chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: doctor prescribed her with antibiotic medication for her sinus; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration, on 16Mar2021, as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cefdinir (CEFDINIR) taken for sinusitis. The patient stated that she got her first dose of the vaccine last 16Mar2021 and was scheduled to get her second dose this 06Apr2021, her doctor prescribed her with antibiotic medication for her sinus -Cefdinir Omnicef (on an unspecified date) and she asked if she could take her second dose of the vaccine if she was taking this medication. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Whole body aches; fatigue; headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not received any other medications  within 2 weeks of vaccination  The patient had penicillin allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   On 30Mar2021 at 17:30, the patient experienced pain at injection site which was started about 4 hours after dose and lasting at least 40 hours improving at the time of this report.. On 31Mar2021, the patient experienced body aches, fatigue and headache starting approximately 20 hours of vaccination and lasting approximately 24 hours. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events pain at injection site, whole body aches, fatigue and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash pruritic, Throat irritation, Urticaria
Clinical narrative: swollen and itchy throat; swollen and itchy throat; hives on face and neck area; itchy rash on face and neck area; This is a spontaneous report from a contactable pharmacist. A 35-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 on 01Apr2021(at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. Concomitant medications were not reported. The patient reported allergies to medications, food or other products as unknown. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 13:00, the patient experienced swollen and itchy throat within 15 minutes of receiving the vaccine. The patient was asked to wait 30 minutes for further evaluation. Once the patient left the vaccination site, the patient experienced hives and an itchy rash on face and neck area. 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 events which included BENADRYL. The clinical outcome of the events swollen and itchy throat, hives and itchy rash on face and neck area was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Periorbital swelling, Swelling face
Clinical narrative: significant swelling underneath both eyes; significant swelling of cheeks; face aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-years-old non-pregnant female patient 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 17Mar2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included facial filler which was done on Nov2020, COVID-19 and known allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. 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 18Mar2021 at 19:00, the patient experienced face aches. On 19Mar2021, the patient woke up with significant swelling under both eyes and cheeks. The patient was nervous about second dose which was scheduled on 04Aug2021. The adverse 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 adverse events included BENADRYL and CLARITIN for over a week and the reactions were slowly subsided. The clinical outcomes of the events face aches, swelling underneath both eyes and significant swelling of cheeks were resolved with sequelae on an unspecified date of Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Heart rate increased, Muscle tightness, Pyrexia
Clinical narrative: heart rate shot up; terrible bran fog/ tired; jaws were extremely tight; TERRIBLE taste; fever; This is a spontaneous report from a contactable consumer, the patient. A 43-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 on the right arm on 30Mar2021 at 08:30(at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history included no thyroid, raynaud's (autoimmune). The patient has known allergy to levaquin. Concomitant medications were not reported. The patient had received medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on the left arm on 09Mar2021 at 08:30, 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 30Mar2021 at 10:00, the patient experienced terrible bran fog/ tired, jaws were extremely tight, TERRIBLE taste in the mouth,100 temperature, these all cleared up by the next morning. On 31Mar2021, the next day the patient thought was fine to exercise (run) but then experienced heart rate immediately (less than 1/2 mile in) shot up to 170 and hovered there even when slowed pace, once the patient quit running heart rate returned to normal quickly. The patient guessed getting winded very easily was the complaint. The patient did not receive any treatment for the events. 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. The clinical outcome of the events terrible bran fog/ tired, jaws were extremely tight, terrible taste, fever and heart rate shot up were recovered on 31Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: heart rate shot up; terrible bran fog/ tired; jaws were extremely tight; TERRIBLE taste; fever; This is a spontaneous report from a contactable consumer, the patient. A 43-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 on the right arm on 30Mar2021 at 08:30(at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history included no thyroid, raynaud's (autoimmune). The patient has known allergy to levaquin. Concomitant medications were not reported. The patient had received medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on the left arm on 09Mar2021 at 08:30, 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 30Mar2021 at 10:00, the patient experienced terrible bran fog/ tired, jaws were extremely tight, TERRIBLE taste in the mouth,100 temperature, these all cleared up by the next morning. On 31Mar2021, the next day the patient thought was fine to exercise (run) but then experienced heart rate immediately (less than 1/2 mile in) shot up to 170 and hovered there even when slowed pace, once the patient quit running heart rate returned to normal quickly. The patient guessed getting winded very easily was the complaint. The patient did not receive any treatment for the events. 