chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Hard swollen lump at the injection site.; Injection site itchy; Becomes red if barely rubbed; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the arm on 22Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously received cephalexin and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), phentermine (MANUFACTURER UNKNOWN), vitamin b nos (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and biotin (MANUFACTURER UNKNOWN). 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. The patient reported that she had no symptoms until one week from the first dose and her arm was not even sore. On 30Mar2021 at 20:00, the patient reported that she had a hard swollen lump at the injection site. It was itchy and became red if she barely rubbed it. No therapeutic measures were taken for any 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 hard swollen lump at the injection site, itchy injection site and red injection site were not resolved.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue
Clinical narrative: Severe gastrointestinal upset; diarrhea; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 54-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 15:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included atherosclerosis, coronary artery disease, spinal stenosis, obesity, mild chronic obstructive pulmonary disease (COPD) (smoking) and penicillin allergy. Concomitant medications included ibuprofen 800 mg (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. Prior to vaccination, the patient had 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 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 04:00, the patient experienced severe gastrointestinal upset, diarrhea and fatigue. The events did not result in doctors 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 severe gastrointestinal upset, diarrhea and fatigue. The clinical outcomes of the events severe gastrointestinal upset, diarrhea and fatigue were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, very loud ringing/buzzing in ear; This is a spontaneous report from a contactable consumer, the patient. 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 the arm right on 10Mar2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN) , prasterone (DHEA) , pregnenolone (MANUFACTURER UNKNOWN) , progesterone (MANUFACTURER UNKNOWN) and estradiol (ESTRAD). 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 14Mar2021 at 00:00, the patient experienced tinnitus, very loud ringing/buzzing in ear. The patient did not receive any treatment for the event. 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 tinnitus, very loud ringing/buzzing in ear was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle contractions involuntary, Pain, SARS-CoV-2 test
Clinical narrative: muscle contracted; Shoulder muscle hurting; Back, legs and both arms hurt, pain all over; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 06Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200) via unspecified route of administration in the right arm on 27Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other medications the patient received within 2 weeks of vaccination. On 25Mar2021 at 01:00, the patient experienced muscles at the left shoulder were contracted and formed a mass and were still hurting. The muscles in the front of both legs were contracted and hurt. The patients back hurt and both arms with pain all over. The patient had not tested positive for COVID-19 since having the vaccine and had nasal swab test (COVID-19 test) on 20Mar2021, resulted negative. The adverse event resulted in emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of events muscle contractions, shoulder pain, and general body pain were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Fatigue
Clinical narrative: Severe muscle ache; Fatigue; High fever (103); Chills; Restless leg; Joint pain; Persistent headache; Mild cough; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old 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 27Mar2021 at 12:00 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient previously took 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 03Mar2021 at 15:00 (at the age of 24-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. The patient did not receive any other medications within 2 weeks of vaccination. On 27Mar2021 at 23:00, the patient experienced severe muscle aches, fatigue, fever (103 units unspecified), chills, restless leg, joint pain, persistent headache and mild cough. 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 patient did not receive any treatment for muscle ache, fatigue, fever, chills, restless leg, joint pain, headache and cough. The clinical outcomes of the events muscle ache, fatigue, fever, chills, restless leg, joint pain, headache and cough were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Restless legs syndrome
