chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: Rashes all over body; Swollen lips; This is a spontaneous report from a contactable consumer, the patient. A 24-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 23Mar2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient apparently had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 14Apr2021 at 07:00, the patient experienced rashes all over body and swollen lips. 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 taken as a result of events and included treatment with diphenhydramine hydrochloride (BENADRYL) and cetrizine hydrochloride (ZERTEC). The clinical outcome of the events rashes all over body and swollen lips were not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pins and needles all over my body (on and off); Numbness in lower arms on both sides and face; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GY2613) via an unspecified route of administration in the right arm on 30Mar2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to food, medicine and other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) since 2012 (reported as for last 10 years) for an unknown indication. On 06Apr2021, the patient experienced pins and needles all over body (on and off), with once in the while feeling of numbness in lower arms on both sides and face. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pins and needles all over my body (on and off) and numbness in lower arms on both sides and face were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Paraesthesia
Clinical narrative: I have been experiencing pins and needles in both arms and hands, and also, to a lesser extent, in my legs.; I am also having some achy pangs in associated areas.; I am also feeling fatigue and headaches.; I am also feeling fatigue and headaches.; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (age at vaccination unknown) as a single dose for COVID-19 immunisation. Medical history included scoliosis and back surgery (reported as scoliosis(spinal surgery)), asthma and allergic to tree nuts, peanuts and pollen. Concomitant medication received within two weeks of vaccination included multi-vitamin taken from unknown date for 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. From 17Apr2021 at 12:30, the patient has been experiencing pins and needles in both arms and hands, and also, to a lesser extent, in her legs. The patient was also having some achy pangs in associated areas. She was also feeling fatigue and headaches. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events has been experiencing pins and needles in both arms and hands, and also, to a lesser extent, in her legs; was also having some achy pangs in associated areas; was also feeling fatigue and headaches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster aka "shingles" from varicella zoster virus (VZV); This is a spontaneous report from a contactable physician. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via intramuscular route of administration on 10Apr2021 at 14:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known drug allergies (NKDA). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced herpes zoster aka "shingles" from varicella zoster virus (VZV). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine, Nasopharyngitis
Clinical narrative: Bad head cold off and on; Triggered migraines; Triggered migraines; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Mar2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. 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. Concomitant medications were not reported. On 03Mar2021 at 00:00, the patient experienced bad head cold off and off since first injection. It had also triggered her migraines. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutics measures were taken as a result of the event and included treatment with unspecified sinus and headache medications. The clinical outcome of the events bad head cold off and on and triggered migraines were not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasal congestion, Pain in extremity
Clinical narrative: Massive migraine; Stuffy nose; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 29-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 23Apr2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING); taken for an unknown indication on an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On 24Apr2021 at 11:00, the patient experienced massive migraine and stuffy nose with a sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether 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 of massive migraine, stuffy nose and sore arm were unknown 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Tingling in right arm; Blurred vision in right eye; weakness in the legs after 15 minutes ofmonitoring; Body aches; Fatigue; soreness on injection site; Right thumb twitched entire day; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. Concomitant medication included phentermine (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unknown date. The patient previously took dextromethorphan (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 02Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 11:00, immediately after receiving the second dose, the patient experienced tingling in right arm and a few moments later, the patient experienced blurred vision in right eye and after 15 minutes of monitoring she had weakness in the legs and also had body aches, fatigue, soreness on injection site and the right thumb twitched the entire day. 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 result of the events. The clinical outcome of the events tingling in right arm, blurred vision in right eye, weakness in the legs, body aches, fatigue, soreness on injection site and right thumb twitched were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: Tingling in right arm; Blurred vision in right eye; weakness in the legs after 15 minutes ofmonitoring; Body aches; Fatigue; soreness on injection site; Right thumb twitched entire day; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. Concomitant medication included phentermine (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unknown date. The patient previously took dextromethorphan (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 02Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 11:00, immediately after receiving the second dose, the patient experienced tingling in right arm and a few moments later, the patient experienced blurred vision in right eye and after 15 minutes of monitoring she had weakness in the legs and also had body aches, fatigue, soreness on injection site and the right thumb twitched the entire day. 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 result of the events. The clinical outcome of the events tingling in right arm, blurred vision in right eye, weakness in the legs, body aches, fatigue, soreness on injection site and right thumb twitched were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Sudden onset high blood pressure with elevated heart rate (40 to 100% higher heart rate); with elevated heart rate (40 to 100% higher heart rate); This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Lot number: ER2613), via an unspecified route in the left arm on 26Mar2021 at 13:00 (age at vaccination: 55-year-old), as a single dose for covid-19 immunization. Medical history included known allergies with duck egg, dairy, doxycycline, indomethacin and tinactin. Other medical history included Reiter's Syndrome- chronic, depression, damage to spinal column -neck and low back. Concomitant medications included trazodone and venlafaxine. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 05Mar2021 at 13:00 (age at vaccination: 55-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 15Apr2021 at 06:30, patient experienced sudden onset high blood pressure with elevated heart rate (40 to 100% higher heart rate). Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included lisinopril, having limited affect. The patient underwent lab test and procedure which included blood pressure with elevated heart rate (40 to 100% higher heart rate) on 15Apr2021. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Nausea, Palpitations
