chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle rupture
Clinical narrative: had grade two muscle tear in left pectoral muscle while performing normal weightlifting routine/torn pectoral; This is a spontaneous report from a non-contactable consumer (patient himself). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: en6200), via an unspecified route of administration, administered in left arm on 18Feb2021 (age at vaccination: 49 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included cholesterol, high blood pressure and elevated uric acid. Patient had no allergies to medications, food or other products. The patient received other unspecified medications within 2 weeks of vaccination. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Feb2021, 2 days after the first dose, the patient experienced grade two muscle tear in left pectoral muscle while performing normal weightlifting routine /torn pectoral. The patient received treatment for the adverse event. The patient visited the doctor office for torn pectoral. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since the vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Leg weakness on left side that resulted in a fall.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer and hypertension (reported as HTN). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and lovastatin (MANUFACTURER UNKNOWN); both for unspecified indications from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified vaccine on 10Mar2021. On 28Mar2021 at 09:00, the patient experienced leg weakness on left side that resulted in a fall. The patient was taken to emergency room for workup - no indication of stroke or spine injury and was released that evening. The patient was advised to follow up with cardiologist and possibly neurology. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event weakness of limbs was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes collarbone; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on an unknown date (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced swollen lymph nodes collarbone. The clinical outcome of the event swollen lymph nodes collarbone was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain
Clinical narrative: Tiredness; Some achiness; Muscle aches more tenseand uncomfortable; Queasiness; This is a spontaneous report received from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included prediabetes and rheumatoid arthritis. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) taken for an unknown indication from an unspecified date. The patient previously received penicillin and sulphonamide and experienced an allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 11Mar2021, the patient experienced tiredness, some achiness and muscle aches. On 12Mar2021, the patient reported that the muscle aches were more tense and uncomfortable. On an unspecified date in Mar2021, the patient experienced queasiness. Therapeutic measures included intake of VICKS flu syrup for the adverse events experienced. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events tiredness, aches, muscle aches and queasiness were resolved on 13Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; nausea; very sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), Claritin and multi-vitamin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 15:00, the patient had experienced very sore arm which she could not lift her arm. On 28Mar2021, the patient experienced fever and nausea. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore arm, fever and nausea was resolving at the time of this report.  No follow-up attempts are possible; No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Profuse sweating without fever; Severe muscle pain; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the right arm on 27Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 vaccines within four weeks prior to the COVID vaccine. Concomitant medication included gabapentin (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), carbamazepine (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN); all for unknown indication on an unknown start date and unknown if ongoing. On 27Mar2021 at 20:00, the patient experienced profuse sweating without fever, severe muscle pain and joint pain, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The patient did not receive any treatment for the reported events. The clinical outcome of the events profuse sweating without fever, severe muscle pain and joint pain and fatigue were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, SARS-CoV-2 test
Clinical narrative: right breast throbbing pain; right armpit hurt; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6190) via an unspecified route of administration in the left arm on 06Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient underwent lab tests and procedures, which included COVID-19 virus test on 25Mar2021 and the result was negative. On 13Mar2021 at 12:00, patient experienced throbbing pain in the right breast and right arm pit hurt for 1.5 weeks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events breast pain and right armpit pain was recovered on an unknown date.    No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Premenstrual syndrome
Clinical narrative: Period cramping; PMS; Period heavier than normal; Period started two weeks early; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration on an unspecified date (at the age of 26-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6955), via an unspecified route of administration on an unspecified date (at the age of 26-years-old) as a single dose for COVID-19 immunisation.  Medical history was reported as not applicable. The patient did not receive any other vaccines within 04 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication with 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that patients period started two weeks early, 12 hours after the patient received the vaccine. The patient had very consistent periods and it came out of nowhere. It included the cramping, pre-menstrual syndrome (PMS) and it was much heavier than normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the events. The clinical outcome of events period cramping, PMS, period heavier than normal and period started two weeks early was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Site injection pain the following day; This is a spontaneous report from a non-contactable other health care professional. A 31-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via unspecified route of administration, at right arm on 19Mar2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included CENTRUM WOMEN. