chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heart rate irregular, Myalgia, Pyrexia
Clinical narrative: Fever (102.5F); Headache; Muscle pain; Fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 49-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 COVID vaccine. On 29Mar2021 at 18:00, the patient experienced fever (102.5F), headache, muscle pain, fast heartbeat. On an unknown date, the patient underwent body temperature measurement and the result was 102.5F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of the event fever (102.5F), headache, muscle pain and fast heartbeat was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Laryngitis, Migraine, Oropharyngeal pain
Clinical narrative: Upper respiratoryinfection, laryngitis.; Fatigue; Sore throat; Severe migraine; Slight cough; 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: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 07:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur, pituitary adenoma, hearing impaired and exercise induced asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 13:00, the patient experienced severe migraine and slight cough. On 28Mar2021, the patient experienced cough, sore throat, fatigue and on 31Mar2021, the patient experienced upper respiratory infection, laryngitis. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received unspecified antibiotics, steroids and inhaler as a treatment for the events. The clinical outcome of the event migraine, cough, sore throat, fatigue and upper respiratory infection, laryngitis were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus, ringing in the ears.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 12:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The concomitant medications of the patient included levothyroxine 88mg (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 03:00, the patient experienced the event tinnitus (ringing in the ears). On 22Mar2021, the patient underwent COVID-19 virus test and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit and visit to emergency room/department or urgent care. Therapeutic measures were taken as a result of the event tinnitus and included treatment with antibiotics from an unknown date. The clinical outcome of the event tinnitus was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer, the patient. A 72-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 on 15Mar2021 at 08:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration on 18Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, the patient experienced fever. The patient did not receive any treatment for the 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 event fever was not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer, the patient. A 72-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 on 15Mar2021 at 08:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration on 18Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, the patient experienced fever. The patient did not receive any treatment for the 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 event fever was not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pruritus
Clinical narrative: Vaccine location : Left leg; Itching through out my body for fewdays.; This is a spontaneous report from a contactable consumer, the patient. A 64-years-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 leg left on 29Mar2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not take any concomitant medications. The patient was allergic to pet's and certain foods. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 00:00, the patient experienced itching throughout body for few days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the itching. The clinical outcome of the event itching throughout body was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme soreness in vaccinated arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8130) via an unspecified route of administration in the arm left on 29Mar2021 at 11:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient did not have any known allergy. 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 29Mar2021 at 16:00 (beginning the evening of vaccinated day), the patient experienced extreme soreness in the vaccinated arm. The patient did not receive any treatment for the adverse event. The clinical outcome of the event extreme soreness in vaccinated arm was resolved on 30Mar2021 (thru Tuesday).   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Severe gout flare in left foot.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ep6955) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 36-year-old) at 18:30 as a single dose for COVID-19 immunisation. Medical history included gout and psoriasis. Concomitant medications included colchicine (MANUFACTURER UNKNOWN) from an unknown date and dietary supplements from an unknown date for an unknown indication. The patient was allergic to penicillin and aspirin. The patient previously took 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 08Mar2021 (at the age of 36-year-old) at 19:15 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 was not tested for COVID-19. On 30Mar2021 at 07:30, 13 hours after the vaccination, the patient experienced a severe gout flare in the left foot. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with colchicine for the reported event. The clinical outcome of the event gout flare was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Pain in extremity
Clinical narrative: sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days (unable to use right arm).; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included dislocated shoulder. The patient was allergic to sulfa and sun screen. Concomitant medications included benazepril (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 17:30 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. The patient previously received lidocaine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN); and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-1. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced sore arm, slight headache and flu like feelings for several days. In addition, the right shoulder became extremely sore for several days (unable to use right arm). It was reported that the right shoulder dislocated 3 times beginning in 1965 through 1996 and the shoulder was almost completely normal after 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of sore arm, slight headache, flu like feelings and right shoulder became extremely sore for several days (unable to use right arm) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Headache, Lip blister, Musculoskeletal stiffness
