chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: physical pain in temples, sensitive to the touch. Painful to touch, talk or chew.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: er8731) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The medical history included blood pressure high and allergy(unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 17Apr2021, the patient experienced physical pain in temples, sensitive to the touch and painful to touch, talk or chew. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events physical pain in temples, sensitive to the touch and painful to touch, talk or chew was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Strong metallic taste and smell; Strong metallic taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 42-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 21Apr2021 at 08:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis in knees. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included celecoxib (CELEBREX), valaciclovir hydrochloride (VALTREX) and unspecified multivitamins; all from an unknown date for an unknown indication and unknown if ongoing. On 21Apr2021 at 08:45, the patient experienced strong metallic taste and smell. The events 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events strong metallic taste and smell were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Soreness at injection site; Tingling on the fingers of the left arm; Numbness on the fingers of the left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 07:00, the patient experienced soreness at injection site and tingling and numbness on the fingers of the left arm. Therapeutic measures were not taken as a result of the adverse events. The events 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. The clinical outcome of the events soreness at injection site, tingling and numbness on the fingers of the left arm were resolving 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: Hypoaesthesia, Paraesthesia, Vaccination site pain
Clinical narrative: Soreness at injection site; Tingling on the fingers of the left arm; Numbness on the fingers of the left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 07:00, the patient experienced soreness at injection site and tingling and numbness on the fingers of the left arm. Therapeutic measures were not taken as a result of the adverse events. The events 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. The clinical outcome of the events soreness at injection site, tingling and numbness on the fingers of the left arm were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Localized Pain in the left arm; Weakness in left arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8734) via an unspecified route of administration in the left arm on 01Apr2021 at 18:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history .The patient had no allergies to medications, food, or other products. Prior to the 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 vaccine. On 02Apr2021, the patient experienced localized pain and weakness in the left arm and it was still present 3 weeks after injection. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events localized pain and weakness in left arm was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit; pain; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer EN6199) via an unspecified route of administration in the left arm on 19Apr2021 at 10:15(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. Patient had no known allergies to food, medication or other products. 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. On 20Apr2021 at 12:00, the patient experienced swollen armpit and pain. The patient did not receive any treatment for the event. The events 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. The clinical outcome of the event swollen armpit and pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swollen armpit; pain; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer EN6199) via an unspecified route of administration in the left arm on 19Apr2021 at 10:15(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. Patient had no known allergies to food, medication or other products. 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. On 20Apr2021 at 12:00, the patient experienced swollen armpit and pain. The patient did not receive any treatment for the event. The events 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. The clinical outcome of the event swollen armpit and pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Ear pain, Headache, Tinnitus
Clinical narrative: Significant headaches; Fatigue; Dizziness; Ear aches; Ringing in the ears; Experienced the "normal" side effects which occurred within the first 48 hours of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included seasonal allergies (hay fever). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), triamcinolone acetonide (NASACORT) and cetirizine hydrochloride (ZYRTEC); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and erythromycin ethylsuccinate; sulfafurazole acetyl (PEDIAZOLE) and experienced drug allergies. 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 17Mar2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Apr2021, the patient initially experienced the "normal" side effects which occurred within the first 48 hours of the vaccine. On 10Apr2021 at 12:00 at the 72-hour mark, the patient experienced significant headaches, fatigue, dizziness, ear aches and ringing in the ears which were non-stop until about 21Apr2021 (2 whole weeks straight). The patient reported that while it had gotten a lot better, the side effects were not completely gone. The patient reported that as there was very little information about dizziness as a side effect and it was particularly scary when it lasted beyond the 3-4 days that most information sites quoted as the typical side effect period for the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN), 40 mg (milligrams) once per day for 3 days. On an unknown date in Apr2021, the patient had a bloodwork done which was ordered by the patients' doctor, the results of which were unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "normal" side effects which occurred within the first 48 hours of the vaccine, significant headaches, fatigue, dizziness, ear aches and ringing in the ears was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear pain, Fatigue, Headache, Tinnitus
Clinical narrative: Significant headaches; Fatigue; Dizziness; Ear aches; Ringing in the ears; Experienced the "normal" side effects which occurred within the first 48 hours of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included seasonal allergies (hay fever). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), triamcinolone acetonide (NASACORT) and cetirizine hydrochloride (ZYRTEC); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and erythromycin ethylsuccinate; sulfafurazole acetyl (PEDIAZOLE) and experienced drug allergies. 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 17Mar2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Apr2021, the patient initially experienced the "normal" side effects which occurred within the first 48 hours of the vaccine. On 10Apr2021 at 12:00 at the 72-hour mark, the patient experienced significant headaches, fatigue, dizziness, ear aches and ringing in the ears which were non-stop until about 21Apr2021 (2 whole weeks straight). The patient reported that while it had gotten a lot better, the side effects were not completely gone. The patient reported that as there was very little information about dizziness as a side effect and it was particularly scary when it lasted beyond the 3-4 days that most information sites quoted as the typical side effect period for the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN), 40 mg (milligrams) once per day for 3 days. On an unknown date in Apr2021, the patient had a bloodwork done which was ordered by the patients' doctor, the results of which were unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "normal" side effects which occurred within the first 48 hours of the vaccine, significant headaches, fatigue, dizziness, ear aches and ringing in the ears was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Neck pain
