chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Left arm bruised; Left arm swollen; Left underarm swollen; Left underarm painful; Left side to waist swollen; Left side to waist painful; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto disease, COVID-19, anxiety due to COVID illness and COVID-19 anosmia. Allergies to medications included ampicillin and penicillin. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY). Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced events of bruise in left arm, swollen left arm, swollen left underarm, painful left underarm, left sided swelling to waist, left sided pain to waist. 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. Treatment received for the adverse events was reported as no. The clinical outcome of events bruise in left arm, swollen left arm, swollen left underarm, painful left underarm, left sided swelling to waist, left sided pain to waist was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sensory disturbance, Vaccination site pain
Clinical narrative: Headache until current (no relief),; occasional random pulsatingsensation in left bicep muscle; Usual injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 28Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis. The patient did not have allergies to medication, food or other products. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D), Isotretinoin (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA). 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 vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 03:00, the patient experienced headache (continuing), occasional random pulsating sensation in left bicep muscle (abnormal sensation of limbs) and usual injection site soreness. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event headache was not resolved. The clinical outcome of the events abnormal sensation of limbs and vaccination site pain was unknown.    No follow-up attempts are needed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Vaccination site pain, Vomiting
Clinical narrative: tender at the injection spot; vomiting,; chills; dizziness; headache; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 29Mar2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypertension from an unknown date. Medications the patient received within 2 weeks of vaccination included nystatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. 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 08Mar2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. 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. Patient did not have allergies to medications, food, or other products. On 29Mar2021 at 22:00, the patient experienced vaccination site tenderness, vomiting, chills, dizziness, headache. (Initially felt fine after the second vaccine, a bit tender at the injection spot. 12 hours later was seriously ill with severe vomiting, chills, dizziness, headache). The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Clinical outcome of vaccination site tenderness, vomiting, chills, dizziness, headache was resolving at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Migraine
Clinical narrative: Metallic taste; Migraines; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 09:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included gluten and amoxicillin allergy. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced metallic taste within first minute on 26Mar2021. The patient had several (three) days of migraines during the five days since vaccination. The patient had not receive treatment for the reported events. 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 metallic taste and migraines was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Tiredness; swollen lymph node by jaw; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration 24Mar2021 at 02:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. There were no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 19:00, the patient experienced tiredness and swollen lymph node by jaw. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tiredness and swollen lymph node by jaw was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysstasia, Fatigue, Headache
Clinical narrative: Headache; Chills; Fatigue; Muscle ache; generalized weakness; unable to stand for minimal amount of time due to chills and generalized weakness; This is a spontaneous report from a contactable Nurse, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration on 27Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib, rheumatoid arthritis (RA), migraine, asthma, congestive heart failure (CHF), prosthetic heart valve, allergies, hyperlipidemia and pacemaker. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), abatacept (ORENCIA), prednisone (MANUFACTURER UNKNOWN), leflunomide (LEFL); all from unknown date for unspecified indication.  The patient had known(Unspecified) allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration on 06Mar2021 at 15.45 (at the age of 60-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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 06.30, the patient experienced headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness. The patient did not receive any treatment for the reported 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 headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Headache; Chills; Fatigue; Muscle ache; generalized weakness; unable to stand for minimal amount of time due to chills and generalized weakness; This is a spontaneous report from a contactable Nurse, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration on 27Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib, rheumatoid arthritis (RA), migraine, asthma, congestive heart failure (CHF), prosthetic heart valve, allergies, hyperlipidemia and pacemaker. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), abatacept (ORENCIA), prednisone (MANUFACTURER UNKNOWN), leflunomide (LEFL); all from unknown date for unspecified indication.  