chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial spasm, Rash
Clinical narrative: Rash to shoulders, back, neck and face.; Facial spasms.; This is a spontaneous report from a contactable consumer. A 17-years-old Non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:30 (Age at vaccination 17 Years) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included current ankle FX, h/o tonsillitis with tonsillectomy and adenoidectomy, ear infections with myringotomy. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate 1/20 (LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported; meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported; diclofenac taken for an unspecified indication, start and stop date were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient was not tested for COVID-19. On 16Apr2021 18:45 the patient experienced rash to shoulders, back, neck and face, facial spasms.  Patient visited Emergency room/department or urgent care. Therapeutic measures were taken as a result of events include Benedryl 50mg, Solumedrol 125mg IV. Reporter enquired about current guidance for administration of second dose after rash and facial tremors seen in a patient 2 hours post 1st dose. Outcome of events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event rash and facial spasm and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen lymph node behind shoulder on the same arm that received the injection 7 days after injection; Extreme fatigue 1 day after injection; Pain in same arm that received the injection 1 day after getting vaccination; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 05Apr2021 at 16:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history (reported as N/A). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VITAMIN C) for an unknown indication from an unknown start date and unknown if ongoing. On 06Apr2021, the patient experienced extreme fatigue and pain in same arm 1 day after getting the vaccination. On 12Apr2021 at 06:00, the patient experienced swollen lymph node behind shoulder on the same arm that received the injection 7 days after injection. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with hot compress, ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) from an unknown start date to an unknown stop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, swollen lymph node behind shoulder and pain in arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain
Clinical narrative: Swollen lymph node behind shoulder on the same arm that received the injection 7 days after injection; Extreme fatigue 1 day after injection; Pain in same arm that received the injection 1 day after getting vaccination; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 05Apr2021 at 16:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history (reported as N/A). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VITAMIN C) for an unknown indication from an unknown start date and unknown if ongoing. On 06Apr2021, the patient experienced extreme fatigue and pain in same arm 1 day after getting the vaccination. On 12Apr2021 at 06:00, the patient experienced swollen lymph node behind shoulder on the same arm that received the injection 7 days after injection. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with hot compress, ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) from an unknown start date to an unknown stop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, swollen lymph node behind shoulder and pain in arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Fatigue, Headache, Mammogram, Pain
Clinical narrative: Headache; Nausea; Fatigue; Irritated lymphnodes on left arm; Underarm tenderness; Tightness; Pain; LROM on left arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and pre-diabetes. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 13Jan2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021, the patient experienced headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and Limited Range of Motion (LROM) on left arm. 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 paracetamol (TYLENOL), ice and was referred for ultrasound and lab work. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and LROM on left arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound Doppler normal
Clinical narrative: Headache; Nausea; Fatigue; Irritated lymphnodes on left arm; Underarm tenderness; Tightness; Pain; LROM on left arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and pre-diabetes. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 13Jan2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021, the patient experienced headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and Limited Range of Motion (LROM) on left arm. 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 paracetamol (TYLENOL), ice and was referred for ultrasound and lab work. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and LROM on left arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Fatigue, Headache, Joint range of motion decreased, Lymphadenitis
Clinical narrative: Headache; Nausea; Fatigue; Irritated lymphnodes on left arm; Underarm tenderness; Tightness; Pain; LROM on left arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and pre-diabetes. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 13Jan2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021, the patient experienced headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and Limited Range of Motion (LROM) on left arm. 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 paracetamol (TYLENOL), ice and was referred for ultrasound and lab work. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and LROM on left arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Nausea, Pain