Clinical narrative: Difficulty swallowing; Headache; Stiffness in limb; Pain; Chills; Blister on lip; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: 6N6808), via an unspecified route of administration in the left arm on 21Mar2021 at 14:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient previously received sulphur (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), salbutamol sulfate (VENTOLIN) and fluticasone propionate, salmeterol xinafoate (SERETIDE); all for an unknown indication from an unknown date. Prior to vaccination, patient was not diagnosed with COVID-19. since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 21:00, the patient experienced difficulty swallowing within seconds of the vaccine, headache and stiffness in limbs and pain, blister on lip after chills. It was unknown if the patient had received any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events difficulty swallowing, headache, stiffness in limbs, pain, chills and lip blisters was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Difficulty swallowing; Headache; Stiffness in limb; Pain; Chills; Blister on lip; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: 6N6808), via an unspecified route of administration in the left arm on 21Mar2021 at 14:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient previously received sulphur (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), salbutamol sulfate (VENTOLIN) and fluticasone propionate, salmeterol xinafoate (SERETIDE); all for an unknown indication from an unknown date. Prior to vaccination, patient was not diagnosed with COVID-19. since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 21:00, the patient experienced difficulty swallowing within seconds of the vaccine, headache and stiffness in limbs and pain, blister on lip after chills. It was unknown if the patient had received any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events difficulty swallowing, headache, stiffness in limbs, pain, chills and lip blisters was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Vertigo
Clinical narrative: Tired; headache; vertigo; Feeling hot; 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: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 11:15 (at the age of 56-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:1470) via an unspecified route of administration in the arm left on 30Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor, hashimoto's hypothyroidism (hashimoto's disease), and asthma. The patient had known allergies to sulfa and gadolinium MRI contrast dye (contrast media dye allergy). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), tamoxifen (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), ibuprofen (ADVIL) and meclozine (MECLIZINE) ; from an unspecified date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, the patient felt tired and spicy (feeling hot) for a couple of day following injection then one day with headache, followed by vertigo until date of second vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures taken included self-medication  with meclizine hydrochloride. The clinical outcome of the events tired and spicy, headache and vertigo were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: loss of sense of smell; This is a spontaneous report from a contactable consumer. A 50-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 09:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia (SVT) and seasonal allergies. The patient had no known allergies. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); both were taken for an unknown indication and within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 09:00, one week after the vaccine, the patient experienced loss of sense of smell, which lasted approximately 1 week. 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 event. The clinical outcome of the event loss of sense of smell was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site pain
Clinical narrative: Extreme pain injection site; Extreme pain injection site up to the neck; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration on right arm on 19Mar2021 at 18:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included Bipolar II, Lymphodema. Patient has known allergies to remeron, clonazepam, Sulfa and tape (adhesive tape allergy). Concomitant medications included calcium 600 plus vitamin D (MANUFACTURER UNKNOWN); taken for an unknown indication from an unknown start date. Prior to 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 COVID-19 vaccination. On 19Mar2021 at 19:00, the patient experienced extreme pain at injection site up to the neck. 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 events. The clinical outcome of the events extreme pain at injection site up to the neck were not resolved at the time this this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain
