chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Burnt taste and smell; Burnt taste and smell; This is a spontaneous report from a contactable consumer, the patient. An 18-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 03Apr2021 at 14:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Mar2021 at 15:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 07Apr2021 at 00:00, the patient experienced burnt taste and smell to everything. The clinical outcome of the events burnt taste and smell to everything was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Lymph nodes behind my right ear swelled; Fever; Felt extremely tired; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 13Apr2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, COPD (Chronic obstructive pulmonary disease), heart disease. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 23Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID 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 17Apr2021 at 08:00, 4 days post second vaccine, the patient experienced lymph nodes behind her right ear swelled, seemed to run a fever and felt extremely tired for about 24 hours. The lymph nodes remained swollen for 6 days, gradually reducing in size over that time. The clinical outcome of lymph nodes behind right ear swelled was recovered on an unknown date in 2021 and the clinical outcomes of fever, felt extremely tired were recovered on 18Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; Tired; Headache; Muscle pain; Chills; Feeling unwell; Low back pain; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er 8733) via an unspecified route of administration in the left arm on 05May2021 at 08:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on 14Apr2021 at 08:45 (at the age of 34-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 the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 08:45 the patient experienced injection site pain, tired, headache, muscle pain, chills, feeling unwell, low back pain and neck pain. The clinical outcome of the events  injection site pain, tired, headache, muscle pain, chills, feeling unwell, low back pain and neck pain was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Vaccination site pain
Clinical narrative: Injection site pain; Tired; Headache; Muscle pain; Chills; Feeling unwell; Low back pain; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er 8733) via an unspecified route of administration in the left arm on 05May2021 at 08:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on 14Apr2021 at 08:45 (at the age of 34-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 the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 08:45 the patient experienced injection site pain, tired, headache, muscle pain, chills, feeling unwell, low back pain and neck pain. The clinical outcome of the events  injection site pain, tired, headache, muscle pain, chills, feeling unwell, low back pain and neck pain was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Neck pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: serious chest pain; neck pain; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis rheumatoid. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received penicillin (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. Since the vaccination, the patient  was tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, 2 days after 2nd vaccine, the patient experienced serious chest pain neck pain and sore throat. It had been 7 days and the patient still had these symptoms. On an unknown date, the patient underwent nasal swab and the result was negative. The clinical outcome of the event serious chest pain, neck pain and sore throat was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Injection site pain; swelling; Body aches; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 05May2021 at 10:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took sulfa. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 58-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 the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 20:00, the patient experienced injection site pain, swelling, body aches, fever, nausea and fatigue. The clinical outcome of the events injection site pain, swelling, body aches, fever, nausea and fatigue were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; swelling; Body aches; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 05May2021 at 10:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took sulfa. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 58-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 the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 20:00, the patient experienced injection site pain, swelling, body aches, fever, nausea and fatigue. The clinical outcome of the events injection site pain, swelling, body aches, fever, nausea and fatigue were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Eczema, Musculoskeletal stiffness
Clinical narrative: Extremely itchy rash/eczema on both armpits spreading down towards torso; Extremely itchy rash/eczema on both armpits spreading down towards torso; Stomach ache; Vomiting; Diarrhea; Fever; Body aches; Chills; Stiff neck; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Apr2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN). The patient previously took tetracycline, doxycycline, minocycline, Z-PAK and experienced drug allergy with all of these. On 17Mar2021, the patient received an allergy shot (MANUFACTURER UNKNOWN). The patient previously 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 05Apr2021 (at the age of 43-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. On 27Apr2021 at 03:30, the patient experienced extremely itchy rash/eczema on both armpits spreading down towards torso, stomach ache, vomiting, diarrhea, fever, body aches, chills, stiff neck and nausea. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event itchy rash/eczema and included treatment with steroid cream. The clinical outcome of the events extremely itchy rash/eczema on both armpits spreading down towards torso, stomach ache, vomiting, diarrhea, fever, body aches, chills, stiff neck and nausea were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rash pruritic, Vomiting
