chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Fatigue, Headache, Nausea
Clinical narrative: Headache; itchy; Achy joints; confusion; Tiredness; nauseous; 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: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, set episodes and anxiety. The patient was allergic to shellfish and Intravenous Pyelogram (IVP) contrast dye. Concomitant medications included bupropion XL (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. 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 31Mar2021 at 12:00 (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. 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 14Apr2021, the patient experienced headache, itchy, achy joints, confusion, tiredness and felt nauseous. 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. The clinical outcome of the events headache, itchy, achy joints, confusion, tiredness and felt nauseous were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Headache; itchy; Achy joints; confusion; Tiredness; nauseous; 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: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, set episodes and anxiety. The patient was allergic to shellfish and Intravenous Pyelogram (IVP) contrast dye. Concomitant medications included bupropion XL (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. 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 31Mar2021 at 12:00 (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. 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 14Apr2021, the patient experienced headache, itchy, achy joints, confusion, tiredness and felt nauseous. 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. The clinical outcome of the events headache, itchy, achy joints, confusion, tiredness and felt nauseous were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Tongue swelling / numbing; Tongue swelling / numbing; 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: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient was allergic to ragweed and mugwort. Concomitant medications included levonorgestrel (MIRENA) Intrauterine Device (IUD) and multivitamin (PURE SYNERGY), both taken for unspecified indications from unknown dates. 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 09Apr2021 at 09:00, about 15 minutes after the vaccine, the patient experienced tongue swelling/numbing. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were taken as a result of the event and included treatment with liquid Benadryl. The clinical outcome of the event tongue swelling/numbing was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Swelling
Clinical narrative: Lump above from collarbone and swollen; Lump above from collarbone and swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 16:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Apr2021, two days after vaccination, the patient got a lump above from her collarbone and swollen. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lump above from collarbone and swollen 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Palpitations, SARS-CoV-2 test, Thirst
Clinical narrative: Rapid heart rate; Dizziness; Extreme thirst; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 00:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, sulfa allergy and latex allergy. The patient did not receive any 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. On 21Mar2021 at 00:00, the patient experienced rapid heart rate, dizziness, extreme thirst and chills. The events 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 which included treatment with fluids and testing. On 26Mar2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events rapid heart rate, dizziness, extreme thirst and chills was resolved with sequelae. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstruation came 2 weeks early (2 weeks right after my cycle ended); heavier flow; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female 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 2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, after receiving the first dose, the patient had menstruation came 2 weeks early (2 weeks right after cycle ended) and heavier flow. Patient stated that this had never happened before. The clinical outcome of the event menstruation irregular and heavier flow were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort
Clinical narrative: Very uncomfortable; Wrist and knuckle joints are having pain; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534/ER8729), via an unspecified route of administration in the right hand on 10Apr2021 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient experienced very uncomfortable and wrist and knuckle joints are having pain. It was reported that the patient could not even wash face with the right hand due to pain. The pain was bearable but very uncomfortable when it comes to doing things. The events resulted in doctor/other health care professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of very uncomfortable and wrist and knuckle joints are having pain was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea
Clinical narrative: Severe chills for a couple days; nausea; very tired; felt unwell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 24Mar2021 at 16:00, as single dose for COVID-19 immunisation. Medical history included diverticulitis, IBD and allergy to penicillin. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medication included levothyroxine sodium (SYNTHROID), antidepressant, allergy meds, ESTROVEN; all from an unknown start date and for unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021, patient experienced severe chills for couple of days, nausea, very tired and felt unwell for 3-4 days. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event severe chills, nausea, very tired and felt unwell were recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears/ hissing in ears; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient was allergic to horse serum. The patient received medication (UNSPECIFIED) within two weeks of vaccination. The patient previously took levaquin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 05:00, the patient experienced ringing and hissing in ears, more in left ear. No therapeutic measures were taken as a result of adverse events. The event 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 ringing and hissing in ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site swelling
Clinical narrative: Large red circle; swollen around injection site; 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: ER8734) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not receive any medication 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. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 the patient experienced large red circle and swollen around injection site. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of large red circle and swollen around vaccination site was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigued; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old 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 left arm on 11Apr2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. It was unknown if the patient was pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously 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 21Mar2021 at 11:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Apr2021, at 17:45 the patient experienced headache which came and went. On 12Apr2021, the day after vaccination the patient felt fatigued and the patient reported that the pain intensity had decreased. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of adverse events. The clinical outcome of the events headache and fatigue were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Loud non-pulsatile tinnitus in left ear only; This is a spontaneous report from a contactable consumer, the patient. A 47-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 13Apr2021 at 11:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included adenoidectomy (adenoid removal), scoliosis surgery and myringotomy (tubes in ears as child) and sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 15:00, the patient experienced loud non-pulsatile tinnitus in left ear only. The patient had not had this before. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event loud non-pulsatile tinnitus in left ear only was not resolved 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: Lymphadenopathy
