chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeding about 12 hours after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 22Mar2021, the patient experienced nose bleeding about 12 hours after the injection. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in a visit to the emergency room/department or urgent care. Therapeutic measures were not taken as the result of the event. The clinical outcome of the event nose bleeding was resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Difficulty in breathing; Increased heart rate; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to seafood. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED6955) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 30-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, two days after the second vaccination, the patient experienced difficulty in breathing and increased heart rate. She monitored for any other symptoms and waited for a week to see if it would subside but the frequency increased in a week. After 2 weeks, the patient went to the doctor's office and got it checked. On an unknown date in Apr2021, the patient underwent EKG and the result was normal but she still had difficulty breathing few days after. The patient just wanted to make sure that she had no lingering or underlying side effect after that. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events difficulty in breathing and increased heart rate were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Neurological examination, SARS-CoV-2 test
Clinical narrative: Constant headache beginning a week after the second dose; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 08May2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. 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: EW0171) via an unspecified route of administration in the arm left on 17Apr2021 at 09:00 (at the age of 21-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 13:00, the patient experienced constant headache beginning a week after the second dose received on 08May2021, headache beginning 16May2021. The patient took a visit to the emergency room, no abnormal blood work, normal neurological test. The event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the event constant headache and included treatment with NSAID. On 22May2021, the patient underwent COVID-19 blood test and the result was pending. The clinical outcome of the event constant headache beginning a week after the second dose was not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness; Itching (localized allergic reaction) at shot site; This is a spontaneous report from a contactable consumer, the patient. A 48-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 22May2021 at 09:15(at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hay fever, and patient was allergic to fenugreek. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 09:15(at the age of 48-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 25May2021, on day 3 of the shot the patient experienced, 2 diameter redness and itching (localized allergic reaction) at shot site. It was unknown if therapeutic measures were taken as a result of adverse events. The clinical outcome of the events redness and itching at vaccination site was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Migraine, Pain
Clinical narrative: Low grade fever, migraine head ache, chills, body aches for two days after my second shot.; body aches for two days after my second shot; migraine; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 09:00 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 45-years-old) for COVID-19 immunisation. The patient's medical history included Under active thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine 25 mcg tablet, vitamin D3 50 mcg. The patient had no known Allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 09:00 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 45-years-old) for COVID-19 immunisation. On 13Apr2021 at 03:00 hours, the patient experienced low grade fever, migraine headache, chills, body aches for two days after the second shot. The patient underwent lab tests and procedures which included body temperature: low grade fever on 13Apr2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were non serious and did not result in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. 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 has not been tested for COVID-19. The patient had recovered from the adverse events on 15Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever, migraine head ache, chills, body aches for two days after my second shot.; body aches for two days after my second shot; migraine; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 09:00 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 45-years-old) for COVID-19 immunisation. The patient's medical history included Under active thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine 25 mcg tablet, vitamin D3 50 mcg. The patient had no known Allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 09:00 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 45-years-old) for COVID-19 immunisation. On 13Apr2021 at 03:00 hours, the patient experienced low grade fever, migraine headache, chills, body aches for two days after the second shot. The patient underwent lab tests and procedures which included body temperature: low grade fever on 13Apr2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were non serious and did not result in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. 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 has not been tested for COVID-19. The patient had recovered from the adverse events on 15Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Overall flu like symptoms; Weakness; Extreme muscle aches; Slight headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 34-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 an unknown date (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 34-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 21May2021 at 23:00, the patient experienced extreme muscle aches, weakness, slight headache, fatigue, overall flu like symptoms. 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 extreme muscle aches, weakness, slight headache, fatigue, overall flu like symptoms was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Night sweats
Clinical narrative: Nausea; Fatigue; Dizziness; Vertigo; Chills; Night sweats; Throat itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 29Apr2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), ascorbic acid (VITAMIN C), multi-vitamins (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known 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 receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 19:00 the patient experienced all sick symptoms nausea, fatigue, dizziness, vertigo, chills, night sweats and throat itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, fatigue, dizziness, vertigo, chills, night sweats and throat itchy was recovering at the time of this report. The 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 21May2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vertigo
Clinical narrative: Nausea; Fatigue; Dizziness; Vertigo; Chills; Night sweats; Throat itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 29Apr2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), ascorbic acid (VITAMIN C), multi-vitamins (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known 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 receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 19:00 the patient experienced all sick symptoms nausea, fatigue, dizziness, vertigo, chills, night sweats and throat itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, fatigue, dizziness, vertigo, chills, night sweats and throat itchy was recovering at the time of this report. The 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 21May2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Neck pain