Clinical narrative: Cramp-like pain between shoulder where I got the injection (left) and top of neck; Cramp-like pain between shoulder where got the injection (left) and top of neck; This is a spontaneous report from a contactable consumer, the patient. A 58-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 18Apr2021 at 14:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products (reported as not that the patient known of). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medicines within two weeks of vaccination. On an unknown date in Apr2021, the patient experienced cramp-like pain between shoulder where the patient got the injection (left) and top of neck. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cramp-like pain between shoulder where the patient got the injection (left) and top of neck was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Cramp-like pain between shoulder where I got the injection (left) and top of neck; Cramp-like pain between shoulder where got the injection (left) and top of neck; This is a spontaneous report from a contactable consumer, the patient. A 58-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 18Apr2021 at 14:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products (reported as not that the patient known of). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medicines within two weeks of vaccination. On an unknown date in Apr2021, the patient experienced cramp-like pain between shoulder where the patient got the injection (left) and top of neck. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cramp-like pain between shoulder where the patient got the injection (left) and top of neck was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus developed evening of first shot; smoke smell; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid nodules and allergic to contrast dye for cat scans. 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 biotin (MANUFACTURER UNKNOWN), ONE A DAY VITAMIN and calcium supplements (unspecified); all for an unspecified indication, from an unknown date and unknown if ongoing. On 13Mar2021, at 19:00 the patient experienced tinnitus on the evening of first shot and later smoke smell. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus and smoke smell which included treatment with steroids (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus and smoke smell was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Tinnitus
Clinical narrative: Tinnitus developed evening of first shot; smoke smell; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid nodules and allergic to contrast dye for cat scans. 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 biotin (MANUFACTURER UNKNOWN), ONE A DAY VITAMIN and calcium supplements (unspecified); all for an unspecified indication, from an unknown date and unknown if ongoing. On 13Mar2021, at 19:00 the patient experienced tinnitus on the evening of first shot and later smoke smell. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus and smoke smell which included treatment with steroids (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus and smoke smell was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus right ear; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included oral allergy syndrome (moderate) and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine (CLARITIN), fluticasone propionate (FLONASE) and fish oil (OMEGA 3); all from unknown date for unknown indication and unknown if ongoing. The patient previously took cefaclor (CECLOR) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 the patient experienced tinnitus right ear, no previous issues. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus right ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Night sweats
Clinical narrative: Diarrhea; Swelling; body pain; This is a Spontaneous Report from contactable consumer via Pfizer Sponsored Program. An unspecified age of male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Diarrhea, Swelling, and Body pain. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Pain, Swelling
Clinical narrative: Diarrhea; Swelling; body pain; This is a Spontaneous Report from contactable consumer via Pfizer Sponsored Program. An unspecified age of male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Diarrhea, Swelling, and Body pain. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Occasional moderate dizziness; Occasional moderatedizziness/vertigo; 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: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included esomeprazole (NEXIUM), loratadine (CLARITIN), magnesium (MANUFACTURER UNKNOWN), cherry extract (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIR) from unknown start dates for unknown indications. In Apr2021, the patient experienced occasional moderate dizziness/vertigo. Since the vaccination, the patient had not been tested for COVID-19. The adverse 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 events. The clinical outcomes of the event occasional moderate dizziness/vertigo was unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Mobility decreased, Oedema peripheral
Clinical narrative: Left armpit got swollen; Pain radiates to elbow and can't use arm; Left armpit got swollen and it started to ache.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 17:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. 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 hyoscine butylbromide (BUSCOPAN), minocycline capsule (MANUFACTURER UNKNOWN) and tretinoin gel (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. On 24Apr2021 at 15:00, 12 days after vaccination, the patient experienced left armpit got swollen and it started to ache, the pain radiates to elbow and can't use her arm. On 22Apr2021, the patient underwent SARS-CoV-2 PCR saliva surveillance and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events left armpit got swollen and it started to ache, the pain radiates to elbow and can't use arm were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain, SARS-CoV-2 test, Swelling
Clinical narrative: Left armpit got swollen; Pain radiates to elbow and can't use arm; Left armpit got swollen and it started to ache.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 17:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. 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 hyoscine butylbromide (BUSCOPAN), minocycline capsule (MANUFACTURER UNKNOWN) and tretinoin gel (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. On 24Apr2021 at 15:00, 12 days after vaccination, the patient experienced left armpit got swollen and it started to ache, the pain radiates to elbow and can't use her arm. On 22Apr2021, the patient underwent SARS-CoV-2 PCR saliva surveillance and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events left armpit got swollen and it started to ache, the pain radiates to elbow and can't use arm were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Dyspnoea, Fatigue, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in throat/neck area; Grape size knot near collar bone on side of injection site; Some loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 14:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. The patient did not receive any concomitant medications. 