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6021) via intramuscular route of administration, at right arm on 26Feb2021 at 12:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient was not allergic to medications, food, or other products. The 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 had not been tested for COVID-19. On 20Mar2021, the patient experienced injection site pain. No therapeutic measures were taken for the reported event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event vaccination site pain was resolved on an unknown date. No follow-up attempts are needed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Mild fever; chills; significant muscle pain throughout body; significant body aches; very significant fatigue; pain at injection site; pain radiating down arm into hand and fingers; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8727) via an unspecified route of administration in the right arm on 26Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergies and general anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included ethinylestradiol (+) levonorgestrel (TRIVORA), EFFEXOR XR and cetirizine hydrochloride (ZYRTEC) all used for an unknown indication and from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Mar2021 at 19:00, the patient experienced mild fever, chills, significant muscle pain throughout body, significant body aches, very significant fatigue, pain at injection site including pain radiating down arm into hand and fingers. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcomes of the events mild fever, chills, significant muscle pain throughout body, significant body aches, very significant fatigue, pain at injection site, including pain radiating down arm into hand and fingers were recovering at the time of this report.  No follow-up attempts are needed; No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild fever; chills; significant muscle pain throughout body; significant body aches; very significant fatigue; pain at injection site; pain radiating down arm into hand and fingers; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8727) via an unspecified route of administration in the right arm on 26Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergies and general anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included ethinylestradiol (+) levonorgestrel (TRIVORA), EFFEXOR XR and cetirizine hydrochloride (ZYRTEC) all used for an unknown indication and from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Mar2021 at 19:00, the patient experienced mild fever, chills, significant muscle pain throughout body, significant body aches, very significant fatigue, pain at injection site including pain radiating down arm into hand and fingers. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcomes of the events mild fever, chills, significant muscle pain throughout body, significant body aches, very significant fatigue, pain at injection site, including pain radiating down arm into hand and fingers were recovering at the time of this report.  No follow-up attempts are needed; No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Considerable swelling in the lymphnodes; Quite painful in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old-non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history includes COVID-19. The patient did not have allergies to medications, food, or other products. 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 26Mar2021, the patient experienced considerable swelling in the lymph nodes and quite painful in left armpit. The patient did not receive any treatment for the events. The clinical outcome of the events considerable swelling in the lymph nodes and quite painful in left armpit was resolving at the time of this report.   No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: severe pounding headache; severe nausea; severe vomiting; fever; chills; injection site pain; This is a spontaneous report from a non-contactable pharmacist. A 46-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an intramuscular route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an intramuscular route of administration in the left arm on 28Feb2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, 47 hours after the vaccination, at 10:00, the patient experienced severe pounding headache, severe nausea and vomiting. On the same day patient also had a fever, chills, and injection site pain. On 24Mar2021, the patient was treated with acetaminophen 500mg for the event fever and headache. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe pounding headache, severe nausea, vomiting, fever, chills, and vaccination site pain was recovered on 25Mar2021.    No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe pounding headache; severe nausea; severe vomiting; fever; chills; injection site pain; This is a spontaneous report from a non-contactable pharmacist. A 46-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an intramuscular route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an intramuscular route of administration in the left arm on 28Feb2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, 47 hours after the vaccination, at 10:00, the patient experienced severe pounding headache, severe nausea and vomiting. On the same day patient also had a fever, chills, and injection site pain. On 24Mar2021, the patient was treated with acetaminophen 500mg for the event fever and headache. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe pounding headache, severe nausea, vomiting, fever, chills, and vaccination site pain was recovered on 25Mar2021.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Injection site tenderness; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the right arm on 18Mar2021 10:15 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and other heart issues. The patient did not have any allergies to medications, food, or other products. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO) prunus cerasus (TART CHERRY), 'ac' (MANUFACTURER UNKNOWN) all taken for an unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the left arm on 01Mar2021 08:15 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Mar2021 13:00, the patient had headache, injection site tenderness only if touched/bumped/rubbed for a couple days (not noticeable during normal activities). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event headache was recovered on 19Mar2021 (reported as gone next morning); while that of the event injection site tenderness was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyposmia, Parosmia, SARS-CoV-2 antibody test
