chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Vaccination site pain
Clinical narrative: Soreness at injection site; Headache; General tiredness; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 66-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 on 10Mar2021 at 14:15 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced soreness at injection site, headache, general tiredness and flu like symptoms. 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 reported events. The clinical outcome of the events injection site, headache, general tiredness and flu like symptoms 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Interchange of vaccine products, Myalgia, Vaccination site pain
Clinical narrative: Left arm pain at injection shot; Tiredness; Headache; All over muscle aches; Received moderna vaccine as dose 1 and  BNT162B2 as dose 2; This is a spontaneous report from a contactable consumer, the patient. A 67-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 12Mar2021 at 15:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and cancer diagnosis 20 years ago and have been in remission since 2001. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received acetylsalicylic acid (ASPIRIN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) in the left arm on 19Feb2021 for immunisation. On 12Mar2021 at 23:00, the patient experienced left arm pain at injection shot, tiredness, headache, and muscle aches all over. 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 left arm pain at injection shot, tiredness, headache, and all over muscle aches were 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose, Blood pressure measurement, Dizziness, Heart rate
Clinical narrative: Feeling anxious; Dizziness; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an intramuscular route of administration on 12Feb2021 at 14:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety disorder (Anxiety DO), post-traumatic stress disorder (PTSD), pre-diabetes (Pre-DM), penicillin allergy (PCN allergy) and shellfish allergy. It was unknown whether the patient was pregnant at the time of this report. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) and metformin (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in on an unknown date as a single dose for COVID-19 immunisation. On 12Feb2021, at 14:15, the patient experienced feeling anxious approximately 15 minutes after vaccine and dizziness. On 12Feb2021 at 14:15, the patient underwent lab test and procedures, vital signs included blood pressure (bp) was found to be 150/90 (unspecified units), heart rate (HR) was found to be 106 (unspecified units), respiratory rate (RR) was found to be 20 (unspecified units) and arterial oxygen saturation (SaO2 on radial artery) was found to be 95 percent. The patient was monitored and given water in first aid station and assessed by emergency medical technician (EMT) on duty and physician on duty. On the same day at 14:20, the patient had vital signs included blood pressure was found to be 150/90 (unspecified units), heart rate was found to be 86 (unspecified units), respiratory rate was found to be 20 (unspecified units) and arterial oxygen saturation was found to be 95 percent and capillary blood glucose (CBG) was found to be 204 (unspecified units), the patient had vital signs stable and alert and oriented to person, place and time. On the same day at 14:25 the patient was cleared to go home by physician on duty. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. It was unknown whether the patient had been tested for COVID-19 since the vaccination. The clinical outcome of the events feeling anxious and dizziness was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Respiratory rate
Clinical narrative: Feeling anxious; Dizziness; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an intramuscular route of administration on 12Feb2021 at 14:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety disorder (Anxiety DO), post-traumatic stress disorder (PTSD), pre-diabetes (Pre-DM), penicillin allergy (PCN allergy) and shellfish allergy. It was unknown whether the patient was pregnant at the time of this report. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) and metformin (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in on an unknown date as a single dose for COVID-19 immunisation. On 12Feb2021, at 14:15, the patient experienced feeling anxious approximately 15 minutes after vaccine and dizziness. On 12Feb2021 at 14:15, the patient underwent lab test and procedures, vital signs included blood pressure (bp) was found to be 150/90 (unspecified units), heart rate (HR) was found to be 106 (unspecified units), respiratory rate (RR) was found to be 20 (unspecified units) and arterial oxygen saturation (SaO2 on radial artery) was found to be 95 percent. The patient was monitored and given water in first aid station and assessed by emergency medical technician (EMT) on duty and physician on duty. On the same day at 14:20, the patient had vital signs included blood pressure was found to be 150/90 (unspecified units), heart rate was found to be 86 (unspecified units), respiratory rate was found to be 20 (unspecified units) and arterial oxygen saturation was found to be 95 percent and capillary blood glucose (CBG) was found to be 204 (unspecified units), the patient had vital signs stable and alert and oriented to person, place and time. On the same day at 14:25 the patient was cleared to go home by physician on duty. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. It was unknown whether the patient had been tested for COVID-19 since the vaccination. The clinical outcome of the events feeling anxious and dizziness was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Poor quality sleep, Psychomotor hyperactivity
Clinical narrative: Extra energy; Hyperactive; More awake; This is a spontaneous report from a contactable consumer, the patient. A 65-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 11Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. 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 14Feb2021 at 12:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced extra energy, was hyperactive and more awake. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. 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. The clinical outcome of the events extra energy, hyperactive and more awake 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: The day after I received the vaccination, my left arm was slightly red and swollen at the injection site; swollen at the injection site and remained that way for 2 days; The evening of the day I received the vaccination, I became nauseated; Could not eat dinner; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 26Feb2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes, chronic lumbar pain and known allergies to penicillin, grasses and insect bites. The patient previously received procaine hydrochloride (NOVOCAINE), and acetylsalicylic acid (ASPIRIN) and experienced allergy to the medications. 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), gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 26Feb2021 at 18:30, the evening of the day the patient received vaccination, she became nauseated and could not eat dinner. This went away by the next morning.  On 27Feb2021, the day after the vaccination, the patient's left arm was slightly red and swollen at the injection site and remained that way for 2 days. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nauseated, could not eat dinner was resolved on 27Feb2021 and slightly red and swollen at the injection site was resolved on 01Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Foggy Brain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EX19581) via an unspecified route of administration in the left arm on 14Jan2021 at 11:00 (at the age of 70-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 04Feb2021 at 11:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included hydrochlorothiazide, valsartan (DIOVAN HCT) and finasteride (PROSCAR); both for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 11:00, the patient experienced foggy brain and fatigue. 