chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium, Postmenopausal haemorrhage, Ultrasound pelvis
Clinical narrative: I began to menstruate for a period length of 6 days/post menopausal bleeding; This is spontaneous report from a contactable consumer (patient) via . This non-pregnant 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 14:30 (at 58-years of age) as a single dose for COVID-19 immunisation. Medical history included asthma, coronary artery disease, gastroesophageal reflux disease (GERD), and chronic hypertension, all from unknown dates and unknown if ongoing; and menopause from an unknown date reported as almost 2 years. The patient received unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6200) in the left arm on 22Feb2021 at 16:30 (at 58-years-old) for COVID-19 immunisation; and lisinopril (ZESTRIL) from an unknown date for an unknown indication and experienced allergies. On 19Mar2021 at 13:00 the patient began to menstruate for a period length of 6 days; she reported this was unusual as she had been considered by medical definition as in menopause for almost 2 years. The patient reported this was treated by her gynecologist as post-menopausal bleeding and required an endometrial biopsy which was negative for cancer. Treatment was received for the event and the patient underwent pelvic ultrasound, the results of which were not reported. The events required a physician office visit. The clinical outcome of the event was recovered on 25Mar2021. Since vaccination the patient had not been tested for COVID-19.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Migraine, Pain
Clinical narrative: Fever of 102 degrees; Chills; Migraine; Body aches; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm on 12Apr2021 at 10:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid condition. The patient had no known allergies (Not that he knows of). 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. Concomitant medications included only men's vitamins (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm on 24Mar2021 at 09:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 04:30, the patient experienced fever of 102 degrees, chills, migraine, body aches and diarrhea. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever of 102 degrees, chills, migraine, body aches and diarrhea was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102 degrees; Chills; Migraine; Body aches; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm on 12Apr2021 at 10:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid condition. The patient had no known allergies (Not that he knows of). 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. Concomitant medications included only men's vitamins (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm on 24Mar2021 at 09:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 04:30, the patient experienced fever of 102 degrees, chills, migraine, body aches and diarrhea. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever of 102 degrees, chills, migraine, body aches and diarrhea was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Illness, Joint swelling
Clinical narrative: feels very sick; headache; lethargic; swelling in ankle; pain in both knees; rash on injectionsite at shoulder; Pain in lower back; Pain in neck joints; Pain in neck joints; This is a spontaneous report from a contactable other HCP (Patient) received from Pfizer sponsored program. A 57-year-old female patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot Number was not reported) via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included rash, psoriasis, joint swelling, from unspecified date if ongoing, patient took 3 epidural injections in back during october/november/december of 2020. The patient's concomitant medications were not reported. It was reported that, preexisting condition improved after start of therapy: rash and psoriasis/pain and swelling in joints. Patient xeljanz was on hold since 26MAR2021, took 1st covid vaccine on 31MAR2021, 2nd one on 28APR2021 and would restart on 12MAY2021. After 1st dose of vaccine, on an unspecified date in Apr2021 patient experienced feels very sick, headache, lethargic, swelling in ankle, pain in both knees, rash on injection site at shoulder, pain in lower back, pain in neck joints which were subsided after start of therapy. Then patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot Number was not reported) via an unspecified route of administration on 28APR2021 as dose 1, single for COVID-19 immunization. The outcome of all events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Neck pain, Vaccination site rash
Clinical narrative: feels very sick; headache; lethargic; swelling in ankle; pain in both knees; rash on injectionsite at shoulder; Pain in lower back; Pain in neck joints; Pain in neck joints; This is a spontaneous report from a contactable other HCP (Patient) received from Pfizer sponsored program. A 57-year-old female patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot Number was not reported) via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included rash, psoriasis, joint swelling, from unspecified date if ongoing, patient took 3 epidural injections in back during october/november/december of 2020. The patient's concomitant medications were not reported. It was reported that, preexisting condition improved after start of therapy: rash and psoriasis/pain and swelling in joints. Patient xeljanz was on hold since 26MAR2021, took 1st covid vaccine on 31MAR2021, 2nd one on 28APR2021 and would restart on 12MAY2021. After 1st dose of vaccine, on an unspecified date in Apr2021 patient experienced feels very sick, headache, lethargic, swelling in ankle, pain in both knees, rash on injection site at shoulder, pain in lower back, pain in neck joints which were subsided after start of therapy. Then patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot Number was not reported) via an unspecified route of administration on 28APR2021 as dose 1, single for COVID-19 immunization. The outcome of all events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Dyspnoea, Pain in extremity, Vaccination site swelling