Clinical narrative: Sense of smell is off, smells like old cigarette smoke.; Can still smell, but not as strong as before; 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: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history include hypothyroidism. The patient had allergies to sulpha antibiotics. Prior to the vaccination, the patient had tested positive for COVID antibodies. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included WP THYROID. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 14.00, the patients sense of smell was off and smelled like old cigarette smoke (altered smell sensation). The patient could still smell but not as strongly (diminished sense of smell) as prior to the vaccine. It was reported that the patient had COVID 3 months ago but sense of smell had fully returned. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events diminished sense of smell and altered smell sensation were not resolved at the time of this report.  No follow-up attempts are needed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hot flush, Vaccination site pain
Clinical narrative: Fatigue extreme; Joint pain; Hot flashes; Chills; Soreness at shot side; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 27Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to lactose (Food allergy). 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 04Mar2021 at 16:00 (at the age of 56-years-old), as single dose for COVID-19 immunisation. The 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 had not been tested for COVID-19. On 27Mar2021 at 23:00, the patient experienced fatigue extreme, joint pain, hot flashes, chills and soreness at shot side. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue extreme, joint pain, hot flashes, chills and injection site pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) administered in left arm on 25Mar2021 at 1800 (at the age of 23-years) for COVID-19 immunisation. No medical history reported. The concomitant medications included zoloft (MANUFACTURER UNKNOWN) and allegra (MANUFACTURER UNKNOWN) for unknown indications. Prior to vaccination patient was not diagnosed with COVID-19. Patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 0700, the patient experienced stomach issues including diarrhea and vomiting. Patient did not receive any treatment for events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events stomach issues including diarrhea and vomiting was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Sore Arm; Diarrhea; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old non pregnant female patient received second dose of BNT162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine Lot no: ER8727) on 26Mar2021 at 12:00 on right arm as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications Lipitor (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received first dose of BNT162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine Lot no: EN6199) on 25Feb2021 at 14:00 on left arm as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 27Mar2021, at 09:00 the patient experienced sore arm and diarrhea. Patient did not receive any treatment for events. The clinical outcome of the events sore arm and diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; head cold; This is a spontaneous report from a contactable consumer, the patient. A 71-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration on 09Mar2021 at 10:30 (at the age of 71 years old) as a single dose for COVID-19 immunisation. Medical history included COPD, depression, anxiety and panic disorders. The patient was allergic to sulphas, alpha blockers and effexor. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), bupropion XL (MANUFACTURER UNKNOWN) and mirtazapine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 06:30, the patient experienced sore throat and felt like head cold symptoms. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore throat and head cold symptoms were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: At first it started with the injection site then spread down my arm; My legs are so sore I can hardly walk; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration on the right arm on 25Mar2021 at 15:30 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included implant birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient was allergic to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 16:30, at first it started with the injection site then spread down her arm and then her legs are so sore that she can hardly walk. However, her arm stopped hurting and legs started hurting instead. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The clinical outcomes of the events leg soreness and vaccination site pain were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Bone pain, Feeling hot, Headache
Clinical narrative: numbness at times; crampy toes; Couldnt sleep; abdominal pain; Pain on back; pain at both legs; pain at both arms; headache; very hot upper body; very cold feet; nauseated; shooting pain on legs; felt like excruciated pain on everybone especially night of vaccinatedday; very shaky feeling; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49 years) at 09:00 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to vancomycin and celecoxib. Concomitant medications included, mesalazine (LIALDA), omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), budesonide (UCERIS) (MANUFUCTURER UNKNOWN) for unknown indications. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19. since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced, pain on back (all along spine) through both legs and both arms along with very bad abdominal pain (as if it will burst anytime soon) pain on head (explosive feeling), very hot upper body and very cold feet and nauseated, shooting pain on side of both legs, it felt like excruciated pain on every bone especially night of vaccinated day, day after and the third day that was on 26Mar2021, the patient couldn't sleep or moved around and felt very shaky after the third day, still had bad back pain, pain on right leg and right arm (numbness at times), crampy toes can't sit as before the vaccination. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events back pain, leg and arm pain, abdominal pain, headache, hot feeling, sleep loss, cold feet, nausea, shooting pain on legs, bone pain, shaky feeling, numbness and crampy toes were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Muscle spasms, Nausea, Nervousness
