chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: sore throat; pain/aches; he said he had a loss of taste that started yesterday, 24Jan2021, but he did not have a complete loss of taste; Coughing; Dry throat; Muscle pain; This is a spontaneous report from a contactable consumer reported for himself. A 74-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246 and expiry date: Apr2021), via an unspecified route of administration on left arm on 18Jan2021 (11:00-11:10 AM) at SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient previously took flu shot on 06Jan2021 with no adverse event. The patient received 1st dose on 18Jan2021, unknown date the patient started experiencing "what sounded like flu": sore throat, pain/aches. He said 2 days ago on 23Jan2021, he had developed a dry throat, coughing, and muscle pain. He said everything else is easing up (clarified as his dry throat and muscle pain), except for his cough. He said he is supposed to have a procedure tomorrow to replace his defibrillator and is wondering if it is OK for him to go ahead with the procedure. Reported he had a loss of taste that started yesterday on 24Jan2021. He said he did not have a complete loss of taste. He said he does not have a strong sense of taste now. He said he could barely taste his coffee this morning, clarifying that his coffee tasted like he was drinking hot water. Declined any reported he had taken some over-thecounter pain killers, like Ibuprofen, in the past couple of weeks. He said he is not a big medication person, except for his heart medication, and the Ibuprofen is something he previously had in his house. The caller clarified his doctor stated he would test him for the COVID-19 Virus tomorrow on 26Jan2021 before his surgery. Reported he had blood work done on 06Jan2021, the same day he had a flu shot. He clarified he did not have any side effects from the flu vaccine on 06Jan2021. He said he never has side effects when he gets vaccines. Reported he had blood work done again on Friday, 22Jan2021, when he went for his preregistration for his surgery that is scheduled on 26Jan2021. Outcome of the events dry throat, and muscle pain was recovering, outcome of the event loss of taste and coughing was not recovered, outcome of the other events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, White blood cell count
Clinical narrative: muscle in the right arm started to hurt.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982) via an unspecified route of administration in right arm on 23Jan2021 09:00 at single dose for COVID-19. Medical history included rotator cuff surgery on her left arm on 28Dec2020 that was affected by a flu shot that she just got (sore left arm Flu vaccine, 26Oct2019-27Oct2019), chronic lymphocytic leukaemia (CLL) (had it 20-25 years ago stated that she watches her white blood cell count on it). Family medical history relevant to AE was none. No vaccine was received within four weeks. There were no concomitant medications. The patient experienced muscle in the right arm started to hurt on 24Jan2021 17:00. She put ice on it as treatment. Relevant tests were none. The event didn't require Emergency Room visit or Physician Office visit. The outcome of event was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Vision blurred
Clinical narrative: Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Chills; This is a spontaneous report from a non-contactable HCP (patient herself).  This adult female patient (age not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No relevant medical history and concomitant medications were provided. No known allergies. On 13Jan2021 at 10:00 the patient developed injection site pain, tiredness, and chills. The events were assessed as non-serious. Post-vaccination COVID-19 test was not performed. The patient had recovered from the events on unknown date in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Developed fever; body aches; This is a spontaneous report from a contactable Other Health Professional reporting for himself. A 34-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot Ek4231), intramuscular in left arm on 13Jan2021 at single dose for covid-19 immunisation. The patient had an ongoing exposure to SARS-CoV-2 since on 21Dec2020 the patient children developed Covid symptoms and tested positive then his wife developed symptoms as well. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685) intramuscular in the left arm on 21Dec2020 for COVID-19 immunisation. The patient developed fever and body aches on 13Jan2021 with outcome of recovered in Jan2021. No treatment was performed due to the events. The patient was not diagnosed positive to COVID-19 prior to vaccination. The patient was tested negative for COVID via nasal swab on 22Jan2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pain in extremity
Clinical narrative: arm pain; headache; back pain; tiredness; This is a spontaneous report from a contactable consumer, reporting for herself. A 34-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261), via an unspecified route of administration at the left arm on 23Jan2021 13:15 at a single dose for COVID-19 immunization. Vaccination was done in a Workplace Clinic. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and estradiol. The patient previously took Keflex and codeine and experienced drug allergy. On 23Jan2021 15:00, the patient experienced arm pain, headache, back pain and tiredness. No treatment was received. The patient was not pregnant at the time 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 outcome of the events was not recovered.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Visual impairment