Clinical narrative: Swelling at injection site; Severe pain shooting through arm to armpit and allthe way to middle of chest.; Shortness of breath; Severe pain shooting through arm to armpit and allthe way to middle of chest.; Severe pain shooting through arm to armpit and allthe way to middle of chest.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chiari and high blood pressure. Concomitant medications included morphine hydrochloride (MORPHINE), hydrocodone bitartrate (HYDROCODONE), tizanidine (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unknown date 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 12Apr2021 at 20:00, the patient experienced swelling at injection site, severe pain shooting through arm to armpit and all the way to middle of chest and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling at injection site, severe pain shooting through arm to armpit and all the way to middle of chest and shortness of breath were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: Awoke with alternating chills; Severe arthralgia; Myalgias; General weakness; an intense vise grip like headache began, behind both eyes; Squeezing, not throbbing; Appetite reduced; This is a spontaneous report from a contactable physician, the patient. A 52-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 08Apr2021 at 13:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, osteoporosis and arthritis. 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 COVID vaccine. Concomitant medications included levothyroxine sodium (UNITHROID), calcium (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, the patient was asymptomatic for first 14 hours, awoke with alternating chills, severe arthralgia, myalgias and general weakness. At approximately 24 hours post, other symptoms continued and an intense vise grip like headache began, behind both eyes, squeezing, not throbbing. No photophobia, nausea, vomiting or fever. The patient had appetite reduced. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of chills, arthralgia, myalgia, weakness, headache, pain and decreased appetite and included treatment with paracetamol (TYLENOL), (3 doses total), intermittently. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arthralgia was recovered on 10Apr2021. The clinical outcome of the events awoke with alternating chills, myalgia, general weakness, vise grip like headache began, behind both eyes, squeezing and appetite reduced were recovered on 11Apr2021 at 13:30, completely back to normal by 72 hours post.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Awoke with alternating chills; Severe arthralgia; Myalgias; General weakness; an intense vise grip like headache began, behind both eyes; Squeezing, not throbbing; Appetite reduced; This is a spontaneous report from a contactable physician, the patient. A 52-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 08Apr2021 at 13:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, osteoporosis and arthritis. 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 COVID vaccine. Concomitant medications included levothyroxine sodium (UNITHROID), calcium (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, the patient was asymptomatic for first 14 hours, awoke with alternating chills, severe arthralgia, myalgias and general weakness. At approximately 24 hours post, other symptoms continued and an intense vise grip like headache began, behind both eyes, squeezing, not throbbing. No photophobia, nausea, vomiting or fever. The patient had appetite reduced. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of chills, arthralgia, myalgia, weakness, headache, pain and decreased appetite and included treatment with paracetamol (TYLENOL), (3 doses total), intermittently. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arthralgia was recovered on 10Apr2021. The clinical outcome of the events awoke with alternating chills, myalgia, general weakness, vise grip like headache began, behind both eyes, squeezing and appetite reduced were recovered on 11Apr2021 at 13:30, completely back to normal by 72 hours post.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Feeling cold, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Began feeling sensitive to the touch approximately 5-8 hours after receiving the vaccine.; A slightly uneasy stomach; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; fever at 100.8 F; First dose: 22Mar2021 and second dose:04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number EW0164), intramuscular, administered in deltoid right (arm right) on 04Apr2021 at 02:00 PM (age at the time of vaccination was 26 years, she was not pregnant at the time of vaccination) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER2613), intramuscular, administered in right deltoid (arm right) on 22Mar2021 at 02:00 PM (age at the time of vaccination was 27 years) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included allergies to medications, food, or other products: Antibiotics: penicillin, septra, zithromax, amoxicillin, arithromycin. The patient's concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Prior Vaccinations was none. Relevant tests were none. The patient began feeling sensitive to the touch approximately 5-8 hours after receiving the vaccine. She began to feel a little run down close to 11 pm local time. Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortable through the night on 04Apr2021. Finally decided to get up 4 hours later, 4:30 AM, took temperature, had a fever at 100.8 F. And a slightly uneasy stomach. Took acetaminophen but took about 1 hour to work. Temperature dropped to about 99.6 F. And stomach subsided. Continued to drink water, temperature dropped again to 98.8 F. No other reaction occurred. She did not receive treatment for other adverse events. Since the vaccination, she had not tested for COVID-19. 8 hours after second dose patient feeling under the weather fever 101.6 after midnight. Took Ibuprofen at 1am. Fever resolved within 24 hours. The patient underwent lab test and procedure included body temperature that was 100.8 F and 101.6 on 04Apr2021 and on unspecified date it was 99.6 F and 98.8 F. The outcome of event fever, slightly uneasy stomach was recovered in Apr2021, feeling sensitive to the touch, hard time falling asleep, feeling very cold and uncomfortable was recovering.   Follow-up attempts were completed. No further information was expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Paraesthesia, Pyrexia