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. The clinical outcome of the events terrible bran fog/ tired, jaws were extremely tight, terrible taste, fever and heart rate shot up were recovered on 31Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I have not had my monthly menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 05Mar2021 at 15:30 (at the age of 46-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 26Mar2021 (at the age of 46-years-old). The patient's medical history included penicillin. The patient had no concomitant medications. The patient previously received amoxicillin and contrast iodine and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 05Mar2021 at 15:30, the patient experienced irregular menstrual cycle. It was reported that it could be just mother nature, but just wanted to note that she not had her monthly menstrual cycle since the first vaccine, that she had never missed. 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 treatment for the adverse events. The clinical outcome of the event irregular menstrual cycle was unknown at the time of report.    No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Joint pain; Knees swelled; Headache(less severe); Migraine; Nausea; Flash hot; Leg pain; Dizziness; Sinus running; chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. This is the first of two cases. A 62-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 left arm on 09Mar2021 at 09:30 (at the age of 62-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included undiagnosed pain in legs and lyme disease. The patient was allergic to most narcotic pain meds (unspecified). Concomitant medications included baclofen (MANUFACTURER UNKNOWN) 5mg, gabapentin (MANUFACTURER UNKNOWN) 300 mg and eyedrops for glauc (unspecified). 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. Worst first dose than second, on 09Mar2021 (1st day), the patient experienced migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills and fatigue. On 10Mar2021 (2nd day) joint pains, knees swelled, headaches (less severe). On 11Mar2021 (3rd day), nausea, dizziness, fatigue. The adverse 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 and treatments were not taken as a result of the events. The clinical outcome of the events migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills, fatigue, joint pain, knee swelled and headache were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Joint swelling, Migraine, Nausea, Pain in extremity
Clinical narrative: Joint pain; Knees swelled; Headache(less severe); Migraine; Nausea; Flash hot; Leg pain; Dizziness; Sinus running; chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. This is the first of two cases. A 62-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 left arm on 09Mar2021 at 09:30 (at the age of 62-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included undiagnosed pain in legs and lyme disease. The patient was allergic to most narcotic pain meds (unspecified). Concomitant medications included baclofen (MANUFACTURER UNKNOWN) 5mg, gabapentin (MANUFACTURER UNKNOWN) 300 mg and eyedrops for glauc (unspecified). 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. Worst first dose than second, on 09Mar2021 (1st day), the patient experienced migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills and fatigue. On 10Mar2021 (2nd day) joint pains, knees swelled, headaches (less severe). On 11Mar2021 (3rd day), nausea, dizziness, fatigue. The adverse 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 and treatments were not taken as a result of the events. The clinical outcome of the events migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills, fatigue, joint pain, knee swelled and headache were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Joint pain; Knees swelled; Headache(less severe); Migraine; Nausea; Flash hot; Leg pain; Dizziness; Sinus running; chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. This is the first of two cases. A 62-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 left arm on 09Mar2021 at 09:30 (at the age of 62-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included undiagnosed pain in legs and lyme disease. The patient was allergic to most narcotic pain meds (unspecified). Concomitant medications included baclofen (MANUFACTURER UNKNOWN) 5mg, gabapentin (MANUFACTURER UNKNOWN) 300 mg and eyedrops for glauc (unspecified). 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. Worst first dose than second, on 09Mar2021 (1st day), the patient experienced migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills and fatigue. On 10Mar2021 (2nd day) joint pains, knees swelled, headaches (less severe). On 11Mar2021 (3rd day), nausea, dizziness, fatigue. The adverse 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 and treatments were not taken as a result of the events. The clinical outcome of the events migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills, fatigue, joint pain, knee swelled and headache were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Nausea, Vomiting
Clinical narrative: Very nauseous; Confused; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient had allergies to animals and dust. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:15, the patient experienced very nauseous, confused, vomiting. The patient did not receive any treatment for the 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. The clinical outcome of the events very nauseous, confused, vomiting was recovered with lasting effects  on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fatigue; headache; mild body aches; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 37-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 arm left on 31Mar2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to clindamycin. Concomitant medication included allegra (MANUFACTURER UNKNOWN) taken in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 10Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation within 4 weeks prior to 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 01Apr2021 at 0000 (after 690 minutes), the patient experienced fatigue, headache, mild body aches (ache) and arm soreness (pain in arm). 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 event. The clinical outcome of the events fatigue, headache, mild body aches and arm soreness was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Fatigue, Macule, Oedema peripheral