Clinical narrative: Neck has been hurting; My head hurts; Bad back pain down my spinal cord; some back pain in my body; This is a spontaneous report from a contactable male consumer reported for himself. A male patient of unspecified age received an unknown dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiration date: Unknown), via an unspecified route on an unknown date (Sunday), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient neck has been hurting, his head hurts and he got bad back pain down his spinal cord, some back pain in body too bad and he 'haven't been currently taken anything (voice feeble). The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Muscle spasms, Pyrexia
Clinical narrative: 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 21May2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications taken within two weeks of vaccination included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) from unknown date for unknown indication. The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen, both for unknown indication and experienced drug 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 22May2021 at 06:00, the patient experienced two days of intermittent fevers, chills, injection site pain, weakness, inappetance, and on 23May2021, the day of report full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about ten minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events two days of intermittent fevers, chills, injection site pain, weakness, inappetance, and on the day of report full body muscle spasms/cramps; first episode lasting over an hour, second episode lasted about 10 minutes was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 21May2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications taken within two weeks of vaccination included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) from unknown date for unknown indication. The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen, both for unknown indication and experienced drug 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 22May2021 at 06:00, the patient experienced two days of intermittent fevers, chills, injection site pain, weakness, inappetance, and on 23May2021, the day of report full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about ten minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events two days of intermittent fevers, chills, injection site pain, weakness, inappetance, and on the day of report full body muscle spasms/cramps; first episode lasting over an hour, second episode lasted about 10 minutes was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: red spots/hives appeared all over body. They are not itchy or painful but are mildly scaly; Inappropriate schedule of vaccine administered to Dose 1:17Apr2021; Dose 2: 05May2021; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05May2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to cephalosporin antibiotics. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 16May2021, about 10 days after 2nd dose the patient experienced red spots/hives appeared all over body. They are not itchy or painful but were mildly scaly. Patient had no other new illness, medication, vaccine, etc. or any other event (such as contact with an allergen like poison ivy) at that time period.  As of 23May2021 they had not yet healed/gone away. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event hives appeared all over the body was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal pain, Tachycardia
Clinical narrative: Mental fogginess; high blood pressure; experience of tachycardia; high blood pressure and pulse; Extreme pain throughout entire spine; Psychotic event/  psychotic episode; Anxiety; compulsion; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 as dose 1, single and the second dose of BNT162b2 (lot number: ER8731) via unspecified route of administration in the left arm on 28Apr2021 at 12:00 as dose 2, single both for COVID-19 immunization, at the age of 58-years-old. Medical history included chronic pain after trauma, asthma and cataract lens replacement. The patient was allergic to minor corn, peppers and had multiple environmental allergies. Patient was also allergic to cefalexin (CEPHALEXIN) and had problem with it. Concomitant medications included oxycodone taken at 15mg, morphine sulfate (MORPHINE SULPHATE) taken at 15mg and cannabis sativa (MARIJUANA) which was reported as medical marijuana (MMJ), all taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 12:00, approximately 10 days after the first dose, the patient experienced anxiety and compulsion. On 21Apr2021, the patient experienced psychotic event that lasted for 3 days. On 25Apr2021, the following fourth day, the patient experienced extreme pain throughout entire spine that felt as if it was caused by an internal pressure. On 18May2021, patient still struggled with high blood pressure and pulse including experience of tachycardia, started on an unspecified date, during Doctor's appointment. On unspecified date, mental fogginess and anxiety was greater upon wakeup and lessened to almost decent before bedtime as of just a week prior the report. Patient saw magazine article referencing long-haulers possible link with antibody effect on some and felt this may be apropos with him as well. The patient could not feel that he could have coincidentally lost it yet with psychotic episode 14 days post first vaccination but, if it was antibody related it made sense to him. He was using diet in attempt to treat symptoms but did not share this information with others including doctors as yet. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, on 18May2021, the patient had been tested for COVID-19 and had antibody test and results were pending. The clinical outcome of the event psychotic event was resolved on 24Apr2021, while the clinical outcome of the other events was resolving at the time of this report.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Gait disturbance, Grip strength decreased, Joint swelling
Clinical narrative: Autoimmune problems; Joints pain swelling; Joints pain/ wrists are very sore; Walking is hard; my hand have lost most grip strength; This is a spontaneous report from a contactable consumer, the patient. This 70-year-old male patient reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in the left arm on 05Mar2021 at 16:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included gout (one every 18 months or so). 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. Concomitant medications the patient received within 2 weeks of vaccination included vitamin (unspecified product) and Tamsulosin hcl (FLOMAX). On 08Mar2021, 2 to 7 days after shot (as reported), the patient experienced autoimmune problems in most joints pain swelling. Patient reported that most symptoms are still with him more than 2.5 months. He reported walking is hard and his hand has lost most grip strength wrists are very sore. There was no treatment received for the events. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vertigo
Clinical narrative: Flu like symptoms; body aches; severe vertigo; nausea and fever lasting around 24 hours; nausea and fever lasting around 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13May2021 at 13:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, not severe. The patient was allergic to penicillin. Concomitant medications included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN) taken once weekly or less for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 09:00 (at the age of 19-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 14May2021 at 08:00, the patient experienced flu like symptoms, body aches and severe vertigo, nausea and fever which lasted around 24 hours, vertigo and nausea lasted 24 hours after. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events flu like symptoms, body aches and fever were resolved on 15May2021, while the clinical outcome of the events severe vertigo and nausea were resolved an unknown date in May2021.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Burning sensation, Chest pain, Chills
