chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia, Rhinorrhoea, Upper respiratory tract congestion
Clinical narrative: Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe arm soreness; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pregnant at the time of vaccination was unknown. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient experienced severe arm soreness after the first injection with outcome recovered on an unspecified date. It was unknown whether treatment was received or not. Event was considered non-serious. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown. Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She tested positive on 20Jan and is currently asymptomatic; She tested positive on 20Jan and is currently asymptomatic; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. The 84-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1283), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE as Preventive and healthcare worker. Medical history and concomitant medications were none. Caller received the first dose of the vaccine on 13Jan. She tested positive on 20Jan and is currently asymptomatic. Her next dose of the vaccine is due on 29Jan and wants to know if she should get this at a later date. The outcome of the events was not recovered.  No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: Arm pit area swollen/ inflamed lymph nodes; Arm pit area swollen/ inflamed lymph nodes; This is a spontaneous report from a contactable Health Professional reported for herself. A 36-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number Ek9231) at right arm 14:30 on 20Jan2021 for Covid-19 immunization. Patient received her first shot at right arm 02:30 PM on 30Dec2020. The patient was allergic to penicillin. Concomitant medication was none. The patient had not received any other vaccines within 4 weeks prior to the Covid-19 vaccine. On 22Jan2021, the patient experienced arm pit area swollen/ inflamed lymph nodes. No treatment was received. The events did not resolve at the time of reporting. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: joint pain; chills; Fatigue; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at 10:15 at single dose on left arm for COVID-19 immunisation.  Medical history included high blood pressure, thyroid cancer, allergy to penicillin and prior to vaccination, was the patient diagnosed with COVID-19. Concomitant medication included irbesartan, fish oil, vitamin D3 (VITAMIN D3). The patient experienced joint pain, chills, fatigue, all on 22Jan2021 05:15 with outcome of not recovered. Since the vaccination, the patient had not been tested for COVID-19. This case was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: Severe headache; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3249), via an unspecified route of administration on 14Jan2021 05:15 at single dose on left arm for COVID-19 immunisation. Medical history included diabetes. Patient had no known allergies to medications, food, or other products. The patient's concomitant medications included metformin.  The patient experienced severe headache on 14Jan2021 with outcome of unknown. No treatment was received for the event. Since the vaccination, the patient had been tested for COVID-19 on 14Jan2021 with unknown result. This case was reported as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site (arm) soreness; This is a spontaneous report from a contactable consumer. This consumer reported a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on arm single dose for COVID-19 immunization on 20Jan2021 at 39-year-old. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had injection site (arm) soreness on 20Jan2021 and was reported as non-serious. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mildly sore 2 inches around the vaccination site; This is a spontaneous report from a contactable consumer reported for herself. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3247) on 22Jan2021 11:30 AM at single dose (vaccine location=right arm) for Covid-19 immunization. Medical history was none. Concomitant medications included vitamins (unspecified) and birth control. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Mildly sore 2 inches around the vaccination site on 22Jan2021, no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypertension, Pain in extremity, Vaccination site pruritus
Clinical narrative: site was itching; Arm was hurting; Body is warm; excruciating Headache; Hypertension; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 vaccine, lot/ batch number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Jan2021, she had an excruciating headache and her body was warm. She had hypertension. On Thursday (21Jan2021) her arm was hurting. Today (23Jan2021) the site was itching. She did not take a temperature. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Nasal congestion, Sneezing
Clinical narrative: When she starts sneezing like this, she then stars coughing and her nose stops up; When she starts sneezing like this, she then stars coughing and her nose stops up; picked up an allergy; she began sneezing on the way to get the second dose the Covid 19 vaccine today and has not stopped since; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 84-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3247) first dose, via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she began sneezing on the way to get the second dose the covid 19 vaccine today and has not stopped since on 22Jan2021, when she starts sneezing like this, she then stars coughing and her nose stops up on an unspecified date, picked up an allergy on an unspecified date.  Patient stated she began sneezing on the way to get the second dose the Covid 19 vaccine today and has not stopped since.  She would like to know if she could take a Benadryl.  When she started sneezing like this, she then started coughing and her nose stopped up. She was experiencing all these symptoms currently.  The patient had a question: she had the second dose of Pfizer COVID vaccine, may she took a Benadryl, she didn't want anything to affect the vaccine working, someone suggested not taking things like aspirin, Aleve, Tylenol, 24 hours after the vaccine, as it may effect the potency. She sneezed before the shot, now she was not blaming the shot, she went out and walked this morning and may have picked up an allergy, but she sneezed all the way to the shot, and she has been sneezing all afternoon and her nose was stopped up, she wanted to know if can take Benadryl, she wanted to clarify this started before she had the shot. She hasn't had this in years this bad, she was stopped up this afternoon, and thought to take a Benadryl that can help this, but she didn't want to mess the shot up. The outcome of event sneezing was not recovered, outcome for other events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: The injection site looks bruised as if a blood vessel was nicked; There was quite a bit of blood; This is a spontaneous report from a contactable pharmacist (patient). A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose in the arm for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the 1st dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday (21Jan2021). She noticed that when the Pharmacist pulled it out of arm, there was quite a bit of blood and upon checking today (22Jan2021), the injection site looks bruised as if a blood vessel was nicked. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test, Swelling