The patient had known(Unspecified) allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration on 06Mar2021 at 15.45 (at the age of 60-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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 06.30, the patient experienced headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness. The patient did not receive any treatment for the reported 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 headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: large swollen whelp at vaccination site; Extreme exhaustion; Fever; Body aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration on 26Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis, gastrooesophageal reflux disease (GERD), anxiety, depression and chronic diverticulitis. The patient received unspecified medication within 2 weeks of vaccination. It was reported that patient had allergies to medications, food or other products which are unspecified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202) via an unspecified route of administration in the right arm on 05Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 04:00, the patient had extreme exhaustion within 12 hours of vaccination. The patient also had fever, body aches, headache within 24 hours. On 29Mar2021, more than 72 hours after vaccination the patient had large swollen whelp at vaccination site. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache was recovered on 29Mar2021.The clinical outcomes of the events extreme exhaustion, fever, body aches and large swollen whelp at vaccination site were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the right arm on 25Mar2021 at 15:45 (at the age of 22-years-old), as a single dose for Covid-19 immunisation. Medical history was not reported. Concomitant medications included men multi-vitamin (MANUFACTURER UNKNOWN) and calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); both taken for unknown indication started from an unknown date. The patient was allergic to cefpodoxime (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 26Mar2021, the patient experienced soreness at the injection site (vaccination site pain). In Mar2021, the patient was tested for SARS-CoV-2 test which resulted in negative. No therapeutic measures were taken as a result of soreness at injection site. The clinical outcome of the event soreness at injection site was resolved in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling under arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 10:15 (at the age of 66-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, anxiety, back and neck(unspecified). Concomitant medications included losartan (MANUFACTURER UNKNOWN), isosorbide (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), paroxetine (MANUFACTURER UNKNOWN) and ga (as reported) for an unknown indication. The patient had a history of allergy to tetracycline. 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 vaccine within four weeks prior to the COVID-19 vaccine. On 07Mar2021, at 23:30, the patient experienced swelling under arm. The adverse events were resulted in doctor or other healthcare professional office. The patient did not receive any treatment for the reported events. The clinical outcome of event swelling under arm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: I've had a raised red bump at the injection site since my 2nd injection. It's not painful but it has not gone down at all since my 2nd shot.; I've had a raised red bump at the injection site since my 2nd injection. It's not painful but it has not gone down at all since my 2nd shot.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and ankylosing spondylitis. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ustekinumab (STELARA) every 3 months and medroxyprogesterone acetate (DEPO PROVERA) every 3 months; both for unknown indications from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 26Feb2021 at 11:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. On 19Mar2021 at 12:00, the patient had a raised red bump at the injection site since second injection and it was not painful but it had not gone down at all since her second shot. The patient did not receive any treatments for the reported 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 raised red bump at the injection site was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: rashes like small red dots; itching; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications were not reported. 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 27Mar2021 after 72 hours at 18:00, the patient had started noticing rashes like small red dots all over body especially from backside and front side of the body. They are kind of itching but not painful. The adverse events did not result in a visit to the doctors or other healthcare professional office or 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 rashes like small red dots and itching was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm. Been 2 weeks and getting worse.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Mar2021 at 16:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hereditary angio edema type 3, something similar to Parkinson's, very light asthma, penicillin allergy, and some unspecified fruits allergy. The patient did not receive concomitant medications. The patient previously received naproxen sodium (ALEVE), MOTRIN (composition unknown) both for an unknown indication and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced pain in arm. It was reported that it had been 2 weeks and was getting worse. 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. No therapeutic measures were taken as a result of the event pain in arm. The clinical outcome of the event pain in arm was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Fluid retention
Clinical narrative: Large lump under right armpit; Water retention on torso, down to stomach on right/SHOT SIDE ONLY; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 25Mar2021 at 12:15 (at the age of 43-years-old) as a single dose for Covid-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products (as far as patient was aware of). The patient did not receive any concomitant medications within 2 weeks of the vaccine.  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021, the patient experienced large lump under right armpit and significant water retention on torso, down to stomach on right and never experienced this before. 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 received treatment for the reported events. The clinical outcome of axillary lump and water retention was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: spotting; irregular period; This is a spontaneous report from a contactable consumer, the patient. A 47-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 arm left on 26Mar2021 at 17:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included beta thalassemia. Concomitant medication included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC D). The patient did not have any allergies to medications, food, or other products. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 05Mar2021 at 17:45 (at the age of 47-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 COVID vaccine. On 28Mar2021, the patient experienced spotting and irregular period. The patient did not have any prior history of irregularity. The patient did not receive any treatment for the event.  The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events spotting, irregular period was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypoaesthesia, Hypoaesthesia eye, Oxygen saturation, Paraesthesia