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 had been tested for COVID-19. On 06Feb2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events foggy brain and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient had c/o feeling lightheaded approximately 5-10 minutes post vaccine.; This is a spontaneous report from a contactable other healthcare professional. A 77-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via intramuscular route of administration on 18Feb2021 at 11:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and known allergies to penicillin and shellfish (unknown reaction). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and unspecified medications (the patient unable to remember other medications at that time); for an unknown indication from an unknown date and unknown if ongoing. On 18Feb2021 at 11:00, approximately 5-10 minutes post vaccine, the patient had complained of feeling lightheaded. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event feeling lightheaded approximately 5-10 minutes post vaccine was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms; Achiness; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the arm right on 11Mar2021 at 13:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included heart disease. 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 rosuvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and famotidine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. 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 18Feb2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient also took cefalexin(KEFLEX) previously on an unknown date and experienced allergy. On 12Mar2021 at 16:00, the patient experienced flu like symptoms, achiness and general malaise. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, achiness and general malaise were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Right elbow swelled with what looks like a fluid- filled sack approximately 4mm x 3mm in diameter.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 15:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Mar2021, the patient experienced right elbow swelled with what looked like a fluid- filled sack approximately 4mm(millimeter) x 3mm in diameter. 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 right elbow swelled with what looks like a fluid- filled sack approximately 4mm x 3mm in diameter was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6204), at the age of 50, via an unspecified route of administration, in the right arm, on Mar 11, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient has no medical history or known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications. On Mar 11, 2021 at 12:00, patient experienced underarm lymph lump in right arm pit. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, patient has not tested for COVID-19. The outcome of underarm lymph lump in right arm pit: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache
Clinical narrative: Severe dizziness and cloudiness; Cloudiness with a pounding headache; Severe dizziness and cloudiness; This is a spontaneous report from a non-contactable consumer, the patient. A 40-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 11Mar2021 at 18:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications 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. On 12Mar2021, the patient experienced severe dizziness and cloudiness with pounding headache. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe dizziness and cloudiness with a pounding headache was unknown 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Heart rate increased
Clinical narrative: Dizzy and light-headed; Heart rate increased; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 30-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 09Mar2021 at 08:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included ascorbic acid, pyridoxine hydrochloride, tocopherol, folic acid, thiamine hydrochloride, colecalciferol, cyanocobalamin, retinol, riboflavin, nicotinamide, calcium pantothenate, iron, magnesium, manganese, chromium, copper, zinc, iodine, selenium (MULTIVITAMIN) and cyanocobalamin-tannin complex (B12); all taken for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 21:30, the patient stated that 4 nights after vaccine she suddenly felt light headed and dizzy, her heart rate shot up, but that might have been due to anxiety of feeling of lightheaded. She felt lessened after drinking water but still persisted after an hour later. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were 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 dizzy, heart rate shot up, anxiety and light-headed was recovering 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: developed burning pain in the tips of the toes and the fingers; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021(at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (DMII), hypertension (HTN) and dyslipidemia (DLP), eggplant allergy, contrast allergy and penicillin 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 did not receive any concomitant medications. On 04Mar2021, 12 hours after vaccination the patient developed burning pain in the tips of the toes and the fingers. The event resulted in doctor or other healthcare professional office/clinic visit. 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 burning pain in the tips of the toes and the fingers 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Excessively tired; Severe body aches; Nausea; Diarrhea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old 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 left arm on 10Mar2021 at 10:00 (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included allergy to persimmon fruit, Guillian-Barre Syndrome, and the patient was hospitalized in 2007 for a rare variant called Miller-Fisher syndrome which the neurologist believed was caused by a virus and laryngitis that the patient had. 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. The patient did not receive any concomitant medications. On 11Mar2021 at 05:00, the morning after the vaccine the patient was excessively tired had severe body aches, nausea, diarrhea, and headache. It was so bad that the patient could not eat and went to bed for the day. The patient had questioned that whether she should forego getting the second shot. The events did not result in doctor or other healthcare professional office/clinic, 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 excessively tired, severe body aches, nausea, diarrhea, and headache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Myalgia, Vomiting
Clinical narrative: Burning arms/legs; Weakness; Vomiting; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 11Mar2021 at 12:15 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 11Mar2021, the patient experienced burning arms/legs, weakness, vomiting and muscle pain. 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. The clinical outcome of the events burning arms/legs, weakness, vomiting and muscle pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Soreness in arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 29-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 11Mar2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypopituitarism and diabetes insipidus. The patient had no known allergies to medication, 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. The patient received unspecified medication within two weeks of vaccination. On 11Mar2021 at 13:00, the patient experienced soreness in arm and nausea. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in arm and nausea were recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Nausea, Somnolence
