chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pain radiating to my back; Night sweats; Severely swollen Lymph Nodes with pain radiating to my back.; Severe chills; probably fever; This is a spontaneous report from a contactable patient. A 51-year-old non- pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on left arm on an unknown date in Mar2021 at 12:30 (at the age of 51-years-old), as single dose for COVID-19 immunisation. Medical history included high cholesterol and anxiety started on an unknown date. The patient's known allergy to sulfa meds and hazel nuts. Concomitant medications included Montelukast Sodium (SINGULAIR), Sertraline (ZOLOFT), Levothyroxine (MANUFACTURER UNKNOWN), Lovastatin (MANUFACTURER UNKNOWN); all for unknown indication, from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 17Mar2021 at 10:00, the patient experienced severely swollen lymph nodes with pain radiating to the back. The patient also experienced severe chills and night sweats (probably a fever but didn't take temp). The patient did not receive any treatments for the events. The clinical outcome of the events severely swollen lymph nodes with pain radiating to the back, severe chills, night sweats, probably fever was recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: severe chill; Fever of 103; Fatigue; Body ache; This is a spontaneous report received from a contactable patient. A 56-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 17Mar2021 at 0930 (at the age of 56 years) as single dose for COVID-19 immunisation. Medical history included penicillin allergy and allergy to walnuts, seasonal Rhinitis, eosinophilic oesophagitis since from unspecified date. Concomitant medication included Vitamins (MANUFACTURER UNKNOWN) since from an unspecified date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 24Feb2021 at 0915 (at the age of 56 years) as single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior vaccination and since vaccination the patient was not tested positive for COVID-19. On 18Mar2021, at 0130 the body temperature was at 103 (unit not specified), later reduced to 99.1 on the same day. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 0130, the patient awoke with severe chills, fever of 103 (unit not specified). The patient received treatment with Acetaminophen (TYLENOL) and Ibuprofen (ADVIL). Fever reduced to 100 by AM. The patient experienced slight fever, fatigue and bodyache on 18Mar2021. The clinical outcome of the events chills and fever was recovering and the outcome of bodyache and fatigue was unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injury, Petechiae, Rash vesicular
Clinical narrative: red "blister-like" papules on leg; petechiae on legs; Trauma; This is a spontaneous report received from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261) via an unspecified route of administration in left arm on 25Jan2021 (at the age of 52-year-old) as single dose for COVID-19 immunisation. The patient was allergic to tetracycline, lasix and penicillin. The patient was not diagnosed with COVID-19 prior vaccination and since vaccination the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), levocetirizine (XYZAL), cyclosporine (RESTASIS), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) since from an unspecified date for an unknown indication. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1686) via an unspecified route of administration in left arm on 04Jan2021 at 14:00 (at the age of 52-year-old) as single dose for COVID-19 immunisation. On 15Feb2021, the patient experienced red blister like papule on toes. It started with second toe (beside the great toe) on right foot. Later in Feb2021, it has spread to the same toe on left foot. There was little petechiae on toes, it sometimes itches and stings and dermatologist said it was trauma and not COVID toe. No therapeutic measures were taken for the reported events. The clinical outcome of events blistery rash, petechial rash and trauma was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: High fever (reduced to 100.6 degrees F); Aches; Chills; Sweats; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in right arm on 16Mar2021 at 15:00 (at the age of 50-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 previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route of administration in right arm on 23Feb2021 at 12:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. On 17Mar2021, patient experienced High fever (reduced to 100.6 degrees F), sweats, chills and aches at 02:15. Therapeutic measures were taken as a result of fever and included treatment with repeated Tylenol doses six hours apart. The clinical outcome of the high fever, sweats, chills and aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Very bad headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown), via an unspecified route of administration and anatomical location on 17Mar2021 at 09:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food or other products. Medical history was not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 15:00, the patient experienced very bad headache and extreme fatigue. The patient received no treatment for the very bad headache and extreme fatigue. The clinical outcome of the very bad headache and extreme fatigue was resolved in Mar2021.   