Clinical narrative: Lymph Node Swelling under the same arm that vaccine was given.; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not receive any medication within two weeks of vaccination. The patient previously took non steroidal anti inflammatory drugs (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced allergy. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) in the left arm on 19Mar2021 at 11:00 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 05Apr2021 at 23:00, the patient experienced lymph node swelling under the same arm that vaccine was given. No therapeutic measures were taken as a result of reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node swelling under the same arm that vaccine was given was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Raised rash on torso, groin, legs, chest, neck and back.; Burning & itching on skin but not at injection site; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hereditary high blood pressure and COVID-19. The patient had unspecified allergies. Concomitant medications included salbutamol (ALBUTEROL) inhaler and losartan (MANUFACTURER UNKNOWN), both taken for asthma and high blood pressure respectively from unknown dates. 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 25Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, 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. On 15Apr2021 at 18:00, the patient experienced raised rash on torso, groin, legs, chest, neck and back and burning and itching on the skin but not at injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Benadryl and if not improved the patient planned to see the doctor. The clinical outcome of the events raised rash on torso, groin, legs, chest, neck and back and burning and itching on skin were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Fatigue, Pain in extremity
Clinical narrative: Fatigue; Leg pain mostly right leg, upper thigh area; Lower back pain; Calf pain; First night after vaccine sharp abdominal pain. Didn't last long.; This is a spontaneous report from a contactable healthcare professional, the patient. A 66-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 on 10Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included insomnia. Concomitant medications were not reported. The patient previously took morphine (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. 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 10Apr2021, the patient experienced sharp abdominal pain, didn't last long. On 11Apr2021, the patient experienced fatigue, then leg and lower back pain which was persistent, leg pain mostly right leg, upper thigh area at times, calf pain. The patient reported that it was really hard to say when it actually started but it appeared to have started after having vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event sharp abdominal pain recovered on an unspecified date in Apr2021. While that of leg and lower back pain, leg pain mostly right leg, upper thigh area at times, calf pain was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling  around the point of injection; Redness around the point of injection; itching; This is a spontaneous report from a contactable consumer, the patient. A 31-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 left arm on 10Apr2021 at 11:00(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and insulin resistance. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and oneadayvitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 20Mar2021 at 16:15 (at the age of 31-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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00, the patient experienced swelling and redness around the point of injection in a circle about 1inch diameter associated with itching started 24 hours post vaccination of 2nd dose, persisted after 72hour at the time of reporting. Therapeutic measures were taken as a result of event and included treatment with anti-histamine(unspecified) from unspecified start date to unspecified stop date. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling around the point of injection, redness around the point of injection and itching were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleeds; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 14:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (food sensitivities) and allergy to grass. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 19Mar2021 at 14:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), ascorbic acid (VITAMIN C), retinol (VITAMIN A), thiamine (VITAMIN B1) and cyanocobalamin (VITAMIN B12); all since an unknown date, for unknown indication and unknown if ongoing. 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 COVID vaccine. On 07Apr2021 at 23:00, the patient experienced nosebleeds. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event nosebleeds was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Bone pain, Cerebrovascular accident, Excessive eye blinking, Headache
Clinical narrative: Feels like I've had a stroke on right side of face; Half of face feels numb and the right side of face higher than left side of face/My cheekbone is totally numb; All bones in my face hurt very badly; Headache won't go away even with two maxalt migraine meds.; my right eye won't stop squinting; my skin my bones in my face and brain really hurt.; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 11:15 (Batch/Lot number was not reported) as single dose (at the age of 47) for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, anxiety, depression, insomnia, migraines, arthritis, allergy to sulfa, allergy to clarithromycin (MACROBID), allergy to amitriptyline, allergy to trazodone, allergy to tamiflu. First dose was received on 17Mar2021 12:45PM (at the age of 47) arm left. No covid prior vaccination. Covid test on 03Apr2021 was Negative. Antibodies test negative on 13Mar2021. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), duloxetine, rizatriptan benzoate (MAXALT), finasteride, bupropion hydrochloride (WELLBUTRIN). The patient experienced feels like I've had a stroke on right side of face on 14Apr2021 12:00, half of face feels numb and the right side of face higher than left side of face/my cheekbone is totally numb on 14Apr2021 12:00, all bones in my face hurt very badly on 14Apr2021 12:00, headache won't go away even with two maxalt migraine meds on 14Apr2021 12:00, my right eye won't stop squinting on 14Apr2021 12:00, my skin my bones in my face and brain really hurt on 14Apr2021 12:00. Patient tried a muscle relaxer for headache and didn't help. No treatment for the other events. The events outcome was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain of skin, SARS-CoV-2 test
