chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm, getting worse; Persistent headache; Dizzy feeling/Lightheaded feeling; Slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 01Mar2021 at 13:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obsessive-compulsive disorder (OCD), pervasive developmental disorder-not otherwise specified (PDD-NOS), anxiety, depression, concussions and known allergies to oral steroids. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), sennoside a+b (SENNOSIDES), fexofenadine (MANUFACTURER UNKNOWN) and diphenhydramine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 02Mar2021 at 12:00, the patient experienced sore arm, getting worse, persistent headache, dizzy feeling, lightheaded feeling and slight nausea. The clinical outcome of the events sore arm, getting worse, persistent headache, dizzy feeling, lightheaded feeling and slight nausea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Heart rate increased, Pain
Clinical narrative: Severe headache; Weakness; Fast heartbeat; Aches/Pain; Tiredness; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03Mar2021 at 19:00, the patient experienced severe headache, weakness, fast heartbeat, tiredness and aches/pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, weakness, fast heartbeat, aches, tiredness and pain was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male 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 27Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) and fexofenadine hydrochloride (ALLEGRA); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021, the patient experienced sore 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Neck pain
Clinical narrative: "I" was injected in my left arm and starting the day after "I" noticed soreness in my arm pit, the soreness/tenderness has been mild,; Soreness on left clavicle/neck; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 10Feb2021 at 16:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had reported sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN), fish oil (OMEGA 3) and calcium, magnesium (CALCIUM; MAGNESIUM); all for unknown indication from an unknown date and unknown if ongoing. On 10Feb2021 at 22:00, the patient noticed soreness in arm pit, the soreness/tenderness has been mild, also soreness on left clavicle/neck- it was mild and has decreased but still there (on 04Mar2021) under armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "I" was injected in my left arm and starting the day after "I" noticed soreness in my arm pit, the soreness/tenderness has been mild and soreness on left clavicle/neck was resolving 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: Dizziness
Clinical narrative: Very dizzy; 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: UNKNOWN) via an unspecified route of administration in the right arm on 23Feb2021 at 08:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to food, medications or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 24Feb2021 at 11:30, the patient experienced very dizzy. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very dizzy was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 17Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included folic acid (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), lithium (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), hydrochlorothiazide/triamterene (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) and rivaroxaban (XARELTO), all from unknown dates for unknown indications and unknown if ongoing. On 01Mar2021, the patient experienced dizziness and tiredness. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness and tiredness were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Hypoaesthesia, Varicose vein, Vascular pain
Clinical narrative: vascular visibility in hands with pain / numbness; vascular visibility in hands with pain / numbness; can see red veins and bruising around it; vascular visibility/ can see red veins; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 619266) via an unspecified route of administration in the left arm on 26Feb2021 at 10:30(at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history included seizure disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levetiracetam (KEPPRA) and lacosamide (VIMPAT); both for an unknown indication from unknown dates and unknown if ongoing. The patient previously took lamotrigine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 27Feb2021, the patient experienced vascular visibility in hands with pain/numbness and he could see red veins and bruising around it. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vascular visibility in hands with pain/numbness and could see red veins and bruising around it was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hangover, Lymphadenopathy, Nausea
Clinical narrative: Lymph node on my left clavicle popped out; Extremely tired; Felt nauseous; Hang over for a few days; Did not feel myself; This is a spontaneous report from a contactable other healthcare professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, 24 hours after the second dose, the patient experienced a lymph node pop out on her left clavicle. She was extremely tired, felt nauseous like and hang over for a few days. She did not feel herself until 5 days after the second dose and the node was pretty much gone then, it was very visible and then it was not. She still can feel a very small bump. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events lymph node on her left clavicle popped out, extremely, felt nauseous, hang over for a few days, did not feel herself, nose is pretty much gone and still feel a very small bump was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt soreness at the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 09:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included dormant prostate cancer, borderline high blood pressure, borderline obesity, prediabetic and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Mar2021 at 21:00, about 12 hours after injection the patient felt soreness at the site of injection, and no other symptoms were noted. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event felt soreness at the site of injection was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Limb discomfort
Clinical narrative: Felt heaviness in left arm; Could not raise arm above shoulder; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 75-years-old) at 13:30, as a single dose for COVID-19 immunisation. Medical history included osteoporosis (Osteoporosity), hypothyroidism (hypothyroid), opioid allergy and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021at 19:00, the patient felt heaviness in left arm and could not raise arm above shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient did not test for COVID-19. The clinical outcome of the events felt heaviness in left arm, could not raise arm above shoulder was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 03Mar2021 at 20:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both for unknown indications from unknown dates and unknown if ongoing. On 04Mar2021 at 03:00, the patient experienced a sore arm at the site of injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at site of injection was resolved on 04Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: development of lymphadenopathy in left sub mandibular region. The lymphadenopathy is about 35*12*10 mm, firm, mobile, non-tender, and positive for little pain and discomfort.; positive for little pain and discomfort.; This is a spontaneous report from a contactable physician, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9263) via an unspecified route of administration in the left arm on 02Feb2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other unspecified medications within two weeks of COVID-19 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 15Jan2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On 10Feb2021, after a week after receiving the second dose, the patient noticed development of lymphadenopathy in left sub mandibular region, the lymphadenopathy was about 35*12*10 mm, firm, mobile, non-tender, and positive for little pain and discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event development of lymphadenopathy in left sub mandibular region and positive for little pain and discomfort was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Somnolence
