chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Heart rate, Heart rate increased
Clinical narrative: an Increased blood  (previous was average 128/90; after vaccine is average 140/100). As of now the increased values are still there.Heartbeats increased by about 15/20 bpm;; Heartbeats increased by about 15/20 bpm; as of now the increase is still there; Headaches started from first dose and are still there.; Tingling sensation on hands and legs, from 1st dose till currently; This is a spontaneous report from a contactable consumer (female patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration on an unspecified date in Mar2021 (age at vaccination: 69-years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0150, expiry date: unknown) via unspecified route of administration, in left arm on 05Apr2021 (age at vaccination: 69-years) as dose 2, single for Covid-19 immunisation. Medical history included hypertension, cerebral vasculopaty, Hashimoto's disease (Thyroid) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There were other prescribed medicines in two weeks. No other vaccine in four weeks was administered to patient. On 05Apr2021, after first dose there was an Increased blood (previous was average 128/90; after vaccine is average 140/100). As of now the increased values are still there. Heartbeats increased by about 15/20 bpm; as of now the increase is still there. Headaches started from first dose and are still there. Tingling sensation on hands and legs, from 1st dose till currently. Treatment was not given as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient underwent lab test which included blood pressure measurement, with results as 140/100 mmHg and 128/90 mmHg, and heart rate with results as increase, on an unspecified date. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: an Increased blood  (previous was average 128/90; after vaccine is average 140/100). As of now the increased values are still there.Heartbeats increased by about 15/20 bpm;; Heartbeats increased by about 15/20 bpm; as of now the increase is still there; Headaches started from first dose and are still there.; Tingling sensation on hands and legs, from 1st dose till currently; This is a spontaneous report from a contactable consumer (female patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration on an unspecified date in Mar2021 (age at vaccination: 69-years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0150, expiry date: unknown) via unspecified route of administration, in left arm on 05Apr2021 (age at vaccination: 69-years) as dose 2, single for Covid-19 immunisation. Medical history included hypertension, cerebral vasculopaty, Hashimoto's disease (Thyroid) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There were other prescribed medicines in two weeks. No other vaccine in four weeks was administered to patient. On 05Apr2021, after first dose there was an Increased blood (previous was average 128/90; after vaccine is average 140/100). As of now the increased values are still there. Heartbeats increased by about 15/20 bpm; as of now the increase is still there. Headaches started from first dose and are still there. Tingling sensation on hands and legs, from 1st dose till currently. Treatment was not given as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient underwent lab test which included blood pressure measurement, with results as 140/100 mmHg and 128/90 mmHg, and heart rate with results as increase, on an unspecified date. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Soreness of arm the next day and then that night tingling of the arm and numbness of the hand.  Then complete left side tingling with burning pain of the lips and hand.; that night tingling of arm; and numbness of hand; with burning pain of lips and hand; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-Fib) and high blood pressure. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), amiodarone (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO) and amlodipine (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. On 06Mar2021 (the next day), the patient experienced soreness of arm and then at that night tingling of the arm and numbness of the hand. Then complete left side tingling with burning pain of the lips and hand. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events soreness, tingling of arm, numbness of hand and left side tingling and burning pain of lips and hands. The patient underwent magnetic resonance imaging (MRI) test on an unknown date and result was negative for stroke. Since the vaccination the patient had not been tested for COVID-19.  The clinical outcome of the event soreness, tingling of arm, numbness of hand and left side tingling and burning pain of lips and hands was not recovered, at this time of report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; This is a spontaneous report from a contactable consumer or other non-HCP. A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 24Mar2021 11:00 as DOSE 1, SINGLE (at the age of: 34-year-old) for covid-19 immunization . Medical history included contraception. Concomitant medication(s) included spironolactone (SPIRONOLACTONE); drospirenone, ethinylestradiol (SYEDA) taken for contraception. No other vaccine in four weeks. Other medications in two weeks mentioned as Spironolactone and Syeda for birth control. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had tested with covid 19 via Nasal swab test on 31Mar2021. No known allergies and Other medical history reported for the patient. On 31Mar2021, the patient experienced covid test result: positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. No treatment was given for the reported events. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Migraine