Clinical narrative: Heart Palpitations for approx. 36 hours.; Fatigue; Irritability; Some light nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 21Apr2021 both (at the age of 50-year-old) as a single dose for COVID-19immunisation. Medical history included allergy to shellfish, cats, dogs, dust, pollen, trees and grasses. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), EMERITA WOMEN'S BALANCE, etc for unknown indication on an unknown date and unknown if ongoing. The patient previously took iodine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 31Mar2021 at 10:15, beginning 20 minutes post first injection, the patient experienced heart palpitations for approximately 36 hours, other symptoms like fatigue, irritability, some light nausea, but most notably were the heart palpitations with no associated rash, hives or shortness of breath. The patient consulted primary care physician to confirm the safety of receiving the second dose of the vaccination and received the second dose. So far the patient had no long-lasting heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart palpitations, fatigue, irritability and nausea was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild soreness in arm lasting 3 weeks; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 51-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. 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 take any concomitant medications. On 03Apr2021 at 06:00, the patient experienced mild soreness in arm lasting 3 weeks. Has n. 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 adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild soreness in arm was recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vital signs measurement
Clinical narrative: Patient reported feeling lightheaded. Vitals were within normal limits.; This is a spontaneous report from a contactable pharmacist. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an intramuscular route of administration in the arm left on 19Apr2021(at the age of 45-year-old) as a single dose for COVID-19 immunisation. The medical history included gastric sleeve three years ago and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an intramuscular route of administration in the left arm on 29Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient felt lightheaded. It was reported that the patient's vitals were within the normal limits. On 19Apr2021, the patient underwent vital signs measurements and were within normal limits. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event felt lightheaded was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in my ears after 2nd dose everyday; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included Type 1, Hashimotos, asthma, Ulcerative Colitis, allergies, penicillin allergy and sulfonamide allergy(sulfa). The patient previously received doxycycline (MANUFACTURER UNKNOWN) and Erythromycin (MANUFACTURER UNKNOWN) on unknown dates for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetrizine hydrochloride (ZYRTEC), insulin aspart (NOVOLOG), budesonide (PULMICORT),calcium ascorbate (ESTER C), folic acid (FOLATE), levothyroxine (LEVOTHYROXIN); all from unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) on 02Mar2021 at 12:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Mar2021 the patient experienced ringing in the ears after second dose every day. 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 event.  On 20Apr2021, the patient underwent Nasal swab,, SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event ringing in the ears was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Very sore arm; Swelling of lymph nodes in armpit; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 23Apr2021 at 09:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 02Apr2021 at 08:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced very sore arm, swelling of lymph nodes in armpit and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very sore arm, swelling of lymph nodes in armpit and fatigue were resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 (at an age of 58-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included COVID-19 respiratory infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Concomitant medications were not reported. On 02Apr2021 at 06:00, the patient experienced sore left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The patient underwent lab test on 20Apr2021 which included SARS-CoV-2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event of sore left arm was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus in right ear (same side as injection) within days of 2nd dose that is still ongoing 8+ weeks later.  Never had it before shot.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 13Feb2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs and shrimp. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 23Jan2021 as a single dose for COVID-19 immunisation. On 15Feb2021, the patient developed tinnitus in right ear (same side as injection) within days of 2nd dose that was still ongoing 8+ weeks later and never had it before shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling cold, Hot flush, Hyperhidrosis
Clinical narrative: Hot flashes; Cold a few days after the second dose.; Alternating sweating; No appetite; Very tired; Very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 18Apr2021 at 13:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimotos thyroiditis and other autoimmune disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 75 mg, liothyronine sodium (CYTOMEL) 5 mg, valsartan (DIOVAN) 160 mg; all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 10:00, the patient experienced hot flashes with alternating sweating and then cold a few days after the second dose. Shortly, after the second dose, the patient had very sore arm for three days, as well as was very tired with no appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sore arm was recovered on 22Apr2021 at 10:00, and the clinical outcome of the events hot flashes, alternating sweating, cold a few days after the second dose, very sore arm, very tired and no appetite was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hot flashes; Cold a few days after the second dose.; Alternating sweating; No appetite; Very tired; Very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 18Apr2021 at 13:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimotos thyroiditis and other autoimmune disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 75 mg, liothyronine sodium (CYTOMEL) 5 mg, valsartan (DIOVAN) 160 mg; all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 10:00, the patient experienced hot flashes with alternating sweating and then cold a few days after the second dose. Shortly, after the second dose, the patient had very sore arm for three days, as well as was very tired with no appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sore arm was recovered on 22Apr2021 at 10:00, and the clinical outcome of the events hot flashes, alternating sweating, cold a few days after the second dose, very sore arm, very tired and no appetite was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Headache; Brain fog; Dizziness; Vertigo; Loss of balance; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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. Concomitant medications included thyroid (ARMOUR THYROID), vitamin d nos (VITAMIN D) and magnesium (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 22Apr2021, the patient experienced headache, brain fog, dizziness, vertigo, loss of balance and nausea. 