chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Headache; Body aches; Difficulty taking full breaths; Insomnia; Chills; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male 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 06Apr2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included ashwagandha and multivitamins. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021 at 07:00, the patient experienced headache, body aches, difficulty taking full breaths, insomnia, chills and sweating. On 06Apr2021, the patient underwent nasal swab test and the result was negative. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events headache, body aches, difficulty taking full breaths, insomnia, chills and sweating were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Headache; Body aches; Difficulty taking full breaths; Insomnia; Chills; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male 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 06Apr2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included ashwagandha and multivitamins. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021 at 07:00, the patient experienced headache, body aches, difficulty taking full breaths, insomnia, chills and sweating. On 06Apr2021, the patient underwent nasal swab test and the result was negative. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events headache, body aches, difficulty taking full breaths, insomnia, chills and sweating were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: high pitch ringing; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 06Apr2021 08:15 as dose 1, single for covid-19 immunization at a pharmacy/drugstore. Medical history included hypertension from an unknown date which is currently in the normal range with medication. Concomitant medication included hydrochlorothiazide; omeprazole; and doxylamine all taken for an unspecified indication, start and stop date were not reported. The patient has not been tested for COVID-19 post vaccination and has not been diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 07Apr2021 08:30, just over 24 hours after receiving the vaccine, the patient was working at her desk, when all of a sudden it sounded like a cicada went off in her head, resulting in a high pitch ringing, which has been constant ever since. The patient had her hearing checked, which is extremely good, and don't have a history of tinnitus, so this seems to be completely new without any other known cause. It has been 4 weeks, and nothing has changed. The patient had a doctor's office visit for consultation. No treatment was given to the patient. The outcome of the event was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: high pitch ringing; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 06Apr2021 08:15 as dose 1, single for covid-19 immunization at a pharmacy/drugstore. Medical history included hypertension from an unknown date which is currently in the normal range with medication. Concomitant medication included hydrochlorothiazide; omeprazole; and doxylamine all taken for an unspecified indication, start and stop date were not reported. The patient has not been tested for COVID-19 post vaccination and has not been diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 07Apr2021 08:30, just over 24 hours after receiving the vaccine, the patient was working at her desk, when all of a sudden it sounded like a cicada went off in her head, resulting in a high pitch ringing, which has been constant ever since. The patient had her hearing checked, which is extremely good, and don't have a history of tinnitus, so this seems to be completely new without any other known cause. It has been 4 weeks, and nothing has changed. The patient had a doctor's office visit for consultation. No treatment was given to the patient. The outcome of the event was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site bruising, Lymphadenopathy
Clinical narrative: Fever; chills; muscle aches (spine); headache; swelling in right armpit; bruising on right arm; tired; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00 the patient experienced fever, chills, muscle aches (spine), headache, swelling in the right armpit, bruising on the right arm and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches (spine), headache, swelling in the right armpit, bruising on the right arm, and tired were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle aches (spine); headache; swelling in right armpit; bruising on right arm; tired; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00 the patient experienced fever, chills, muscle aches (spine), headache, swelling in the right armpit, bruising on the right arm and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches (spine), headache, swelling in the right armpit, bruising on the right arm, and tired were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Contusion, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Fever; chills; muscle aches (spine); headache; swelling in right armpit; bruising on right arm; tired; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00 the patient experienced fever, chills, muscle aches (spine), headache, swelling in the right armpit, bruising on the right arm and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches (spine), headache, swelling in the right armpit, bruising on the right arm, and tired were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Left armpit - swollen lymph node; Armpit is sore; felt a large bump, the bump is visible.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 15:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included vitamin d nos (VITAMIN D), finasteride (PROPECIA) and cetirizine hydrochloride (ZYRTEC), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 15:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient previously took azithromycin(ZITHROMAX) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 18:30 approx. 24 hours of second dose vaccine administration, the patient experienced swollen lymph node on left armpit, the armpit was sore and felt a large bump. The bump was visible. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events of swollen lymph node in left armpit, armpit sore and armpit bump was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Axillary pain, Lymphadenopathy