Clinical narrative: Began feeling sensitive to the touch approximately 5-8 hours after receiving the vaccine.; A slightly uneasy stomach; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; fever at 100.8 F; First dose: 22Mar2021 and second dose:04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number EW0164), intramuscular, administered in deltoid right (arm right) on 04Apr2021 at 02:00 PM (age at the time of vaccination was 26 years, she was not pregnant at the time of vaccination) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER2613), intramuscular, administered in right deltoid (arm right) on 22Mar2021 at 02:00 PM (age at the time of vaccination was 27 years) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included allergies to medications, food, or other products: Antibiotics: penicillin, septra, zithromax, amoxicillin, arithromycin. The patient's concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Prior Vaccinations was none. Relevant tests were none. The patient began feeling sensitive to the touch approximately 5-8 hours after receiving the vaccine. She began to feel a little run down close to 11 pm local time. Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortable through the night on 04Apr2021. Finally decided to get up 4 hours later, 4:30 AM, took temperature, had a fever at 100.8 F. And a slightly uneasy stomach. Took acetaminophen but took about 1 hour to work. Temperature dropped to about 99.6 F. And stomach subsided. Continued to drink water, temperature dropped again to 98.8 F. No other reaction occurred. She did not receive treatment for other adverse events. Since the vaccination, she had not tested for COVID-19. 8 hours after second dose patient feeling under the weather fever 101.6 after midnight. Took Ibuprofen at 1am. Fever resolved within 24 hours. The patient underwent lab test and procedure included body temperature that was 100.8 F and 101.6 on 04Apr2021 and on unspecified date it was 99.6 F and 98.8 F. The outcome of event fever, slightly uneasy stomach was recovered in Apr2021, feeling sensitive to the touch, hard time falling asleep, feeling very cold and uncomfortable was recovering.   Follow-up attempts were completed. No further information was expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast haematoma, Breast pain, Breast swelling
Clinical narrative: Swelling, pain and hematoma in left breast; Swelling, pain and hematoma in left breast; Swelling, pain and hematoma in left breast; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 at 18:00 (at the age of 55-years-old) in left arm as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine and no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Patient had no known allergies to medications, food, or other products. On 21Mar2021 at 19:00, the patient experienced swelling, pain, and hematoma in left breast. The events were reported as non-serious. The adverse events resulted in physician or other health professional office visit, urgency, or emergency room/department visit. Treatment medication included sedatives, anti-inflammatories, and antibiotics. The outcome of all the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Sinus disorder
Clinical narrative: Low-grade fever; Sore arm; Extreme fatigue; Sinus problems; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes type 2 and penicillin allergy. 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 received unspecified concomitant medications. On 21Mar2021 at 15:00, the patient experienced low-grade fever, sore arm, extreme fatigue and sinus problems. 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 low-grade fever, sore arm, extreme fatigue and sinus problems was resolved on an unspecified date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased
Clinical narrative: Weakness; Elevated BP; Elevated glucose readings; This is a spontaneous report from a contactable other healthcare professional. A 82-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration on 21Mar2021 (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, hyperlipidemia, osteoporosis, seasonal allergies, COVID-19 and anxiety. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had received an unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 22Mar2021, since taking her second dose of vaccination, the patient had weakness, elevated blood pressure (BP) and elevated glucose readings (200's). On 22Mar2021, the patient underwent blood pressure test and the result was found to be elevated and on the same date, the patient also underwent blood glucose levels test and the result was found to be elevated glucose readings (200's). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weakness, elevated BP and elevated glucose readings (200's) was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Polymenorrhoea
Clinical narrative: Irregular menstruation; Polymenorrhea; This is a spontaneous report from a contactable consumer, the patient. A 41-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 01Apr2021 at 10:30 (at the age of 41-years-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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient reported that she was menstruating on April 1st when she has received her second dose, began menstruating again less than two weeks after finishing her period. She never had period come that early before. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstruation, polymenorrhea was 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: Severe nausea; Feeling unwell; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 12Apr2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and spinal stenosis. 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 received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 16Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient previously took hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 12Apr2021 at 17:00, the patient experienced severe nausea, was feeling unwell and experienced headache. 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 severe nausea, feeling unwell and experienced headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever on and off from past three days.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that patient got a first Pfizer shot on 05Apr2021 at night-time (as reported on Monday). On 06Apr2021 (as reported on Tuesday), the patient had a fever on and off and was for three days. Patient asked was this normal. At the time of this report, the outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Intentional dose omission
