chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Continued alternating chills/fever through Sunday morning.; Muscle aches Saturday thru Sunday, but began to improve mid-day Sunday.; By 3:00pm shivering with cold and went to bed. Continued alternating chills/fever through Sunday morning.; 4/23 Friday- Diarrhea all day, but otherwise ok until after noon.; This is a spontaneous report from a contactable consumer, the patient. A 63-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 15Apr2021 at 10:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within two weeks of vaccination. 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: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 07:00, Friday, the patient experienced diarrhea all day, but otherwise okay until that afternoon. On 23Apr2021 by 15:00, the patient experienced shivering with cold and went to bed. It continued with alternating chills and fever through Sunday morning. On 24Apr2021, Saturday, the patient experienced muscle aches, which began to improve in the mid-day of Sunday. On 25Apr2021, Sunday, the patient experienced fever. The patient had slept most of the weekend and was on fluids. By Monday morning, all symptoms were gone. The patient could find no report of reaction a full week after second dose. The patient reported that she worked remotely and followed safety guidelines on the rare occasions when left home. The patient was seldom sick at any time, and she didn't even have a cold, much less any other illness in over a year of heightened precautions. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was resolved on 23Apr2021; while that of shivering or chills, muscle aches and fever was resolved on 26Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash by the injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 24Mar2021 at 08:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN) 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: EN6198) in the left arm on 03Mar2021 at 08:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, few days after the second dose, the patient developed rash by the injection site which lasted about a week before going away. 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 been tested for COVID-19. The clinical outcome of the event rash by the injection site was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia, Vertigo, Visual impairment
Clinical narrative: 24 hours after shot developed a fever of 100.8 which lasted for 36 hours.; Extreme dizziness/vertigo approximately 2.5 hours after shot w/ impaired vision; Extreme dizziness/vertigo approximately 2.5 hours after shot w/ impaired vision.; Extreme dizziness/vertigo approximately 2.5 hours after shot w/ impaired vision.; This is a spontaneous report from a contactable consumer, the patient. A 55-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 right arm on 23Apr2021 at 16:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 23Apr2021 at 18:45, approximately 2.5 hours after the shot, the patient experienced extreme dizziness/vertigo with impaired vision. It was made better by closing the eyes and was lessened after slept for 6 hours. But it came back in waves for the next 48 hours. On 24Apr2021, 24 hours after the shot, the patient experienced a fever of 100.8 which lasted for 36 hours. On the same day, the patient underwent body temperature test and the result was 100.8 (unknown units). 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 fever of 100.8 was resolved on an unspecified date in Apr2021; while the clinical outcome of the events extreme dizziness, vertigo and impaired vision were resolving 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash; Hives; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 16:45 (at the age of 68-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received ranitidine hydrochloride (ZANTAC) for unknown indication from an unknown date and experienced drug allergy. On 06Mar2021 at 07:00, the patient experienced itchy rash/hives which was coming and going on arms, legs, hands, around the neck, under the arms and down her side which worsened after her second shot. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 events itchy rash/hives which included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events itchy rash/hives was not resolved at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain in extremity, Pyrexia
Clinical narrative: After second vaccine, had a dry, tracheal cough.; "I" also had a fever; "I" also had a fever, chills, and sore arm, all of which were expected.; "I" also had a fever, chills, and sore arm, all of which were expected.; This is a spontaneous report from a contactable consumer, the patient. A 64-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 arm left on 21Apr2021 at 14:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The medical history included allergies to shellfish, poison ivy and soap. 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 concomitant medications were reported as none. 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 arm left on 31Mar2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, after second vaccine, the patient had a dry, tracheal cough. She also had a fever, chills and sore arm, all of which were expected. The cough was not expected and she could find nobody else with that symptom. The cough was the last to resolve. It was substantially better after day 3. The patient reported that she was completely socially isolated prior to the vaccine, so it could not have been caused from another virus. 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 events dry, tracheal cough, fever, chills and sore arm  were recovered on unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bradyphrenia, Chills, Decreased appetite, Disorientation