Clinical narrative: severe chills; feeling hot at night; Headache; General body ache.; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration on the left arm on 30Mar2021 (at the age of 25-year-old) at 13:30, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on the left arm on 09Mar2021, 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 vaccination, the patient was not tested with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 31Mar2021 at 04:00, the patient experienced severe chills, feeling hot, headache and general body pains. Therapeutic measures were taken for all the events severe chills, feeling hot, headache and general body pains with advil 400mg only one time. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe chills, feeling hot, headache and general body pains were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Left arm pit swollen and sore; Left arm pit swollen and sore; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia. The patient received other medication within two weeks of vaccination which included Vitamin D (MANUFACTURER UNKNOWN) and a Multi-Vitamin for unknown indication. The patient received vaccine within four weeks prior to the vaccination which included 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 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. On 31Mar2021 at 17:00 the patient experienced left arm pit swollen and sore. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events left arm pit swollen and sore was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headache/progresses to bad headache after a week; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male 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 06Mar2021 at 12:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. The concomitant medication included High blood medicine and ibuprofen (MANUFACTURER UNKNOWN).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 COVID vaccine. On 08Mar2021 at 04:00, the patient experienced headache and then headache progresses to bad headache after a week. On an unknown date in Mar2021, (last week as reported) the patient had dizziness when he moves, the patient still had and reported that he was not able to report to work. The adverse events resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measure  taken as a result of the event headache included ibuprofen (MANUFACTURER UNKNOWN) taken three times everyday. The clinical outcome of the event headache/progresses to bad headache after a week and dizziness was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck; This is a spontaneous report from a contactable consumer, the patient. A 61-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 08Mar2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patients medical history included osteopenia. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) and a multi-vitamin (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 08:00, the patient experienced rash on neck. 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 rash on neck and included treatment with triamcinolone 0.1% Cream, prescribed by dermatologist. The clinical outcome of the event rash on neck was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and mixed connective tissue disease. Concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 23Mar2021, the patient experienced severe diarrhea. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the event severe diarrhea was resolving at the time of this report.   No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: upper respiratory infection; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced upper respiratory infection on an unspecified date. The patient received treatment with Z-Pak (azithromycin), an antibiotic and prednisone for 3 days. The outcome of the event was unknown. It was reported that, he was scheduled to receive the second dose of the Pfizer COVID vaccine this Friday (02Apr2021) and wanted to know if he can go ahead and take his second dose of the vaccine. Caller stated on Monday his primary care prescribed a Z-pack and prednisone steroids for an upper respiratory infection. Patient wanted to know if it is okay to receive the second dose of the vaccine this Friday. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blister, Burning sensation, Chills, Cough
Clinical narrative: Burning lungs; Constant cough; Headache; Chills; Stomach pains; Toe blisters; Finger pain; Burning lungs; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, allergy (mouthwash allergy), sulfonamide allergy (sulfa drugs) and covid-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) 325 mg one pill per day taken for an unknown indication started from an unknown date. The patient previously took lidocaine (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 15Feb2021 at 10:00, the patient experienced burning lungs, constant cough, headache, chills, stomach pains, toe blisters and finger pain. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events burning lungs, constant cough, headache, chills, stomach pains, toe blisters and finger pain. The clinical outcomes of the events Disorder lung, Cough, headache, chills, stomach pain, blisters, pain in fingers and burning sensation were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lung disorder, Pain in extremity
Clinical narrative: Burning lungs; Constant cough; Headache; Chills; Stomach pains; Toe blisters; Finger pain; Burning lungs; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, allergy (mouthwash allergy), sulfonamide allergy (sulfa drugs) and covid-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) 325 mg one pill per day taken for an unknown indication started from an unknown date. The patient previously took lidocaine (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 15Feb2021 at 10:00, the patient experienced burning lungs, constant cough, headache, chills, stomach pains, toe blisters and finger pain. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events burning lungs, constant cough, headache, chills, stomach pains, toe blisters and finger pain. The clinical outcomes of the events Disorder lung, Cough, headache, chills, stomach pain, blisters, pain in fingers and burning sensation were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Lethargy
