chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 15:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medications included unspecified medications from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient previously took Keflex and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 21:00, the patient experienced hives on neck and chest. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of hives on neck and chest and included treatment with Benadryl. The clinical outcome of the event hives on neck and chest was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Migraine, Oropharyngeal pain
Clinical narrative: Consistent migraine; Headache; Sore throat; Upset stomach; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 24-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 07Apr2021 at 17:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced consistent migraine, headache, sore throat, upset stomach and diarrhoea. Therapeutic measures were not taken as a result of adverse events. The adverse 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 consistent migraine, headache, sore throat, upset stomach and diarrhoea was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Mass, Pruritus, Vaccination site warmth
Clinical narrative: Hot flash; small black and blue and a big red patch with lump; Later that night small black and blue and a big red patch with lump; itchy; Injection area hot to touch/ hot to touch,; This is a spontaneous report from a contactable consumer, the patient. A 42-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 on 08Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, after the 15 minutes wait, the patient experienced hot flash and injection area hot to touch. Later that night small black and blue and a big red patch with lump which was hot to touch and itchy. Every day it was getting larger. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of hot flash, injection area hot to touch, small black and blue and a big red patch with lump which was hot to touch and itchy was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; Chills; Headache; Muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on an unknown date (at the age of 59-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 21:30, the patient experienced fever, chills, headache, muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 24Mar2021, the patient underwent COVID test and the result was negative. The clinical outcome of the events fever, chills, headache, muscle pain was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait disturbance, Headache, Myalgia
Clinical narrative: Unable to stand or walk.; I was very weak; Extreme Headache; Muscle Aches; Chills; Fever; Nausea; 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: ER8731) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (The patient had COVID before (end of Mar2021) and her symptoms were 10x worse with the vaccine than when she had during COVID). The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 08:45, the patient experienced extreme headache, muscle aches, chills, fever, nausea and she was very weak and unable to stand or walk. The patient was desperate and ended up taking 2 paracetamols (TYLENOL) at 19:15 because she needed some sort of relief. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of extreme headache, muscle aches, chills, fever, nausea, weakness and unable to walk or stand which included 2 paracetamols (TYLENOL) at 19:15. The clinical outcomes of extreme headache, muscle aches, chills, fever, nausea, weakness and unable to walk or stand were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Unable to stand or walk.; I was very weak; Extreme Headache; Muscle Aches; Chills; Fever; Nausea; 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: ER8731) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (The patient had COVID before (end of Mar2021) and her symptoms were 10x worse with the vaccine than when she had during COVID). The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 08:45, the patient experienced extreme headache, muscle aches, chills, fever, nausea and she was very weak and unable to stand or walk. The patient was desperate and ended up taking 2 paracetamols (TYLENOL) at 19:15 because she needed some sort of relief. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of extreme headache, muscle aches, chills, fever, nausea, weakness and unable to walk or stand which included 2 paracetamols (TYLENOL) at 19:15. The clinical outcomes of extreme headache, muscle aches, chills, fever, nausea, weakness and unable to walk or stand were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Blister at site of injection. Size is 1 inch by 0.1 inch.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male 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 10Apr2021 at 00:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 00:00, the patient experienced blister at site of injection. Size was 1 inch by 0.1 inch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of injection site blister was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient did not have any known allergies to food, medications, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D3), acetylsalicylic acid (ASA) and fish oil (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 08:00, the patient experienced diarrhea after 3 days of receiving vaccine which was still ongoing at the time of this report. No therapeutic measures were taken for the events. The events 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 diarrhea was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hypoaesthesia, Vomiting
Clinical narrative: Vomiting; Diarrhea; Chills; Numbness in hands and legs; This is a spontaneous report from a contactable consumer, the patient. A 37-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 11Apr2021 at 16:00(at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as no. Concomitant medications included alprazolam (XANAX) from an unknown date and for an unknown indication. The patient had no known allergies. 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 11Apr2021 at 19:00, the patient experienced vomiting, diarrhea, chills, numbness in hands and legs. The patient did not receive any treatment for the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event vomiting, diarrhea, chills and numbness in hands and legs were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for mild covid-19 disease (confirmed by PCR); Positive for mild covid-19 disease (confirmed by PCR); This is a spontaneous report from a contactable pharmacist (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Jan2021 17:00 (Batch/Lot Number: Unknown, unable to locate or read the details) as dose 2, single; via an unspecified route of administration on 21Dec2020 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient experienced positive for mild covid-19 disease (confirmed by PCR) on 09Apr2021. The patient had been tested for COVID-19 since the vaccination. The patient underwent PCR test: positive on 09Apr2021. No treatment was received for the adverse event. The outcome of the event was recovering. The event was reported as non-serious.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hot flush, Nausea
