chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8727) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. 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 take any other medications in two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 00:00, the patient experienced loss of taste. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event loss of taste was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthma, Cough, Disorientation, Headache
Clinical narrative: Loss of memory, time, place, reason; Loss of memory, time, place, reason; Several asthma attacks; involuntary body shake; headaches; muscle pain from left shoulder to left side of the head; coughing; small bumps in the face and back of the ears; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9266), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (age at the vaccination 38-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The Patient experienced loss of memory, time, place, reason, involuntary body shake, headaches, muscle pain from left shoulder to left side of the head, coughing and small bumps in the face and back of the ears and several asthma attacks on 16Feb2021. Patient visited physician office. Therapeutic measures were taken as a result of loss of memory, time, place, reason, involuntary body shake, headaches, muscle pain from left shoulder to left side of the head, coughing and small bumps in the face and back of the ears and several asthma attacks. The outcome of the events was resolved with Sequel.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Skin disorder, Tremor
Clinical narrative: Loss of memory, time, place, reason; Loss of memory, time, place, reason; Several asthma attacks; involuntary body shake; headaches; muscle pain from left shoulder to left side of the head; coughing; small bumps in the face and back of the ears; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9266), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (age at the vaccination 38-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The Patient experienced loss of memory, time, place, reason, involuntary body shake, headaches, muscle pain from left shoulder to left side of the head, coughing and small bumps in the face and back of the ears and several asthma attacks on 16Feb2021. Patient visited physician office. Therapeutic measures were taken as a result of loss of memory, time, place, reason, involuntary body shake, headaches, muscle pain from left shoulder to left side of the head, coughing and small bumps in the face and back of the ears and several asthma attacks. The outcome of the events was resolved with Sequel.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Mild to severe lingering pain at the injection site and up into left shoulder.; Mild to severe lingering pain at the injection site and up into left shoulder.; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 40-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 02Apr2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to nuts and grass. Concomitant medications included ibuprofen (MANUFRATURER UNKNOWN) from an unknown date and for unknown indication taken within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced mild to severe lingering pain at the injection site and up into left shoulder. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of mild to severe lingering pain at the injection site and up into left shoulder was  resolving.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Disturbance in attention, Hypogeusia
Clinical narrative: slight achiness to upper back; slight inability to focus on complex tasks; Reduced sense of taste; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included hemochromatosis. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA), both  from unknown dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 10Mar2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 12:00, the patient experienced slight achiness to upper back, then slight inability to focus on complex tasks, then reduced sense of taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events slight achiness to upper back, slight inability to focus on complex tasks and reduced sense of taste was recovered with lasting effects.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe body aches all over; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 15:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, thyroid, COVID-19 and blood pressure high. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 20:00 the patient experienced severe body aches all over. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe body aches all over was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Ear pain, Nausea, Oropharyngeal pain
Clinical narrative: Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body aches; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID 175), vitamin B+ (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. 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-19 vaccine. On 03Mar2021 at 15:00, the patient experienced stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Photophobia, Swelling
Clinical narrative: Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body aches; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID 175), vitamin B+ (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. 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-19 vaccine. On 03Mar2021 at 15:00, the patient experienced stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: Anticipated sore arm,; Flare up then a remission of psoriasis.; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea, psoriasis, allergies, gluten intolerance and COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) and multivitamin (MANUFACTURER UNKNOWN) for unknown indications and from an unknown date. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 10Mar2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 07:00, the patient experienced sore arm which was anticipated and beside that had a flare up then a remission of psoriasis. The patient never had experienced anything like that so fast and then so clear. The 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 reported events. The clinical outcome of the events sore arm and psoriasis was resolved with a sequela on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the body after 31 hours of injection; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and triglycerides high from an unspecified date. The patient had no known allergies. Concomitant medications included fenofibrate (MANUFACTURER UNKNOWN) 160 mg tablet, amlodipine (MANUFACTURER UNKNOWN) 2.5 mg tablet all from an unknown date for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm left on 12Mar2021 at 17:30 (at the age of 57-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 02Apr2021 at 17:30 the patient experienced Rash all over the body after 31 hours of injection. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash all over the body after 31 hours of injection was not resolved.   No follow-up attempts are needed; no further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via unknown route of administration on 16Mar2021 13:00 as dose 2, single in left arm for COVID-19 immunisation at hospital. Medical history included penicillin allergy, steri strip allergy and gamma-globulin infusions. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included rosuvastatin, escitalopram oxalate (LEXAPRO). Patient previously took first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE) on 23Feb2021 07:30 AM, (at age of 64-year-old) as dose 1 single in left arm for COVID-19 immunization and also patient took Codeine and had allergy. On 30Mar2021 20:00, patient experienced shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Morphine shot was given as treatment.  Patient had not taken other vaccine in four weeks. Patient had not had covid prior vaccination. Patient was not covid tested post vaccination. The outcome of event was not recovered.  Information about batch/Lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphoedema, Product administered at inappropriate site
Clinical narrative: Swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerned for swelling to continue and/or lymphadema; lymphadema; Anatomical Location- Left leg; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and Lot Number: EP7533), via an unspecified route of administration, in Leg Left on 02Apr2021 12:45 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included breast cancer (Still receiving treatment, Double mastectomy 02Jun for breast cancer, incl lymph node removal right side. Expanders placed during surgery for implants at later date) and known allergies: Penicillin. Concomitant medications included gabapentin, trazodone, celecoxib (CELEXA) and ergocalciferol (ERGOCALCIFEROL). The patient experienced swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerned for swelling to continue and/or lymphadema on 03Apr2021 07:00, anatomical location- left leg on 02Apr2021 and lymphadema on 03Apr2021 07:00. Prior and Since the vaccination, was the patient diagnosed with COVID-19 reported as no. For breast swelling and Lymphedema emergency room visit reported as yes and the treatment were reported as unknown. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Tightness in chest; Trouble breathing, sometimes if patient inhale air, feel like need to cough; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 31Mar2021 at 09:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within two weeks of vaccination. Patient did not report any known allergies to food, medications or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 19:00, the patient experienced tightness in the chest and trouble breathing. Sometimes if the patient inhaled air, the patient felt like need to cough. 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 event tightness in chest and trouble breathing were not recovered 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: Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; very mild muscle aches; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 07:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, premenstrual dysphoric disorder and seasonal allergy. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC) and loratadine (CLARITIN) all for unknown indications and from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 11Mar2021 at 08:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 11:00, the patient experienced sore arm, very mild muscle aches and headache. 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 sore arm, muscle ache and headache were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dehydration, SARS-CoV-2 test, Throat irritation, Vomiting
Clinical narrative: Vomiting; Dehydration; Chest pain; Throat irritation; This is a spontaneous report received from a contactable consumer (patient).  A 32-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 19:30 (Lot number Er87277121) as DOSE 1, SINGLE (age at vaccination 32 years old) for covid-19 immunization. Medical history included known allergies: Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 21:30, the patient experienced vomiting. In 2021 the patient experienced dehydration, chest pain and throat irritation.The patient experienced continuous vomiting which began approximately 2 hours after receiving injection. It has now been 72 hours. Vomiting has not stopped. Vomiting causing chest pain and throat irritation. Patient needed to go to Urgent care for dehydration. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19The patient underwent lab tests and procedures which included Covid test post vaccination Nasal Swab: negative on 02Apr2021. Therapeutic measures were taken as a result of dehydration which included intravenous (IV drip). Outcome of the events were not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Neck pain, Pain in extremity