Clinical narrative: Headache; Migraine; Chills; Fever; Profuse sweating; Body aches; Tinnitus; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and hypertension. The patient had allergies to food, medications, or other products. The patient received unspecified concomitant medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 12:00, the patient experienced headache, migraine, chills, fever, profuse sweating, body aches, tinnitus and loss of appetite. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events headache, migraine, chills, fever, profuse sweating, body aches, tinnitus and loss of appetite were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: Headache; Migraine; Chills; Fever; Profuse sweating; Body aches; Tinnitus; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and hypertension. The patient had allergies to food, medications, or other products. The patient received unspecified concomitant medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 12:00, the patient experienced headache, migraine, chills, fever, profuse sweating, body aches, tinnitus and loss of appetite. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events headache, migraine, chills, fever, profuse sweating, body aches, tinnitus and loss of appetite were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruise at injection site; Second dose of BNT162b2 was received on 18th day after the first dose; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 06Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 19Mar2021 at 09:45 (at the age of 51-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 06Apr2021 at 20:30, the patient experienced a bruise at injection site. Even after 2 weeks of vaccination the bruise at injection site was ongoing. This patient did not experienced bruise at injection site with the first dose of vaccination. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event bruise at injection site was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Chills; Swollen lymph nodes under armpit; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis 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 COVID vaccine. Concomitant medications included sulfasalazine (MANUFACTURER UNKNOWN) and ethinylestradiol, etonogestrel (NUVARING); both for unspecified indication and unknown date. On 18Apr2021 at 19:00, the patient experienced fever, body aches, chills and swollen lymph nodes under armpit. 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, body aches, chills and swollen lymph nodes under armpit were resolved on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained;No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Swelling in left elbow, not painful, very soft, feels like fluid.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (Corn) 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 COVID-19 vaccine. Concomitant medications were not reported. On 19Apr2021 at 11:00, the patient experienced swelling in left elbow, not painful, very soft, felt like fluid. 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 swelling in left elbow, not painful, very soft, felt like fluid was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Parosmia
Clinical narrative: Started something like car exhaust 2 days after vaccination. The car exhaust smell is what was bothering a lot.; Have swollen tender axillary lymph nodes.; Had tender axillary lymph nodes.; Had extreme fatigue fever chills for 1 day after vaccine.; Had extreme fatigue fever chills for 1 day after vaccine.; Had extreme fatigue fever chills for 1 day after vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced started something like car exhaust 2 days after vaccination, the car exhaust smell was what bothered her a lot. The patient experienced swollen tender axillary lymph nodes and had extreme fatigue, fever and chills for 1 day after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen tender axillary lymph nodes and started something like car exhaust was unknown at the time of this report. The clinical outcome of the events extreme fatigue, fever and chills was resolved on an unknown date, after the duration of 1 day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started something like car exhaust 2 days after vaccination. The car exhaust smell is what was bothering a lot.; Have swollen tender axillary lymph nodes.; Had tender axillary lymph nodes.; Had extreme fatigue fever chills for 1 day after vaccine.; Had extreme fatigue fever chills for 1 day after vaccine.; Had extreme fatigue fever chills for 1 day after vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced started something like car exhaust 2 days after vaccination, the car exhaust smell was what bothered her a lot. The patient experienced swollen tender axillary lymph nodes and had extreme fatigue, fever and chills for 1 day after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen tender axillary lymph nodes and started something like car exhaust was unknown at the time of this report. The clinical outcome of the events extreme fatigue, fever and chills was resolved on an unknown date, after the duration of 1 day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Nausea
Clinical narrative: Really hot; Sweating like crazy; Intense nausea; Shaking (could not hold phone from shaking); Headache; Intense chills; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 at 09:15 (at the age of 19-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 COVID vaccine. Concomitant medications were not reported. On 19Apr2021, the patient experienced intense chills, shaking (could not hold the phone from shaking), and headache. On 20Apr2021, the morning, it was really hot for the patient, sweating like crazy, and had intense nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense chills, shaking (could not hold phone from shaking), headache, really hot, sweating like crazy and intense nausea were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Really hot; Sweating like crazy; Intense nausea; Shaking (could not hold phone from shaking); Headache; Intense chills; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 at 09:15 (at the age of 19-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 COVID vaccine. Concomitant medications were not reported. On 19Apr2021, the patient experienced intense chills, shaking (could not hold the phone from shaking), and headache. On 20Apr2021, the morning, it was really hot for the patient, sweating like crazy, and had intense nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense chills, shaking (could not hold phone from shaking), headache, really hot, sweating like crazy and intense nausea were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; Headache; Mild body aches; This is a spontaneous report from a contactable consumer, the patient. A 16-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 right arm on 19Apr2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within 2 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 on an unknown date 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 4 weeks prior to the vaccination. On 19Apr2021 at 18:00, the patient experienced sore arm, headache and mild body aches. 