chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient age at vaccination: 11 years; Sore arm; This is a spontaneous report from a contactable consumer. A 11-year-old patient of an unknown gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date in Sep2021 (age at vaccination: UNKNOWN) as a single dose for COVID-19 immunisation. Medical history included asthma; allergy to nuts and egg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified asthma inhaler taken for asthma from an unknown date and unknown if ongoing; and unspecified allergy medication taken for an unspecified indication from an unknown date and unknown if ongoing. On an unknown date in Sep2021, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolved on an unknown date in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Soreness at vaccination site of left arm; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 04Sep2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and allergy to peanuts. It was also reported that the patient could have had COVID-19 in Jan/Feb2021 as family members had it, but the patient was not tested. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included over the counter cetirizine hydrochloride (WAL ZYR) taken for allergies from an unknown date and unknown if ongoing. On 06Sep2021 at 08:00 in the morning, the patient experienced diarrhea which lasted all day and soreness at vaccination site of left arm. On 07Sep2021 in the morning, the patient still had diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness at vaccination site of left arm and diarrhea were not resolved at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin disorder, Skin exfoliation
Clinical narrative: Strange bruise; Overlying skin became leathery; Skin started peeling off revealing white tissue underneath; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL3181) via an unspecified route of administration in the left arm on 21Aug2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Aug2021 at 14:00, the patient developed strange bruise within 30 minutes of vaccination which persisted for 2 weeks and the overlying skin became leathery. Then, the patient's skin started peeling off revealing white tissue underneath. The patient had no cavitation and pain. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events strange bruise, overlying skin became leathery and skin started peeling off revealing white tissue underneath was not resolved at the time of this report.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash papular, Rash pruritic, SARS-CoV-2 test, Skin lesion
Clinical narrative: Red flat spot on left shoulder/ flat red itchy spots then got 3 on her butt next day (those are going away) 3rd day got on on her thigh (going away) her arm will fade then it will flare up again; After 24 hours of first shot she got bug bite looking clusters on her arm itchy and red bumps turned to flat red itchy spots; After 24 hours of first shot she got bug bite looking clusters on her arm itchy and red bumps turned to flat red itchy spots; Bug bite looking clusters on her arm; This is a spontaneous report from a contactable healthcare professional. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Sep2021 at 14:00 (at the age of 18-year-old), as a single dose for COVID-19 immunisation. Medical history included sometimes A Fib (Atrial fibrillation) and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA) and unspecified multivitamins and birth control medications; all for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Sep2021, at 14:00, the patient had an immediate, not realized at the time, a red flat spot in left shoulder. After 24 hours of first shot, the patient got bug bite looking clusters on her arm, itchy and red bumps turned to flat red itchy spots, got 3 on her "butt" next day (those were going away) and on third day, got on her thigh (was going away). The spots on arm would fade, then it would flare up again. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were taken as a result of event itchy and red bumps turned to flat red itchy spots which included treatment with fexofenadine hydrochloride (ALLEGRA) and diphenhydramine hydrochloride (BENEDRYL). Therapeutic measures were not taken as a result of the reported other events. The clinical outcome of the events red flat spot on left shoulder after 24 hours of first shot she got bug bite looking clusters on her arm itchy and red bumps turned to flat red itchy spots then got 3 on her butt next day (those are going away) 3rd day got on her thigh (going away) her arm will fade then, it will flare up again were unknown at the time of report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Maternal exposure during pregnancy, SARS-CoV-2 test, Tachycardia
Clinical narrative: Patient is pregnant at the time of vaccination/ Gestation period: 30 weeks; Dizziness; Tachycardia; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 02Sep2021 at 08:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included recurrent kidney stones and cluster headaches. The patient's last menstrual date was on 08Feb2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent SARS-CoV-2 polymerase chain reaction (PCR) test via nasal swab on 16Jan2021, 09Feb2021 and 16Jun2021 respectively and the results were negative. The patient received other vaccine within four weeks prior to the COVID-19 vaccine which included first dose of tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine (MANUFACTURER UNKNOWN), Lot Number: 59TH3 in the left arm on 16Aug2021 for immunisation. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), levetiracetam (KEPPRA) and acetylsalicylic acid (ASA)/butalbital/caffeine/codeine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received sumatriptan (MANUFACTURER UNKNOWN) and experienced drug allergy. On 02Sep2021, the patient experienced dizziness and tachycardia. The gestational period was 30 weeks. The patient's estimated delivery date was 08Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and tachycardia was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic increased, Blood pressure measurement, Blood pressure systolic increased
Clinical narrative: Blood pressure has risen by over 10 systolic and more diastolic; Blood pressure has risen by over 10 systolic and more diastolic; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 03Sep2021 at 11:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, emphysema, chronic obstructive pulmonary disease (reported as copd), hypertension and many allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin glargine (TOUJEO), metformin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and fenofibrate (FENOFIBRATE MICRO); all from unknown dates for unknown indications and unknown if ongoing. On 03Sep2021, the patient had hypertension and her blood pressure had risen by over ten systolic and more diastolic. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event blood pressure had risen by over ten systolic and more diastolic was not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash pruritic, Urticaria