Clinical narrative: having chills; my body is just sweating profusely; it feels as my head has like pressure all around it; my entire abdomen and lower back is sore; my body burning all through my leg; my entire abdomen and lower back is sore; I had chest pain; headache relevant symptoms; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22May2021 patient experienced chest pain, headache relevant symptoms and on 23May2021 patient having chills, body is just sweating profusely, it feels as my head has like pressure all around it, entire abdomen and lower back is sore, body burning all through my leg. It was reported that patient received second vaccine of Pfizer yesterday and would say that may be so it was even a headache relevant symptoms and going through the night, and now this morning, patient having chills, body is just sweating profusely, it feels as patient head has like pressure all around it, entire abdomen and lower back is sore and patient body burning all through my leg and had chest pain through the night. Patient asking So should I go to the doctor or what should I do. Patient have never tested positive for Covid. The outcome of all event was Unknown.   Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hyperhidrosis
Clinical narrative: having chills; my body is just sweating profusely; it feels as my head has like pressure all around it; my entire abdomen and lower back is sore; my body burning all through my leg; my entire abdomen and lower back is sore; I had chest pain; headache relevant symptoms; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22May2021 patient experienced chest pain, headache relevant symptoms and on 23May2021 patient having chills, body is just sweating profusely, it feels as my head has like pressure all around it, entire abdomen and lower back is sore, body burning all through my leg. It was reported that patient received second vaccine of Pfizer yesterday and would say that may be so it was even a headache relevant symptoms and going through the night, and now this morning, patient having chills, body is just sweating profusely, it feels as patient head has like pressure all around it, entire abdomen and lower back is sore and patient body burning all through my leg and had chest pain through the night. Patient asking So should I go to the doctor or what should I do. Patient have never tested positive for Covid. The outcome of all event was Unknown.   Information on the lot/batch number has been requested
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bladder discomfort, Dysuria, Pollakiuria, Vulvovaginal pruritus
Clinical narrative: A few days after the first vaccination experienced painful and frequent urination; A few days after the first vaccination experienced painful and frequent urination; Vaginal itching; Abdominal pain; Feeling like bladder wass full but wasn't; This is a spontaneous report from a non-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: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on 19Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, few days after the first vaccination the patient experienced painful urination, frequent urination, vaginal itching, abdominal pain and "feeling like bladder was full but it wasn't". The patient had experienced the same events a few days after the second vaccination also. On an unknown date, the patient underwent lab test which included urine test for UTI and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful urination, frequent urination, vaginal itching, abdominal pain and " feeling like bladder was full but it wasn't" was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pyrexia, Vaccination site erythema
Clinical narrative: fever; chills; tired; arm red and swollenaround shot around,; arm red and swollenaround shot around,; swelling of armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0168) via an unspecified route of administration in the left arm on 15May2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. 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 16May2021, the patient experienced fever, chills, tired, arm red and swollen around shot, swelling of armpit. 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 fever, chills, tired, arm red and swollen around shot, swelling of armpit recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: fever; chills; tired; arm red and swollenaround shot around,; arm red and swollenaround shot around,; swelling of armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0168) via an unspecified route of administration in the left arm on 15May2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. 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 16May2021, the patient experienced fever, chills, tired, arm red and swollen around shot, swelling of armpit. 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 fever, chills, tired, arm red and swollen around shot, swelling of armpit recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Muscle spasms like charley horses in foot and calf; few back spasms; Numbness and tingling in hands; Numbness and tingling in hands; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 21May2021 at 16:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies. Concomitant medications included birth control pills (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. Prior to the vaccination, it was unknown whether 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 21May2021 at 22:00, the patient experienced muscle spasms like Charley horses that lasted for hours at a time in foot and calf, a few back spasms, numbness and tingling in hands like arm fell asleep even though not laying on it. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events muscle spasms like Charley horses in foot and calf, a few back spasms, numbness and tingling in hands were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: yeast infection; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 21May2021 at 09:45(at the age of 27-year-old) as a single dose for COVID-19 immunisation. Patient had allergy to amoxicillin family. 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 23May2021 at 01:00 the patient experienced yeast infection. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event yeast infection was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Shot sight red; Shot sight raised; Shot site tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 22May2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of the COVID-19 vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 59-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 vaccination. On 22May2021 at 14:00, the patient experienced "shot sight red, raised and tender to touch". Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events "shot sight red, raised and tender to touch" was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Slight itching on upper extremities; Developed a few hives; This is a spontaneous report from a contactable healthcare professional. A 66-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 right arm on 21May2021 at 10:45(at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, osteoarthritis and allergy to penicillin V. Patient previously took potassium (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), fluticasone propionate (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE) 10mg 1 tablet daily from unknown start date and for 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 COVID vaccine. On 21May2021 at 10:45, the patient experienced slight itching on upper extremities and developed a few hives. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with one dose of oral BENADRYL. The clinical outcome of the event slight itching on upper extremities and developed a few hives were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.