Clinical narrative: Severe muscle ache; Fatigue; High fever (103); Chills; Restless leg; Joint pain; Persistent headache; Mild cough; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old 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 27Mar2021 at 12:00 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient previously took 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 03Mar2021 at 15:00 (at the age of 24-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. The patient did not receive any other medications within 2 weeks of vaccination. On 27Mar2021 at 23:00, the patient experienced severe muscle aches, fatigue, fever (103 units unspecified), chills, restless leg, joint pain, persistent headache and mild cough. 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 patient did not receive any treatment for muscle ache, fatigue, fever, chills, restless leg, joint pain, headache and cough. The clinical outcomes of the events muscle ache, fatigue, fever, chills, restless leg, joint pain, headache and cough were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Chills; Fever; Body aches; pounding horrible headache; Unable to sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: FP6955) via an unspecified route of administration on 22Mar2021 at 11:30, (at the age of 44- years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, eczema, seasonal allergies. The patient was allergic to Brazil nuts. The concomitant medication included ibuprofen (MANUFRATURER UNKNOWN) as needed, but not on the day of (unspecified). The patient did not receive any other 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 tested for COVID-19. On 22Mar2021 at 23.30 (12 hours after jab), the patient experienced chills alternating with fever, body aches, pounding horrible headache, unable to sleep (waking every hour) which lasted until 36 hours after jab. The patient did not receive any treatment for reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, fever, headache, body aches and unable to sleep was resolved on 24Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Feeling abnormal, Pharyngeal swelling, Throat tightness
Clinical narrative: was 56-year-old at the time of vaccination), via an unspecified route of administration in arm left on 23Mar2021 at 09:41 as single dose for COVID-19 immunisation. Medical history included tooth infection and allergies to foods (she has allergies but she does not know, she does have some allergies to foods that would cause her throat to act up like that, but she avoids them at all costs). Vaccination facility type was hospital. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered. The patient did not receive prior vaccinations within 4 weeks. The patient stated that she had the first vaccine on 23Mar2021 at 09:41 and she went to her local hospital in town and sat there for approximately 15 minutes after throat started feeling tight but there were a number of people in there, so it was warm in the room, and she had her mask on, so she thought her throat was just dry, since she was excited about getting the vaccine and that's why she did not say anything when the vaccine administration staff asked if the caller was ok, she thought she felt perfectly fine. She felt that in her throat literally 10-15 minutes and it progressively kept getting worse for 2.5 hours and she kept drinking ice water to cool her throat and took lozenges and went outside for some fresh air, it was cold outside and then she went home. She stated that it did not get to a point where she had to go back to the hospital, but it was very noticeable that her throat was swelling and she felt like she had a tumbleweed in her throat. The feeling lasted for two and a half hours, then it started dissipating but she did not feel normal until the next day. She could breathe but she just had a constriction in her throat for two and a half hours and then it started getting a little better where she could tell there was some relief. She kept moving her arm around so the vaccine could spread, but now she was concerned about getting the second one because of the experience with her throat. Her general practitioner told her to take five Benadryl 30 minutes before the vaccine and to stay an hour at the facility. She took one Benadryl on Wednesday after which knocked her out so there was no way she could take that, she would be in a drug coma if she took 5 Benadryl. No further details on the one Benadryl that knocked her out, were provided by the caller. The events did not require a visit to emergency room or physician office. The outcomes of the events throat tightness, throat swelling was recovered on 23May2021 and was unknown for the rest of the events.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Extreme migraine; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration as a single dose on 23Mar2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to sulfa and onions. The concomitant medications included buspirone hydrochloride (BUSPAR) and quetiapine (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient has not tested for COVID-19 since vaccination. On 23Mar2021 at 15:30, the patient experienced extreme migraine since injection. The patient did not receive any treatment for reported event. The clinical outcome of migraine was not resolved at the time of this report.   No follow-up attempts are needed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Thirst
Clinical narrative: been very thirsty; headache; left arm is very sore like if had been punched several times; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 35-years old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. 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 concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 35-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 15:30, after receiving the vaccine, the patient had a headache shortly afterwards that lasted a few hours. Her left arm was very sore like if had been punched several times. The patient had been very thirsty. The adverse events did not result in a visit to the 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 headache, left arm is very sore like if had been punched several times and been very thirsty. The clinical outcomes of the events headache, left arm is very sore like if had been punched several times and been very thirsty were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Influenza like illness, Lymphadenopathy, Lymphoedema