Clinical narrative: marked swelling; swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side; Very Painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL3302), via an unspecified route of administration on 19Jan2021 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19  immunization. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included unspecified medications that were received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1284), via an unspecified route of administration on 29Dec2020 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19  immunization. On 20Jan2021 at 06:00, the patient experienced marked swelling and swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, very painful. The patient stated she did not have redness. The clinical outcomes of the swelling, swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, and pain were not recovered. It was also reported that since the vaccination, the patient has been tested for COVID-19, the patient had PCR nasal swab on 18Jan2021, which was negative and rapid test nasal swab on 21Jan2021 which was negative.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Rash, Vaccination site pain
Clinical narrative: injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient).  A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swelling and feeling bloated; no appetite; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 69-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EJ 1686, exp date not reported), via an unspecified route of administration (left arm) on 14Jan2021 13:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. Medical history included allergies to seafood, latex, and steroids. The patient had COVID prior to vaccination (date/s unknown). The patient had no other relevant history. The patient was not pregnant at time of vaccination and was not pregnant at the time of reporting. Concomitant medications/other medications the patient received within 2 weeks of vaccination included amoxicillin, calcium, cinnamomum verum (CINNAMON), chromium, and multivitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ephedrine and codeine and experienced allergy to both. On 15Jan2021 13:30, the patient experienced fever, chills, fatigue, nauseous, throwing up, diarrhea, severe stomach pain with swelling and feeling bloated; and no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the reporter. Treatment for the events included ondansetron (ZOFRAN), dexamethasone 0.5 (unit not reported), and doxycycline 20 mg. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events at the time of reporting.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swelling and feeling bloated; no appetite; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 69-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EJ 1686, exp date not reported), via an unspecified route of administration (left arm) on 14Jan2021 13:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. Medical history included allergies to seafood, latex, and steroids. The patient had COVID prior to vaccination (date/s unknown). The patient had no other relevant history. The patient was not pregnant at time of vaccination and was not pregnant at the time of reporting. Concomitant medications/other medications the patient received within 2 weeks of vaccination included amoxicillin, calcium, cinnamomum verum (CINNAMON), chromium, and multivitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ephedrine and codeine and experienced allergy to both. On 15Jan2021 13:30, the patient experienced fever, chills, fatigue, nauseous, throwing up, diarrhea, severe stomach pain with swelling and feeling bloated; and no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the reporter. Treatment for the events included ondansetron (ZOFRAN), dexamethasone 0.5 (unit not reported), and doxycycline 20 mg. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events at the time of reporting.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort
Clinical narrative: Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swelling and feeling bloated; no appetite; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 69-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EJ 1686, exp date not reported), via an unspecified route of administration (left arm) on 14Jan2021 13:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. Medical history included allergies to seafood, latex, and steroids. The patient had COVID prior to vaccination (date/s unknown). The patient had no other relevant history. The patient was not pregnant at time of vaccination and was not pregnant at the time of reporting. Concomitant medications/other medications the patient received within 2 weeks of vaccination included amoxicillin, calcium, cinnamomum verum (CINNAMON), chromium, and multivitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ephedrine and codeine and experienced allergy to both. On 15Jan2021 13:30, the patient experienced fever, chills, fatigue, nauseous, throwing up, diarrhea, severe stomach pain with swelling and feeling bloated; and no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the reporter. Treatment for the events included ondansetron (ZOFRAN), dexamethasone 0.5 (unit not reported), and doxycycline 20 mg. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events at the time of reporting.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Myalgia, SARS-CoV-2 test positive