Clinical narrative: she took it upon herself to hold doses x 2 days; occasional headache; This is a spontaneous report from a contactable other healthcare professional and contactable consumer via Pfizer. A 45-year-old female patient received tofacitinib citrate (XELJANZ XR 11mg), via an unspecified route of administration from 01Apr2021 (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication; and bnt162b2 (BNT162B2), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she took it upon herself to hold doses x 2 days after first covid vaccine dose on 17Mar2021. Patient was advised to contact MD when inquired about whether to hold doses again when she received her 2nd covid vaccine dose on 14Apr2021. The patient also did report occasional headache but could not "associate " headache with Xeljanz. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, the safety profile of the drug and in agreement with the reporter, there is not a reasonable possibility that tofacitinib citrate contributed to the occurrence of the event. of Headache.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Premature menarche
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 15:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and 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 receive concomitant medications. On 13Apr2021, the patient experienced 5 days early menstrual cycle. The event 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early menstrual cycle was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: COMIRNATY was administered before 19 days of primary dose.; Fever; Extreme sweatiness; Ringing in ears; Headache; Chills; Stomach cramps; 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: EW0151) via an unspecified route of administration in the arm left on 05Apr2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to plants (tress), grass allergy, pollen allergy, dust allergy and mite allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D 12 HOUR) and fexofenadine hydrochloride (ALLEGRA 12 HOUR) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 22Mar2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. On 05Apr2021, the patient experienced fever (48 hours), extreme sweatiness (30 minutes), ringing in ears (30 minutes), headache, chills and stomach cramps. 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 fever, extreme sweatiness, ringing in ears, headache, chills and stomach cramps was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: COMIRNATY was administered before 19 days of primary dose.; Fever; Extreme sweatiness; Ringing in ears; Headache; Chills; Stomach cramps; 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: EW0151) via an unspecified route of administration in the arm left on 05Apr2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to plants (tress), grass allergy, pollen allergy, dust allergy and mite allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D 12 HOUR) and fexofenadine hydrochloride (ALLEGRA 12 HOUR) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 22Mar2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. On 05Apr2021, the patient experienced fever (48 hours), extreme sweatiness (30 minutes), ringing in ears (30 minutes), headache, chills and stomach cramps. 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 fever, extreme sweatiness, ringing in ears, headache, chills and stomach cramps was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Diarrhea; Fever; Headache; Bodyache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 22-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 left arm on 13Apr2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. 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 13Apr2021 at 18:00, the patient experienced diarrhea for a few hours in the night, fever, headache and body ache. On an unknown date in Apr2021, the patient experienced vomiting in the morning.  The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 13Apr2021, the patient underwent body temperature test and the result was 100.7 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, fever, headache and body ache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Fever; Headache; Bodyache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 22-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 left arm on 13Apr2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. 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 13Apr2021 at 18:00, the patient experienced diarrhea for a few hours in the night, fever, headache and body ache. On an unknown date in Apr2021, the patient experienced vomiting in the morning.  The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 13Apr2021, the patient underwent body temperature test and the result was 100.7 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, fever, headache and body ache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 05Apr2021 at 19:15 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history included slightly high blood pressure and body mass index over 30. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included hydroxyzine hydrochloride (VISTARIL), bupropion (MANUFACTURER UNKNOWN), emtricitabine/tenofovir disoproxil fumarate (TRUVADA), ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received pethidine hydrochloride (DEMEROL) for unspecified indication from unknown date and experienced drug allergy. On 05Apr2021, since the date of vaccination, the patient experienced diarrhea. On an unknown date, the patient underwent lab test and procedures which included body mass index (BMI) and the result was over 30. The event 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disturbance in attention, Dizziness, Feeling abnormal, Impaired driving ability
Clinical narrative: light headed/ Dizziness; Extreme brain fog; Loss of balance (Loss of bal fe); Loss of ability to focus; Vertigo; Difficulty driving; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 13Apr2021 at 08:00, (also reported as almost a week after the shot), the patient experienced dizziness, light headed, extreme brain fog, loss of balance (Loss of bal fe), loss of ability to focus, vertigo and difficulty driving. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, light headed, extreme brain fog, loss of balance, loss of ability to focus, vertigo and difficulty driving was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: light headed/ Dizziness; Extreme brain fog; Loss of balance (Loss of bal fe); Loss of ability to focus; Vertigo; Difficulty driving; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 13Apr2021 at 08:00, (also reported as almost a week after the shot), the patient experienced dizziness, light headed, extreme brain fog, loss of balance (Loss of bal fe), loss of ability to focus, vertigo and difficulty driving. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, light headed, extreme brain fog, loss of balance, loss of ability to focus, vertigo and difficulty driving was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.