Clinical narrative: numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; numbness and tingling on left side of face, around left eye; numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 08:55(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no chronic illness. The patient did not take any concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have 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. On 30Mar2021 at 9:00, the patient experienced numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear. Within about 10 minutes of symptom onset, intensity subsided, but still felt lingering slight numbness. The patient had no dizziness and balance was fine. The patient still felt slight/lasting numbness in affected area at the time of this report(11:15).On 30Mar2021, the blood pressure and oxygen saturation was reported as normal.  The patient did not receive treatment for the reported 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 numbness in face, eye numbness and tingling was recovered with sequelae at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Joint swelling
Clinical narrative: Inflammation; Swollen joints in hands andfingers, and left jaw; Painful joints in hands and fingers, and left jaw (feels something like arthritis); This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm, on 12Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included amlodipine besilate (MANUFACTURER UNKNOWN), sotalol hydrochloride (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all since an unknown date for unknown indication. 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 was not tested for COVID-19. On an unknown date in Mar2021 at 12:00 (as reported), the patient had experienced swollen, painful joints in hands, fingers, and left jaw. The patient felt something like arthritis and inflammation. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the reported events. The clinical outcome of the events swollen joints, inflammation and arthritic-like pain were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Distractibility, Lymphadenopathy, Musculoskeletal stiffness, Tinnitus
Clinical narrative: Ringing in ears; stiff neck; swollen lymph nodes; it is distracting me; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration on the right arm on 22Mar2021 at 03:45 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ascending aortic aneurysm. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 03:45, the patient experienced ringing in ears, stiff neck, swollen lymph nodes and distracting. The patient also reported that ringing started 3 minutes after getting shot and it was distracting her. No therapeutic measures were taken as the result of reported adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome ringing in ears, stiff neck, swollen lymph nodes and distracting were unknown.    No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Large red rash on left hand left middle finger; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 at 13:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included fish allergy (Salmon allergy). Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ) 50mg daily and ibuprofen (MOTRIN) 500mg morning; both for unknown indication started for an unknown date. The patient previously took PERCOCET, VICODIN, AUGMENTIN, CELEBREX, LEVAQUIN 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 10Mar2021 at 04:00, the patient on the left hand in the left middle finger experienced a large red rash size of a 1/2 dollar coin. It doesn't bot hurt or itch. Just very noticeable. The patient did not receive any treatments for red rash. The clinical outcome of the event red rash was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Large bruise left forearm; left forearm swollen; left forearm painful; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: BR128733) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously received iodine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication on an unspecified date and experienced drug allergy and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On an unspecified date in Mar2021 at 12:00, the patient experienced large bruise in the left forearm, swollen, painful, fever, fatigue and nausea. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events large bruise on left forearm, swollen arm, painful left arm, fever, fatigue and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Large bruise left forearm; left forearm swollen; left forearm painful; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: BR128733) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously received iodine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication on an unspecified date and experienced drug allergy and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On an unspecified date in Mar2021 at 12:00, the patient experienced large bruise in the left forearm, swollen, painful, fever, fatigue and nausea. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events large bruise on left forearm, swollen arm, painful left arm, fever, fatigue and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: stiff right shoulder; pain upper back.; severe low back pain; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) via an unspecified route of administration in left arm on 11Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke on an unknown date in 2010, aneurysm repair on an unknown date in 2020, asthma, bilateral hip replacements, kidney stones, osteopenia, amyloid disease from an unspecified date. The patient did not have allergies to medications, food, or other products.  Medications the patient received within 2 weeks of vaccination included Aspirin (MANUFACTURER UNKNOWN), pulmicort (MANUFACTURER UNKNOWN) 180mcg, atorvastatin (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: EL3246) via an unspecified route of administration in the left arm on 21Jan2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Feb2021, the patient experienced stiff right shoulder and upper back pain. Four weeks later the patient experienced severe low back pain on getting up from a seated position. The adverse events resulted in a doctor or other healthcare professional office or clinic visit. The patient received Muscle relaxant and Medrol pack as therapeutic measures for the reported events. The clinical outcome of the event upper and lower back pain, stiff right shoulder was resolving at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest pain, Chills, Hyperhidrosis