Clinical narrative: petechial hemes on both of my lower legs. They were inpatches as well as scattered randomly; They were deep red and purple in color and were notelevated or blister-like.; significant edema of my lower legs and ankles; fatigue; This is a spontaneous report from a contactable healthcare professional. A 59-year-old non-pregnant 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 19Mar2021 at 11:15 AM (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (reported as DCIS), osteoporosis, psoriasis, eczema, sulfa allergy, penicillin allergy and allergy to gluten. Concomitant medications included calcium carbonate; magnesium oxide; colecalciferol (CAL-MAG-D) as a supplement from unknown date. 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 26Mar2021 at 23:45 (one week after the vaccine), the patient experienced fatigue, petechial hemes on both of her lower legs which were in patches as well as scattered randomly. They were deep red and purple in color and were not elevated or blister-like. There was significant edema in her lower legs and ankles. Her right leg more affected than her left leg. On 27Mar2021, dermatologist suggested to get blood work to rule out low platelets. On 28Mar2021, the patient's lymphocytes were low. On 29Mar2021, the hemes seemed to be fading and leg swelling was resolved without any treatment. The patient had improvement until 31Mar2021 when new spots developed on both lower legs (looked a little different), not itchy and again fatigued. The events resulted in doctor or other healthcare professional office/clinic visit. On 31Mar2021, the patient underwent saliva pool testing and the result was unknown. The patient did not receive any treatment for the events. On 01Apr2021, the patient underwent biopsy and the result was unknown. The clinical outcome of the petechiae, purple red macule, lower leg edema and fatigue were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, SARS-CoV-2 test
Clinical narrative: petechial hemes on both of my lower legs. They were inpatches as well as scattered randomly; They were deep red and purple in color and were notelevated or blister-like.; significant edema of my lower legs and ankles; fatigue; This is a spontaneous report from a contactable healthcare professional. A 59-year-old non-pregnant 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 19Mar2021 at 11:15 AM (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (reported as DCIS), osteoporosis, psoriasis, eczema, sulfa allergy, penicillin allergy and allergy to gluten. Concomitant medications included calcium carbonate; magnesium oxide; colecalciferol (CAL-MAG-D) as a supplement from unknown date. 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 26Mar2021 at 23:45 (one week after the vaccine), the patient experienced fatigue, petechial hemes on both of her lower legs which were in patches as well as scattered randomly. They were deep red and purple in color and were not elevated or blister-like. There was significant edema in her lower legs and ankles. Her right leg more affected than her left leg. On 27Mar2021, dermatologist suggested to get blood work to rule out low platelets. On 28Mar2021, the patient's lymphocytes were low. On 29Mar2021, the hemes seemed to be fading and leg swelling was resolved without any treatment. The patient had improvement until 31Mar2021 when new spots developed on both lower legs (looked a little different), not itchy and again fatigued. The events resulted in doctor or other healthcare professional office/clinic visit. On 31Mar2021, the patient underwent saliva pool testing and the result was unknown. The patient did not receive any treatment for the events. On 01Apr2021, the patient underwent biopsy and the result was unknown. The clinical outcome of the petechiae, purple red macule, lower leg edema and fatigue were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; body ache; headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 31Mar2021 at 08:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to food, medications, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 31Mar2021, the patient experienced fever, body ache and headache. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of fever, body ache and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hot flush, Nausea
Clinical narrative: Dizziness; nausea; hot flashes; bouts of chills; runny nose; headache started on left side of head behind ear then progressed to frontal portion of head; Injection site pain; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERS737) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 31Mar2021 at 15:30, few hours after getting vaccine, injection site pain/sore arm became noticeable. The patient woke up the next morning and arm was still feeling heavy and sore. The patient also experienced dizziness and nausea within 20 minutes of getting out of bed and while in shower, to the point of that the patient had to stop shower to go lay down. Then the patient experienced what seemed like hot flashes while laying down, got up about 25 minutes later and dizziness had subsided but later in the day experienced bouts of chills and runny nose, then headache started on left side of head behind ear then progressed to frontal portion of head. Therapeutic measures were not taken as a result of the reported events. 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. The clinical outcome of the events injection site pain, sore arm, dizziness, nausea, hot flashes, bouts of chills, runny nose and headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, Vaccination site pain
Clinical narrative: Dizziness; nausea; hot flashes; bouts of chills; runny nose; headache started on left side of head behind ear then progressed to frontal portion of head; Injection site pain; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERS737) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 31Mar2021 at 15:30, few hours after getting vaccine, injection site pain/sore arm became noticeable. The patient woke up the next morning and arm was still feeling heavy and sore. The patient also experienced dizziness and nausea within 20 minutes of getting out of bed and while in shower, to the point of that the patient had to stop shower to go lay down. Then the patient experienced what seemed like hot flashes while laying down, got up about 25 minutes later and dizziness had subsided but later in the day experienced bouts of chills and runny nose, then headache started on left side of head behind ear then progressed to frontal portion of head. Therapeutic measures were not taken as a result of the reported events. 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. The clinical outcome of the events injection site pain, sore arm, dizziness, nausea, hot flashes, bouts of chills, runny nose and headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test, Swelling