Clinical narrative: Feels like I've had a stroke on right side of face; Half of face feels numb and the right side of face higher than left side of face/My cheekbone is totally numb; All bones in my face hurt very badly; Headache won't go away even with two maxalt migraine meds.; my right eye won't stop squinting; my skin my bones in my face and brain really hurt.; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 11:15 (Batch/Lot number was not reported) as single dose (at the age of 47) for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, anxiety, depression, insomnia, migraines, arthritis, allergy to sulfa, allergy to clarithromycin (MACROBID), allergy to amitriptyline, allergy to trazodone, allergy to tamiflu. First dose was received on 17Mar2021 12:45PM (at the age of 47) arm left. No covid prior vaccination. Covid test on 03Apr2021 was Negative. Antibodies test negative on 13Mar2021. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), duloxetine, rizatriptan benzoate (MAXALT), finasteride, bupropion hydrochloride (WELLBUTRIN). The patient experienced feels like I've had a stroke on right side of face on 14Apr2021 12:00, half of face feels numb and the right side of face higher than left side of face/my cheekbone is totally numb on 14Apr2021 12:00, all bones in my face hurt very badly on 14Apr2021 12:00, headache won't go away even with two maxalt migraine meds on 14Apr2021 12:00, my right eye won't stop squinting on 14Apr2021 12:00, my skin my bones in my face and brain really hurt on 14Apr2021 12:00. Patient tried a muscle relaxer for headache and didn't help. No treatment for the other events. The events outcome was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The muscle where the vaccine was injected swelled quite a bit and is still swollen.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the arm right on 06Apr2021 at 15:30(at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included ibuprofen (MOTRIN) from unknown for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration on 07Mar2021 at 15:45 as single dose for COVID-19 immunisation. Prior to 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 09Apr2021 the patient experienced muscle where the vaccine was injected swelled quite a bit and is still swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event muscle where the vaccine was injected swelled quite a bit and is still swollen. was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Extreme muscular soreness; Fever of 102; Nausea; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A 26-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 right arm on an unknown date in Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. 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 medications within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on an unknown date in Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in Mar2021, the day after the second dose only, the patient experienced extreme muscular soreness, fever of 102 (unspecified units), nausea, headache and fatigue. 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 event's extreme muscular soreness, fever of 102 (unspecified units), nausea, headache and fatigue were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme muscular soreness; Fever of 102; Nausea; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A 26-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 right arm on an unknown date in Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. 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 medications within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on an unknown date in Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in Mar2021, the day after the second dose only, the patient experienced extreme muscular soreness, fever of 102 (unspecified units), nausea, headache and fatigue. 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 event's extreme muscular soreness, fever of 102 (unspecified units), nausea, headache and fatigue were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild Headache; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 13Apr2021 at 12:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to tree nuts. The patient did not receive any concomitant medications. The patient previously received the dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3274) via an unspecified route of administration on 22Mar2021 at 12:30 (at the age of 21-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 vaccine within four weeks prior to the COVID Vaccine. On 13Apr2021 at 20:00, the patient experienced mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event mild headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Flushing, Pain
Clinical narrative: FACIAL FLUSHING WITH HOT FACE; BODY ACHES; hOT AND COLD FEELING OVERALL; This is a spontaneous report from a contactable nurse, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and allergic to tetanus. Concomitant medications included olmesartan (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and hydrochlorothiazide (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 26Feb2021 at 14:30(at the age of 71-year-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. On 01Apr2021 at 09:30, the patient experienced facial flushing with hot face, body aches, hot and cold feeling overall with no fever. 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. The clinical outcome of the events facial flushing with hot face, body aches, cold and hot feeling were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER2613), at the age of 39, via an unspecified route of administration, left arm, on Apr 12, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history included long QT syndrome and major depression. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient previously took lamotrigine on an unknown date for an unknown indication and experienced allergy. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 39, via an unspecified route of administration, on Mar 22, 2021, at 10:30, single dose, for COVID-19 immunisation. Concomitant medications included potassium, nadolol and desvenlafaxine; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 12, 2021, patient experienced nausea, brain fog, dizziness, some cotton mouth, malaise, fatigue and pain in injection site. No therapeutic measures taken as a result of the events. The events did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not been tested for COVID-19. The outcome of nausea, brain fog, dizziness, some cotton mouth, malaise, fatigue and pain in injection site: not recovered (at the time of this report). No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oral fungal infection, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER2613), at the age of 39, via an unspecified route of administration, left arm, on Apr 12, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history included long QT syndrome and major depression. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient previously took lamotrigine on an unknown date for an unknown indication and experienced allergy. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 39, via an unspecified route of administration, on Mar 22, 2021, at 10:30, single dose, for COVID-19 immunisation. Concomitant medications included potassium, nadolol and desvenlafaxine; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 12, 2021, patient experienced nausea, brain fog, dizziness, some cotton mouth, malaise, fatigue and pain in injection site. No therapeutic measures taken as a result of the events. The events did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not been tested for COVID-19. The outcome of nausea, brain fog, dizziness, some cotton mouth, malaise, fatigue and pain in injection site: not recovered (at the time of this report). No follow-up attempts possible. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever; Headache; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 at 09:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 30-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 12Apr2021 at 23:00, the patient experienced chills, fever and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever and headache was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula
Clinical narrative: Swollen uvula; This is a spontaneous report from a contactable consumer, the patient. A 45-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 09Apr2021 at 11:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP) and penicillin allergy. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA) and lisinopril (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. 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 09Apr2021 at 16:00, the patient experienced swollen uvula. No therapeutic measures were taken as a result of the reported event. The event 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 event swollen uvula was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.