chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site warmth
Clinical narrative: Warmth at injection site; Aching pain in upper left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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. The patient did not receive any concomitant medications. On 24Feb2021 at 15:00, the patient experienced warmth at injection site and aching pain in upper left arm lasting about 2 days after the vaccination. On 24Feb2021, the same evening as the vaccination the patient experienced headache. On 25Feb2021, one day after the vaccination headache continued with fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and fatigue were recovered on 25Feb2021 after a duration of 1 day and that of the events warmth at injection site and aching pain in upper left arm were recovered on 26Feb2021, after the duration of 2 days.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (allergies to medications, food, or other products: Penicillin). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR) and escitalopram oxalate (LEXAPRO); both medications from an unknown date and unknown if ongoing for unknown indications. On 07Mar2021, the patient experienced persistent headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event persistent headache was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen lymph nodes in neck. Very painful; Sore throat on same side as swollen nodes.; Swollen lymph nodes in neck; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 27Feb2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib (Atrial fibrillation). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included rivaroxaban (XARELTO) and nebivolol hydrochloride (BYSTOLIC), both for an unknown indication from an unknown dates and unknown if ongoing. 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 06Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 08:00, the patient experienced swollen lymph nodes in neck, very painful. Sore throat on same side as swollen nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events swollen lymph nodes in neck, very painful, sore throat on same side as swollen nodes were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Eructation, Nausea, Parosmia
Clinical narrative: Chills; Nasty taste in her mouth/ She described this to be a metallic taste; She described this to be a metallic taste later on and stated she could smell it as well which was making her nauseous.; She described this to be a metallic taste later on and stated she could smell it as well which was making her nauseous.; Belching; This is a spontaneous report from a non-contactable healthcare professional. A 36-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on an unknown date (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, during 15minutes waiting period after the injection the patient experienced chills and a nasty taste in the mouth. The patient described this to be a metallic taste later on and stated the patient could smell it as well which was making her nauseous. The patient also mentioned belching started after her vaccine. The patient denied difficulty breathing, difficulty swallowing, throat tightness, facial swelling, lip swelling and tongue swelling. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included water and pepcid (MANUFACTURER UNKNOWN) and two lozenges to help with bad taste. Follow up response to treatment was good. The patient had complete resolution of symptoms within a few minutes of taking the pepcid 20mg solution. The patient was observed for another 10 minutes and the taste did not return. The patient was discharged, was stable to go home and advised to follow up with primary care physician (PCP). The clinical outcome of the events chills, nasty taste in the mouth, described this to be a metallic taste later on and stated the patient could smell it as well which was making her nauseous and belching was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat; Swollen glands in neck; Nausea; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 23Feb2021 at 15:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The medical history included mediterranean fever and penicillin allergy. 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. The concomitant medications included colchicine (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 at 15:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced sore throat, swollen glands in neck, nausea and lethargy. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, swollen glands in neck, nausea and lethargy were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Very brief moments of losing equilibrium.  Lasted no more than a second, but felt like the world tilted.  This occurred 5 different times after the second dose about 2 weeks after the second shot.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9206) via an unspecified route of administration in the arm left on 13Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included probiotics nos (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN), all 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: EL3249) via an unspecified route of administration in the arm left on 19Jan2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 22Feb2021, the patient experienced very brief moments of losing equilibrium.  Lasted no more than a second, but felt like the world tilted.  This occurred 5 different times after the second dose about 2 weeks after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event equilibrium loss was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Palpitations, Tremor
Clinical narrative: felt very jumpy.; Heart was racing; Shaky; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG198) via an unspecified route of administration in the left arm on 27Feb2021 at 13:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included lymphomatoid papulosis, raynauds, lactose intolerant (cream), allergic reaction to analgesics (allergy to pain relievers in the vicodin family) and fruit allergy (citric acid sensitivity). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 27Feb2021 at 13:30, about 15-20 minutes after the vaccine, the patient felt very jumpy, she compared it to excessive caffeine jitters. The patient felt her heart was racing and like she was shaky. It subsided later that day. 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 felt very jumpy, heart was racing and shaky was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Decreased appetite, Hyperhidrosis, Insomnia
