chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 36-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 01Oct2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonidine (CATAPRESS) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Oct2021 at 09:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not resolved at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday; Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday. Itchy and it hurts and is swollen; Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday. Itchy and it hurts and is swollen; Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday. Itchy and it hurts and is swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308a) via an unspecified route of administration in the left deltoid on 11Oct2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and PCN (penicillin) allergy. Concomitant medications included hydrochlorothiazide/ telmisartan (TELMISARTAN HCTZ) 40-12.5 mg (milligram) for an unknown indication from an unknown date and unknown if ongoing. 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 previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy.  On 11Oct2021 at 16:00, the patient experienced large red quarter size bump at injection site which had grown to size of fifty cent piece since the previous day of report. It was itchy and it hurt and was swollen. 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 large red quarter size bump at injection site which had grown to size of fifty cent piece since the previous day of report, itchy and it hurt and was swollen was not resolved at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very sore arm near injection site; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the right arm on 11Oct2021 at 20:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 30Aug2021 at 10:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 12Oct2021 at 08:00, the patient experienced very sore arm near injection site. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event very sore arm near injection site was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Pain in extremity
Clinical narrative: Headache; Sore arm; Tired; Joint aches; Administration date 12Oct2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 12Oct2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and 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 acetylsalicylic acid (ASPIRIN); from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. On 12Oct2021 at 12:00, the patient had "administration date 12Oct2021, dose number=3". On 13Oct2021 at 10:00, the patient experienced headache, sore arm, tired and joint aches. 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 headache, sore arm, tired and joint aches. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, sore arm, tired and joint aches was not recovered. The clinical outcome of the event "administration date 12Oct2021, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cough, Illness, Pyrexia
Clinical narrative: fever; back/joints hurting/ her back was killing her and every joint was hurting her.; back/joints hurting/ her back was killing her and every joint was hurting her.; cough; got really sick; might have covid; This is a spontaneous report from a contactable consumer or other non hcp.     A 57-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 08Oct2021 15:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, on 11Oct2021, the patient experienced fever, back/joints hurting/ her back was killing her and every joint was hurting her, cough with outcome of recovering, got really sick and might have covid  with outcome of unknown.  Follow-up (13Oct2021): This is a follow-up spontaneous report from  a contactable 57-year-old female consumer (patient) who reported information included.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: fever; back/joints hurting/ her back was killing her and every joint was hurting her.; back/joints hurting/ her back was killing her and every joint was hurting her.; cough; got really sick; might have covid; This is a spontaneous report from a contactable consumer or other non hcp.     A 57-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 08Oct2021 15:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, on 11Oct2021, the patient experienced fever, back/joints hurting/ her back was killing her and every joint was hurting her, cough with outcome of recovering, got really sick and might have covid  with outcome of unknown.  Follow-up (13Oct2021): This is a follow-up spontaneous report from  a contactable 57-year-old female consumer (patient) who reported information included.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypersomnia, Ill-defined disorder, Pain
Clinical narrative: Body pain all over; Dizzy; Fatigue; Slept for 27 hours straight; I thought I was dying; 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: FE3590) via an unspecified route of administration in the left arm on 10Oct2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 10Sep2021 at 17:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 11Oct2021 at 01:45, the patient experienced the most extreme body pain all over that lasted for 24 hours after it began also dizzy and fatigue. The patient slept for 27 hours straight and thought she was dying. 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. The clinical outcome of the event most extreme body pain all over was resolved on 12Oct2021; while that of event dizzy, fatigue, slept for 27 hours straight and thought was dying was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Decreased appetite, Fatigue
Clinical narrative: Fatigue; Pain in arm; Pain under arm pits; Breast swollen with pain; Breast swollen with pain; Thirsty; Loss appetite; Couldn't do daily activities; Booster dose; This is a spontaneous report from contactable other healthcare professional. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 05Oct2021 at 11:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic, asthma and allergic to bananas and latex (Known allergies: bananas and latex). 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 daily vitamins from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 04Jan2021 at 11:15 (at the age of 45-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 25Jan2021 at 12:00 (at the age of 45-year-old) both as a single dose for COVID-19 immunisation. On 06Oct2021 at 09:00, the patient experienced fatigue, pain in arm, pain under armpits, breast swollen with pain, thirsty, loss of appetite and couldn't do daily activities. The events did not result in doctor or other healthcare professional office/clinic visits, 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 fatigue, pain in arm, pain under armpits, breast swollen with pain, thirsty, loss of appetite and couldn't do daily activities were not resolved at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of personal independence in daily activities, Pain in extremity, Thirst