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 the events which included treatment paracetamol (TYLENOL). The clinical outcome of the events sore arm, headache and mild body aches were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness at injection site is not going away; Injection site itching ongoing; Injection site itching ongoing and little swelling; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. It was unknown whether the patient had any 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 10Apr2021, the patient experienced  redness at injection site, which was not going away, injection site itching ongoing and little swelling. The adverse 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 event injection site redness, injection site itching and little swelling was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Ear pain, Fatigue, Headache
Clinical narrative: Was tired; Was not hungry; Was sweating; Head hurt; Ear hurt; Could not fall asleep the night of receiving the second vaccine; Arm hurt so badly/ arm hurt again; Chills; This is a spontaneous report from a contactable nurse. An adult female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 18Apr2021 at 12:30 as a single dose for COVID-19 immunisation. The patients' medical history was not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included unspecified antibiotics taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 28Mar2021 at 12:30 as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Apr2021, the patient could not fall asleep the night of receiving the second vaccine, her arm hurt so badly and she had chills. On 19Apr2021, in the morning of the day after she received the vaccine, her arm was better, but not the chills, she was tired and was not hungry. On 19Apr2021, in the afternoon of the day after she received the vaccine, the patient was tired, remained with chills all day and was sweating, her head and ear hurt and arm hurt again. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events could not fall asleep the night, arm hurt so badly, chills, tired, not hungry, sweating, head hurt, ear hurt and arm hurt again 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.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Pain in extremity
Clinical narrative: Was tired; Was not hungry; Was sweating; Head hurt; Ear hurt; Could not fall asleep the night of receiving the second vaccine; Arm hurt so badly/ arm hurt again; Chills; This is a spontaneous report from a contactable nurse. An adult female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 18Apr2021 at 12:30 as a single dose for COVID-19 immunisation. The patients' medical history was not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included unspecified antibiotics taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 28Mar2021 at 12:30 as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Apr2021, the patient could not fall asleep the night of receiving the second vaccine, her arm hurt so badly and she had chills. On 19Apr2021, in the morning of the day after she received the vaccine, her arm was better, but not the chills, she was tired and was not hungry. On 19Apr2021, in the afternoon of the day after she received the vaccine, the patient was tired, remained with chills all day and was sweating, her head and ear hurt and arm hurt again. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events could not fall asleep the night, arm hurt so badly, chills, tired, not hungry, sweating, head hurt, ear hurt and arm hurt again 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Urticaria, Hives; Red blotches in her arm, neck and legs; This is a spontaneous report from a contactable consumer, the patient. A 62-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 an unknown date in Mar2021 at 18:00 (at the age of 62-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 31Mar2021 at 18:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic asthma and chronic obstructive pulmonary disease (COPD). The patient had allergy to shellfish. 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 budesonide/ formoterol fumarate (SYMBICORT), fluticasone furoate (ARNUITY), tiotropium bromide monohydrate (SPIRIVA), montelukast sodium (SINGULAIR) and pseudoephedrine hydrochloride (SUDAFED 12); all from unknown date for an unknown indication and unknown if ongoing. On 15Mar2021, the patient experienced urticaria, hives and red blotches in her arm, neck and legs. 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 the reported events and included treatment with diphenhydramine hydrochloride (BENADRYL) tablets twice a day. The clinical outcome of the events urticaria, hives and red blotches in her arm, neck and legs was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Musculoskeletal pain
Clinical narrative: Pain in shoulders and back; Pain in shoulders and back/ the pain throughout the day shifted until it settled in lower back / upper butt, on the left side; The pain throughout the day shifted until it settled in lower back / upper butt, on the left side; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-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 07Apr2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and the patient was lactose sensitive. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and probiotic; all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 14:00, exactly 24 hours after the first shot, the patient experienced pain in her shoulders and back. The pain throughout the day shifted until it settled in her lower back / upper butt, on the left side. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result the events and included treatment with ibuprofen and muscle relaxer. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in shoulders and back/ the pain throughout the day shifted until it settled in lower back / upper butt, on the left side were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea
Clinical narrative: Headache; Nausea; Chills; Overall feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-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 14Apr2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 60-years-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 16Apr2021, at 07:00 the patient experienced headache, nausea, chills and overall feeling unwell. 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 headache, nausea, chills and overall feeling unwell were recovered on an unspecified date in Apr2021.    No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain assessment, Vaccination site pain
Clinical narrative: Arm pain at injection site 9 days after the injection starting in morning of 18Apr2021. Did not limit arm motion, but pain was enough that it prevented me from doing normal activities and impossible to ignore, probably 6 on pain scale.; Arm pain at injection site 9 days after the injection starting in morning of 18Apr2021. Did not limit arm motion, but pain was enough that it prevented me from doing normal activities and impossible to ignore, probably 6 on pain scale.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, bipolar ii disorder (reported as bipolar II). The patient had environmental allergy, latex allergy (reported as Latex sensitivity). Concomitant medications taken within two weeks of vaccination included bupropion (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) fluticasone (MANUFACTURER UNKNOWN) and multivitamin; all from unknown date for unknown indication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm pain at injection site nine days after the injection starting in morning of 18Apr2021 at 10:00. Did not limit arm motion, but pain was enough that it prevented her from doing normal activities and impossible to ignore, probably 6 on pain scale. 650mg Tylenol eased pain, but pain returned about every 4 hours. Pain was gone by next morning (19Apr2021). Therapeutic measures were taken as a result of arm pain at injection site nine days after the injection starting in morning of 18Apr2021 at 10:00; did not limit arm motion, but pain was enough that it prevented her from doing normal activities and impossible to ignore, probably 6 on pain scale and included treatment with Tylenol 650mg 3x on 18Apr2021. 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 arm pain at injection site nine days after the injection starting in morning of 18Apr2021 at 10:00; did not limit arm motion, but pain was enough that it prevented her from doing normal activities and impossible to ignore, probably 6 on pain scale. 650mg Tylenol eased pain, but pain returned about every 4 hours. Pain was gone by next morning (19Apr2021) was resolved on 19Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site nodule, Vaccination site rash, Vaccination site warmth
Clinical narrative: a rash appeared at injection site that is warm to the touch and feels as though a knot is under the skin; a rash appeared at injection site that is warm to the touch and feels as though a knot is under the skin; a rash appeared at injection site that is warm to the touch and feels as though a knot is under the skin; cellulitis; This is a spontaneous report from a contactable consumer (patient). This 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 12:45 PM (lot ER8729), at the age of 32 years, as the first single dose, in left arm, for COVID-19 immunisation. Medical history included dermatographia and sulfa & contrast dye allergies. The patient did not have COVID prior vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine was administered in four weeks. On 17Apr2021 at 12:00 PM, 9 days after vaccination, a rash appeared at injection site that was warm to the touch and felt as though a knot was under the skin. On 20Apr2021 the rash was bigger in size. Treatment was received for the adverse event and included Kelfex antibiotics for cellulitis. The events resulted in Doctor or other healthcare professional office/clinic visit. COVID was not tested post vaccination. The patient had not yet recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 18Apr2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included moderate asthma from an unknown date. 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 formoterol fumarate, mometasone furoate (DULERA), cyclobenzaprine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all for unspecified indication from an unknown date. The patient had no allergies to food, medication or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 28Mar2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced pain at injection site, tiredness, headache, muscle pain and nausea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, tiredness, headache, muscle pain and nausea were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle aches; Body aches for 2 days; Constant headache since March 22; Fever off/on since March 22; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant 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 right arm on 22Mar2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included knee arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), meloxicam (MOBIC) and cetirizine hydrochloride (ZYRTEC) all taken from unknown date for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 01Mar2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 16:00, the patient experienced constant headache since March 22, if she clasped his hands behind head that the region, it hurt to lay head on pillow at times, plus fever off/on since March 22. On March 23, she ran 101 fever (units unspecified), muscle aches, headaches and body aches for 2 days. On 20Apr2021, at the day of reporting 99.8 temp (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the events constant headache, fever off/on, muscle aches, headaches, body aches were recovered with sequelae in an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Migraine, Nasopharyngitis
Clinical narrative: Fierce cold; shivers; fever; headache; migraine; vomiting; Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had slight berry allergy which was not dangerous. The patient did not receive any other medications within 2 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 29Mar2021 at 13:30 (at the age of 20-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 19Apr2021 at 23:00, the patient experienced fierce cold, shivers, fever, headache, migraine, vomiting and insomnia. 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 adverse events. The clinical outcome of the events fierce cold, shivers, fever, headache, migraine, vomiting and insomnia were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.