Clinical narrative: contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days to be exact; This is a spontaneous report from a contactable other health professional (patient).  A 66-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3246) at single dose at right arm on 14Jan2021 for covid-19 immunisation, administered at hospital.  Medical history included rheumatoid arthritis, allergies to morphine and related, PCN, sulfa, quinidine, Xeljanz. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: upadacitinib (RINVOQ), folic acid (FOLIC ACID), ropinirole hydrochloride (REQUIP). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Lot # EJ1685) at single dose at right arm on 26Dec2020 03:00 PM for covid-19 immunisation, administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced contracted Covid after her 2nd dose, muscle aches and fatigue 3 days to be exact on 17Jan2021 17:00, Covid test result positive on 22Jan2021. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): positive on 22Jan2021. No treatment was received for the adverse event. The outcome of Covid test result positive was unknown, of the other events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lack of efficacy cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 1st of 14 reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021065206 same reporter/drug/event, different patient.;US-PFIZER INC-2021065202 same reporter/drug/event, different patient.;US-PFIZER INC-2021065199 same reporter/drug/event, different patient.;US-PFIZER INC-2021065208 same reporter/drug/event, different patient.;US-PFIZER INC-2021065203 same reporter/drug/event, different patient.;US-PFIZER INC-2021065200 same reporter/drug/event, different patient.;US-PFIZER INC-2021065205 same reporter/drug/event, different patient.;US-PFIZER INC-2021065210 same reporter/drug/event, different patient.;US-PFIZER INC-2021065201 same reporter/drug/event, different patient.;US-PFIZER INC-2021065209 same reporter/drug/event, different patient.;US-PFIZER INC-2021065207 same reporter/drug/event, different patient.;US-PFIZER INC-2021065198 same reporter/drug/event, different patient.;US-PFIZER INC-2021065204 same reporter/drug/event, different patient.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Sleeplessness; Diarrhea; Nausea; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer (patient):    A 39-year-old female patient received the 1st doe of bnt162b2 (BNT162B2, batch/lot is unknown misplaced/discarded) at single dose at right arm on 21Jan2021 19:00 for covid-19 immunisation, administered at hospital  Medical history included ankylosing spondylitis, uveitis, coeliac disease, postural orthostatic tachycardia syndrome (POTS), food allergy, mycotic allergy. Allergies: Coconut, ASPIRIN, REGLAN, mold. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: atenolol (manufacturer unknown), cetirizine hydrochloride (ZYRTEC), infliximab (REMICADE). The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00 AM the patient experienced sleeplessness, diarrhea, nausea, headache and fatigue. No treatment received for the adverse events. Events were considered non serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash, Skin warm
Clinical narrative: swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back of neck; started lightly at injection site but rash more prominent on sides and back of neck; scratch throat; This is a spontaneous report from a contactable other health professional (patient).  A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown due to not available/provided to reporter at the time of report completion), via an unspecified route of administration in left arm on 20Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included mild hashimotos (no meds, just monitor) and Polycystic ovarian syndrome (PCOS). No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. It was reported that "48 hours" post injection patient developed neck rash, swelling, hot to touch, started lightly at injection site but rash more prominent on sides and back of neck, and scratch throat. All the events resulted in: emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all the events: Steroid and Benadryl injection. The outcome of the events was recovered with lasting effects. The events was considered as non-serious by reporter, as no resulting in death, no life threatening, no causing/prolonging hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.?; Sender's Comments: Causality cannot be excluded for PFIZER-BIONTECH COVID-19 VACCINE and the reported events.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat irritation
Clinical narrative: swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back of neck; started lightly at injection site but rash more prominent on sides and back of neck; scratch throat; This is a spontaneous report from a contactable other health professional (patient).  A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown due to not available/provided to reporter at the time of report completion), via an unspecified route of administration in left arm on 20Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included mild hashimotos (no meds, just monitor) and Polycystic ovarian syndrome (PCOS). No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. It was reported that "48 hours" post injection patient developed neck rash, swelling, hot to touch, started lightly at injection site but rash more prominent on sides and back of neck, and scratch throat. All the events resulted in: emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all the events: Steroid and Benadryl injection. The outcome of the events was recovered with lasting effects. The events was considered as non-serious by reporter, as no resulting in death, no life threatening, no causing/prolonging hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.?; Sender's Comments: Causality cannot be excluded for PFIZER-BIONTECH COVID-19 VACCINE and the reported events.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: After injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck.  Feels  like patient had dental work and the numbing is wearing off.; After  face felt numb afterwards including head and neck.  Feels like patient had dental work and the numbing is wearing off.; This is a spontaneous report from a contactable consumer reporting for himself. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL3249, via an unspecified route of administration on 22Jan2021 10:00 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination.   Medical history included acromegaly (surgery done to remove tumor) from an unknown date and unknown. The patient's concomitant medications were not reported.  The patient previously took doxycycline and experienced drug allergy.  The facility where the most recent COVID-19 vaccine was administered was at a hospital.On 22Jan2021 10:00AM, the patient experienced after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off. The events after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off were reported as non-serious and did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. The clinical outcomes of the "after injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck.  Feels like patient had dental work and the numbing is wearing off" was not recovered. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested Covid19 positive; tested Covid19 positive; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 or 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 05Jan2021 or 06Jan2021 and then 2 weeks later tested positive for COVID in Jan2021. The patient asked how long he was supposed to wait for the second dose. It was just a mild case and he has already recovered the few days in Jan2021.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for "tested Covid19 positive".