Clinical narrative: flulike symptoms (chills, body aches,slight fever, headache); Left arm/hand lymphedema (mastectomy area); Joint pain; flare of arthritis in hips, knees, ankles and feet; water retention/puffy face,; swollen lymph nodes in chest; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207/59267-1000-1) via an unspecified route of administration in the right arm on 22Mar2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included heart arrhythmia, breast cancer survivor, arthritis, mastectomy, autoimmune disease of blood and thyroid and severe sepsis survivor. The patient was allergic to tramadol (MANUFACTURER UNKNOWN), moxifloxacin (MANUFACTURER UNKNOWN) and hydrocodone (MANUFACTURER UNKNOWN). Concomitant medications included dronedarone hydrochloride (MULTAQ), levothyroxine sodium (SYNTHROID), metoprolol (MANUFACTURER UNKNOWN) and various supplements (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not tested with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 19:00, the patient had flulike symptoms (chills, body aches, slight fever, headache), lymphedema left arm/hand (mastectomy area), followed by joint pain, flare of arthritis (in hips, knees, ankles, feet), water retention/puffy face, swollen lymph nodes in chest and heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were taken for the adverse events included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events flulike symptoms (chills, body aches, slight fever, headache), lymphedema left arm/hand (mastectomy area), joint pain, flare of arthritis (in hips, knees, ankles, feet), water retention/puffy face, swollen lymph nodes in chest and heart palpitations were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Swelling face
Clinical narrative: flulike symptoms (chills, body aches,slight fever, headache); Left arm/hand lymphedema (mastectomy area); Joint pain; flare of arthritis in hips, knees, ankles and feet; water retention/puffy face,; swollen lymph nodes in chest; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207/59267-1000-1) via an unspecified route of administration in the right arm on 22Mar2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included heart arrhythmia, breast cancer survivor, arthritis, mastectomy, autoimmune disease of blood and thyroid and severe sepsis survivor. The patient was allergic to tramadol (MANUFACTURER UNKNOWN), moxifloxacin (MANUFACTURER UNKNOWN) and hydrocodone (MANUFACTURER UNKNOWN). Concomitant medications included dronedarone hydrochloride (MULTAQ), levothyroxine sodium (SYNTHROID), metoprolol (MANUFACTURER UNKNOWN) and various supplements (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not tested with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 19:00, the patient had flulike symptoms (chills, body aches, slight fever, headache), lymphedema left arm/hand (mastectomy area), followed by joint pain, flare of arthritis (in hips, knees, ankles, feet), water retention/puffy face, swollen lymph nodes in chest and heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were taken for the adverse events included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events flulike symptoms (chills, body aches, slight fever, headache), lymphedema left arm/hand (mastectomy area), joint pain, flare of arthritis (in hips, knees, ankles, feet), water retention/puffy face, swollen lymph nodes in chest and heart palpitations were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills; Body aches; Fever 102.1; headache; felt fatigued; This is a spontaneous report from a non-contactable consumer, the patient . A 27-years old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 16:45 (at the age of 27-years-old) as a single for COVID-19 immunisation. The patient medical history included gastritis due to H. Pylori. The concomitant medications included Famotidine (UNKNOWN MANUFACTURER),ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), bifidobacterium infantis (ALIGN), and Iron (UNKNOWN MANUFACTURER); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Mar2021 at 08:30, the patient experienced headache and felt fatigued throughout the morning and about 16:00, the headache became unbearable and began to have chills and body aches and ended up having a 102.1 fever. The patient underwent lab tests and procedures, which included COVID test(nasal swab) on 24Mar2021 and resulted negative. Therapeutic measures were taken as a result of the events and included treatment herself Tylenol and woke up the next morning fever free and slight body aches which only lasted for a few more hours. 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 body aches, chills, fatigue, unbearable headache and fever was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Body aches; Fever 102.1; headache; felt fatigued; This is a spontaneous report from a non-contactable consumer, the patient . A 27-years old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 16:45 (at the age of 27-years-old) as a single for COVID-19 immunisation. The patient medical history included gastritis due to H. Pylori. The concomitant medications included Famotidine (UNKNOWN MANUFACTURER),ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), bifidobacterium infantis (ALIGN), and Iron (UNKNOWN MANUFACTURER); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Mar2021 at 08:30, the patient experienced headache and felt fatigued throughout the morning and about 16:00, the headache became unbearable and began to have chills and body aches and ended up having a 102.1 fever. The patient underwent lab tests and procedures, which included COVID test(nasal swab) on 24Mar2021 and resulted negative. Therapeutic measures were taken as a result of the events and included treatment herself Tylenol and woke up the next morning fever free and slight body aches which only lasted for a few more hours. 