Clinical narrative: Extremely itchy rash/eczema on both armpits spreading down towards torso; Extremely itchy rash/eczema on both armpits spreading down towards torso; Stomach ache; Vomiting; Diarrhea; Fever; Body aches; Chills; Stiff neck; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Apr2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN). The patient previously took tetracycline, doxycycline, minocycline, Z-PAK and experienced drug allergy with all of these. On 17Mar2021, the patient received an allergy shot (MANUFACTURER UNKNOWN). The patient previously 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 05Apr2021 (at the age of 43-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. On 27Apr2021 at 03:30, the patient experienced extremely itchy rash/eczema on both armpits spreading down towards torso, stomach ache, vomiting, diarrhea, fever, body aches, chills, stiff neck and nausea. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event itchy rash/eczema and included treatment with steroid cream. The clinical outcome of the events extremely itchy rash/eczema on both armpits spreading down towards torso, stomach ache, vomiting, diarrhea, fever, body aches, chills, stiff neck and nausea were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: started getting hives; vomiting; nausea; This is a spontaneous report from a contactable consumer, the patient. A 22-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 the arm right on 20Apr2021 at 09:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included shrimp/shellfish allergy. The patient did not receive any medication within two weeks of vaccination. 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 20Apr2021 at 10:00, 10 minutes after the wait time for the vaccine, patient started getting hives (not critical enough to warrant a hospital as had worse allergic reactions) and from 22:00 patient was vomiting due to the nausea that had been increasing throughout the day from the vaccine. The hives and vomiting lasted until 02:00 the next day. The clinical outcome of the event hives and vomiting were recovered on 21Apr2021 at 02:00. The clinical outcome of the event nausea was recovered on an unknown date Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles symptoms; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 44-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 COVID vaccine. On 12Apr2021, the patient experienced shingles symptoms after the first shot and diagnosed a few days later. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles symptoms which was unspecified. The clinical outcome of shingles symptoms was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed Shingles in my chest and back on the right side of my body.; This is a spontaneous report from a contactable consumer, the Patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 06Apr2021 at 16:30(at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and diabetes. The patient did not take any concomitant medication. 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 arm left on 06Mar2021 at 11:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation and Ciprofloxacin on 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. On 28Apr2021 the patient developed Shingles in his chest and back on the right side of his body. The events  resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir. The clinical outcome of the event Shingles in his chest and back on the right side of his body was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Lethargy, Nausea, Vertigo
Clinical narrative: Nausea; vomiting; diarrhea; severe vertigo; lethargy; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not received any concomitant 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 04May2021 at 10:00 the patient experienced nausea, vomiting, diarrhea, severe vertigo, lethargy and brain fog. The clinical outcome of the events nausea, vomiting, diarrhea, severe vertigo, lethargy and brain fog was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; vomiting; diarrhea; severe vertigo; lethargy; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not received any concomitant 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 04May2021 at 10:00 the patient experienced nausea, vomiting, diarrhea, severe vertigo, lethargy and brain fog. The clinical outcome of the events nausea, vomiting, diarrhea, severe vertigo, lethargy and brain fog was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain
Clinical narrative: Low-level continuous burning sensation at the injection site; Bit unsettling.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the arm left on 22Mar2021 at 14:30 (at the age of 58-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 for COVID -19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: e9264l) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 58-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. On 22Mar2021, the patient experienced low-level continuous burning sensation at the injection site. It was not painful or debilitating but it was a bit unsettling. The clinical outcome of low-level continuous burning sensation at the injection site and bit unsettling were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Disturbance in attention, Fatigue, Headache