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: she had the virus last year; she had the virus last year; This is a spontaneous report from a non-contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2020 (reported as last year), the patient "had the virus". It was not confirmed if the patient received the 1st dose of the vaccination prior to or after having the virus. The patient queried if she should continue to receive the 2nd dose. The clinical outcome of "had the virus" was unknown.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at vaccination site; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), lot number: EL1283, via an unspecified route of administration Left arm from 23Jan2021 14:15 to 23Jan2021 14:15 at SINGLE DOSE (first dose) for COVID-19 immunisation.  Medical history included asthma and penicillin allergy.  Concomitant medication included montelukast sodium 10 mg tab, fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol [SALBUTAMOL].  The patient experienced sore arm at vaccination site on 23Jan2021 15:00 with outcome of recovering.  The patient is not pregnant at the time of vaccination. No treatment was received for the event.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever,  nausea, dizziness, muscle aches; Fever,  nausea, dizziness, muscle aches; Fever,  nausea, dizziness, muscle aches; Fever,  nausea, dizziness, muscle aches; This is a spontaneous report from a contactable other hcp, the patient. This 49-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL3302), second dose, via an unspecified route of administration in the right arm on 23Jan2021 at 18:30 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, penicillin allergy from an unknown date and unknown if ongoing (Penicillin type antibiotics) and a shellfish allergy from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium (CALCIUM) and probiotics (PROBIOTICS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, intramuscularly on 02Jan2021 at 0830 in the left arm as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 23Jan2021 at 11:00, the patient experienced fever, nausea, dizziness and muscle aches. No therapeutic measures were taken as a result of the events. The clinical outcome of the fever, nausea, dizziness and muscle aches was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Myalgia
Clinical narrative: Muscle and Joint pain for 16 days; Muscle and Joint pain for 16 days; This is a spontaneous report from a contactable other hcp, the patient. This 50-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL1284), dose number 2, via an unspecified route of administration in the right arm on 07Jan2021 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Hashimoto's disease from an unknown date and unknown if ongoing and migraines from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), dose #1, intramuscularly in the left arm on 17Dec2020 at 1300 as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen (IBUPROFEN). On 08Jan2021 at 0500, the patient experienced muscle and joint pain lasting 16 days. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient also spoke with the physician and blood work was done. All results were normal. Unspecified therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included blood work (Unknown date): results were normal. The clinical outcomes of the muscle and joint pain were resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Insomnia, Pain, Pain in extremity
Clinical narrative: heavy sweat; night of shot arm hurt so bad I could not sleep, arm still sore; night of shot arm hurt so bad I could not sleep; achy; chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 19Jan2021 10:30 AM at single dose for COVID-19 immunisation. Vaccine location was Left arm. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Patient was allergies to penicillin, keflex lisinopril and Spiriva Respimat. Other medical history included asthma and heart electrical problem. Concomitant medications the patient received within 2 weeks of vaccination included many for asthma and heart etc. Patient administered the most recent COVID-19 vaccine at Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced shot arm hurt so bad and she could not sleep became achy and chills in the night of 19Jan2021, slept deeply Wed (20Jan2021) and Thursday (21Jan2021) nights. The patient experienced heavy sweat in the night of 21Jan2021 (Thursday) bedclothes very wet in morning Friday (22Jan2021) feel better but arm still sore. Patient was not received treatment for the adverse events. The outcome of events reported as recovering. All events reported as non-serious: adverse event resulted in none of seriousness criteria.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle pain; fatigue; fever; This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Jan2021 at 11:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received amlodipine and experienced allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 13:30, the patient experienced muscle pain, fatigue, and fever. The patient did not receive any treatment for the events. The clinical outcomes of the muscle pain, fatigue, and fever was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Nausea; aches; tiredness; This is a spontaneous report from a contactable consumer (patient).  A 83-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) , via an unspecified route of administration on 21Jan2021 18:30 at SINGLE DOSE at left arm for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced nausea, aches, tiredness on 22Jan2021 17:30. No treatment for the events. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling hot, Lymph node pain
Clinical narrative: fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as "Age: 46; Unit: Unknown") received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it was normal to have swollen lymph nodes after getting the 1st dose of the COVID 19 vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.