Clinical narrative: headache; arm hurt all the way up to neck L; arm hurt all the way up to neck L; dizziness; queasy; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 19Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia (SVT), hypergamagolbulinaemia benign monoclonal, asthma, diverticulosis, fatty liver, clot blood, perimenopause and borderline diabetes. Patient reported allergies to latex allergy, sulfonamide allergy. The patient previously received KEFLEX, verapamil (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN) and enalapril maleate, lercanidipine hydrochloride (ZANEXTRA) from unknown date for an unknown indication received within 2 weeks of vaccination. 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 experienced headache, arm hurt all the way up to neck L, dizziness, queasy on 19Mar2021. Details were as follows: on 19Mar2021, within 10 minutes after the vaccine, the patient experienced headache, left side pain all the way up to neck, queasy and dizziness. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. On 03Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was pending. The clinical outcome of experienced headache, arm hurt all the way up to neck L, dizziness, queasy was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: headache; arm hurt all the way up to neck L; arm hurt all the way up to neck L; dizziness; queasy; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 19Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia (SVT), hypergamagolbulinaemia benign monoclonal, asthma, diverticulosis, fatty liver, clot blood, perimenopause and borderline diabetes. Patient reported allergies to latex allergy, sulfonamide allergy. The patient previously received KEFLEX, verapamil (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN) and enalapril maleate, lercanidipine hydrochloride (ZANEXTRA) from unknown date for an unknown indication received within 2 weeks of vaccination. 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 experienced headache, arm hurt all the way up to neck L, dizziness, queasy on 19Mar2021. Details were as follows: on 19Mar2021, within 10 minutes after the vaccine, the patient experienced headache, left side pain all the way up to neck, queasy and dizziness. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. On 03Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was pending. The clinical outcome of experienced headache, arm hurt all the way up to neck L, dizziness, queasy was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pruritus, Urticaria
Clinical narrative: red itchy hives all over body.  Mostly on back side; red itchy hives all over body.  Mostly on back side; red itchy hives all over body.  Mostly on back side; cold chills; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Feb2021 17:15 (at the age of 66-year-old) as a dose 2, single for COVID-19 immunization. The Medical history was not reported, and the concomitant medications were reported as no. The patient had known allergies to penicillin. The patient did not receive other medications in two weeks. 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 22Feb2021 the patient experienced red, itchy, hives all over body mostly on back side and cold chills. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included treatment with antihistamine and CORTIZONE 10. The clinical outcomes of the events red, itchy, hives all over body and cold chills were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information which included: Age at Vaccination update as 66 years, Start Date/Stop date' update as: 21-FEB-2021 17:15; 'Anatomical Location' select as: 'Arm Left', Narrative 'The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left (at the age of 65-year-old) as a single dose for COVID-19 immunization on an unknown date' deleted since not reported, 'Historical Vaccine' deleted.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: sudden onset of breathlessness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old contactable female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiry date not reported) via unspecified route of administration, on 26Jan2021 (at the age of 68-year-old), as Dose 1, single for COVID-19 Immunisation. Patient's medical history included Moderate asthma (She hasn't had it all her life but a good number of years), Pulmonary embolism from 2014, Cutaneous T-cell lymphoma from 2000, and pneumonia (she got pneumonia and was hospitalized for 4 weeks). Patient family history included as she was sensitive to medications, so was her mother she has a long history. The patient would not take the pneumonia vaccine because she had a little thing after the pneumonia vaccine one time, she got pneumonia and was hospitalized for 4 weeks, she had no idea if it was related. Her mom, when she had the pneumonia vaccine at the doctor's office had a severe reaction and her mom had reactions a lot. Concomitant medication included Asthma inhalers (drug not specified) (She had been on them for years, she can't remember when she started them, she guesses it's been 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Caller wanted to report a side effect she had; it was unusual. First of all, after the first shot of the Covid Vaccine which was on 26Jan2021, the day after she started to try to do a walk in the morning and quickly could not. She had a sudden onset of breathlessness, on 27Jan2021 (one day after vaccination). She just laid down and felt fine a minute later. She felt fine and rested all day. Patient had to visit emergency visit room for event. By the following day she was fine, she was not worried about it. She has had no other reactions. The outcome of event was resolved, on 28Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Whole body aches; swollen left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the arm left on 03Apr2021 at 13:00(at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, headache and drug allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) started from an unknown date and 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. 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: EN6204), via an unspecified route of administration in the arm left on 13Mar2021 at 12:45 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. The patient was allergic to levaquin (anaphylactic), sulfa based meds (rash) and amoxicillin (rash). On an unknown date in 2021, the patient experienced whole body aches and swollen left arm pit. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event whole body aches and swollen left arm pit was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site red and swollen starting 3rd day; Injection site red and swollen starting 3rd day; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the left arm on 01Apr2021 at 16:30 as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to food, medications, or other products. . 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 11Mar2021 at 16:30 as a single dose for COVID-19 immunisation. The patient did not receive any other medication 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 03Apr2021 at 17:00, the patient experienced injection site red(vaccination site erythema) and swollen(vaccination site swelling) starting 3rd day. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site red (vaccination site erythema) and swollen(vaccination site swelling) starting 3rd day was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sore arm; Sleepy; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 03Apr2021 at 08:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history, concomitant medications and allergic history 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 COVID-19 vaccine. On 03Apr2021 at 18:00, the patient experienced sore arm and felt sleepy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm and sleepy was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Malaise, Pyrexia
Clinical narrative: Was sick; Ringing in the ears; Headaches; Fever; Chills; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 15:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (hbp), leukopenia and a heart murmur that was just discovered on 04Feb2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MOBIC) taken from an unknown date for an unknown indication, sulfamethoxazole; trimethoprim (BACTRIM DS) taken from an unknown date for an unknown indication and unspecified acid reflux medicine. The patient had allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 18:00, the patient felt sick as though she had COVID-19 for 7 days. On 19Mar2021 at 18:00, the patient experienced ringing in the ears that did not go away, occasional headache, fever, chills and cough. The patient reported that she never had either before the vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events experienced which also included unspecified medicines for coughing. On 22Mar2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. The clinical outcome of the events felt sick, ringing in the ears, occasional headaches, fever, chills and coughing was resolved with lasting effects on an unspecified date in 2021.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Was sick; Ringing in the ears; Headaches; Fever; Chills; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 15:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (hbp), leukopenia and a heart murmur that was just discovered on 04Feb2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MOBIC) taken from an unknown date for an unknown indication, sulfamethoxazole; trimethoprim (BACTRIM DS) taken from an unknown date for an unknown indication and unspecified acid reflux medicine. The patient had allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 18:00, the patient felt sick as though she had COVID-19 for 7 days. On 19Mar2021 at 18:00, the patient experienced ringing in the ears that did not go away, occasional headache, fever, chills and cough. The patient reported that she never had either before the vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events experienced which also included unspecified medicines for coughing. On 22Mar2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. The clinical outcome of the events felt sick, ringing in the ears, occasional headaches, fever, chills and coughing was resolved with lasting effects on an unspecified date in 2021.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm for a day and a half.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 04:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 03Apr2021, the patient experienced soreness in arm for a day and a half. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event soreness in arm for a day and a half was recovered on 04Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, diarrhea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, diarrhea and fatigue. The clinical outcome of the events headache, diarrhea and fatigue were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Fatigue; Muscle aches; Fever around 99-100; Chills; Nausea; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had food allergy which included allergy to bell peppers. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 08:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 03Apr2021 at 17:30, the patient experienced fatigue, muscle aches, fever around 99-100 (unspecified units), chills, nausea and injection site soreness. The adverse 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 adverse events. The clinical outcome of the events fatigue, muscle aches, fever around 99-100, chills, nausea and injection site soreness were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fatigue; Muscle aches; Fever around 99-100; Chills; Nausea; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had food allergy which included allergy to bell peppers. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 08:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 03Apr2021 at 17:30, the patient experienced fatigue, muscle aches, fever around 99-100 (unspecified units), chills, nausea and injection site soreness. The adverse 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 adverse events. The clinical outcome of the events fatigue, muscle aches, fever around 99-100, chills, nausea and injection site soreness were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.