Clinical narrative: Severe tiredness and feeling sleepy even after 12 days of 1st dose.; Severe tiredness and feeling sleepyeven after 12 days of 1st dose; Hot flashes; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old 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 right on 01Mar2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and radiation in 2014. 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 CLINDAMYCIN from an unknown date for unknown indication and unknown if ongoing. On 02Mar2021, at 14:00, the patient experienced severe tiredness and feeling sleepy even after 12 days of 1st dose, hot flashes and nausea where she was not feeling like getting up from bed. 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 tiredness and feeling sleepy even after 12 days of 1st dose, hot flashes and nausea not feeling like getting up from bed 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes between collar bone and neck on left side and under arm. Same side as vaccine was given.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 16Feb2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 16:00 the patient experienced enlarged lymph nodes between collar bone and neck on left side and under arm, same side as vaccine was given. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date patient underwent CT scan for the reported event and the result was unknown.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event enlarged lymph nodes between collar bone and neck on left side and under arm, same side as vaccine was given was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Headache, Nausea, Pain in extremity, Sinus congestion
Clinical narrative: The next day, "my" sinuses were stuffed up and "I" still had a headache; "My" arm was sore right away; "I" got a headache; Felt queasy several hours after getting the vaccine; "I" had a difficult time eating dinner and threwup later in the evening; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 13:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine/liothyronine (NP THYROID) for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 17:00, the patient experienced sore arm right away, got a headache and felt queasy several hours after getting the vaccine. On the same day, the patient had a difficult time eating dinner and threw up later in the evening. On 13Mar2021, the next day, the patient experienced stuffed up sinuses and still had a headache. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or 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 sore arm, headache, felt queasy, stuffed up sinuses, difficult time eating dinner and threw up later in the evening were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme pain between wrist and elbow in inoculation arm on use of the limb; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number and expiration date not provided), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination or any medications in two weeks. On 05Mar2021, the patient experienced extreme pain between wrist and elbow in inoculation arm on use of the limb. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: patient age group was adult.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Amnesia for 6 hours.; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 23Feb2021 at 13:00 (at the age of 73-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 to 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 were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021 at 19:00, the patient experienced amnesia for 6 hours that began 30 hours after receiving the second dose. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event amnesia was resolved on 25Feb2021 at 01:00, after the duration of 6 hours.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under right arm pit; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 23Feb2021 at 15:30 (at the age of 64-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 vaccination. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) 5 mg (milligram) 1x day and linagliptin (TRADJENTA) tablet 5 mg; both for unknown indications from unknown dates and unknown if ongoing.  On 09Mar2021 at 02:00, the patient experienced swollen lymph nodes under right arm pit. 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 swollen lymph nodes under right arm pit was unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Constant feeling of ears being plugged, ''I'' would describe it as when you are taking off on a airplane; This is a spontaneous report from a contactable nurse, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included known allergies to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 05Feb2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 27Feb2021, the patient had a constant feeling of her ears being plugged since receiving her second dose. The patient would describe it as while taking off on an airplane. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event constant feeling of ears being plugged was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Developed a big red bump on face which was about 5cm in diameter and was hard.; This is a spontaneous report from a contactable consumer, the patient. A 19-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 10Mar2021 at 09:30 (at the age of 19-years old) as a single dose for COVID-19 immunisation. Medical history included c diff (clostridium difficile infection). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 11:00, about an hour and a half after first shot, the patient developed a big red bump on face which was about 5cm in diameter and was hard. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a big red bump on face was recovered on an unknown date in Mar2021.  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: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient 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 30Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The medical history included chronic fatigue syndrome. The patient had unspecified known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. On 01Feb2021, the patient experienced diarrhea and fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and fatigue were not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 21Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Pain in extremity
Clinical narrative: Dry mouth; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer. A 48-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 08Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included glipizide, metformin (GLIPIZIDE; METFORMIN) 5mg/500mg taken for an unknown indication from an unknown date and unknown if ongoing. On 08Mar2021, the patient experienced dry mouth, fatigue and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dry mouth, fatigue and sore arm was resolved on an unknown date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Pain around theinjection site; Slight headache; This is a spontaneous report from a non-contactable pharmacist, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 08Mar2021 at 09:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks included ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. On 08Mar2021 at 18:00, hours after taking the first dose of the COVID-19 vaccine the patient experienced, pain around the injection site. Also in the evening, developed a slight headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events pain around the injection site and slight headache was resolved on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.