Clinical narrative: Hot flashes; Itchy; Nausea; Fatigue; Headache; Asthma attack (difficulty breathing); Arm soreness; Quarter size bruise at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 09:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and nervous system itch. The patient has taken unspecified concomitant medications. The patient had unspecified known allergies. 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 02Apr2021 at 11:00, the patient experienced hot flashes, itchy, nausea, fatigue, head ache, asthma attack (difficulty breathing), arm soreness and a quarter size bruise at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with asthma inhaler and TYLENOL from an unknown start date to an unknown stop date. The clinical outcome of the event arm soreness recovered on an unknown date after a duration of 3 days. The clinical outcome of the events hot flashes, itchy, nausea, fatigue, head ache, asthma attack (difficulty breathing) and a quarter size bruise at injection site was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site bruising
Clinical narrative: Hot flashes; Itchy; Nausea; Fatigue; Headache; Asthma attack (difficulty breathing); Arm soreness; Quarter size bruise at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 09:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and nervous system itch. The patient has taken unspecified concomitant medications. The patient had unspecified known allergies. 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 02Apr2021 at 11:00, the patient experienced hot flashes, itchy, nausea, fatigue, head ache, asthma attack (difficulty breathing), arm soreness and a quarter size bruise at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with asthma inhaler and TYLENOL from an unknown start date to an unknown stop date. The clinical outcome of the event arm soreness recovered on an unknown date after a duration of 3 days. The clinical outcome of the events hot flashes, itchy, nausea, fatigue, head ache, asthma attack (difficulty breathing) and a quarter size bruise at injection site was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: headache; fatigue; low grade fever; chills, shivering; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 15:45(at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included HPV, spinal issues, acid reflux and COVID-19. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021 at 07:00 the patient experienced headache. fatigue, low grade fever, chills, shivering and diarrhea. On 12Apr2021, the patient underwent DNA genotek oracollect(COVID test) and the result was unknown. 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 event. The clinical outcome of the events headache. fatigue, low grade fever, chills, shivering and diarrhea were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: headache; fatigue; low grade fever; chills, shivering; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 15:45(at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included HPV, spinal issues, acid reflux and COVID-19. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021 at 07:00 the patient experienced headache. fatigue, low grade fever, chills, shivering and diarrhea. On 12Apr2021, the patient underwent DNA genotek oracollect(COVID test) and the result was unknown. 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 event. The clinical outcome of the events headache. fatigue, low grade fever, chills, shivering and diarrhea were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: weakness; faint feeling within 5 minutes; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 28Feb2021 at 09:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included premature ventricular contractions heart beats. The patient had known food allergy to gluten. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), clonazepam (CLONOPIN), estrogen nos (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), and testosterone (TESTOSTERON); all were taken for an unknown indication on unknown dates within two weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Feb2021 at 09:00 the patient experienced weakness and faint feeling within 5 minutes. The patient was ok by laying down, persisted for about an hour, and then felt fine. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events weakness and faint feeling were recovered on 28Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Explosive diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medication. 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 12Apr2021, at 06:15 the patient experienced explosive diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event explosive diarrhea was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Nodule
Clinical narrative: "lump on my neck just above my collar bone that appeared after my shot on the left side of my neck"; "lump on my neck just above my collar bone that appeared after my shot on the left side of my neck. it was very painful in the beginning"; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 31Mar2021 at 13:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP). Concomitant medications included irbesartan (MANUFACTURER UNKNOWN); taken for high blood pressure from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 03Mar2021 at 14:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient experienced a lump on neck just above collar bone that appeared after shot on the left side of neck. It was very painful in the beginning and had to apply heat for several days and now the pain was coming back. 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 event. The clinical outcome of the event "have a lump on neck just above collar bone that appeared after shot on the left side of neck. It was very painful in the beginning" was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Severe shaking; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 12:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included reactive hypoglycemia. The patient was allergic to sulfa (sulfonamide allergy). Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN) and estradiol (YUVAFEM); all for an unknown indication from an unknown date and unknow if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 12:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 01:30, the patient experienced severe shaking that lasted about 2 hours. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures was taken as a result of the adverse events. The clinical outcome of the event severe shaking was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Approximately 15-18 hours after receiving second dose had Fever 102.1; Severe Headache for roughly 24 hours; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 03Apr2021 at 08:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient did not receive any concomitant medications. The patient previously took sulfur (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 02:00, approximately 15-18 hours after receiving second dose, the patient had fever 102.1, severe headache for roughly 24 hours and fatigue for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever which included treatment with paracetamol (TYLENOL) twice which lowered fever. The clinical outcome of fever 102.1 was recovered on an unknown date in Apr2021, headache for roughly 24 hours was recovered on 05Apr2021 and fatigue was recovered on 06Apr2021, after the duration of 48 hours.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chest discomfort, Fatigue, Feeling cold
