101 (unspecified units), she felt fatigued, achy and felt some weakness. She napped for some time that afternoon. She felt some nausea. The patient went to bed at 18:30 and slept off and on all night. Her temperature was 101.7 (unspecified units) at the highest she took. On 07Apr2021, the next morning she could tell that she felt better although she had an achy head and felt off, but could continue some of the normal activities. She did not nap and went to bed at 22:00 and slept all night. On 08Apr2021, the patient woke up sweaty and changed tops. On 09Apr2021 in the morning, the patient felt better but still noticed an achiness in her head. The patient also had hives on her left lower arm "during this time" on an unspecified date in Apr2021 and during the first time on an unspecified date in 2021, they were on her temple area. The adverse event 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 for the events feeling off, fever, felt fatigued, achy, felt some weakness, felt some nausea, achy head, sweaty and hives on the left lower arm and hives on the temple region were recovered with sequelae.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea, Paraesthesia oral
Clinical narrative: About 15 to 20 minutes lips tingling; numbness; Immeduately after injection light headed, dizzy; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in left arm on 08Apr2021 at 10:00 (at the age of 46-years-old) as single dose for COVID-19 immunisation. Medical history included unspecified allergies. Concomitant medication included Fluticasone propionate (FLONASE); Montelukast sodium (SINGULAIR) ; cetirizine hydrochloride (ZYRTEC); Memantine hydrochloride (ALZANTINA); all from unknown dates and for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 08Apr2021 at 10:00, immediately after the injection, the patient felt light-headed, dizzy and nauseated. After 15 to 20 minutes of vaccination, the patient experienced tingling lips and numbness. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events light-headed, dizzy, nausea, tingling lips and numbness was not recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin mass, Urticaria
Clinical narrative: small bumps; both arms itchy; hives; Itchy hives; redness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and restless leg syndrome. The patient did not have any allergies to food, medications, or other products. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), cyanocobalamin-tannin complex (B12), multivitamin and rubus idaeus leaf, sambucus nigra flower, sambucus nigra fruit ELDERBERRY; all for unknown indication and from unknown start date. 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 09Apr2021 at 12:00, the patient experienced redness itchy hives around both ankles. Therapeutic measures were taken as a result of event redness itchy hives around both ankles and included treatment with soap and water. On 09Apr2021 at 17:00, the patient experienced small bumps and both arms itchy. 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 event redness itchy hives around both ankles was recovered on an unknown date in 2021. The clinical outcome of the event small bumps and both arms itchy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 08:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to any medications, food, or other products. Medication taken within two weeks prior to the vaccination included M (unspecified). 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 vaccination. On 02Apr2021 at 21:00, the patient experienced fever, chills and fatigue. 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 patient underwent lab tests and procedures which included Rapid test via nasal swab on 08Apr2021, and the result was negative. The clinical outcome of the events fever, chills and fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 07Apr2021 at 16:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included ethinylestradiol, etonogestrel (ELURYNG). 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 09Apr2021 at 09:00, one and a half days after the first short, the patient experienced numbness in arms which started in right forearm to pinky. Then both pinkies felt like they were asleep/ tingly for 2 plus hours. It went away for an hour and came back from backs of elbows, went down bottom of both forearms and through tips of both pinkies. 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 event numbness in arms, started in right forearm to pinky, from backs of elbows, went down bottom of both forearms and through tips of both pinkies and the event both pinkies felt like they were asleep/ tingly were unknown, at the time of this report.  No follow-up attempts are needed. No further information is expected.