Clinical narrative: Fatigue; Pain in arm; Pain under arm pits; Breast swollen with pain; Breast swollen with pain; Thirsty; Loss appetite; Couldn't do daily activities; Booster dose; This is a spontaneous report from contactable other healthcare professional. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 05Oct2021 at 11:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic, asthma and allergic to bananas and latex (Known allergies: bananas and latex). 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 daily vitamins from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 04Jan2021 at 11:15 (at the age of 45-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 25Jan2021 at 12:00 (at the age of 45-year-old) both as a single dose for COVID-19 immunisation. On 06Oct2021 at 09:00, the patient experienced fatigue, pain in arm, pain under armpits, breast swollen with pain, thirsty, loss of appetite and couldn't do daily activities. The events did not result in doctor or other healthcare professional office/clinic visits, 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 fatigue, pain in arm, pain under armpits, breast swollen with pain, thirsty, loss of appetite and couldn't do daily activities were not resolved at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymphadenopathy, Pain
Clinical narrative: Swelling between armpit and chest; Body aches; Headache; Fatigue; Booster\ received dose 3; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Oct2021 at 14:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to dust, dogs and cats. 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. Concomitant medications included collagen (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jan2021 at 18:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Feb2021 at 16:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. On 12Oct2021 at 12:00 AM, the patient experienced swelling between armpit and chest, body aches, headache and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling between armpit and chest, body aches, headache and fatigue was resolving at the time of the report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash vesicular
Clinical narrative: Rash with blisters like a burn on arm very painful; Rash with blisters like a burn on arm very painful; This is a spontaneous report from a contactable consumer, the patient. A 43-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 right arm on 08Oct2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication 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: UNKNOWN) via an unspecified route of administration in the right arm on 15Sep2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 18:00, the patient experienced rash with blisters like a burn on arm very painful. 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 rash with blisters like a burn on arm very painful was resolving at the time of the report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: started menstruating 4 days early after the first dose of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 38-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 13Sep2021 at 19:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received ciprofloxacin (CIPRO) for an unknown indication on an unknown date and experienced drug allergy. On 16Sep2021 at 12:00, after the first dose of vaccine. the patient started menstruating 4 days early. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started menstruating 4 days early was resolved with sequelae on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dizziness, Migraine
Clinical narrative: Fever for 5 days; Chills; Migraine; Cough; Extreme dizziness; Loss of appetite; Nausea; Hives for one day; Rash several days later that lasted two weeks and counting; This is a spontaneous report from a non-contactable consumer, the patient. A 21-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 left arm on 23Sep2021 at 10:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome which was ongoing and 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 metoprolol (MANUFACTURER UNKNOWN), isotretinoin (ACCUTANE) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 24Sep2021 at 15:00, the patient experienced fever for 5 days, chills, migraine, cough, extreme dizziness, loss of appetite, nausea, hives for one day; and then rash several days later that lasted two weeks and counting. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and included treatment with labs from an unknown date. Therapeutic measures were taken as a result of nausea and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives was resolved on 25Sep2021; while that of the event fever was resolved on 29Sep2021, after the duration of 5 days; and that of the events chills, migraine, cough, extreme dizziness, loss of appetite, nausea and rash were not resolved 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, Urticaria
Clinical narrative: Fever for 5 days; Chills; Migraine; Cough; Extreme dizziness; Loss of appetite; Nausea; Hives for one day; Rash several days later that lasted two weeks and counting; This is a spontaneous report from a non-contactable consumer, the patient. A 21-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 left arm on 23Sep2021 at 10:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome which was ongoing and 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 metoprolol (MANUFACTURER UNKNOWN), isotretinoin (ACCUTANE) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 24Sep2021 at 15:00, the patient experienced fever for 5 days, chills, migraine, cough, extreme dizziness, loss of appetite, nausea, hives for one day; and then rash several days later that lasted two weeks and counting. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and included treatment with labs from an unknown date. Therapeutic measures were taken as a result of nausea and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives was resolved on 25Sep2021; while that of the event fever was resolved on 29Sep2021, after the duration of 5 days; and that of the events chills, migraine, cough, extreme dizziness, loss of appetite, nausea and rash were not resolved 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.