Clinical narrative: Disorientation; Dizziness; Chills; Fever; Joint aches; Severe headache; Loss of appetite; Nausea; Inability to articulate words and phrases; 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: EW0161) via an unspecified route of administration in the arm left on 23Apr2021 at 12:00 (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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 12:00, the patient experienced disorientation, dizziness, chills, fever, joint aches, severe headache, loss of appetite, nausea and inability to articulate words and phrases. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events disorientation, dizziness, chills, fever, joint ache, headache, appetite lost, nausea and thinking slow was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Disorientation; Dizziness; Chills; Fever; Joint aches; Severe headache; Loss of appetite; Nausea; Inability to articulate words and phrases; 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: EW0161) via an unspecified route of administration in the arm left on 23Apr2021 at 12:00 (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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 12:00, the patient experienced disorientation, dizziness, chills, fever, joint aches, severe headache, loss of appetite, nausea and inability to articulate words and phrases. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events disorientation, dizziness, chills, fever, joint ache, headache, appetite lost, nausea and thinking slow was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Periarthritis
Clinical narrative: joint pain bilateral arms, hands and hip; swelling of glands under left arm; Left shoulder frozen; This is a spontaneous report from a non-contactable nurse, the patient. A 61-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 an unknown date in Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021, post injection, the patient experienced joint pain bilateral arms, hands and hip, swelling of glands under left arm and left shoulder frozen and ongoing pain was 8/10 past the 4 week. 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 joint pain bilateral arms, hands and hip, swelling of glands under left arm and left shoulder frozen was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia oral, Paraesthesia oral, SARS-CoV-2 test, Swelling face
Clinical narrative: Face/cheek swelling.; Cheeks and mouth/teeth felt numb / Teeth felt like after dental anasthetic; Cheeks and mouth/teeth felt tingly; Flushing appearance; This is a spontaneous report from a contactable consumer, the patient. A 46-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 08Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known allergies to pomegranate. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mepyramine maleate, pamabrom, paracetamol (PAMPRIN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levofloxacin (LEVAQUIN) and experienced drug allergy. On 08Apr2021 at 10:45, the patient experienced face/cheek swelling and no swelling of lips. The swelling and flush appearance/feeling progressed over 3 hours then subsided. Cheeks and mouth/teeth felt numb, tingly and teeth felt like after dental anesthetic. On 14Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events face/cheek swelling, flush appearance and mouth/teeth felt numb, tingly and teeth felt like after dental anesthetic was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: little bit tired; besides just sore site injection and little bit tired; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm (Anatomical site of administration: patient stated, the upper left arm) on 02Apr2021 (Age at vaccination: 50-year-old) as DOSE 1, SINGLE for COVID-19 immunization at Rite Aid; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication (taken Ibuprofen after but nothing). The patient medical and concomitant medication history were report-ed. It was reported that patient not on any medication. In Apr2021, it was reported that, patient did not have any side effect on the first shot, besides just sore site injection and little bit tired. Patient was little worried that this was like permanent thing that patient have to deal with now. The event was not treated. The outcome of the event was unknown.   No follow up attempts are needed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metallic taste; Metallic smell; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Apr2021 at 17:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, prior to the vaccination. The patient did not have any known allergies. Concomitant medications were not reported. 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: EN6955) via an unspecified route of administration in the right arm on 23Mar2021 at 17:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced metallic taste and metallic smell which was ongoing for 4 days. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 event metallic taste and metallic smell was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity
Clinical narrative: Pain on backside of leg. NOT JOINT but as sciatic nerve leg pain.; Anxiety; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 11:00, the patient experienced pain on backside of leg. It was not joint but as sciatic nerve leg pain. On 25Apr2021 at 11:00 the patient also experienced anxiety. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain on backside of leg; not joint but as sciatic nerve leg pain and anxiety was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pain
Clinical narrative: Vaginal pain on labia, not cramping; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 22Apr2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and allergies to sulfa. 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 cetirizine hydrochloride (ZYRTEC), montelukast (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID); all for an unspecified indication from 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 in the right arm on 29Mar2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 01:00, the patient experienced vaginal pain on labia, not cramping. 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 vaginal pain on labia, not cramping was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Rash similar to hives started on April 23 and have continued to date. The rash is itchy and hasnt responded to allergy medications.; The rash is itchy and hasnt responded to allergy medications.