Clinical narrative: feeling bad; Had no energy; everything spins inside the room/ went black; everything spins inside the room/ went black; This is a spontaneous report from a contactable consumer reporting for himself. An 83-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer- BioNTech, lot# lot# EL1284), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing wheelchair user, blood pressure abnormal and prostate infection. Patient's body weight was 218-220 pounds. Concomitant medications included acetylsalicylic acid (ASPIRIN) for many years at 1 DF daily, an unspecified prostate medication and an unspecified drug for blood pressure at 20 mg, another unspecified drug that is mixed and eye drops. The patient experienced feeling bad, had no energy, everything spins inside the room/ went black all in Feb2021 with outcome of unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: Extreme tiredness; chills; fever; muscle aches; runny nose; sore throat; nausea; pale skin; malaise; night sweats; This is a spontaneous report from a contactable 37-year-old Other HCP reported for herself. A 37 Years old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 on Arm left at single dose (lot: EL0140) for covid-19 immunisation. Medical history included PTSD, and anxiety. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL), clonazepam (KLONOPIN) and Zinc. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:45 AM arm left at single dose (lot: EJ1685) for covid-19 immunisation. Covid test date (nasal swab Rapid) on 03Jan2021: positive. The patient experienced Extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats all on 24Jan2021 12:00 AM which were non serious. No treatments were received. Outcome of the events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Oropharyngeal pain, Pallor, Pyrexia, Rhinorrhoea
Clinical narrative: Extreme tiredness; chills; fever; muscle aches; runny nose; sore throat; nausea; pale skin; malaise; night sweats; This is a spontaneous report from a contactable 37-year-old Other HCP reported for herself. A 37 Years old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 on Arm left at single dose (lot: EL0140) for covid-19 immunisation. Medical history included PTSD, and anxiety. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL), clonazepam (KLONOPIN) and Zinc. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:45 AM arm left at single dose (lot: EJ1685) for covid-19 immunisation. Covid test date (nasal swab Rapid) on 03Jan2021: positive. The patient experienced Extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats all on 24Jan2021 12:00 AM which were non serious. No treatments were received. Outcome of the events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Extreme tiredness; chills; fever; muscle aches; runny nose; sore throat; nausea; pale skin; malaise; night sweats; This is a spontaneous report from a contactable 37-year-old Other HCP reported for herself. A 37 Years old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 on Arm left at single dose (lot: EL0140) for covid-19 immunisation. Medical history included PTSD, and anxiety. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL), clonazepam (KLONOPIN) and Zinc. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:45 AM arm left at single dose (lot: EJ1685) for covid-19 immunisation. Covid test date (nasal swab Rapid) on 03Jan2021: positive. The patient experienced Extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats all on 24Jan2021 12:00 AM which were non serious. No treatments were received. Outcome of the events was recovering.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at arm at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient asking if one have a sore arm, are one allowed to take Ibuprofen. Female consumer received the first dose of the COVID-19 vaccine today and had a sore arm (25Jan2021). When she received the vaccine, it was administered closer to her shoulder. patient asked what does intramuscularly mean. Outcome of the event was unknown. It was a non-serious report.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: a stye on his eye; This is a spontaneous report from a contactable physician reported for self. This male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for covid-19 immunisation. Scheduled for their second doses of Pfizer-Biontech Covid19 vaccine on 01Feb2021. Scheduled for their second doses of Pfizer-Biontech Covid19 vaccine on 01Feb2021. He developed a stye on his eye in Jan2021 after his first dose of Covid19 vaccine- unrelated, and has been treating it with antibiotic and steroid eye drops, but MD has prescribed him oral doxycycline. Outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.; Sender's Comments: In concurrence with the reporting physician, the Company deems the reported stye an inter-current disease, unrelated to the COVID-19 vaccine, BNT162B2.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin lesion, Skin warm