Information about lot number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Menstrual disorder, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 32-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 16Mar2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's' medical history includes Birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included TRI FEMYNOR for an unknown indication from an unknown date. On 17Mar2021 at 20:00 the patient began period early, which was not due for another week since the patient has been on birth control for over a decade it was  extremely consistent and patient experienced chills and nausea. The patient did not receive any treatment for event. The clinical outcome of events menstrual cycle abnormal, feeling chills and nausea was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Congestion; Coughing; headaches; fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year old female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN; Dose number: 1st dose), via an unspecified route of administration in unspecified site on 14Mar2021 at 15:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had penicillin allergy. The patients concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 13: 00, the patient experienced sore throat, coughing, headaches, congestion and fever. The clinical outcomes of events sore throat, coughing, headaches, congestion and fever were recovering at the time of reporting.   Information about lot number cannot be obtained. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Myalgia
Clinical narrative: Bad headache; muscle soreness; metallic taste; This is a spontaneous report received from a non-contactable consumer, the patient. A 55-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in right arm on 26Feb2021 at 17:45 hours (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and obesity. The patient received metformin ER (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and multivitamins and vit D (MANUFACTURER UNKNOWN) for an unknown indication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was not known that the patient had allergies to medications, food, or other products. On 26Feb2021, about 30 minutes after injection, the patient noticed metallic taste, which faded within a few hours. On 27Feb2021, at 3:00, the patient woke up with bad headache, which persisted through that day up until going to bed around midnight. The patient also experienced moderate widespread muscle soreness through that day and the next. The patient did not receive any treatment for the reported events. The clinical outcome of the events metallic taste, headache and muscle soreness was resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pruritus, Pyrexia
Clinical narrative: FEVER; CHILLS; SERVER BODY PAIN; ITCHY SKIN ALL OVER; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 13Mar2021 at 09:45 AM (at the age of 53-year-old), as single dose for COVID-19 immunisation. The patient's medical history included codeine allergy and rheumatoid arthritis. Concomitant medications included hydroxychloroquine 200 mg tablet (MANUFACTURER UNKNOWN), meloxicam 15 mg (MANUFACTURER UNKNOWN) for unspecified indications from unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 16:00, the patient experienced fever, chills, severe body pain and itchy skin all over. Therapeutic measures were taken as a result of events included methylprednisolone 4 mg tablet. The clinical outcome of events fever, chills, severe body pain and itchy skin all over were not recovered at  the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles, Musculoskeletal stiffness, Neck pain, Vaccination site erythema
Clinical narrative: red and blistered at the injectionsite; neck sore; Stiff neck; red at injection site; This is a spontaneous report from contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA) (Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 02Mar2021at 12:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications simvastatin (MANUFACTURE UNKNOWN), metoprolol (MANUFACTURE UNKNOWN), vitamin c (MANUFACTURE UNKNOWN), and vitamin d (MANUFACTURE UNKNOWN), zinc (MANUFACTURE UNKNOWN), reported for unknown indication from unknown date. On 17Mar2021 at 09:00 the patient experienced red and blistered at the injection site. Although it was looking like a burn, there was no associated pain. Also, not sure if related, but the patient also had a very sore, stiff neck all day that seemed to get worse instead of better as the day progressed. The patient experienced the small blisters turned into one large blister that broke and arm was still red at injection site, but neck is still sore but not as bad as previous day. No therapeutic measures were taken as a result of event. The clinical outcomes of stiff neck, sore neck, red and blistered at the injection site were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation under arm; This is a spontaneous report from a contactable consumer. A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the right arm on 15Mar2021 at13:30 hrs, as a single dose for COVID-19 immunisation. The patients medical history and concomitant medication were not reported. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 22Feb2021 at13:30 hrs, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 16Mar2021, the patient had experienced inflammation in under arms. No therapeutic measures were taken against adverse event. The clinical outcomes of under arm inflammation was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Insomnia, Migraine, Nausea