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 body aches, chills, fatigue, unbearable headache and fever was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Headache; Muscle pain; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 69-year-old) at 09:45 and second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, high blood pressure (BP) The patient was allergic to penicillin and sulfonamide (Sulfa). Concomitant medications received within 2 weeks of the vaccination included unspecified daily prescription medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not tested positive for COVID-19. On 03Mar2021, after the first dose of vaccination, the patient experienced chills, fever, nausea, headache, muscle pain and joint pain. No therapeutic measures were taken for the reported events. The adverse 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 such as Chills, fever, nausea, headache, muscle pain and joint pain were recovered with lasting effects at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Large lump under the right arm.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose, for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown 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 right arm on an unspecified date at 11:30, 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 20Mar2021 at 16:00, the patient experienced large lump under the right arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. The clinical outcome of large lump under the right arm was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Achiness; Nausea; This is a spontaneous report received from a non contactable consumer, the patient. A 36-years-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 24Mar2021 at 13:00(at the age of 36 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The Patient previously took Penicillin for unknown indication and experienced an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the Patient had not tested for COVID-19. On 25Mar2021 at 04:00, the patient experienced achiness and nausea. 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 achiness and nausea was recovering.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal sensation in eye, Epistaxis, Limb discomfort
Clinical narrative: Thumping sensation in eye, behind calf, abdomen, arm; Nosebleed; Thumping sensation in eye, behind calf, abdomen, arm; Thumping sensation in eye, behind calf, abdomen, arm; Thumping sensation in eye, behind calf, abdomen, arm; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unknown route of administration in left arm on an unknown date in Mar2021 at 12:30 (at the age of 62-year-old), as single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient was allergic to prednisone. Concomitant medications included unspecified blood pressure medication, iron pill and multi-vitamin. 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 tested for COVID-19. On an unknown date in Mar2021 at 00:30, the patient experienced nosebleed and thumping sensation in eye, behind calf, abdomen and arm. The patient had not received treatment for the reported events. The events had resulted in the visit to the doctor or other healthcare professional office/clinic visit. The clinical outcome of the events nosebleed and thumping sensation in eye, behind calf, abdomen and arm was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Rash vesicular
Clinical narrative: Red blisters rashes on the left side of the my body, right below my chest; Sharp pain at my left rib.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unknown route of administration in the left arm on 21Mar2021 at 10:30 (at the age of 52-year-old) as first single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. No known allergies reported. 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 4 weeks prior to the COVID-19 vaccine. Concomitant medication included benazepril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), aspirin (BAYER) and paracetamol (TYLENOL); all taken for unknown indication within two weeks of vaccination. On 21Mar2021 at 23:00, the patient experienced red blisters rashes on the left side of the body, right below the chest, and also experienced sharp pain at the left rib. The patient did not receive any treatment for the events. The clinical outcome of red blisters rashes on the left side of the body, right below the chest and sharp pain at the left rib was not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Eye irritation, Joint swelling
Clinical narrative: swollen wrists; swollen hands; swollen knees; red hands; severe generalized reaction of significant swelling at all extremities and face; Upset stomach; loose stool; eye burning sensation; skin peeling in both hands; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to some food (beans, pistachios, lactose intolerant), chemicals (in respirators, formol, latex etc), environmental, (dust, pollen, some trees) and medicine (tetracycline). Concomitant medications included claritine (MANUFACTURER UNKNOWN),vitamin C (MANUFACTURER UNKNOWN) and d3 (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. 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-19 vaccine. The patient experienced red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation and skin peeling in both hands on 10Mar2021 at 14:45. The patient experienced swollen wrists, hands and knees after 19 days after the first vaccination on an unknown date. The patient received treatment for the reported events included claritin and benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation, skin peeling in both hands, swollen wrists, hands and knees were not recovered 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: Peripheral swelling, Skin exfoliation, Skin reaction