Clinical narrative: Tiredness; Sleepy; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 13:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had received concomitant medication within two weeks of vaccination which was not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 the patient experienced tiredness and sleepy. Since the vaccination, the patient had been tested for COVID-19. On 04Mar2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events tiredness and sleepy were unknown 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: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes around the collarbone area; 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 unspecified route of administration in the left arm on 05Feb2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 26Feb2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease, acid reflux (esophageal) and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within 2 weeks of vaccination. On an unknown date in Feb2021, the patient experienced swelling of lymph nodes around the collarbone area. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lymph nodes around the collarbone area was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: About 8 days after receiving 2nd dose," I "started feeling swollen lymph nodes in the L armpit (the arm that was vaccinated).; Currently have 2 swollen lymph nodes. Small and somewhat painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 13Jan2021, at 08:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included syncope and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020, at 08:30 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. On 22Jan2021, about 8 days after second dose, the patient experienced swollen lymph nodes in the left (L) armpit (the arm that was vaccinated), they went away approximately 10 days later, however had returned and gone away two more times, the patient had 2 swollen lymph nodes, small and somewhat painful, (its been 7 weeks post second dose when patient reported). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in the left (L) armpit (the arm that was vaccinated), they went away approximately 10 days later, however had returned and gone away two more times, the patient had 2 swollen lymph nodes, small and somewhat painful was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, Malaise
Clinical narrative: profuse sweating; felt unwell; pain in stomach; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 38-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 the left arm on 03Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and surgically induced menopause. The patient had sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Other vaccine the patient received within four weeks prior to the vaccination included tetanus vaccine toxoid/ diphtheria vaccine toxoid/ pertussis vaccine acellular (TDAP) via an unspecified route of administration on the right arm on 15Feb2021. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); levothyroxine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 04Mar2021 at 13.30, 20 hours to 20.5 hours after vaccination, the patient experienced profuse sweating, felt unwell and pain in stomach. Diarrhea began 21 hours after injection and was still continuing at 26-hour mark. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events profuse sweating, felt unwell, pain in stomach and diarrhea were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Large red area on arm of vaccination. This happened after the 2nd dose 2 days after injection, which I expected since this happens with other vaccines.. It went away and then returned again 7 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 68-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 26Feb2021 at 16:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and seasonal allergy. Concomitant medications taken within two weeks of vaccination included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC) and budesonide (NASOCORT); all for unknown indication, from unknown date and unknown if ongoing. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) and experienced flu shot side effects, delayed immune response, red arm and lymph node areas of her body got red for a few days. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Feb2021, the patient experienced large red area on arm of vaccination. This happened after the second dose two days after injection, which she expected since this happened with other vaccines. It went away and then returned again 7 days after injection. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large red area on arm of vaccination; happened after the second dose two days after injection; it went away and then returned again 7 days after injection was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Nausea; Diarrhea; Body aches; Chills; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 14:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, hypertension, and obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included HYDROCHLOROTHIAZIDE and LOSARTAN, both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 19:00, the patient experienced nausea, diarrhea, body aches, chills, and headache. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, diarrhea, body aches, chills, and headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: Sore on injection site; Fatigue; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9267) via an unspecified route of administration in the right arm on 02Mar2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFIB), hypertension, pre-diabetes and allergy to dogs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included flecainide (MANUFACTURER UNKNOWN), Lisinopril (MANUFACTURER UNKNOWN), diltiazem (CARDIZEM) and apixaban (ELIQUIS); all for an unknown indication from an unknown dates and unknown if ongoing. On 03Mar2021, the patient experienced sore on injection site, fatigue and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore on injection site, fatigue and feeling unwell was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Flue like symptom of body aches and low grade temporary abt 36 hours;; Swollen glands left arm pit and into breast tissue - can physically locate and feel swollen glands.; "I"feel pain it they are touched or pressed by clothing.; Flue like symptom of body aches and low grade temporary abt 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received BNT162b2 (PFIZEWR BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 13:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included hashimoto's disease and morbid obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included loratadine(CLARITIN), levothyroxine sodium (SYNTHROID) and cyanocobalamin (B-12), all from unknown dates for unknown indications and unknown if ongoing. On 01Mar2021 at 16:30, the patient experienced flu like symptom of body aches and low grade temperature about 36 hours and swollen glands left armpit and into breast tissue. It can physically locate and felt the swollen glands. The patient felt pain when they are touched or pressed by clothing. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room or department/ urgent care. Therapeutic measures were not taken as the result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptom of body aches, low grade temperature, swollen glands left armpit and into breast tissue and felt pain when they are touched or pressed by clothing was not recovered at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Vaccination site pain
Clinical narrative: tiredness; sore arm at the injection site; loss of appetite; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Feb2021 at 17:45 (20-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and dairy allergy.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included birth control. The patient previously received amoxicillin and clavulanic acid (AUGMENTIN) and experienced allergy. On 01Mar2021 at 08:00, the day after having the first dose of vaccine, the patient experienced tiredness, a sore arm at the injection site, loss of appetite and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 22Feb2021, the patient underwent COVID-19 virus test (it was reported that the patient submits a saliva sample every week for pooled testing at her university) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events tiredness, a sore arm at the injection site, loss of appetite and diarrhea was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm for 3 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, diabetes and known allergies to silk tape. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 24Feb2021 at 13:00, the patient experienced sore left arm for 3 days after injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse event. The clinical outcome of the event sore left arm for 3 days after injection was resolved on 27Feb2021, 3 days after injection.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Facial pain, Neck pain, Pain in extremity
Clinical narrative: Having difficulty staying balanced when standing; Very weak and intermittent pain on left side of arm, neck and face; Very weak and intermittent pain on left side of arm, neck and face; Very weak and intermittent pain on left side of arm, neck and face; Very weak and intermittent pain on left side of arm, neck and face; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 17:45 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received paracetamol; oxycodone hydrochloride (PERCOCET) for unspecified indication from unknown date and experienced drug allergy. On 04Mar2021 at 19:45, the patient experienced difficulty staying balanced when standing and felt very weak and experienced intermittent pain on left side of arm, neck and face. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events having difficulty staying balanced when standing and was very weak and intermittent pain on left side of arm, neck and face was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: By 1:00am the patient's blister was better. By 9:00pm the following evening it was gone.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Mar2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and herpes labialis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 at 01:00 the patient woke up on the morning of the vaccine with a herpes simplex on her lip. Normally her blisters swell and quadruple quickly. The patient applied the usual docosanol (ABREVA) and got the vaccine. By 01:00 the blister was better. By 21:00 the following evening it was gone. This is extremely unusual as it normally takes over 14 days for the blister to heal. 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. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was recovered on 04Mar2021 at 21:00.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: About 5 days after receiving the vaccine, I noticed itchy red bumps appear on my right calf leg.; After a few days, the bumps became redder and bigger after some itching and more bumps rose on my left thigh; After a few days, the bumps became redder and bigger after some itching and more bumps rose on my left thigh; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm right on 08Feb2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021, 5 days after the vaccination, the patient noticed itchy red bumps appear on her right calf leg. After a few days, the bumps became redder and bigger after some itching and more bumps rose on her left thigh. These were initially thought to be caused by bed bugs, so all the linings and blankets of the bed were thoroughly dry cleaned. However, the bumps persisted. It was believed to be an allergic response of some kind; however, causation was unclear. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy red bumps appear on he right calf leg, bumps became redder and bigger after some itching were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Great difficulty walking; This is a spontaneous report from a non-contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included left knee replacement in 2016. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Feb2021, as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe pain and swelling in left knee, ankle and leg and also experienced great difficulty in walking. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event severe pain and swelling in left knee, ankle and leg and great difficulty in walking was recovering at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph nodes in right axilla; Swollen and painful lymph nodes in right axilla; DOSE 1: 09Feb2021;  DOSE 2: 26Feb2021; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 26Feb2021 at 11:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 09Feb2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 13:00, the patient experienced swollen and painful lymph nodes in right axilla. Therapeutic measures were not taken as a result of the events.. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the events swollen and painful lymph nodes in right axilla was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This is a spontaneous report from a non-contactable healthcare professional. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an intramuscular route of administration in the left arm on 01Mar2021 at 11:15 (at the age of 28-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an intramuscular route of administration in the left arm on 08Feb2021 at 11:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 13:30, the patient experienced brain fog. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event brain fog. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event brain fog was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.