Clinical narrative: 3 inch lesion. Red, swollen, hot and painful. Grew ins ice over 48 hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable consumer reported for herself. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREL1283), via an unspecified route of administration on left arm on 13Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included diabetic, highwood pressure, kidney issues. The patient's concomitant medications were not reported. The patient previously took hydrocodone, morphine, oxycontin, metformin, trulicity, all experienced drug allergy. The patient experienced chills, fatigue, headache, soreness in her arm, all on 13Jan2021 16:00 with outcome of recovered on 14Jan2021 16:00. This last for about 24 hrs. No treatment received for these events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: bump at vaccination site and it was itchy; bump at vaccination site and it was itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age:70, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 14Jan2021 and still has a bump at vaccination site and it was itchy. The patient wanted to know if it was normal. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbing in her pinkie and ring finger; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL8982, expiration date unknown), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL6412, expiration date unknown) for COVID-19 immunization. The patient received her second dose on Thursday, 21Jan2021 and immediately following the injection she experienced numbing in her pinkie and ring finger that have not gone away. Numbness in pinky and ring finger, it did not seem to be improving. The outcome of the event was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash macular
Clinical narrative: site of injection developed a bump and itchy rash.  The area became red and blotchy.  The bump disappeared after two days,  The rash and itch lasted 5 days, it disappeared the day after I took a Benadryl.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: developed a Metallic taste in the mouth; This is a spontaneous report from a contactable nurse (wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, the patient developed a metallic taste in the mouth a couple of hours after the vaccine which lasted from Thursday-Saturday. The outcome of the event was recovered on 24Jan2021.   Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she has covid; she has covid; This is a spontaneous report from a contactable Nurse reporting for herself and also received from the Nurse via a Pfizer-sponsored program. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She was supposed to get the 2nd dose yesterday on 24Jan2021, but was unable to get it since she was on quarantine. The patient mentioned that she had covid on an unknown date in Jan2021, and asking when and where she can get it and if she had to wait 30 days from covid detection, and also asked if the vaccine has made she more susceptible to covid. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex reactivation
Clinical narrative: Herpes simplex 1 outbreak 36 hrs after vaccination. First symptoms subsequent to disease onset 15 years ago; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm, via an unspecified route of administration on 23Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included fluconazole allergy, sulfa allergy, herpes simplex 1 (15 years ago). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included naproxen. On 25Jan2021, the patient experienced herpes simplex 1 outbreak 36 hrs after vaccination. First symptoms subsequent to disease onset 15 years ago. Treatment received for the adverse event included Medication for Herpes Simplex Virus (hsv). Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Gait inability, Myalgia, Neuralgia, Pain
Clinical narrative: Horrible muscle and nerve pain in lower extremities.  Burning sensation  with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Horrible muscle and nerve pain in lower extremities.  Burning sensation  with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive with covid-19; tested positive with covid-19; This is a spontaneous report from a contactable consumer (patient).   A 29-year-old female patient received the 1sy dose of bnt162b2 (BNT162B2, Batch/lot # E23249) at single dose at left arm on 11Jan2021 for Covid-19 immunisation, as being a teacher.  Medical history was none. There were no concomitant medications.   The patient was tested positive with covid-19 on 19Jan2021. On 19Jan2021 she took a rapid test and a PCR: the rapid test came back negative the PCR test came back positive (received on 22Jan2021, as reported). The outcome of events unknown. She asked if she can still receive the second dose or  what to do if she would miss the receipt of the second dose of the COVID-19 vaccine due to isolation measure, and if she get excluded or if she need to get revaccinated?. A Product Complaint was filed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 09Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 18Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Jan2021. She was still sick.  The information on the Lot/Batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-severe), fatigue, loss of appetite. within 72 hours symptoms subsided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: extreme fatigue; joint (knee) ache; chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the left arm on 10Jan2021 15:45 at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, hyperthyroidism, high cholesterol, and COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, hydrochlorothiazide, lovastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient experienced extreme fatigue, joint (knee) ache, chills. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Nervousness