Clinical narrative: Itchy hived rash over thighs; Itchy hived rash over thighs; Heat-like rash on shins; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 24Aug2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The medical history included allergies to sulfa, adhesives and onions. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included various over the counter (OTC) vitamins for unknown indications from unknown dates and unknown if ongoing. On 29Aug2021, the patient experienced itchy hived rash over thighs and heat like rash on shins. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy hived rash over thighs and heat like rash on shins was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). This report received from a Pfizer-sponsored program. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot number: unknown), at the age of 64 years old, in Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two weeks later, the patient experienced tested positive for COVID-19 on an unspecified date in 2021. Caller was asking about taking the second dose. Caller stated he wouldn't be allowed to receive the second dose until he tested negative for COVID-19, "which put him over the 42 days window." Caller was asking if there was adverse effect receiving the second dose now. Seriousness criteria was reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 test: positive in 2021. The outcome of events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: His grandmother received the Pfizer COVID 19 vaccine and died 3 days later; This is a spontaneous report from a contactable consumer or other non-healthcare professional (reporter's grandson reported for his grandmother). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that his grandmother received the Pfizer COVID 19 vaccine and died 3 days later. It was reported that caller's grandmother who was 71-year-old received the Pfizer COVID 19 vaccine and died 3 days later. He wanted to talk to medical information department about why there was no FDA information on the boxes about who is liable before he gets the vaccine. He worked in the medical field but was not a medical professional and he has seen the packaging there was just a QR code and a fact sheet. His questions are one, he has to sign a form before he gets the vaccine. He has a lawyer, and they said its still under emergency use. His lawyer was saying that the company he works for was not liable if anything happens. He was a single father with two kids. His question was after seeing on the news that said its 100% approved but the lawyer was saying it was not. Other countries are saying it was not even a pandemic. He has to weigh out the pros and cons and he wants to know if it's safe. Product quality complaint was reported as yes. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].; Reported Cause(s) of Death: His grandmother received the Pfizer COVID 19 vaccine and died 3 days later
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dizziness, Fatigue
Clinical narrative: Feeling unwell (bad cough); Weakness; Dizziness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell (bad cough); This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 03Sep2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not aware of any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Sep2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, feeling unwell (bad cough), dizziness and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, fever, feeling unwell (bad cough), dizziness and weakness was not resolved at the time of the report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Feeling unwell (bad cough); Weakness; Dizziness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell (bad cough); This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 03Sep2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not aware of any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Sep2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, feeling unwell (bad cough), dizziness and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, fever, feeling unwell (bad cough), dizziness and weakness was not resolved at the time of the report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, SARS-CoV-2 test
Clinical narrative: Muscle and joint pain in left shoulder; Muscle and joint pain in left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 10Aug2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 20Jul2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 12Aug2021, the patient experienced muscle and joint pain in left shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 30Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events muscle and joint pain in left shoulder was not recovered at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Bilateral  pain in both wrists developed out of the blue which progressively worsened with both hurting.; This is a spontaneous report from a contactable pharmacist, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 17Aug2021 at 11:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no chronic diseases, no significant medical history and had no history of wrist problems or arthritis. . The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D) and zinc (MANUFACTURER UNKNOWN); both taken for unknown indications from unknown dates and unknown if ongoing. On 24Aug2021 at 08:00, the patient experienced bilateral pain in both wrists that developed out of the blue which was followed by the vaccine shot. It had progressively worsened with both wrists hurting. On 04Sep2021, the patient wrapped right wrist with bandage and then bought wrist brace at store on 07Sep2021 for right wrist since the patient was right-handed and complete rest for that wrist was not possible. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures taken as a result of the event included treatment with wrapping of ace type bandage on the right wrist from 04Sep2021 and wrist braces which was used from 07Sep2021. The clinical outcome of the event bilateral pain in both wrists was not resolved at the time of this report.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle aches; Tired; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Sep2021 at 16:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 16:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 00:00, the patient experienced fever, chills, muscle aches and tired. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches, and tired were recovered on an unknown date in Sep2021.  The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3102) via an unspecified route of administration in the left arm on 01Sep2021 at 20:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as not applicable. On 05Sep2021 at 00:00, the patient experienced loss of taste and smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events loss of taste and smell was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Lower extremity body aches 24 hours following second injection; Severe headache starting 24 hours after second injection and mild lingering headache for 96 hours following the second injection.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Sep2021 at 18:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergy and medical history was reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included estradiol/norgestimate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Aug2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 04Sep2021 at 18:00, the patient had mild lingering headache for 96 hours following the second injection. On 04Sep2021 at 18:30 (24 hours following second injection), the patient experienced lower extremity body aches and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event severe headache starting 24 hours and mild lingering headache for 96 hours following the second injection, lower extremity body aches 24 hours following second injection was recovering 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness down the right arm into hands/right side of face has numbness/also down to right leg; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Sep2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, type 1 diabetes and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received other unspecified medicines within two weeks prior to the COVID-19 vaccine. On 07Sep2021 at 14:45, the patient experienced numbness down the right arm into hands, right side to face has numbness and also down to right leg. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event numbness down the right arm into hands/right side of face has numbness/also down to right leg was not recovered at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphonia, Head discomfort, Migraine
Clinical narrative: Severe migraine 21+ days; Pressure inside head; Unable to use loud voice or talk aloud for extended periods of time; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via intramuscular route of administration in the left arm on 17Aug2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received ceftriaxone sodium (ROCEPHIN), clindamycin (MANUFACTURER UNKNOWN), amoxicillin/clavulanate potassium (AUGMENTIN), epinephrine (MANUFACTURER UNKNOWN), and methylprednisolone sodium succinate (SOLU-MEDROL) and experienced drug allergy. On 17Aug2021 at 13:30, the patient experienced severe migraine for more than 21 days, pressure inside head and was unable to use loud voice or talk aloud for extended periods of time. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient underwent computed tomography (CT) scan and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with unspecified pain relievers. The patient also reported that the pain relievers did not work. The clinical outcome of the events severe migraine 21+ days, pressure inside head and unable to use loud voice or talk aloud for extended periods of time were not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Brother died; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 36-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced brother died. During the phone call received, the reporter stated, "I want to thank you for your vaccine, it was most likely that, that got my 99-year-old aunt, she would've died in her sleep anyway at 104. No cane, no walker. Full head of hair.  Something slipped up the heart now. You're the responsibility party. This man from the (inaudible) brother died. He was 36 years old, I don't know if that was yours." The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Brother died
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Discomfort, Lethargy, Pain in extremity
Clinical narrative: Swelling at site which extended to the forearm; Swelling at site which extended to the forearm; Some discomfort; Lethargic; Appetite decreased; Loss of energy; Sore arm; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 28Aug2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to shellfish and nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 07Aug2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 (reported as Saturday evening), the patient was lethargic and it increased on Sunday which was the day of and the day after. The patient experienced appetite decreased and loss of energy. He complained of a sore arm and some discomfort on Saturday. On 29Aug2021 (reported as Sunday evening), the patient showed swelling at site which extended to the forearm. The patient was observed on an additional day for swelling. On 30Aug2021 (reported as Monday), he was kept home to insure that swelling was subsided. It was reported that improvement was seen on 31Aug2021 (reported as Tuesday), to monitor soreness to site and less lethargic. The patient returned to school on Tuesday and the events were reported to paediatrician via phone call. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL), ice pack, calamine/ glycerol/zinc oxide (CALAMINE LOTION) to swollen area,  diphenhydramine hydrochloride (BENADRYL) with 1 dissolvable allergy tablet and cetirizine hydrochloride (ZYRTEC). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lethargic, appetite decreased, loss of energy, sore arm, some discomfort and swelling at site which extended to the forearm was resolved on an unknown date in 2021.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: Swelling at site which extended to the forearm; Swelling at site which extended to the forearm; Some discomfort; Lethargic; Appetite decreased; Loss of energy; Sore arm; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 28Aug2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to shellfish and nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 07Aug2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 (reported as Saturday evening), the patient was lethargic and it increased on Sunday which was the day of and the day after. The patient experienced appetite decreased and loss of energy. He complained of a sore arm and some discomfort on Saturday. On 29Aug2021 (reported as Sunday evening), the patient showed swelling at site which extended to the forearm. The patient was observed on an additional day for swelling. On 30Aug2021 (reported as Monday), he was kept home to insure that swelling was subsided. It was reported that improvement was seen on 31Aug2021 (reported as Tuesday), to monitor soreness to site and less lethargic. The patient returned to school on Tuesday and the events were reported to paediatrician via phone call. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL), ice pack, calamine/ glycerol/zinc oxide (CALAMINE LOTION) to swollen area,  diphenhydramine hydrochloride (BENADRYL) with 1 dissolvable allergy tablet and cetirizine hydrochloride (ZYRTEC). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lethargic, appetite decreased, loss of energy, sore arm, some discomfort and swelling at site which extended to the forearm was resolved on an unknown date in 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Numbness like feeling in the little finger of the left hand/ symptoms were present in little finger and ring finger; Finger is tender anytime the patient have hand in water; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On an unknown date in Apr2021, the patient experienced numbness like feeling in the little finger of the left hand. The finger was tender anytime the patient had her hand in water (washing dishes, taking shower etc.). It was reported that the patient noticed the symptoms shortly after the shot and it was not going away. Initially, the symptoms were present in little finger and ring finger, but symptoms persisted in little finger. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 28Apr2021, the patient underwent polymerase chain reaction (PCR) testing via nasal swab and the result was negative. The clinical outcome of the events numbness like feeling in the little finger of the left hand/ symptoms were present in little finger and ring finger and finger is tender anytime the patient have hand in water was not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 05May2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular, Muscle spasms
Clinical narrative: Next period after received the vaccine was completely off; Bled longer, heavier and was accompanied with painful headaches and cramps.; Bled longer, heavier and was accompanied with painful headaches and cramps.; It has been 4 months since and periods are still irregular but no longer last 10 days; Bled longer, heavier and was accompanied with painful headaches and cramps.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14May2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and vitamins (unspecified); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 22May2021, the next period after the patient received the vaccine was completely off. The patient bled longer, heavier and was accompanied with painful headaches and cramps. It had been four months since, and her periods were still irregular but thankfully no longer lasted ten days. The patient was still dealing with significantly more bleeding with her periods but at least it had slowed somewhat from before. It had been the only lasting effect the patient had but was highly concerning and frustrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events next period after the patient received the vaccine was completely off; bled longer, heavier and was accompanied with painful headaches and cramps and it has been four months since and her periods are still irregular but no longer last ten days was unknown at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, Throat irritation
Clinical narrative: Swollen lips; Itchy throat; Fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 10Aug2021 (at the age of 45-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03Sep2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shell fish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine hydrochloride (PAXIL) and THRIVE vitamins; both for unknown indication from unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPRIN) for unknown indication on unknown date and experienced drug allergy. On an unknown date in 2021, the patient experienced swollen lips, itchy throat and fever. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lips, itchy throat, fever was resolved on an unknown date in Sep2021.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Migraine, Pain
Clinical narrative: Early, very much longer than usual, heavier and more painful menstrual cycle; Early, very much longer than usual, heavier and more painful menstrual cycle; Early, very much longer than usual, heavier and more painful menstrual cycle; Early, very much longer than usual, heavier and more painful menstrual cycle; Feeling terrible body aches; Migraines; Pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 20-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 29Aug2021 at 12:30 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 08Aug2021 at 16:30 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. On 30Aug2021 at 07:45, the patient experienced early, very much longer than usual, heavier and more painful menstrual cycle as well as felt terrible body aches, pain and migraines. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early menstruation, very much longer than usual menstruation, heavier menstruation, more painful menstrual cycle, felt terrible body aches, pain and migraines were recovered with sequelae on an unspecified date in 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Headaches began day after and continue to today- 5 days later; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Immediate swelling at site; Severe fatigue for 3 days after, moderate today; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; GI upset with diarrhea x 3 days; GI upset with diarrhea x 3 days; Lymph node swelling underarm on side of injection; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 03Sep2021 at 12:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 03Sep2021 at 17:30, the patient experienced immediate swelling at site. On 04Sep2021, the next morning, patient experienced grapefruit size hot tender knot at injection site. On 05Sep201, the patient had headaches which began day after and continued to current day, 5 days later. The patient had severe fatigue for 3 days after, moderate the current day and muscle, body and neck aches which were continuing. The patient also had gastrointestinal upset (GI upset) with diarrhea for three days and lymph node swelling in underarm on side of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events immediate swelling at site, next morning grapefruit size hot tender knot at injection site, headaches began day after and continue to today- 5 days later, severe fatigue for 3 days after, moderate today, muscle, body and neck aches continuing, lymph node swelling underarm on side of injection was not recovered at the time of this report and of GI upset with diarrhea x 3 days was recovered on an unknown date of Sep2021.