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 14Apr2021 at 21:45, within 8 hours of the vaccination, the patient experienced swollen lymph nodes in throat/neck area. On an unknown date in Apr2021, 3-4 days after vaccination, the patient experienced grape size knot near collar bone on side of injection site with some loss of voice. No 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 swollen lymph nodes in throat/neck area and grape size knot near collar bone on side of injection site and some loss of voice were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Swollen lymph nodes in throat/neck area; Grape size knot near collar bone on side of injection site; Some loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 14:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. The patient did not receive any concomitant medications. 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 14Apr2021 at 21:45, within 8 hours of the vaccination, the patient experienced swollen lymph nodes in throat/neck area. On an unknown date in Apr2021, 3-4 days after vaccination, the patient experienced grape size knot near collar bone on side of injection site with some loss of voice. No 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 swollen lymph nodes in throat/neck area and grape size knot near collar bone on side of injection site and some loss of voice were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Lymphadenopathy, Mass
Clinical narrative: Swollen lymph nodes in throat/neck area; Grape size knot near collar bone on side of injection site; Some loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 14:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. The patient did not receive any concomitant medications. 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 14Apr2021 at 21:45, within 8 hours of the vaccination, the patient experienced swollen lymph nodes in throat/neck area. On an unknown date in Apr2021, 3-4 days after vaccination, the patient experienced grape size knot near collar bone on side of injection site with some loss of voice. No 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 swollen lymph nodes in throat/neck area and grape size knot near collar bone on side of injection site and some loss of voice were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid increased, Chest X-ray normal, Dizziness, Headache, Intensive care
Clinical narrative: my lactic acid was like 4; This is a spontaneous report from a Pfizer sponsored program.  A contactable Other HCP (patient) reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 2, single for covid-19 immunization. The patient medical history included diabetes. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. On unspecified date of 2021, the patient reported that she was hospitalized after her second dose, stating "my lactic acid was like 4". Patient had a history of diabetes which is "not very controlled right now". She works in emergency medicine and was not sure what to do about receiving a 3rd dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event "lactic acid decreased" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Urine analysis, Vomiting
Clinical narrative: my lactic acid was like 4; This is a spontaneous report from a Pfizer sponsored program.  A contactable Other HCP (patient) reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 2, single for covid-19 immunization. The patient medical history included diabetes. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. On unspecified date of 2021, the patient reported that she was hospitalized after her second dose, stating "my lactic acid was like 4". Patient had a history of diabetes which is "not very controlled right now". She works in emergency medicine and was not sure what to do about receiving a 3rd dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event "lactic acid decreased" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: my lactic acid was like 4; This is a spontaneous report from a Pfizer sponsored program.  A contactable Other HCP (patient) reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 2, single for covid-19 immunization. The patient medical history included diabetes. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. On unspecified date of 2021, the patient reported that she was hospitalized after her second dose, stating "my lactic acid was like 4". Patient had a history of diabetes which is "not very controlled right now". She works in emergency medicine and was not sure what to do about receiving a 3rd dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event "lactic acid decreased" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Blood lactic acid increased, Heart rate, Heart rate irregular
Clinical narrative: my lactic acid was like 4; This is a spontaneous report from a Pfizer sponsored program.  A contactable Other HCP (patient) reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 2, single for covid-19 immunization. The patient medical history included diabetes. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. On unspecified date of 2021, the patient reported that she was hospitalized after her second dose, stating "my lactic acid was like 4". Patient had a history of diabetes which is "not very controlled right now". She works in emergency medicine and was not sure what to do about receiving a 3rd dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event "lactic acid decreased" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Blood lactic acid decreased
Clinical narrative: my lactic acid was like 4; This is a spontaneous report from a Pfizer sponsored program.  A contactable Other HCP (patient) reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 2, single for covid-19 immunization. The patient medical history included diabetes. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. On unspecified date of 2021, the patient reported that she was hospitalized after her second dose, stating "my lactic acid was like 4". Patient had a history of diabetes which is "not very controlled right now". She works in emergency medicine and was not sure what to do about receiving a 3rd dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event "lactic acid decreased" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Gait disturbance, Hand-eye coordination impaired
Clinical narrative: Dizziness; Vertigo/ feel like going to collapse many times throughout the day.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew 0150) via an unspecified route of administration in the left arm on 16Apr2021 at 10:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any medications within two weeks of the COVID-19 vaccine. On 18Apr2021 at 00:00, the patient experienced dizziness, vertigo. Felt like he was going to collapse many times throughout the day. Side effect started a couple days after shot and still continued. 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 dizziness, vertigo. Felt like he was going to collapse many times throughout the day was not recovered at the time of this report.  No follow-up attempts are needed; No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo/ feel like going to collapse many times throughout the day.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew 0150) via an unspecified route of administration in the left arm on 16Apr2021 at 10:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any medications within two weeks of the COVID-19 vaccine. On 18Apr2021 at 00:00, the patient experienced dizziness, vertigo. Felt like he was going to collapse many times throughout the day. Side effect started a couple days after shot and still continued. 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 dizziness, vertigo. Felt like he was going to collapse many times throughout the day was not recovered at the time of this report.  No follow-up attempts are needed; No further information is expected.