Clinical narrative: Immense back pain; vomiting; Nausea; super fatigued; Migraine; not sleeping or sleeping over 20 hours.This has been happening for 5 days; This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; lot number:en6206) via an unspecified route of administration in left arm, on 12Mar2021 at 16:45 (at the age of 24-year-old),as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included citalopram (CELEXA) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Immense back pain, vomiting, nausea, fatigue, migraine and difficulty sleeping on 14Mar2021 at 00:00. The patient did not receive any treatment for the reported events. The clinical outcome of Immense back pain, vomiting, nausea, fatigue, migraine and difficulty sleeping was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Immense back pain; vomiting; Nausea; super fatigued; Migraine; not sleeping or sleeping over 20 hours.This has been happening for 5 days; This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; lot number:en6206) via an unspecified route of administration in left arm, on 12Mar2021 at 16:45 (at the age of 24-year-old),as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included citalopram (CELEXA) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Immense back pain, vomiting, nausea, fatigue, migraine and difficulty sleeping on 14Mar2021 at 00:00. The patient did not receive any treatment for the reported events. The clinical outcome of Immense back pain, vomiting, nausea, fatigue, migraine and difficulty sleeping was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Extreme exhaustion; Nausea; Feverish; Minor aches; Horrible headache; This is a spontaneous report from a contactable consumer (the patient). A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202) via an unspecified route of administration in the Right Arm on 03Mar2021 at 20:15 PM as a single dose for COVID-19 immunisation. The patients medical history includes Diabetes, Obesity, High Blood Pressure and Migraines. The patient was allergic to medications such as Leveler, Lisinopril and Doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021, after administration of the vaccine (within 24 hours at 15:00 PM), the patient experienced extreme exhaustion, nausea, felt feverish, minor aches, and a horrible headache. The headache lasted for several days and the other events resolved within 10 to 12 hours. The clinical outcome of the events such as extreme exhaustion, nausea, feverish and minor aches was recovered on 05Mar2021 and for headache, the outcome was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Soreness in left armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 42-years-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 00:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced a feeling of soreness in the left armpit on 17Mar2021 at 16:00. It was reported with adverse event that patient having to take ibuprofen. The patient did not receive treatment for the reported event. . The clinical outcome of axillary pain was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever 101.2; Headache; Nausea; Pain in left arm; Chills; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 17Mar2021(at the age of 68 years old) at 09:00 as a single dose for COVID-19 immunisation. Medical history included Migraines, sjogrens and allergy to metals (nickel and gold). The patient also previously had first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 09:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not tested positive for COVID- 19, post vaccination. Concomitant medications included Lexapro (MANUFACTURER UNKNOWN), Wellbutrin (MANUFACTURER UNKNOWN), Sumatriptan (MANUFACTURER UNKNOWN), Ambien (MANUFACTURER UNKNOWN), Ativan (MANUFACTURER UNKNOWN) and Tizanidine (MANUFACTURER UNKNOWN) within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 06:00, the patient experienced fever, headache, nausea, pain in left arm and chills. The patients fever 101.2 decreased after taking Excedrin for Migraines and sumatriptan. The clinical outcome of the events headache, nausea, pain in left arm, fever and chills was recovering at the time of reporting. No therapeutic measures were reported for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Upset stomach; Low gradefever; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6208), via unspecified route of administration in left arm on 16Mar2021 at 11:45 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), depression and fractured arm and leg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: em9810), via unspecified route of administration and in left arm on 05Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient had no known allergies. Concomitant medications included LIPITOR, gabapentin (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and blood pressure medications (unspecified); all for unknown indications from an unknown date. Prior to vaccination, the patient had no symptoms associated with COVID-19. Since vaccination, the patient was not tested COVID-19 positive. On 16Mar2021 at 15:00, the patient experienced diarrhea, upset stomach and low grade fever. Therapeutic measures were taken as a result of diarrhea, upset stomach and low grade fever and included treatment with IMODIUM AD and TYLENOL from an unknown date. The clinical outcome of diarrhea, upset stomach and low grade fever were not resolved.   No follow-up attempts are possible. No further information is available.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Low fever; chills; severe headache; body aches; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6204) via an unspecified route of administration on the left arm on 18Mar2021 at 10:15 as single dose for COVID-19 immunisation. The past drug history included BNT162B2 (BNT162B2); Lot no: EN6202 via unspecified route of administration administered on 25feb2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Medical history included High Cholesterol, heart disease on an unknown date. Concomitant therapies were not reported. The patient experienced Low fever, chills, severe headache, body aches, sore arm on 19Mar2021 after vaccination. No therapeutic measures were taken for the events. The clinical outcome of the events Low fever, chills, severe headache, body aches, sore arm were reported as resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral, Tongue discomfort