Clinical narrative: Left armpit - swollen lymph node; Armpit is sore; felt a large bump, the bump is visible.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 15:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included vitamin d nos (VITAMIN D), finasteride (PROPECIA) and cetirizine hydrochloride (ZYRTEC), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 15:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient previously took azithromycin(ZITHROMAX) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 18:30 approx. 24 hours of second dose vaccine administration, the patient experienced swollen lymph node on left armpit, the armpit was sore and felt a large bump. The bump was visible. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events of swollen lymph node in left armpit, armpit sore and armpit bump was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: +100 temp for three days as of now.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT) and guanfacine (MANUFACTURER UNKNOWN) both were taken for an unknown indication. The patient previously took prochlorperazine edisylate (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced allergy. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00 the patient experienced +100 temperature for three days as of now (as reported). The event did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care.  It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event +100 temp for three days as of now was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: +100 temp for three days as of now.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT) and guanfacine (MANUFACTURER UNKNOWN) both were taken for an unknown indication. The patient previously took prochlorperazine edisylate (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced allergy. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00 the patient experienced +100 temperature for three days as of now (as reported). The event did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care.  It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event +100 temp for three days as of now was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 15:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa, coconut, cats and outdoor allergies. Concomitant medications included ethinylestradiol, norgestimate (TRI-LINYAH BIRTH CONTROL) started on an unknown date for birth control and vitamins started on an unknown en for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 19:00 the patient experienced hives all over the body. 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 event. The clinical outcome of the event hives all over the body was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 15:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa, coconut, cats and outdoor allergies. Concomitant medications included ethinylestradiol, norgestimate (TRI-LINYAH BIRTH CONTROL) started on an unknown date for birth control and vitamins started on an unknown en for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 19:00 the patient experienced hives all over the body. 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 event. The clinical outcome of the event hives all over the body was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Left side of face went numb and was tingling; Left side of face went numb and was tingling; This is a spontaneous report from a contactable consumer, the patient. A 26-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 03Apr2021 at 12:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN) and lamotrigine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 13:30, the patient experienced left side of face went numb and was tingling. The patient could still smile evenly but could feel the numb/tingle moving throughout face. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left side of face went numb and was tingling was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal blistering, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: sore body and throat; sore body and throat; blisters at the edge of my mouth (which is very odd as I dont get cold sores); Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 07Apr2021 at 15:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic temporomandibular joint disorder (TMJ)/compressed neck nerve and recovered from hyperthyroid in 2020. The patient did not receive any  concomitant medications. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 15:30, on day 1 (injection day) the patient experienced sore arm, on 08Apr2021, day 2, the patient experienced sore body and throat and on 08Apr2021, day 2-3, the patient had blisters at the edge of the mouth (which is very odd as she doesn't get cold sores). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events sore arm, sore body and throat and blisters at the edge of the mouth was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 19Mar2021 at 11:15 (at an age of 45-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure and patient had no history of tinnitus. The patient did not have any allergies to medications, food, or other products. Concomitant medications included valsartan (MANUFACTURER UNKNOWN). The patient did not receive other vaccination within 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in left arm on 26Feb2021 at 11:45 hours as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 18:30 hours, 4 days after the second shot, the patient developed tinnitus. The ear, nose, and throat (ENT) doctor confirmed tinnitus was not caused by hearing loss, wax build up or sinus infection. Therapeutic measures were not taken as a result of the event. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 19Mar2021 at 11:15 (at an age of 45-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure and patient had no history of tinnitus. The patient did not have any allergies to medications, food, or other products. Concomitant medications included valsartan (MANUFACTURER UNKNOWN). The patient did not receive other vaccination within 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in left arm on 26Feb2021 at 11:45 hours as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 18:30 hours, 4 days after the second shot, the patient developed tinnitus. The ear, nose, and throat (ENT) doctor confirmed tinnitus was not caused by hearing loss, wax build up or sinus infection. Therapeutic measures were not taken as a result of the event. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Body ache; Arm soreness and pain; Fever-102; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 08Apr2021 at 16:00 (at the age of 69-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 had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 08:00, the patient experienced body ache, arm soreness and pain, fever-102. The events did not result in any of these 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. The clinical outcome of body ache, arm soreness and pain, fever-102 was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body ache; Arm soreness and pain; Fever-102; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 08Apr2021 at 16:00 (at the age of 69-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 had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 08:00, the patient experienced body ache, arm soreness and pain, fever-102. The events did not result in any of these 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. The clinical outcome of body ache, arm soreness and pain, fever-102 was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Burning sensation, Hypoaesthesia, Musculoskeletal stiffness, Pain