Clinical narrative: Headache; Nausea; Fatigue; Irritated lymphnodes on left arm; Underarm tenderness; Tightness; Pain; LROM on left arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and pre-diabetes. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 13Jan2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021, the patient experienced headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and Limited Range of Motion (LROM) on left arm. 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 paracetamol (TYLENOL), ice and was referred for ultrasound and lab work. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, fatigue, irritated lymph nodes on left arm, underarm tenderness, tightness, pain and LROM on left arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Lymphadenopathy
Clinical narrative: Severe body aches; Muscle and bones pain; Muscle and bones pain; Fever; Chills; Dizziness; Weakness; Nausea; Strong headache; Painful and swollen lymph node on the arm i got the vaccine.; Painful and swollen lymph node on the arm i got the vaccine.; 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: EP7533) via an unspecified route of administration in the right arm on 15Apr2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), both for unknown indications, from unknown dates and unknown if ongoing. 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 24Mar2021 at 17:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (Test type: nasal swab) and the result was negative. On 15Apr2021 at 23:00, the patient experienced severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Severe body aches; Muscle and bones pain; Muscle and bones pain; Fever; Chills; Dizziness; Weakness; Nausea; Strong headache; Painful and swollen lymph node on the arm i got the vaccine.; Painful and swollen lymph node on the arm i got the vaccine.; 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: EP7533) via an unspecified route of administration in the right arm on 15Apr2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), both for unknown indications, from unknown dates and unknown if ongoing. 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 24Mar2021 at 17:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (Test type: nasal swab) and the result was negative. On 15Apr2021 at 23:00, the patient experienced severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Bone pain, Chills, Dizziness, Headache
Clinical narrative: Severe body aches; Muscle and bones pain; Muscle and bones pain; Fever; Chills; Dizziness; Weakness; Nausea; Strong headache; Painful and swollen lymph node on the arm i got the vaccine.; Painful and swollen lymph node on the arm i got the vaccine.; 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: EP7533) via an unspecified route of administration in the right arm on 15Apr2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), both for unknown indications, from unknown dates and unknown if ongoing. 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 24Mar2021 at 17:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (Test type: nasal swab) and the result was negative. On 15Apr2021 at 23:00, the patient experienced severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Nausea, Pain
Clinical narrative: Severe body aches; Muscle and bones pain; Muscle and bones pain; Fever; Chills; Dizziness; Weakness; Nausea; Strong headache; Painful and swollen lymph node on the arm i got the vaccine.; Painful and swollen lymph node on the arm i got the vaccine.; 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: EP7533) via an unspecified route of administration in the right arm on 15Apr2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), both for unknown indications, from unknown dates and unknown if ongoing. 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 24Mar2021 at 17:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (Test type: nasal swab) and the result was negative. On 15Apr2021 at 23:00, the patient experienced severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe body aches; Muscle and bones pain; Muscle and bones pain; Fever; Chills; Dizziness; Weakness; Nausea; Strong headache; Painful and swollen lymph node on the arm i got the vaccine.; Painful and swollen lymph node on the arm i got the vaccine.; 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: EP7533) via an unspecified route of administration in the right arm on 15Apr2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), both for unknown indications, from unknown dates and unknown if ongoing. 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 24Mar2021 at 17:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (Test type: nasal swab) and the result was negative. On 15Apr2021 at 23:00, the patient experienced severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, muscle and bones pain, fever, chills, dizziness, weakness, nausea, strong headache, painful and swollen lymph node on the arm the patient got the vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram ambulatory, Thyroid function test, Ultrasound scan
Clinical narrative: Swollen lymph nodes on the left side of the neck; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified blood pressure medications for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 17Feb2021 at 15:30 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 16:00, the patient experienced swollen lymph nodes on the left side of the neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes on the left side of the neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event, X-ray
Clinical narrative: Swollen lymph nodes on the left side of the neck; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified blood pressure medications for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 17Feb2021 at 15:30 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 16:00, the patient experienced swollen lymph nodes on the left side of the neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes on the left side of the neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on the left side of the neck; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified blood pressure medications for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 17Feb2021 at 15:30 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 16:00, the patient experienced swollen lymph nodes on the left side of the neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes on the left side of the neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hydrocele, Ultrasound testes abnormal