Clinical narrative: tonguetingling; burning sensation tongue; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: UNKNOWN), via an unspecified route of administration in his left arm on 05Mar2021 at 11:30 AM (at the age of 67-years-old) for COVID-19 immunisation. The patient medical history included high blood pressure and the patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. The patient received unknown medication within 2 weeks of vaccination and the exact therapy dates were not provided. On 10Mar2021, the patient experienced tingling tongue, burning tongue and sore throat. Therapeutic measures were not taken for events experienced. The clinical outcome of the events tingling tongue, burning tongue and sore throat was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine administered in left leg; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0207) via an unspecified route of administration in left leg (characterised as vaccine administered at inappropriate site) on 16Mar2021, at 14:00 hours, (at the age of 48-year-old) as a single dose, for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No medications were received within 2 weeks of vaccination. Since the vaccination patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 17Mar2021, the patient experienced swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea. The clinical outcome of the events swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea was not recovered at the time of this report. While it was unknown for vaccine administered at inappropriate site.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pyrexia
Clinical narrative: Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine administered in left leg; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0207) via an unspecified route of administration in left leg (characterised as vaccine administered at inappropriate site) on 16Mar2021, at 14:00 hours, (at the age of 48-year-old) as a single dose, for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No medications were received within 2 weeks of vaccination. Since the vaccination patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 17Mar2021, the patient experienced swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea. The clinical outcome of the events swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea was not recovered at the time of this report. While it was unknown for vaccine administered at inappropriate site.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 57-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), FLONASE as allergy medication on an unknown date for unknown indications. Patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not have any allergies to medications, food, or other products. On 18Mar2021 at 10:00, the patient experienced body pain, vertigo, nausea, fever, chills, brain fog, severe fatigue, headache and coughing. Patient did not receive any treatment for the events. The clinical outcome of the events body pain, vertigo, nausea, fever, chills, severe fatigue, headache and coughing was resolving at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vertigo
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 57-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), FLONASE as allergy medication on an unknown date for unknown indications. Patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not have any allergies to medications, food, or other products. On 18Mar2021 at 10:00, the patient experienced body pain, vertigo, nausea, fever, chills, brain fog, severe fatigue, headache and coughing. Patient did not receive any treatment for the events. The clinical outcome of the events body pain, vertigo, nausea, fever, chills, severe fatigue, headache and coughing was resolving at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from contactable consumer, the patient. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: En6204), via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 hours (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included acid reflux, mild fibromyalgia. The patient was known allergic to latex. The patient previously took one shot shingles vaccine a couple of years ago. Concomitant medications included generic protonix (Pantoprazole Sodium) and generic Elavil (Amitriptyline Hydrochloride). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 15Mar2021, the patient noticed shingles outbreak. The patient was diagnosed with Shingles on 17Mar2021. The clinical outcome of shingles was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives with itching/ bump on chest below the left breast and small raised swelling on the shoulder of right arm; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot no: EN 6207) via unspecified route of administration as a single dose for COVID-19 immunisation on 18Mar2021 (at the age of 53-year-old). The medical history reported are mild depression, allergies and allergies to penicillin. The concomitant medications included zoloft (MANUFACTURER UNKNOWN) and zyrtec (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 19Mar2021, the patient experienced hives and itching around 2:00, approximately 14 hours after receiving the first shot. The patient reported that there was a small bump on her chest below the left breast as well as a small raised swelling on the shoulder of my right arm and both the bumps were itchy. There was no treatment received for the reported events. The clinical outcome of hives with itching/ bump on chest below the left breast and small raised swelling on the shoulder of right arm was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report from a contactable Other Healthcare professional reporting on behalf of a patient. A 46-year-old Male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number:EN6205] through an unspecified route of administration and an unspecified anatomical location on 16Mar2021 as a single dose for Covid-19 immunisation. Medical history of the patient was not reported. On 16Mar2021, during his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching, dizziness, facial swelling, lip swelling and tongue swelling. The patient was obese but not