Clinical narrative: Nausea; Stomach cramps; Tiredness; Feeling very cold; Feeling tightness in stomach; Tightness in chest muscles; This is a spontaneous report from a contactable consumer, the patient. A 52-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 left arm on 07Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, chronic back / neck - degenerative disc disease. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), empagliflozin (JARDIANCE), ibuprofen (MANUFACTURER UNKNOWN) and cinnamomum cassia (CINNAMON); all from an unknown date for unknown indication. The patient previously took exenatide (BYDUREON) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, started 3 days later, the patient experienced nausea, stomach cramps, tiredness, feeling very cold, feeling tightness in stomach and chest muscles on Monday morning. 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. The clinical outcomes of nausea, stomach cramps, tiredness, feeling very cold, feeling tightness in stomach and chest muscles was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; Stomach cramps; Tiredness; Feeling very cold; Feeling tightness in stomach; Tightness in chest muscles; This is a spontaneous report from a contactable consumer, the patient. A 52-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 left arm on 07Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, chronic back / neck - degenerative disc disease. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), empagliflozin (JARDIANCE), ibuprofen (MANUFACTURER UNKNOWN) and cinnamomum cassia (CINNAMON); all from an unknown date for unknown indication. The patient previously took exenatide (BYDUREON) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, started 3 days later, the patient experienced nausea, stomach cramps, tiredness, feeling very cold, feeling tightness in stomach and chest muscles on Monday morning. 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. The clinical outcomes of nausea, stomach cramps, tiredness, feeling very cold, feeling tightness in stomach and chest muscles was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Dizzy; runny nose; sore throat; headache; tired; weak; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included back pain and migraine. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and ascorbic acid (VITAMIN C), all taken for unspecified indications from unknown dates. The patient previously took codone and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 14:00, the patient experienced dizzy, runny nose, sore throat, headache, tired and felt weak. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizzy, runny nose, sore throat, headache, tired and felt weak were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Dizzy; runny nose; sore throat; headache; tired; weak; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included back pain and migraine. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and ascorbic acid (VITAMIN C), all taken for unspecified indications from unknown dates. The patient previously took codone and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 14:00, the patient experienced dizzy, runny nose, sore throat, headache, tired and felt weak. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizzy, runny nose, sore throat, headache, tired and felt weak were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Maternal exposure timing unspecified
Clinical narrative: she was pregnant; she was feeling so bad and terrible; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself. A female patient of an unspecified age (patient was pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she took the first dose of the vaccine and when she got home, like the second or third day, she was feeling so bad and terrible and went to the ER and found out she was pregnant. She did not know how far along she was but she will be seeing her OBGYN on the 28th. She wanted to know if she should continue with her second dose. The outcome of the event she was feeling so bad and terrible was unknown.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Hurts when swallow; Swollen gland on left side above collar bone up into ear; Had a stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 31Mar2021 at 15:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, 5 days after the second dose, the patient had a stiff neck. On 06Apr2021 at 00:00, 6 days after the second dose, the patient had a swollen gland on left side above collar bone, up into ear and hurt when patient swallowed. The swollen gland was persisting at the time of reporting. 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. The clinical outcome of the events had a stiff neck, hurts when swallow and swollen gland on left side above collar bone up into ear was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Entirely debilitated for the day (unable to do anything); Extreme exhaustion; Severe headache; Muscle pain; Sweating; Joint pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN2613) via an unspecified route of administration in the left arm on 26Mar2021 at 10:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, hypothyroidism, kidney stones and had severe COVID in Oct2020, requiring hospitalization. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline (MANUFACTURER UNKNOWN), potassium citrate (MANUFACTURER UNKNOWN) and trazodone hydrochloride (DEPRAX) for unspecified indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 02:00 for 3 days after the vaccine, the patient was in bed with all the less severe side effects, however unable to do anything. It went away on day 4, however every third day however every third day since then the side effects return to the point where the patient entirely debilitated for the day. Extreme exhaustion, severe headache, muscle pain, sweating, joint pain. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events entirely debilitated for the day (unable to do anything), extreme exhaustion, severe headache, muscle pain, sweating, joint pain were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Entirely debilitated for the day (unable to do anything); Extreme exhaustion; Severe headache; Muscle pain; Sweating; Joint pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN2613) via an unspecified route of administration in the left arm on 26Mar2021 at 10:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, hypothyroidism, kidney stones and had severe COVID in Oct2020, requiring hospitalization. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline (MANUFACTURER UNKNOWN), potassium citrate (MANUFACTURER UNKNOWN) and trazodone hydrochloride (DEPRAX) for unspecified indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 02:00 for 3 days after the vaccine, the patient was in bed with all the less severe side effects, however unable to do anything. It went away on day 4, however every third day however every third day since then the side effects return to the point where the patient entirely debilitated for the day. Extreme exhaustion, severe headache, muscle pain, sweating, joint pain. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events entirely debilitated for the day (unable to do anything), extreme exhaustion, severe headache, muscle pain, sweating, joint pain were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-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 06Apr2021 at 10:15 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included post infectious irritable bowel syndrome (Pi ibs). The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 20:00, the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event diarrhea was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Nausea in AM,; fever (103.4 F measured) ~20 hours after the second dose. Fever was gone the following morning. Less severe,; but soreness at injection site; joint aches.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 19Mar2021 at 17:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 09:45, the patient experienced nausea. Approximately 20 hours after vaccination, the patient experienced fever (103.4 F measured). Fever was gone the following morning. Less severe, but soreness at injection site and joint aches were there. The clinical outcome of the events nausea, fever, soreness at injection site and joint aches were recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.