Clinical narrative: began to feel numbness in the forehead and lip; began to feel numbness in the forehead and lip; nervousness; This is a spontaneous report received from a contactable consumer (patient's daughter). A female patient of an unspecified age (reported as 65, year not provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of COVID vaccine on 25Jan2021. They waited 15 minutes for some adverse event, and nothing happened. On 25Jan2021, on their way back home, the patient began to feel numbness in the forehead and lip. The reporter wanted to know if this was reported or was it just nervousness. The outcome of the events was unknown. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Temperature 99.2; sinus pressure/headache; sinus pressure/headache; whole body ache; My first and second dose was less than 21 days apart.; This is a spontaneous report from a contactable (patient). A 42-year-old female patient receive second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration, at arm left, on 21Jan2021 at single dose for covid-19 immunisation. Medical history was none. Not Pregnant at the time of vaccination. No Allergies to medications, food, or other products. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included vitamin d nos (VITAMIN D NOS), ascorbic acid (VIT C), fish oil (FISH OIL), chondroitin sulfate sodium, glucosamine (GLUCOSAMINE AND CHONDROITIN). The patient historical vaccine included first dose of bnt162b2 (lot number: EK9231), intramuscular, at Arm Left, on 07Jan2021 09:00 AM (42-year-old) for covid-19 immunisation. 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 temperature 99.2, sinuspressure/headache, whole body ache. Her first and second dose was less than 21 days apart. The adverse event started from 21Jan2021 09:00 PM. No treatment was received for the adverse event. Seriousness was reported as NO. The outcome of the event was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: Temperature 99.2; sinus pressure/headache; sinus pressure/headache; whole body ache; My first and second dose was less than 21 days apart.; This is a spontaneous report from a contactable (patient). A 42-year-old female patient receive second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration, at arm left, on 21Jan2021 at single dose for covid-19 immunisation. Medical history was none. Not Pregnant at the time of vaccination. No Allergies to medications, food, or other products. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included vitamin d nos (VITAMIN D NOS), ascorbic acid (VIT C), fish oil (FISH OIL), chondroitin sulfate sodium, glucosamine (GLUCOSAMINE AND CHONDROITIN). The patient historical vaccine included first dose of bnt162b2 (lot number: EK9231), intramuscular, at Arm Left, on 07Jan2021 09:00 AM (42-year-old) for covid-19 immunisation. 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 temperature 99.2, sinuspressure/headache, whole body ache. Her first and second dose was less than 21 days apart. The adverse event started from 21Jan2021 09:00 PM. No treatment was received for the adverse event. Seriousness was reported as NO. The outcome of the event was recovering.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 6 days after the first dose i've noticed swelling of lymph nodes. Supraclavicular lymph nodes are swollen and sore to touch as well as swollen lymph nodes under my left arm pit. The Calvicular lymph nodes is also located on the left side. The same as the injection point.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Soreness; Fatigue; headache; This is a spontaneous report from a contactable healthcare professional (patient herself). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 22Jan2021 18:00 at single dose for COVID-19 immunization. Medical history included Hodgkin's disease and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number and expiry date not reported) in the left arm on 02Jan2021 at single dose for COVID-19 immunization. On 24Jan2021, the patient experienced soreness, fatigue, and headache. Clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Fatigue, Headache, Hypertension
Clinical narrative: headache; extreme fatigue/exhausted in bed/cannot get out of bed; blood pressure is up; diarrhea.; This is a spontaneous report from two contactable consumers (patient and patient's wife).  A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E13302) at Left arm, via an unspecified route of administration on 15Jan2021 16:00 at single dose for covid-19 immunisation.  Medical history included high blood pressure but usually under control. Patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced headache and extreme fatigue, blood pressure is up on 24Jan2021 17:00, diarrhea on 24Jan2021. No treatment for the events headache and extreme fatigue, blood pressure is up. Patient did not have covid tested post vaccination. The patient was having COVID-like symptoms, including fatigue and diarrhea. He was having full blown symptoms like Covid. He was exhausted in bed, had a headache and it was unsure if he had a temperature. He cannot get out of bed and had diarrhea. His blood pressure was high yesterday. All night long that he had a headache and that was up and down. He had a tendency to have diarrhea and he known when its worst than normal and it was worst than normal. The outcome of events was not recovered. Diarrhea was worsened.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Vaccination site induration, Vaccination site mass
Clinical narrative: Large, hot, red circle that appeared within 24 hours of shot, at site.. It was painful, hard and grew in size for 2-3 days before slowly subsiding. As of 2/9/2021, there is still occasional itching at the site, no redness but still a little muscle "stiffness".
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Large, hot, red circle that appeared within 24 hours of shot, at site.. It was painful, hard and grew in size for 2-3 days before slowly subsiding. As of 2/9/2021, there is still occasional itching at the site, no redness but still a little muscle "stiffness".