Clinical narrative: lower back / shoulder musclespasms.; I developed pretty severe paresthesias very soon after receiving this vaccination which have not fully gone away after 7 days.; The sensations are everything from severe numbness/tingling in my hands / feet /arms, sometimes shooting into my chest from my arms at night.; Sometimes is a feeling of like burning or electricity throughout my entire body; I also had brief, stabbing pains in my leg muscles at times; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 15:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease and fibromyalgia. The patient was not allergic to any medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced pretty severe paresthesia very soon after receiving the vaccination which had not fully gone away after 7 days. The sensations were everything from severe numbness/tingling in her hands/feet /arms, sometimes shooting into her chest from arms at night. Sometimes there was a feeling like burning or electricity throughout her entire body. The patient also had brief, stabbing pains in leg muscles at times and then some lower back / shoulder muscle spasms. The patient reported that it seemed to be slowly dissipating over time but it was concerning that it hadn't gone away after 7 days. No therapeutic measures were taken as a result of reported events. The reported events resulted in a visit to doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events paresthesia, numbness, burning sensation, muscle pain and muscle spasm were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: lower back / shoulder musclespasms.; I developed pretty severe paresthesias very soon after receiving this vaccination which have not fully gone away after 7 days.; The sensations are everything from severe numbness/tingling in my hands / feet /arms, sometimes shooting into my chest from my arms at night.; Sometimes is a feeling of like burning or electricity throughout my entire body; I also had brief, stabbing pains in my leg muscles at times; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 15:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease and fibromyalgia. The patient was not allergic to any medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced pretty severe paresthesia very soon after receiving the vaccination which had not fully gone away after 7 days. The sensations were everything from severe numbness/tingling in her hands/feet /arms, sometimes shooting into her chest from arms at night. Sometimes there was a feeling like burning or electricity throughout her entire body. The patient also had brief, stabbing pains in leg muscles at times and then some lower back / shoulder muscle spasms. The patient reported that it seemed to be slowly dissipating over time but it was concerning that it hadn't gone away after 7 days. No therapeutic measures were taken as a result of reported events. The reported events resulted in a visit to doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events paresthesia, numbness, burning sensation, muscle pain and muscle spasm were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: lower back / shoulder musclespasms.; I developed pretty severe paresthesias very soon after receiving this vaccination which have not fully gone away after 7 days.; The sensations are everything from severe numbness/tingling in my hands / feet /arms, sometimes shooting into my chest from my arms at night.; Sometimes is a feeling of like burning or electricity throughout my entire body; I also had brief, stabbing pains in my leg muscles at times; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 15:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease and fibromyalgia. The patient was not allergic to any medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced pretty severe paresthesia very soon after receiving the vaccination which had not fully gone away after 7 days. The sensations were everything from severe numbness/tingling in her hands/feet /arms, sometimes shooting into her chest from arms at night. Sometimes there was a feeling like burning or electricity throughout her entire body. The patient also had brief, stabbing pains in leg muscles at times and then some lower back / shoulder muscle spasms. The patient reported that it seemed to be slowly dissipating over time but it was concerning that it hadn't gone away after 7 days. No therapeutic measures were taken as a result of reported events. The reported events resulted in a visit to doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events paresthesia, numbness, burning sensation, muscle pain and muscle spasm were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Severe rash right arm, shoulder and back; Very Itchy; Red raised bumps; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6201) via an unspecified route of administration in the right arm on 01Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high, asthma, sleep apnea, bee sting and vegetable allergy (Radish allergy). Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D), vitamin xy (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took levofloxacin (LEVAQUIN) for tendon pain and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced severe rash right arm, shoulder and back. Red raised bumps. Looks like measles. Very itchy. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL, and hydrocortisone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of severe rash right arm, shoulder and back. Red raised bumps. Very itchy was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Severe rash right arm, shoulder and back; Very Itchy; Red raised bumps; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6201) via an unspecified route of administration in the right arm on 01Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high, asthma, sleep apnea, bee sting and vegetable allergy (Radish allergy). Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D), vitamin xy (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took levofloxacin (LEVAQUIN) for tendon pain and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced severe rash right arm, shoulder and back. Red raised bumps. Looks like measles. Very itchy. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL, and hydrocortisone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of severe rash right arm, shoulder and back. Red raised bumps. Very itchy was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears; Slightly nauseous; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 31-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's from an unknown date. Concomitant medication included ustekinumab (STELARA) taken for Crohn's disease from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 20:00, the same day after receiving the first dose, the patient experienced ringing in the ears. It was mild and the patient was also slightly nauseous. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ringing in the ears and slightly nauseous were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Ringing in the ears; Slightly nauseous; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 31-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's from an unknown date. Concomitant medication included ustekinumab (STELARA) taken for Crohn's disease from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 20:00, the same day after receiving the first dose, the patient experienced ringing in the ears. It was mild and the patient was also slightly nauseous. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ringing in the ears and slightly nauseous were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eye pain, Headache, Nausea
Clinical narrative: Major headache; Pain around eye; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153) via an unspecified route of administration in the arm left on 05Apr2021 at 10:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 10:45, the patient experienced major headache, pain around eye, dizziness and nausea. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events major headache, pain around eye, dizziness and nausea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.