Clinical narrative: Very ill; chills; fever; severe headache; nausea; diarrhea; lethargy; aches; tiredness; eye lid swelled; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 27Mar2021 at 12:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within two weeks of vaccination. The patient previously took 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 10Mar2021 at 15:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation and the patient received amoxicillin and was allergic to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 12:00, approximately 24 hours after the vaccination, the patient became very ill, had chills, fever, severe headache, nausea, diarrhoea, lethargy, aches and eyelids swelled up a little. The patient slept for 14 hours and felt much better the next day, but had lingering symptoms of aches, tiredness and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the events very ill, chills, fever, severe headache, nausea, diarrheic, lethargy, aches, eyelids swelled and tiredness was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia, Swelling of eyelid
Clinical narrative: Very ill; chills; fever; severe headache; nausea; diarrhea; lethargy; aches; tiredness; eye lid swelled; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 27Mar2021 at 12:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within two weeks of vaccination. The patient previously took 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 10Mar2021 at 15:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation and the patient received amoxicillin and was allergic to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 12:00, approximately 24 hours after the vaccination, the patient became very ill, had chills, fever, severe headache, nausea, diarrhoea, lethargy, aches and eyelids swelled up a little. The patient slept for 14 hours and felt much better the next day, but had lingering symptoms of aches, tiredness and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the events very ill, chills, fever, severe headache, nausea, diarrheic, lethargy, aches, eyelids swelled and tiredness was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: blotchy; bit lumpy under the skin; itching; started having itching at the vaccine site on left arm; started having itching at the vaccine site on left arm, it was red, and the size of a coin.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic lyme disease, chronic fatigue syndrome (CFS), hypothyroid, methylenetetrahydrofolate reductase (MTHFR) mutations and others. The patient's known allergies included sensitive to sulphur. Concomitant medication included rubidium, selenium, catalase, herbal nos, superoxide dismutase and animal unspecified as a thyroid supplement from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 08:00, day seven after receiving vaccine, the patient experienced itching at the vaccine site on the left arm, it was red, and the size of a coin. Throughout the day, the lesion started growing and the itchiness travelled away from the vaccine site. On 28Mar2021, the patient experienced red, itchy, blotchy and a bit lumpy lesion under the skin and the area had grown to about eight inches by five inches. As the days went by, patient only experienced mild itching about two times a day. It was reported that the patient would like to know what caused this, and if there was a concern for the second vaccine which was scheduled for 10Apr2021.  The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events itching, red, itchy, blotchy and a bit lumpy lesion under the skin was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Muscle spasms
Clinical narrative: slight headache; muscle cramps; lymph node pain under arm; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Feb2021 at 13:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart attack and bypass surgery. The patient had a history of allergy to ciprofloxacin (CIPRO). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), montelukast sodium (VICTOR) and metoprolol succinate (METOPROLOL) all for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 14:00(at the age of 77-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 24Feb2021, the patient experienced slight headache for a month which was still continuing, muscle cramps for 2 days and had lymph node pain under arm when lying on side with arm under body which started two weeks after shot and continued for several weeks. The patient did not receive any treatment for the reported 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 event muscle cramps was resolved on 20210226. The clinical outcome of the events slight headache and lymph node pain under arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: slight fever; chills; tiredness; achy all over; slightly dizzy; This is a spontaneous report from a contactable consumer, the patient. A 77-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: OW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included enlarged prostate and cholesterol. Concomitant medications included atorvastatin calcium (ATORVASTIN), finasteride (MANUFACTURER UNKNOWN)  and dexamethasone, tobramycin sulfate (TOBRAMYCIN/DEXAMET) . The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 77-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 tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00 the patient experienced slight fever, chills, tiredness, achy all over, and slightly dizzy. 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 events. The clinical outcomes of the event slight fever, chills, tiredness, achy all over, and slightly dizzy were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Headache; fever ranging from 99 - 101; Shortness of breath; Fatigue; Body ache; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-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 04Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), obesity, type 2 diabetes, asthma and COVID-19 in Mar2020 and Apr2020. It was reported that the patient was on unspecified concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 05Mar2021 at 02:30, the patient experienced, headache, fever ranging from 99 - 101, shortness of breath, fatigue, body aches, nausea, vomiting, and diarrhea. The symptoms lasted for about forty hours after they began. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken included tylenol (MANUFACTURER UNKNOWN) for fever and ondansetron (MANUFACTURER UNKNOWN) for nausea. The clinical outcome of the events headache, fever, shortness of breath, fatigue, body ache, nausea, vomiting and diarrhea were resolved on 07Mar2021.   No follow-up attempts are needed. No further information is expected.