Clinical narrative: numbness at times; crampy toes; Couldnt sleep; abdominal pain; Pain on back; pain at both legs; pain at both arms; headache; very hot upper body; very cold feet; nauseated; shooting pain on legs; felt like excruciated pain on everybone especially night of vaccinatedday; very shaky feeling; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49 years) at 09:00 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to vancomycin and celecoxib. Concomitant medications included, mesalazine (LIALDA), omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), budesonide (UCERIS) (MANUFUCTURER UNKNOWN) for unknown indications. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19. since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced, pain on back (all along spine) through both legs and both arms along with very bad abdominal pain (as if it will burst anytime soon) pain on head (explosive feeling), very hot upper body and very cold feet and nauseated, shooting pain on side of both legs, it felt like excruciated pain on every bone especially night of vaccinated day, day after and the third day that was on 26Mar2021, the patient couldn't sleep or moved around and felt very shaky after the third day, still had bad back pain, pain on right leg and right arm (numbness at times), crampy toes can't sit as before the vaccination. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events back pain, leg and arm pain, abdominal pain, headache, hot feeling, sleep loss, cold feet, nausea, shooting pain on legs, bone pain, shaky feeling, numbness and crampy toes were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral coldness
Clinical narrative: numbness at times; crampy toes; Couldnt sleep; abdominal pain; Pain on back; pain at both legs; pain at both arms; headache; very hot upper body; very cold feet; nauseated; shooting pain on legs; felt like excruciated pain on everybone especially night of vaccinatedday; very shaky feeling; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49 years) at 09:00 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to vancomycin and celecoxib. Concomitant medications included, mesalazine (LIALDA), omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), budesonide (UCERIS) (MANUFUCTURER UNKNOWN) for unknown indications. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19. since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced, pain on back (all along spine) through both legs and both arms along with very bad abdominal pain (as if it will burst anytime soon) pain on head (explosive feeling), very hot upper body and very cold feet and nauseated, shooting pain on side of both legs, it felt like excruciated pain on every bone especially night of vaccinated day, day after and the third day that was on 26Mar2021, the patient couldn't sleep or moved around and felt very shaky after the third day, still had bad back pain, pain on right leg and right arm (numbness at times), crampy toes can't sit as before the vaccination. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events back pain, leg and arm pain, abdominal pain, headache, hot feeling, sleep loss, cold feet, nausea, shooting pain on legs, bone pain, shaky feeling, numbness and crampy toes were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Fatigue, Feeling abnormal
Clinical narrative: depression; anxiety; brain fog, brain zaps,; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included anxiety and depression. Concomitant medications included fluoxetine hydrochloride (PROZAC) and bupropion hydrochloride (WELLBUTRIN). The patient had no allergy to any medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 11:00 (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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 19Feb2021, the patient experienced an increase in mental health issues such as depression, anxiety and had brain fog, brain zaps, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the events. The clinical outcome of the events increased mental health issues such as depression, anxiety and had brain fog, brain zaps, and fatigue were resolved after a week on 26Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Minor headache after second dose.; This is a spontaneous report received from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 25-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced minor headache after second dose of vaccination. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. Therapeutic measures and treatments were not taken as a result of headache. The clinical outcome of the headache was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Daily dizziness; spinning head; nausea; This is a spontaneous report from a contactable healthcare professional. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via intramuscular route of administration in the right arm on 01Feb2021 at 17:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and elevated cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), rosuvastatin calcium (CRESTOR), fexofenadine hydrochloride (ALLEGRA) and Botulinum toxin type a (BOTOX) all on unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EL3302) via an unspecified route of administration in the right arm on 11Jan2021 at 18:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 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 tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 12:00, the patient experienced daily dizziness, spinning head followed by nausea. The events had resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the adverse events. The clinical outcomes of the events daily dizziness, spinning head followed by nausea was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red and itchy rash by injection site; Red and itchy rash by injection site; Red and itchy rash by injection site; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021 at 19:00, the patient experienced red and itchy rash at injection site one week after the first shot. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events vaccination site erythema, vaccination site rash and vaccination site pruritus. The clinical outcomes of the events vaccination site erythema, vaccination site rash and vaccination site pruritus were not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.