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: Unable to lift right arm after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 09Sep2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included hypertension (Htn) and COVID-19. The patient had known allergies to nickel (Ni). Prior to 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 were not reported. On 27Sep2021, the patient was unable to lift right arm after receiving vaccine. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were 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 unable to lift right arm after receiving vaccine was unknown 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood urine present, Joint swelling, Neck pain, Pollakiuria
Clinical narrative: Back ache; Urinating up to 40 times a day; Severe neck pain; Swelling of ankles; Blood in urine; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Sep2021 at 09:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. 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 COVID-19 vaccine. The patient did not receive any concomitant medications. Within days of vaccine administration i.e. on 17Sep2021, the patient developed back ache, started urinating up to 40 times a day, severe neck pain and swelling of ankles. It took weeks to get appointment with her general physician. On an unknown date in 2021, the patient had blood in urine. 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 unspecified antibiotics for an unknown duration in 2021 for 5 days. There was no change even after antibiotic treatment and the patient was recommended to see a urologist. At the time of this report, the patient was scheduled for ultrasound to find out what is going on. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events back ache, started urinating up to 40 times a day, severe neck pain, swelling of ankles and blood in urine was not resolved 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: I have never suffered from Shingles, I have no stressors, and I had a sudden outburst in my back and my thigh.; It was excruciatingly painful; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 13Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and 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. The patient had never suffered from shingles and had no stressors. On 01Oct2021, the patient had a sudden outburst in her back and thigh, it was excruciatingly painful, this had been the most pain, she ever had. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with unspecified medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she had never suffered from shingles, she had no stressors, she had a sudden outburst in her back and her thigh was resolved on an unknown date in Oct2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the upper right arm on 12Oct2021 at 19:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pyrexia, Sensitive skin
Clinical narrative: Intense fatigue lasted for approx 72 hours post injection and still semi fatigued 5 days post vaccine; Dizzy within 10-15 mins of vaccine; 8-10 hours later skin became severely sensitive and sensation of being scraped or peeled with anything brushing against or touching it.; 10-12 hours after vaccine low grade fever began and remained for 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Sep2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included flu (The patient had never experienced in her life even with various rounds of flu) and possible penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Aug2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced dizzy within 10-15 mins of vaccine. On 14Sep2021, 8-10 hours later. skin became severely sensitive and sensation of being scraped or peeled with anything brushing against or touching it. This lasted approximately 12 hours. On 14Sep2021, 10-12 hours after vaccine, low grade fever began and remained for 48 hours. Intense fatigue lasted for approximately 72 hours post injection and still semi fatigued 5 days post vaccine. Still the patient was noticing skin sensory type sensitivity, but not as intense as it was week of vaccine. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events skin became severely sensitive and sensation, fatigue was not resolved, low grade fever was resolved on 16Sep2021 and dizzy was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Off label; Booster third dose; Aches; Fever; Swollen Lymph nodes; Fatigue; This is a spontaneous report from a contactable healthcare professional. An adult female patient of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Oct2021, 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. It was unknown whether the patient receive any other vaccines within four weeks prior to the vaccination or not. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced aches, fever, swollen lymph nodes and fatigue. It was unknown whether any therapeutic measures were 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 aches, fever, swollen lymph nodes and fatigue was resolved on an unknown date of Oct2021 at the time of this report.   The lot/batch number for BNT162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Migraine