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 21Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ursodeoxycholic acid (URSODIOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously patient 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 29Mar2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 18Mar2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 23Apr2021 at 08:00, the patient experienced rash which was similar to hives and had continued to date. The rash was itchy and was not responded to allergy medications. 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 taken as a result of the reported events which included treatment with allergy medications. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events rash similar to hives and rash was itchy were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: In the evening the day "I" received the vaccine "I" felt itchy all over "my" body; Since then, "my" neck continues to be itchy and "I" have developed a rash; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included abdominal adhesions and related pain, and allergy to avocado. 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 medication. On 08Apr2021 at 17:00, in the evening of the day of vaccination, the patient had felt itchy all over her body. Since then, her neck continued to be itchy and she developed a rash. 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 felt itchy all over body; since then, neck continued to be itchy and developed a rash was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Fatigue, Feeling abnormal, Flushing
Clinical narrative: Facial flushing within 15 minutes, went away after 30 minutes.; Facial puffiness within 15 minutes, went away after 30 minutes.; Arm got swollen later in the day; Arm got swollen and very warm later in the day; itchy later in the day; Experienced Fatigue off and on for 6 days after; Experienced brain fog off and on for 6 days after; Experienced 101 fever off and on 6 days after; temporary loss of taste off and on for 6 days after; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, high blood pressure, allergies to diary and sulfa. It was unknown, whether the patient was pregnant at the time 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. Concomitant medications were not reported. The patient previously received amoxicillin/ clavulanic acid (AUGMENTIN) for an unknown indication on an unknown date and experienced drug allergy. On 19Apr2021 at 13:45 within 15 minutes, the patient experienced facial flushing and puffiness which went away after 30 minutes. Arm got swollen, very warm and itchy later in the day. On the same day, the patient also experienced fatigue, brain fog, 101 fever and temporary loss of taste off and on for 6 days after. On 19Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was found to be 101 (unspecified units). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events facial flushing, puffiness within 15 minutes were recovered on an unknown date in Apr2021 after 30 minutes, while the events fatigue, brain fog, 101 fever and temporary loss of taste off and on were recovered on an unknown date in Apr2021 after 6 days and the events arm got swollen, very warm and itchy later in the day were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Skin warm, Swelling face
Clinical narrative: Facial flushing within 15 minutes, went away after 30 minutes.; Facial puffiness within 15 minutes, went away after 30 minutes.; Arm got swollen later in the day; Arm got swollen and very warm later in the day; itchy later in the day; Experienced Fatigue off and on for 6 days after; Experienced brain fog off and on for 6 days after; Experienced 101 fever off and on 6 days after; temporary loss of taste off and on for 6 days after; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, high blood pressure, allergies to diary and sulfa. It was unknown, whether the patient was pregnant at the time 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. Concomitant medications were not reported. The patient previously received amoxicillin/ clavulanic acid (AUGMENTIN) for an unknown indication on an unknown date and experienced drug allergy. On 19Apr2021 at 13:45 within 15 minutes, the patient experienced facial flushing and puffiness which went away after 30 minutes. Arm got swollen, very warm and itchy later in the day. On the same day, the patient also experienced fatigue, brain fog, 101 fever and temporary loss of taste off and on for 6 days after. On 19Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was found to be 101 (unspecified units). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events facial flushing, puffiness within 15 minutes were recovered on an unknown date in Apr2021 after 30 minutes, while the events fatigue, brain fog, 101 fever and temporary loss of taste off and on were recovered on an unknown date in Apr2021 after 6 days and the events arm got swollen, very warm and itchy later in the day were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: Painful lymph node; Painful lymph node swelling in collarbone on side of injection site; Also fatigued; This is a spontaneous report from a non-contactable consumer, the patient. A 22-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 arm left on 16Apr2021 at 16:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 23Apr2021 at 12:00 the patient experienced painful lymph node swelling in collarbone on side of injection site, also fatigued. All occurred 1 week after first dose. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful lymph node swelling in collarbone on side of injection site, also fatigued were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Insomnia, Myalgia, Nasopharyngitis