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 headache, brain fog, dizziness, vertigo, loss of balance and nausea were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Headache; Brain fog; Dizziness; Vertigo; Loss of balance; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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. Concomitant medications included thyroid (ARMOUR THYROID), vitamin d nos (VITAMIN D) and magnesium (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 22Apr2021, the patient experienced headache, brain fog, dizziness, vertigo, loss of balance and nausea. 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 headache, brain fog, dizziness, vertigo, loss of balance and nausea were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: was able to taste flavors she had not experienced in the previous 4 years, also reported a 'flowery' smell that seems to be related to external stimuli (which was not previously the case); This is a spontaneous report from a contactable consumer. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 16Apr2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included traumatic brain injury (TBI) approximately four years ago and the patient had lost sense of smell and taste. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19 and also unknown that if the patient had allergies to medications, food, or other products. Concomitant medications were not reported and it was unknown if the patient received any other vaccines within four weeks prior to the vaccination. 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 21Apr2021, the patient was able to taste flavors she had not experienced in the previous four years. The patient also reported a 'flowery' smell that seemed to be related to external stimuli (which was not previously the case). 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events able to taste flavors she had not experienced in the previous four years and 'flowery' smell that seemed to be related to external stimuli was 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Large red spot on arm at the injection site for multiple days after second shot; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 30Mar2021 at 15:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced large red spot on arm at the injection site for multiple days after second shot. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as result of reported event. The clinical outcome of the event large red spot on arm at the injection site for multiple days after second shot was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash all over; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medication 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. The patient did not receive any other medication within two weeks of vaccination. 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 01Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 13:00, the patient experienced itchy rash all over. 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 event itchy rash all over was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Within three minutes of 2nd dose of vaccine, my lips  began tingling.; Soon roof of mouth, lips and tongue went numb; This is a spontaneous report from a contactable consumer, the patient. A 39-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 28Apr2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications were not reported. The patient previously took cefalexin (KEFLEX) on an unknown date and experienced drug allergy. 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 07Apr2021 at 09:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. 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 28Apr2021 at 13:03, within three minutes of second dose of vaccine, the patient experienced lips and tongue tingling. Soon roof of mouth, lips and tongue went numb, which lasted for an hour or so. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in lips and tongue, numbness in roof of mouth, lips and tongue was recovered on 28Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Body temperature, Insomnia, Loss of consciousness, Malaise
Clinical narrative: I actually blacked out./But the blackout was scary; trouble sleeping; fevered; sick feeling; don't remember much from Friday morning at all; threw up the tylenol; scratches; could not form coherent sentences; This is a spontaneous report from a contactable consumer (patient). This 33-year-old  non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 16:15 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE (at the age of 33 years) for covid-19 immunisation.  Historical vaccine included BNT162B2 for Covid-19 immunization as DOSE 1 SINGLE (at the age of 33 years) on 01Apr2021 16:30 in the right arm Brand: Pfizer Lot number: ER8732 and experienced insomnia.  The patient had no other vaccine other than BNT162B2 in four weeks. The patient medical history was not reported. The patient reported she did not have any known allergies.  The patient did not have Covid prior vaccination.  Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced "I actually blacked out./but the blackout was scary " on 23Apr2021 04:00 with outcome of recovered, trouble sleeping on 23Apr2021 04:00 with outcome of recovered , got up at 4am running a fever on 23Apr2021 04:00 with outcome of recovered, sick feeling on 23Apr2021 04:00 with outcome of recovered, threw up the Tylenol on 23Apr2021 with outcome of recovered, scratches on 23Apr2021 with outcome of recovered, could not form coherent sentences on 23Apr2021 with outcome of recovered, "don't remember much from Friday morning at all" on 23Apr2021 with outcome of recovered, "The next thing I remember is my dog waking me up by licking my face about 20 mins later. I was laying face down in the hallway between the bathroom and the bedroom. Other than some scratches, I didn't get hurt. I also could not form coherent sentences while trying to call my husband to tell him to come home from work. I don't remember much from Friday morning at all. It is all a fog. But the blackout was scary. I was fevered and sick feeling for 24 hours and then was fine again."   The patient underwent lab tests and procedures which included body temperature: fever on 23Apr2021.  Therapeutic measures were taken as a result of fevered (Tylenol).  Fever and sick feeling resolved on 24Apr2021.  All other events recovered in 2021. The patient did not have a Covid test-post-vaccination.    No follow-up attempts are required. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021458876 same reporter/patient, different vaccine dose and event