Clinical narrative: Irritation; Anxiety; Unable to concentrate; Blurry vision; Loss of appetite; Fatigue; Pounding headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: AE178057) via an unspecified route of administration in the left arm on 01May2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. 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 06May2021 at 20:00, the patient experienced irritation, anxiety, unable to concentrate, blurry vision, fatigue, event loss of appetite and pounding headache. The clinical outcomes of irritation, anxiety, unable to concentrate, blurry vision, fatigue, event loss of appetite and pounding headache were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Vision blurred
Clinical narrative: Irritation; Anxiety; Unable to concentrate; Blurry vision; Loss of appetite; Fatigue; Pounding headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: AE178057) via an unspecified route of administration in the left arm on 01May2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. 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 06May2021 at 20:00, the patient experienced irritation, anxiety, unable to concentrate, blurry vision, fatigue, event loss of appetite and pounding headache. The clinical outcomes of irritation, anxiety, unable to concentrate, blurry vision, fatigue, event loss of appetite and pounding headache were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Very tired; sore left arm; bone/muscle aches for first day and a half; bone/muscle aches for first day and a half; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unspecified date. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), and iron (MANUFACTURER UNKNOWN) 25 mg all from an unknown date for an unspecified 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. On 18Apr2021 at 16:15 the patient experienced very tired, sore left arm, random bone/muscle aches for first day and a half. The clinical outcome of the events tiredness, pain in arm, bone pain, muscle pain was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Severe arm pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non- pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 03May2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history included. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 13:00 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 vaccine within four weeks prior to the vaccination.  On 03May2021 at 15:30, the patient experienced severe arm pain and headache. Therapeutic measures were taken as a result of severe arm pain and headache and included treatment with ADVIL twice on 2nd day after shot to an unknown stop date. The clinical outcomes of the events severe arm pain and headache were recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included interstitial cystitis. Concomitant medications included vitamin a nos (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and LDA trace minerals (MANUFAUCTRER UNKNOWN); all from unknown dates for unknown indications. 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 right arm on 10Apr2021 at 15:45, 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 01May2021 at 08:00, the patient experienced fever, chills, nausea and joint pain. The clinical outcome of the events fever, chills, nausea and joint pain were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Food aversion, Nausea, Taste disorder
Clinical narrative: Change in taste; Developed taste aversion to seafood and eggs; Seafood and eggs; eating such foods caused nausea; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 04May202 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included alopecia areata. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously took Bactrim on an unknown 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 vaccination. On 05May202, the patient experienced change in taste, developed taste aversion to seafood and eggs and eating such foods caused nausea. The clinical outcome of the events of change in taste, developed taste aversion to seafood and eggs and eating such foods caused nausea were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm progression, Positron emission tomogram, SARS-CoV-2 test
Clinical narrative: My cancer had spread significantly.; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL1203), via an unspecified route of administration on 03Feb2021 (at the age of 70-year-old) in the right arm as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EN5318), via an unspecified route of administration on 13Jan2021 (at the age of 70-year-old) in the Left Arm as a single dose for COVID-19 immunisation. Medical history included Cancer, allergies to Latex, Stage 4 Metastatic Breast cancer. Concomitant medication(s) included everolimus (AFINITOR); everolimus. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccine in four weeks. On 04Apr2021, the patient cancer had spread significantly. The patient took chemotherapy for the event. It was reported that I have had Stage 4 Metastatic Breast Cancer for the last 4 years and have been successfully treated by oral therapies. Shortly after receiving the second Covid-19 vaccine, I had a P.E.T. scan, the results of which showed my cancer had spread significantly. My question is this. have you had any other adverse effects from other cancer patients? Also, did Pfizer have sufficient data on the results of their vaccine on cancer patients. I find it remarkable that I was doing so well for so long and then all of a sudden, after the vaccine, my cancer "blew up". Coincidence? Device Date: 18May2021. The patient underwent lab tests and procedures which included PET Scan with result which showed my cancer had spread significantly on an unspecified date, sars-cov-2 test with negative result on 20Apr2021.The outcome of the event was not recovered.  Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: clicking in my ears and different high pitched sounds; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), via an unspecified route of administration on 05Apr2021 at 12:30 PM (at the age of 46-years-old), as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history included COVID-19 (diagnosed prior to vaccination). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 12:00 PM, the patient had clicking in the ears and different high-pitched sounds. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the clicking in my ears and different high pitched sounds was not recovered at the time of this report.   Information about lot/batch number have been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue
Clinical narrative: fatigued; Dizzy; fatigued, tired was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration administered in Arm Left on 18May2021 09:10 (at the age of 31-years-old) as single dose for covid-19 immunisation. The patient's medical history included ongoing G6PD deficiency. She says she only found out about it a couple of years ago but she assumes it's a life thing, dust mold and blood deficiency. The patient's concomitant medications were not reported. It was reported that the patient got her vaccine about 9:00 yesterday and a little after, she stayed 30 minutes to be watched because she has some blood disorders, she was fully getting more and more fatigued throughout the day on 19May2021. She says her one concern is part of the severe allergic reaction: she is dizzy on 19May2021. She says the dizzy is not so bad. She says she is tired and wants to make sure she was ok if she would go to sleep would that be an issue. The patient said that her vaccination card was in her car. She does not know the NDC number, LOT number, or expiration date of the first dose. The outcome of the events fatigued and dizzy was not recovered while, the outcome of another event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Malaise
Clinical narrative: diarrhea/ loose bowel movements; depressed; does not feel well; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). a 73-years-old female patient received BNT162B2 (pfizer-BioNtech covid-19 vaccine, formulation solution for injection, batch/lot number was not reported) via intramuscular, administered in arm left on 03may2021 at 12:00-13:00 as dose 2, single dose for covid-19 immunization (at the age of 73-years-old). Medical history included ataxia, which was a genetic abnormality, diagnosed 5 years ago she got the diagnose but she had symptoms since 2008 and irritable bowel syndrome which was diagnosed prior to receiving the vaccine and patient upped her medication for that because her system is being irritated. The patient's concomitant medications were not reported. the patient previously received first dose BNT162B2 (pfizer-Biontech covid-19 vaccine) on an unspecified date, as single dose for covid-19 immunization and received flu vaccine on Feb2021 for flu vaccination. It was reported that on 03may2021 patient received second dose of vaccine and stated that on 04may2021 she experienced diarrhea/loose bowel movements, was depressed and does not feel well. the patient stated that after receiving vaccine she was having diarrhea, no ER or physician's office required. She stated that she had a family physician visit on Friday after the vaccination and she said she had diarrhea that had not stopped. Her doctor told her to go to the ER. she told her it was not that bad and did not go. she has irritable bowel syndrome, and she upped her medication for that because her system is being irritated. it helped somewhat. she was still having loose bowel movements and it was not watery or explosive but just draining. she was getting depressed and she does not feel well and has been drinking lots of fluids so that she does not get dehydrated. She mentioned that she was diagnosed with irritable bowel syndrome prior to receiving the vaccine. The medication that she increased was dicyclomine 10 mg capsules. She stated it was in a pharmacy vial and she does not have a lot or expiration. She just empties the bottle into another bottle and no longer has it. The count size was 270 capsules. There was no seal on the bottle and she would be willing to send a sample. She has a new bottle, but she has not used any out of them yet. She gets them from (pharmacy name) and they get from different placed. The directions are for her to take one 10 mg capsules three times daily. She was now having to take 4 pills daily and that has helped somewhat. instructions on bottle say she can double dose with acute episodes. She has not doubled it, just taken an extra dose. product strength and count size dispensed was 10mg, 270 count. The outcome of the event diarrhoea was not recovered and outcome was unknown for rest of the other events.  Information on the Lot/batch number has been requested.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling sensation on the injection site to the thumb.; numbing; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unknown date, the patient experienced numbing and tingling sensation on the injection site to the thumb. The outcome of the events was reported as unknown.  Follow up attempts are needed. Further information has been requested.  Follow-up (22Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Suspect product BNT162B2 recoded appropriately.