Clinical narrative: Developed a small hydrocele (smaller than a fingernail) on right testicle./ testicular ultrasound that showed the hydrocele on my right testicle.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Mar2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 27Mar2021 at 18:00, the patient developed a small hydrocele which was smaller than a fingernail on right testicle following the first dose of the vaccine. The patient experienced no other adverse effects. The symptoms lasted about 4 days and self-resolved. The events resulted in emergency room/department or urgent care. On an unknown date, the patient underwent ultrasound testes and the result was hydrocele on right testicle. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event small hydrocele on right testicle was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hydrocele, Ultrasound testes
Clinical narrative: Developed a small hydrocele (smaller than a fingernail) on right testicle./ testicular ultrasound that showed the hydrocele on my right testicle.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Mar2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 27Mar2021 at 18:00, the patient developed a small hydrocele which was smaller than a fingernail on right testicle following the first dose of the vaccine. The patient experienced no other adverse effects. The symptoms lasted about 4 days and self-resolved. The events resulted in emergency room/department or urgent care. On an unknown date, the patient underwent ultrasound testes and the result was hydrocele on right testicle. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event small hydrocele on right testicle was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Dysstasia
Clinical narrative: Chills/ Chattering teeth; Severe vertigo; Nausea; loose bowels; Profuse sweating; Lethargy; Headache; Joint pain; General disorientation; Slept 16 straight hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0160) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carbidopa, levodopa (MANUFACTURER UNKNOWN) and rasagiline mesylate (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00, the patient experienced chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, joint pain, general disorientation, slept 16 straight hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, Joint pain, general disorientation, slept 16 straight hours was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Lethargy, Loss of consciousness, Nausea
Clinical narrative: Chills/ Chattering teeth; Severe vertigo; Nausea; loose bowels; Profuse sweating; Lethargy; Headache; Joint pain; General disorientation; Slept 16 straight hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0160) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carbidopa, levodopa (MANUFACTURER UNKNOWN) and rasagiline mesylate (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00, the patient experienced chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, joint pain, general disorientation, slept 16 straight hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, Joint pain, general disorientation, slept 16 straight hours was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sleep disorder, Vertigo
Clinical narrative: Chills/ Chattering teeth; Severe vertigo; Nausea; loose bowels; Profuse sweating; Lethargy; Headache; Joint pain; General disorientation; Slept 16 straight hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0160) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carbidopa, levodopa (MANUFACTURER UNKNOWN) and rasagiline mesylate (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00, the patient experienced chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, joint pain, general disorientation, slept 16 straight hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, Joint pain, general disorientation, slept 16 straight hours was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Disorientation, Headache
Clinical narrative: Chills/ Chattering teeth; Severe vertigo; Nausea; loose bowels; Profuse sweating; Lethargy; Headache; Joint pain; General disorientation; Slept 16 straight hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0160) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carbidopa, levodopa (MANUFACTURER UNKNOWN) and rasagiline mesylate (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00, the patient experienced chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, joint pain, general disorientation, slept 16 straight hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, Joint pain, general disorientation, slept 16 straight hours was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Lethargy, Nausea, Vertigo
Clinical narrative: Chills/ Chattering teeth; Severe vertigo; Nausea; loose bowels; Profuse sweating; Lethargy; Headache; Joint pain; General disorientation; Slept 16 straight hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0160) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carbidopa, levodopa (MANUFACTURER UNKNOWN) and rasagiline mesylate (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00, the patient experienced chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, joint pain, general disorientation, slept 16 straight hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills/ chattering teeth, severe vertigo, nausea, loose bowels, profuse sweating, lethargy, headache, Joint pain, general disorientation, slept 16 straight hours was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: Chills; Vomiting; Diarrhea; Headache; 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: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medication (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN) and mirtazapine (MIRTAZAPIN); all medications from an unknown date, for unknown indications and unknown if ongoing. On 15Apr2021 at 17:00, day of vaccination, the patient experienced headache and on the same day at 23:00, the patient experienced chills, vomiting and diarrhea. Diarrhea was still persisting 4 days after vaccine. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, vomiting and diarrhea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.