Clinical narrative: Shaky; Cold; Clammy; Sore neck muscles; Joint pain; Couldnt sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient 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 04Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 at 21:30, the patient experienced shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep and all lasted for about 5 hours. On 23Mar2021, the patient underwent COVID-19 test and the result was negative. 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 shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep was resolved on13Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Shaky; Cold; Clammy; Sore neck muscles; Joint pain; Couldnt sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient 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 04Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 at 21:30, the patient experienced shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep and all lasted for about 5 hours. On 23Mar2021, the patient underwent COVID-19 test and the result was negative. 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 shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep was resolved on13Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 06Apr2021 at 15:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included type ii diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Apr2021, the patient experienced skin rash and itchy from 2 days after the shot for about 10 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event itchy and included treatment with unspecified anti-itchy skin medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events skin rash and itchy was resolved on 18Apr2021, after the duration of 10 days.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Tinnitus
Clinical narrative: Diarrhea; Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer in 2015. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 22Apr2021, the patient experienced diarrhea and severe tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and severe tinnitus was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Period a week late; Abnormally heavy bleeding; Cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on the left arm on 05Apr2021 at 14:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported for the patient. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications were not reported for the patient. On 16Apr2021, the patient experienced period a week late, abnormally heavy bleeding and cramping. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 period a week late, abnormally heavy bleeding and cramping was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Wrong product administered
Clinical narrative: Diarrhea; Pfizer Covid Vaccine Dose and Moderna Covid Vaccine Dose both administered on the same day, 21APR2021.; This is a spontaneous report from a contactable other healthcare professional.   A contactable other healthcare professional (Pharmacy technician calling on behalf of the pharmacist) reported for a 38-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0161, Expiry date: 26May2021) via an unspecified route of administration on 21Apr2021 at 19:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 21Apr2021 at 19:30 (Lot number was not reported, Batch number: 002C21A, Expiry date: 14Oct2021) to 21Apr2021 19:30, at dose 1, single for covid-19 immunisation (NDC# 80777027399). The patient medical history was not reported. Concomitant medications included gabapentin (GABAPENTIN) and pramipexole (PRAMIPEXOLE) taken for unspecified indications, start and stop dates were not reported. On 21Apr2021, the patient experienced diarrhea and Pfizer covid vaccine dose and Moderna covid vaccine dose both administered on the same day, 21Apr2021. No investigation assessment. No treatments. Caller states they had an instance where a patient received a dose of the Pfizer vaccine and Moderna vaccine dose on the same day and enquired if there were any adverse reactions to look for or any steps they need to take. No history of previous immunization with the Pfizer vaccine considered as suspect. States he may have gone to the doctors office because he needed refills for his medication but she was unsure. No ER or physician office visit. Additional vaccines administered on same date of the Pfizer suspect was Moderna Covid Vaccine. No prior vaccinations (within 4 weeks). He did mark he had a reaction to vaccines before, nothing specific, just checked yes. Outcome was resolved on 22Apr2021 for event diarrhea and was unknown for the other event. The action taken in response to the events for covid-19 vaccine mrna (mrna 1273) was not applicable.  No follow up attempt are possible. No further Information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain
Clinical narrative: A protuberance around ''my'' left clavicle bone. Can move it up and down the clavicle, feels like a nodule; Not actively painful but a bit of soreness; This is a spontaneous report from a contactable pharmacist, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies (NKA). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in left arm on 31Mar2021 at 08:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 08:00, the patient experienced a protuberance around left clavicle bone, could move it up and down the clavicle, felt like a nodule, not actively painful but a bit of soreness. She noticed when showering Saturday on 24Apr2021 morning and today Monday 26Apr2021 still had it. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events a protuberance around left clavicle bone and bit of soreness 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: Abdominal discomfort, Vaccination site pain
Clinical narrative: Soreness at injection site; Gastrointestinal discomfort; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 13Apr2021, after vaccination the patient experienced soreness at injection site and gastrointestinal discomfort. The patient feeling much better 36 hours after the shot than before the shot, including resolution of symptoms from a prior COVID-19 infection, shortness of breath, lethargy, and brain fog that had been lingering for months prior to the vaccination. It was unknown if patient received treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. It was unknown if the patient been tested for COVID-19 since the vaccination. The clinical outcome of the events soreness at injection site and gastrointestinal discomfort was resolved on an unknown date of Apr2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.