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: having a flare-up of her migraines; chronic daily headaches/ other complicated headache syndrome; This is a spontaneous report from a contactable physician. A 75-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as a single dose for covid-19 immunization. Medical history included migraine and headache from an unknown date and unknown if ongoing. Concomitant medication included pregabalin (LYRICA) taken for prophylactic treatment, start and stop date were not reported. The physician previously talked to the patient at her last appointment on 24Mar2021 and asked if her headaches worsened over the summer monsoon season, so they could potentially go up on her Lyrica. The patient was diagnosed with other complicated headache syndrome. The physician spoke with the patient on 23Apr2021 and reported that she experienced flare-up of her migraines and had chronic daily headaches, especially after her recent covid vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Fatigue, Pruritus, Sluggishness
Clinical narrative: Itchiness/Feel itchiness on legs, other times on arms. At times in neck, and other times in head; Sluggish/she is feeling a bit sluggish; tired/Is feeling tired; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number was not reported, dose 1 via an un-specified route of administration on 19May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date reporter calling because she is having secondary effects of the COVID-19 Vaccine. Caller requested an interpreter. Got vaccine on 19May2021and didn't feel anything on the first day but is now itchy. Feel itchiness on legs, other times on arms. At times in neck, and other times in head. Filled out a form before taking the vaccine. At the moment of getting it, did tell the representative about all the allergies she has. Second dose is scheduled to take place on 09Jun2021, that is why she is kind of worried. Vaccine. Advised caller Pfizer does not have information regarding specific vaccination facilities. Is feeling tired. Due to the COVID-19 Vaccine, she is feeling a bit sluggish and a bit tired. The patient underwent lab tests and procedures which included body height: 5.5 on an unspecified date. The outcome of the event was unknown.  Information about lot/batch no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Condition aggravated, Tinnitus
Clinical narrative: Tinnitus; It improved slightly a few weeks later but got worse again after the second dose; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182), via an unspecified route on unspecified date of 2021 as dose 2, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8731), via an unspecified route on unspecified date of 2021 as dose 1, single in the left arm for covid-19 immunisation experienced very loud tinnitus 3 days after the first shot. 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 18Apr2021, the patient experienced tinnitus: Patient started getting very loud tinnitus 3 days after the first shot. Patient received an audiogram which showed no hearing loss in the tested frequencies. It improved slightly a few weeks later but got worse again after the second dose. It's been 5 weeks now and it hadn't gone away. Patient received sought treatment and was told there was none. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diahrea after first shot; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced diahrea after first shot. The reporter wanted to know if not receiving second shot would cause further adverse reactions. The outcome of the event was unknown.  Information on lot/batch number has been requested. Additional information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye disorder, Feeling abnormal, Headache, Nasopharyngitis
Clinical narrative: can't keep eyes open; ache all over; chills; they just lay down and sleep; then they are cold; they have a headache; still get this annoying thing that will pop up; This is a spontaneous report from contactable consumer. This consumer reported for a female patient (2nd cousin). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date the patient experienced can't keep eyes open, ache all over, chills, they just lay down and sleep, then they are cold, they have a headache, still get this annoying thing that will pop up. Clinical course was reported as she was going to call a while back and she thought no, until she spoke with her cousin who had the same thing she went through. Report 2 of 2. Report 2 is she reporting on her cousins. She has a first cousin and her sister who live in and they had their shots pretty close the same time she did. Talking to her cousin, she has gone through the same thing and wanted her to find out if this is the same. There was a tough spell 4 days after the shot, then she was fine, then the same thing happened again for a couple of days at a time were they can't keep their eyes open because they ache all over, have chills, and then it goes away and then comes back. she adds her other cousin had the same shots and she did the same thing she had. She does not want to complete her report or complete a report on her cousins. That it has been the same for them as hers, their last shot was a few days before her second one. hey had the exact same thing happen. She does not know if maybe it is in the DNA or something. They still get this annoying thing that will pop up and they just lay down and sleep, then they are cold, then they have a headache. It does not last long, a day or a day and a half. The clinical outcome of events they just lay down and sleep, cold, headache was recovered and another still get this annoying thing that will pop up was not recovered other was unknown.  Information about lot/batch number has been requested.