ill-appearing. The patient received treatment for lightheadedness which included water and snacks. The follow up response to treatment was good. Patient was stable to go home and follow up with PCP. Clinical outcome of the event lightheadedness was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitation; Not fast heart rate just felt like it was constantly pounding hard; This is a spontaneous report received from a contactable consumer, the patient. A 38-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 right arm on 06Mar2021 at 09:00, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included Vancomycin and Gentamycin; to which the patient developed allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 08:30, 9 days after the first dose, the patient experienced palpitations for 3 1/2 days morning to night. Not fast heart rate just felt like it was constantly pounding hard. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of palpitation and heart rate just felt like it was constantly pounding hard was recovering at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a small rash on rt flank; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in left arm on 11Jan2021 at 12:00 PM (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patients medical history included hypertension and seasonal allergies. The patient had known allergies to TESSALON PERLE and codeine(MANUFRACTURER UNKNOWN). The patients concomitant medications included IRBESARTAN, NORVASC and atenolo l (MANUFRACTURER UNKNOWN). The patient has not received any other vaccines within 4 weeks prior vaccination. Prior to vaccination, the patient has not had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in left arm on 21Dec2020 at 12:00 PM as a single dose for COVID-19 immunisation. On 02Feb2021, the patient developed a small rash on right flank lasting 1 week, about 1 week ago developed a similar rash, in the same area and on left arm. It was reported that the patient received steroids and antihistamines as a treatment measure for the reported events. The clinical outcome of the event small rash on right flank was not resolved at the time of this report.   Information about lot number cannot be obtained. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pruritus, Rash, Throat clearing
Clinical narrative: throat tightness; Frequent throat clearing; During patient's 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty b; rash; hives; Itching of skin; headaches; This is a spontaneous report from a non-contactable other health care professional. A 21-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in an unspecified anatomical location on unknown date (at the age of 21-year-old), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications have not been provided. During her 15 minutes waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. Patient complained of frequent throat clearing, itching of skin and headaches. Treatment included antihistamines. Follow up response to treatment was excellent. Patient on discharge was stable to go home and follow up with PCP. The outcome of all the events were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: throat tightness; Frequent throat clearing; During patient's 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty b; rash; hives; Itching of skin; headaches; This is a spontaneous report from a non-contactable other health care professional. A 21-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in an unspecified anatomical location on unknown date (at the age of 21-year-old), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications have not been provided. During her 15 minutes waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. Patient complained of frequent throat clearing, itching of skin and headaches. Treatment included antihistamines. Follow up response to treatment was excellent. Patient on discharge was stable to go home and follow up with PCP. The outcome of all the events were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Severe dizziness; Blurred vision in right eye; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) in the left arm on 09Mar2021 at 10:30 AM (at the age of 67years) as a single dose for COVID-19 immunisation. The patient had no past medical history. Patient's concomitant medications included thyroid medication (MANUFACTURER UNKNOWN) which were taken within two weeks of vaccination. Patient had no history of allergy to food, medications or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 10Mar2021, patient experienced severe dizziness for 10 days with no improvement and two days after vaccine on 11Mar2021, patient experienced blurred vision of in right eye only for one day. Therapeutic measures taken as a result of dizziness and blurred vision included prednisone and meclizine. The clinical outcome of the event severe dizziness was not resolved, and the clinical outcome of the event blurred vision in right eye was reported as resolved on 11Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I have a very itchy rash on my stomach and legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration at right arm on 17Mar2021 at 17:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient's concomitant medications included valsartan(MANUFACTURER UNKNOWN), buproprion(MANUFACTURER UNKNOWN), metropolol(MANUFACTURER UNKNOWN) and thyroid(NP THYROID), all from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration and anatomical site on an unknown date as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. She did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 18Mar2021the patient experienced very itchy rash on her stomach and legs. Therapeutic measures were taken as a result of the events was unknown. The clinical outcome of the event very itchy rash on stomach and legs was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.