Clinical narrative: Extreme chills; Sweats; Achy; Loss of appetite; Couldn't sleep; trouble controlling body temperature; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 02Mar2021 at 08:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine (CLARITIN) and probiotic vitamins (MANUFACTURER UNKNOWN); all from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the arm left on 02Mar2021 at 16:00 (at the age of 38-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. On 02Mar2021 at 20:30, the patient experienced extreme chills, achy, loss of appetite, could not sleep, sweats and had trouble controlling body temperature. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme chills, achy, loss of appetite, could not sleep, trouble controlling body temperature and sweats were recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme chills; Sweats; Achy; Loss of appetite; Couldn't sleep; trouble controlling body temperature; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 02Mar2021 at 08:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine (CLARITIN) and probiotic vitamins (MANUFACTURER UNKNOWN); all from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the arm left on 02Mar2021 at 16:00 (at the age of 38-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. On 02Mar2021 at 20:30, the patient experienced extreme chills, achy, loss of appetite, could not sleep, sweats and had trouble controlling body temperature. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme chills, achy, loss of appetite, could not sleep, trouble controlling body temperature and sweats were recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: For the 2 days following the shot I had a deep fatigue; 20 -25 min post shot I had a flush go through my mouth; My lips were tingly and then all around my mouth felt slightly numb; My lips were tingly and then all around my mouth felt slightly numb; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 06Mar2021 at 08:45 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer on an unknown date in 2009, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (B12), fish oil (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN), Ibupr (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) taken for an unknown indication in an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 09:15, 20 -25 min post shot the patient had a flush go through her mouth. The patient lips were tingly and then all around her mouth felt slightly numb. It only lasted 10 min or so. The patient had no breathing issues. On 08Mar2021, For the 2 days following the shot the patient had a deep fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had flush go through her mouth, her lips were tingly and then all around her mouth felt slightly numb were recovered on 06Mar2021 and deep fatigue was recovered on 08Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Sluggishness, Vomiting
Clinical narrative: Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea. Also have a slight headache and sluggish; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea. Also have a slight headache and sluggish; This is a spontaneous report from a contactable other healthcare professional. A 54-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 01Mar2021 at 10:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient's medical history were reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 03Mar2021 at 01:00, the patient woke up with severe nausea, vomiting, diarrhoea, slight headache and was sluggish. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting, diarrhoea, slight headache and sluggish were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Deep soreness at injection site; This is a spontaneous report from a contactable nurse, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the left arm on 15Feb2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 17:00, the patient experienced deep soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event deep soreness at injection site was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea; Chills; Muscle aches; Fatigue; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), simvastatin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received hydrocodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 11:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 11:00, the patient experienced nausea, chills, muscle aches, fatigue and mild headache. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, muscle aches, fatigue and mild headache were recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Mild sore throat; Mild headache; Body aches; Fatigue; Weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the right arm on 02Mar2021 at 14:45(at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication include prenatal vitamins (MANUFACTURER UNKNOWN)  for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm 02Feb2021 at 14:45(at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021 at 04:00, the patient experienced mild sore throat, mild headache, body aches, fatigue and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild sore throat, mild headache, body aches, fatigue and weakness were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Impaired driving ability, Nausea
Clinical narrative: Dizziness; Loss of equilibrium,; Nausea; So dizzy "I" could not drive.; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9269) via an unspecified route of administration in the left arm on 25Feb2021 at 08:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN) and multi-vitamins (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. On 25Feb2021 at 10:00, the patient experienced dizziness, loss of equilibrium and nausea. Since getting vaccinated, the patient had been dizzy and at times, so dizzy that could not drive and had a loss of equilibrium. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, loss of equilibrium nausea and so dizzy "I" could not drive was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 17Jan2021 at 11:15 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib), type 2 diabetes, and hypertension (HPTN). 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. The patient received unspecified concomitant medications. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 19Jan2021, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 07Feb2021 at 13:15 (at the age of 80-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the arm left on 28Feb2021 at 17:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin calcium (LIPITOR), tadalafil (CIALIS) and sertraline hydrochloride (ZOLOFT) all from unknown date for unknown indication and unknown if ongoing. On 02Mar2021 at 17:00, the patient experienced vomiting. 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. Since the vaccination, the patient had not been been tested for COVID-19. The clinical outcome of the event vomiting was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Injection site pain; Headache.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 03Mar2021 (at the age of 54-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced injection site pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain and headache were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Influenza like illness, Pain
Clinical narrative: Low back pain; Whole body aches; No energy; Flu like symptoms, but no fever; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0205) via an unspecified route of administration in the left arm on 02Mar2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included familial hypercholesterolemia, cardiovascular disorder, arthritis, Hashimoto's disease, attention deficit disorder and hypertension. The patient had known allergies (unspecified allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 18:30, the patient experienced low back pain, whole body aches, no energy, flu like symptoms, but no fever. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events low back pain, whole body aches, no energy, flu like symptoms, but no fever were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment
Clinical narrative: Brain fog; Forgetfulness; This is a spontaneous report from a contactable consumer, the patient. A 45-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 07Mar2021 (at the age of 45-years-old) at 09:15 as a single dose for COVID-19 immunisation. Medical history included known allergies to corn, turkey, pork, strawberries and rye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Mar2021 at 07:30, the patient experienced brain fog, she kept writing a instead of h while teaching. This was her 17th year teaching that subject, no way she would make that mistake over and over again normally. The patient also had forgetfulness, she kept forgetting what she was teaching, as she was teaching it which was not normal for her at all. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog and forgetfulness was resolving at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes above and below clavicle and side of neck on injection site side (left arm); This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via intramuscular route of administration in the left arm on 11Feb2021 at 09:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration on 03Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia and sulfonamide allergy (Allergies to medications, food, or other products: sulfa). Concomitant medications included atorvastatin calcium (LIPITOR) from an unknown date and unknown if ongoing for an unknown indication. 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. On an unknown date in Feb2021 the patient experienced swollen lymph nodes above and below clavicle and side of neck on injection site side (left arm). 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes above and below clavicle and side of neck on injection site side (left arm) was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Fatigue, Nausea
Clinical narrative: Three days later constipation; "I" had tiredness; Nausea; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 05Mar2021 at 16:15(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetic, cancer, hypertension(HTN), Poly-Cystic Overian Syndrome (PCOS), sleep apnea, acid reflux, depression, anxiety and known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin (HUMALIN), rosuvastatin (MANUFACTURER UNKNOWN), semaglutide (OZEMPIC) and irbesartan (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9870) via an unspecified route of administration in the right arm on 11Feb2021 at 12:00(at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 18:00 the patient had tiredness and nausea. On 08Mar2021, three days later the patient experienced constipation. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with unspecified OTC (over the counter) drugs bought by patient. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, nausea and constipation were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Headache starting 48 hours later; Fatigue moderate - Severe - missed work started 36 hours after injection; Diarrhea mild starting same day in the evening - lasting 48 hours.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 06Mar2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, neuropathy in feet and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), vitamin d nos (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), fluticasone propionate, salmeterol xinafoate (ADVAIR) and testosterone undecanoate (TESTOS). On 06Mar2021, patient experienced diarrhea mild starting same day in the evening - lasting 48 hours. Headache starting 48 hours later, fatigue moderate - Severe - missed work started 36 hours after injection. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea was recovered on 08Mar2021; while that of the events headache and fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain
Clinical narrative: Patient shared that she had severe headache, body ache, diarrhea.; Patient shared that she had severe headache, body ache, diarrhea.; Patient shared that she had severe headache, body ache, diarrhea.; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received 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. It was unknown whether the patient was pregnant. Medical history and concomitant medication was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. The patient shared with the reporter that on an unknown date she had severe headache, body ache, diarrhea. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events severe headache, body ache, diarrhea were resolved on an unknown date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Salivary hypersecretion, Tongue discomfort
Clinical narrative: Progressed to burning tongue; Mouth with excessive salvation; Within 15 min started with "fuzzy" tongue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient 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 06Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, asthma, Irritable Bowel Syndrome (IBS), dysautonomia (Postural Orthostatic Tachycardia Syndrome (POTS)), hypothyroidism, vitamin D and B deficiencies, history of autoimmune hemolytic anemia and autoimmune pancreatitis. The patient was allergic to sulfa drugs, wheat, soy, sesame, scallops and nuts, was lactose intolerant and had intolerance to fructose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received ciprofloxacin (CIPRO), clindamycin (MANUFACTURER UNKNOWN), daptomycin (MANUFACTURER UNKNOWN) and duloxetine hydrochloride (CYMBALTA) and experienced drug allergy with all these medications. On 06Mar2021 at 13:15, within 15 minutes, the patient experienced fuzzy tongue and on the same day at 13:30, it had progressed to burning tongue and then mouth with excessive salvation. 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 diphenhydramine (BENADRYL) 50 mg x 2 doses. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fuzzy tongue, burning tongue and mouth with excessive salvation were recovered on an unknown date on Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Right arm was extremely itchy, swollen, red and warm around the injection site.; Right arm was extremely itchy, swollen, red and warm around the injection site.; Right arm was extremely itchy, swollen, red and warm around the injection site.; Right arm was extremely itchy, swollen, red and warm around the injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 91-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm right on 05Mar2021 at 13:15 (at the age of 91-year-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure and parkinson's disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the arm left on 07Feb2021 at 12:00 (at the age of 91-year-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 15:00, the patient's right arm was extremely itchy, swollen, red and warm around the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm was extremely itchy, swollen, red and warm around the injection site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday; Extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday; 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: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient received the shot on Thursday afternoon. On 06Mar2021 at 07:00, the patient experienced extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.