Clinical narrative: swollen wrists; swollen hands; swollen knees; red hands; severe generalized reaction of significant swelling at all extremities and face; Upset stomach; loose stool; eye burning sensation; skin peeling in both hands; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to some food (beans, pistachios, lactose intolerant), chemicals (in respirators, formol, latex etc), environmental, (dust, pollen, some trees) and medicine (tetracycline). Concomitant medications included claritine (MANUFACTURER UNKNOWN),vitamin C (MANUFACTURER UNKNOWN) and d3 (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. 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-19 vaccine. The patient experienced red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation and skin peeling in both hands on 10Mar2021 at 14:45. The patient experienced swollen wrists, hands and knees after 19 days after the first vaccination on an unknown date. The patient received treatment for the reported events included claritin and benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation, skin peeling in both hands, swollen wrists, hands and knees were not recovered at the time of this report.  No follow up attempts are needed. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue; Extreme nausea; Fever; Body aches; This is a spontaneous report from a contactable other health care professional, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in the left arm on 04Mar2021 at 18:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovary syndrome). Concomitant medications included norethisterone acetate, ethinylestradioal and ferrous fumarate(HAILEY FE 1.5/30), spironolactone (MANUFACTURER UNKNOWN) and valacyclovir (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The Patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The Patient had not tested for COVID-19 since the vaccination. On 07Mar2021 at 13:00, the patient experienced fatigue, extreme nausea, fever and body aches. 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 events. The clinical outcome of the events fatigue, extreme nausea, fever and body aches was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: head pain on the right near ear and on top of head; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old elderly male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via unspecified route of administration in the right arm on 13Mar2021 at 18:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. The patient was allergic to eggs. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of COVID vaccine. On 15Mar2021 at 18:00, 48 hours after the first shot piercing the patient experienced head pain on the right near ear and on top of head which was sore to touch. The patient did not receive any treatment for the adverse event. 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 clinical outcome of the event headache was not recovered at the time of report.   No follow-up attempts possible. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling
Clinical narrative: Lymph node swollen in arm pit; Legs red swollen and heated.; Legs red swollen and heated.; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 12:00, the patient experienced lymph node swollen in arm pit, legs red swollen and heated. 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 events swollen lymph nodes, swelling of legs and redness legs was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache
Clinical narrative: Loss of taste and smell.; Severe headache.; Loss of taste and smell.; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200 59267-1000) via an unspecified route of administration in the left arm on 02Mar2021 at 11.00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 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 24Mar2021 at 06.00, the patient experienced loss of taste and smell and severe headache. The patient did not receive any treatment for the reported events. 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. The clinical outcome of the events loss of taste and smell and severe headache was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: unexpected therapeutic benefit; This is a spontaneous report from contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as allergic asthma, hypothyroidism, post-nasal drip, sneezing, and cough expectorating phlegm. The patient had drug allergies to sulfonamide drugs, fluconazole, montelukast, spriva and allergies to wines, melon and sulfites. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced unexpected therapeutic benefit on 29Mar2021 at 12:45. It was reported that the event was a happy and unintended one, she believed. she had cough-variant allergic asthma and take inhalers for it daily, including bronco-dilators. The patient coughed a lot even with the inhalers was on a five-month hiatus from her allergy injections and off antihistamines while awaiting a skin test, so the patient coughing had been particularly severe. Within an hour of receiving her first COVID vaccine, her allergy symptoms (post-nasal drip, sneezing, and severe asthma cough expectorating phlegm) were completely gone. It was the weirdest thing but she was thrilled. The clinical outcome of event unexpected therapeutic benefit was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.