Clinical narrative: Irregular period; Excessive bleeding; Developed migraines; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 14Aug2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19.  The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Aug2021, the patient experienced irregular period, excessive bleeding and developed migraines. 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 irregular period, excessive bleeding and developed migraines were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Monthly period is now heavier with more days of cramps/ pain, lasts a longer duration (total period time).; Monthly period is now heavier with more days of cramps/ pain; Monthly period is now heavier with more days of cramps/ pain; The bleeding is MUCH heavier and ''I'' occasionally vomit due to severe pain due to sustained cramping; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 18Jun2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included menstrual cramp (Before vaccine she only had severe cramping on first day of 3-4 days period) and known allergies to latex and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and fish oil (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing (not everyday). The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 22May2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 28Jun2021, the patient experienced monthly period that was now heavier with more days of cramps/ pain, and lasted a longer duration (total period time). The bleeding was much heavier and patient occasionally vomited due to severe pain due to sustained cramping. Then she had severe cramping for 3 days of a 5-6 days periods. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 23Aug2021, the patient underwent nasal swab test and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of event monthly period was now heavier with more days of cramps, pain and vomited due to severe pain due to sustained cramping was resolved with sequelae on an unknown date in 2021.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Chills; Fatigue; 3rd booster dose; This is a spontaneous report from a contactable consumer, the patient. An 83-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Oct2021 at 14:45 (at the age of 83-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 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jan2021 at 14:45 (at the age of 82-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Feb2021 at 14:45 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. On 13Oct2021, the patient experienced body aches, fever, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, fever, chills and fatigue was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 105; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Oct2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Sep2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021 at 13:00, the patient experienced fever of 105. On the same day, the patient underwent body temperature test and the result was 105 (units unspecified). The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever and included treatment with paracetamol (TYLENOL) 1000 mg and ibuprofen (MANUFACTURER UNKNOWN) 800 mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 105 was resolved on an unknown date in Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  .
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation
Clinical narrative: Tiredness and mild headache last night; Tiredness and mild headache last night; The patient received third (Booster) dose of BNT162b2; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 08Oct2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines with tiredness, cognitive and physical disabilities as well, that can make communicating as how the patient felt was difficult. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6205) via an unspecified route of administration on 01Mar2021 (at the age of 19-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 23Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021 at 21:00, the night before this report, the patient experienced tiredness and mild headache. He had an extra busy day and the weather was warm. The patient's hydration was monitored. The reporter obtained permission to file basic report from the patient's mother/legal guardian. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with over the counter (OTC) pain medication (unspecified) at home, based on medical history. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness and mild headache were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Psoriasis
Clinical narrative: psoriasis flare; Tiredness; This is a spontaneous report based on information received by Pfizer (Mfr. Control No.: (21K-163-4110909-00). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via intramuscular route on an unspecified date as dose 2, single, and first dose via intramuscular route on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriasis. Medical history included severe psoriasis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient's past medications included COSENTYX for unknown indication. The patient experienced psoriasis flare and tiredness on an unspecified date. The patient was on Skyrizi now forever 7 months. Her body was clear except for her scalp and arm but now had a flare she thought. She had both Pfizer vaccines and did not have any effects beside a little more tired for a day. Her flare couldn't be from vaccine because it has been over two and a half months or so. All her doctors recommended her for Covid-19 vaccine because She had more moderate to severe Psoriasis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st and 2nd dose COVID-19 Vaccine manufactured by Pfizer. The reporter's causality for the event(s) of PSORIASIS FLARE and TIRED was not provided. The outcome of event psoriasis flare was unknown and the outcome for tiredness was recovered on unspecified date of 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Polymenorrhoea
Clinical narrative: Menstrual cycle changes; Menstrual cycle changes heavier bleeding; Shorter cycles between periods; This is a spontaneous report from a contactable consumer, the patient. A 38-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 21May2021 at 15:00 (at the age of 38-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 vaccination. On 28May2021, the patient had menstrual cycle changes, heavier bleeding and shorter cycles between periods. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle changes, heavier bleeding and shorter cycles between periods was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.