Clinical narrative: fever 101 degree; sweating; Chills; whole body aching; muscles in back and chest were hurting so bad; muscles in back and chest were hurting so bad; managed to go back to sleep but woke up every few hours; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm at 10:00 am on 29Mar2021 (at the age of vaccination 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously had no known allergies. Concomitant medications included Fluoxetine hydrochloride (PROZAC) started on an unknown date for unspecified indication. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3302) via an unspecified route of administration in the right arm on 08Mar2021 at 09:45 am (at the age of 33-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 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 29Mar2021 at 23:45, the patient experienced sweating with chills, whole body aching, muscles in back and chest were hurting so bad, managed to go back to sleep but woke up every few hours. Followed by next day on 30Mar2021, the patient did not have a fever until around 6:00 AM when measured was 101 degrees. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any therapeutic measures. The patient underwent body temperature test on 30Mar2021 with result 101degrees. The clinical outcome of the event sweating with chills, whole body aching, muscles in back and chest were hurting so bad, managed to go back to sleep but woke up every few hours and fever was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: fever 101 degree; sweating; Chills; whole body aching; muscles in back and chest were hurting so bad; muscles in back and chest were hurting so bad; managed to go back to sleep but woke up every few hours; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm at 10:00 am on 29Mar2021 (at the age of vaccination 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously had no known allergies. Concomitant medications included Fluoxetine hydrochloride (PROZAC) started on an unknown date for unspecified indication. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3302) via an unspecified route of administration in the right arm on 08Mar2021 at 09:45 am (at the age of 33-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 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 29Mar2021 at 23:45, the patient experienced sweating with chills, whole body aching, muscles in back and chest were hurting so bad, managed to go back to sleep but woke up every few hours. Followed by next day on 30Mar2021, the patient did not have a fever until around 6:00 AM when measured was 101 degrees. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any therapeutic measures. The patient underwent body temperature test on 30Mar2021 with result 101degrees. The clinical outcome of the event sweating with chills, whole body aching, muscles in back and chest were hurting so bad, managed to go back to sleep but woke up every few hours and fever was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Cyst, Neoplasm, Nerve injury, Thanatophobia
Clinical narrative: a leg cist or cancer tumor; a leg cist or cancer tumor; loss of nerve damage; diabetes drops real low; I can die at any time, my functions are all out of walk.; This is a spontaneous report from a contactable Other health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Booster dose was administered. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced a leg cyst or cancer tumor, loss of nerve damage with, diabetes drops real low and he can die at any time, his functions were all out of walk. Patient mentioned that, he need serious help. He lives in a nursing home and was having serious health issues after getting the 2 doses of the Pfizer covid vaccine. He said that approximately 2 months ago he received the second dose and about the same time a leg cyst or cancer tumor started growing on him. He was going to pursuit a lawsuit against Pfizer and he was looking for legal counsel. He said he had photos to send to prove this. Patient reported that, he was going through serious symptoms after he got his second shot. he now had to see a surgeon, loss of nerve damage and diabetes drops real low. Patient said, I felt like I can die at any time, my functions are all out of walk. Outcome of the leg cyst or cancer tumor was not recovered whereas outcome of the loss of nerve damage, diabetes drops real low and i can die at any time, my functions are all out of walk were unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Throat tightness
Clinical narrative: throat was kind of tight; rash on neck and face; itching on my chest; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient (age at vaccination: 66-year-old) received bnt162b2 (BNT162B2 also reported as COVID-19 MRNA VACCINE BIONTECH, lot EN6208), via an unspecified route of administration on 16Mar2021 as dose 2, single for Covid-19 immunisation. Medical history included did have a little bump that was looking dry prior to the first dose of the vaccine (keratosis follicular). There were no concomitant medications. She had her first dose of bnt162b2 on 23Feb2021 (lot EN9581) in the left arm. On Mar2021, the patient experienced itching on her face, neck and chest - right below her neck, not the whole neck. On 21Mar2021, she had rash on neck and face and on 30Mar2021, her throat was kind of tight. She informed that she went to dermatologist and gave her medication, a steroid, and that was clearing up and once the dose ended it came back. She took 10mg of cetirizine this morning for her throat and it has improved. The outcome of itching was unknown; for rash was not recovered; for throat tightness was recovering.  No follow-up attempts are possible. No further information is expected.