Clinical narrative: Swollen lymph node in armpit and neck; Swollen neck on side of body (left); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 29Mar2021 at 0930 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included allergy. Concomitant medication included Zyrtec (MANUFACTURER UNKNOWN). The patient received this medication (Zyrtec) within two weeks of vaccination. The patient had no known allergies to food, medications or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 08Mar2021 at 0830 as a single dose for COVID-19 immunisation. 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 been tested for COVID-19. On 31Mar2021 at 0700 the patient experienced swollen lymph node in armpit and neck on side of body (left) where she received the vaccine. The lymph node swelling started 48 hours after second dose and lasted over 24 hours. The patient did not receive any treatment for the event. It was reported that the adverse events resulted in none of the above. On 30Dec2020, the patient underwent nasal swab test and the result was negative. The clinical outcome of swollen lymph node in armpit and swollen neck was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: extreme weakness; lightheaded; This is a spontaneous report from a non-contactable consumer, the patient. A 40-years-old adult non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ethinylestradiol, etonogestrel (NOVARING), escitalopram (MANUFACTURER UNKNOWN) and valaciclovir (VALACYCLOVIR); all for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced extreme weakness and lightheaded. The adverse 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 events extreme weakness and lightheadedness were resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nasal congestion, Pain, Pyrexia
Clinical narrative: Fever; Diarrhea; Chills; Aches; Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old, adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications reported. 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 01Apr2021, the patient experienced fever, diarrhea, chills, aches and nasal congestion. 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 fever, diarrhea, chills, aches and nasal congestion was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Headaches; Chills; Fever; Tiredness; Nausea; Muscle pain; General overall feeling ill; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 10:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included cholesterol high, bladder and basal cell cancer and COVID-19 (which was diagnosed prior to vaccination). The patient did not have any allergies to medications, food or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) 20 mg, lactobacillus acidophilus (FLORAGEN ACIDOPHOLIS) and MULTIVITA; all for unknown indications, from unknown dates and unknown if ongoing. 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 05Mar2021 at 04:00, the patient experienced headaches, chills, fever, tiredness, nausea, muscle pain and general overall feeling ill. The patient did not receive any treatment for the 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 event headaches, chills, fever, tiredness, nausea, muscle pain and feeling ill were recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headaches; Chills; Fever; Tiredness; Nausea; Muscle pain; General overall feeling ill; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 10:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included cholesterol high, bladder and basal cell cancer and COVID-19 (which was diagnosed prior to vaccination). The patient did not have any allergies to medications, food or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) 20 mg, lactobacillus acidophilus (FLORAGEN ACIDOPHOLIS) and MULTIVITA; all for unknown indications, from unknown dates and unknown if ongoing. 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 05Mar2021 at 04:00, the patient experienced headaches, chills, fever, tiredness, nausea, muscle pain and general overall feeling ill. The patient did not receive any treatment for the 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 event headaches, chills, fever, tiredness, nausea, muscle pain and feeling ill were recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Left ear pulsatile tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient 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 20Mar2021 at 16:30 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for unknown indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021, the patient experienced left ear pulsatile tinnitus. Therapeutic measures were taken as a result of pulsatile tinnitus and included treatment with steroid therapy - prednisone. This adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event left ear pulsatile tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Persistent tingling in the feet; This is a spontaneous report from a contactable consumer, the patient. A 33-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 in the right arm on 30Mar2021 at 15:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included sports induced asthma, prostatitis and rhinitis. The patient had no known allergies. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL INHALER) from unknown dates and unknown indications. 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 30Mar2021 at 20:00, the patient experienced persistent tingling in the feet front half of the foot, 55 hours post first vaccination and still continued at the time of the report. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event persistent tingling in the feet was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Large red spot; Warm to the touch; This is a spontaneous report from a contactable other healthcare professional, the patient. A 65-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 right arm on 29Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included addison's disease. The patient had no allergies to medications, food, or other products. Concomitant medication included hydrocortisone (MANUFACTURER UNKOWN) for unknown indication. 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 08Mar2021 at 13:45 (at the age of 64-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. 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 31Mar2021 at 17:00, the patient experienced large red spot which was warm to the touch. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the event large red spot which was warm to the touch was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.