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I'm experiencing dizziness from time to time that I have experienced before the vaccination.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EL3249), on 23Jan2021 09:45 at SINGLE DOSE in Left arm for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included anxiety, dizziness.  Concomitant medication received within 2 weeks of vaccination included vortioxetine hydrobromide (TRINTELLIX), naproxen sodium (ALEVE), fluticasone propionate (FLONASE), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER).  The patient experiencing dizziness from time to time on 23Jan2021 03:00 PM that he has experienced before the vaccination. The outcome was Not recovered. No treatment received for the adverse event. The event was 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypersensitivity, Pain, Peripheral swelling
Clinical narrative: fever; body aches/aches and pains; headache; allergic reaction; her feet a little, were swollen. Her hands were very swollen/both hands swelled up very much; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), 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. Caller reported patient got vaccinated 3 weeks ago, got the first one and patient was very symptomatic; had fever, headache, body aches. Patient had an unusual symptom: both hands swelled up very much and they weren't red and were not itchy. Caller, a directed of nursing in a long-term care facility, who is reporting on the Pfizer COVID vaccine. It is explained she got the first vaccine and afterwar was pretty symptomatic with fever, aches and pains, and a headache. On the 2nd day her hands, and her feet a little, were swollen. Her hands were very swollen. This went away after 2 days but it was reported to the (name). She was told that based on the swelling it was not recommend she get the booster dose, she is assuming it was allergic reaction and not just a reaction. The caller explains that she has been told that this has happened to a few people, even when they had COVID not just with the vaccine. She is wondering if she has to miss the second dose and if we have an recommendations for her. The caller has no information or specifics for these patients. This was just conversations here and there with different people. She notes a coworker's son's hands were swollen after getting COVID. She confirms (coworker's son's) after getting the virus not vaccine. The outcome of event her hands were very swollen/both hands swelled up very much was recovered on an unspecified date. The outcome of other events was unknown.  Information of lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; body aches/aches and pains; headache; allergic reaction; her feet a little, were swollen. Her hands were very swollen/both hands swelled up very much; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), 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. Caller reported patient got vaccinated 3 weeks ago, got the first one and patient was very symptomatic; had fever, headache, body aches. Patient had an unusual symptom: both hands swelled up very much and they weren't red and were not itchy. Caller, a directed of nursing in a long-term care facility, who is reporting on the Pfizer COVID vaccine. It is explained she got the first vaccine and afterwar was pretty symptomatic with fever, aches and pains, and a headache. On the 2nd day her hands, and her feet a little, were swollen. Her hands were very swollen. This went away after 2 days but it was reported to the (name). She was told that based on the swelling it was not recommend she get the booster dose, she is assuming it was allergic reaction and not just a reaction. The caller explains that she has been told that this has happened to a few people, even when they had COVID not just with the vaccine. She is wondering if she has to miss the second dose and if we have an recommendations for her. The caller has no information or specifics for these patients. This was just conversations here and there with different people. She notes a coworker's son's hands were swollen after getting COVID. She confirms (coworker's son's) after getting the virus not vaccine. The outcome of event her hands were very swollen/both hands swelled up very much was recovered on an unspecified date. The outcome of other events was unknown.  Information of lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Hypoaesthesia, Hypoaesthesia oral, Ocular hyperaemia, Rash
Clinical narrative: Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minutes, then began to subside - the swelling and numbness in face and lips first and then the itching of rash - rash went away and also itching and redness in eyes
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minutes, then began to subside - the swelling and numbness in face and lips first and then the itching of rash - rash went away and also itching and redness in eyes
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination site pain
Clinical narrative: Slight soreness at injection site; fatigue; feeling a little spacey.; This is a spontaneous report from a contactable consumer (patient). The 46-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, lot number: EL8982), via an unspecified route of administration in left arm on 25Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety. 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. Concomitant medication included hydroxyzine embonate (VISTARIL), sertraline hydrochloride (ZOLOFT), vitamin c [ascorbic acid], fish oil, acetylsalicylic acid ASPIRIN (E.C.). The patient previously took codeine and doxycycline and experienced Allergy. The patient experienced slight soreness at injection site, fatigue, feeling a little spacey on 25Jan2021 11:00. No treatment received. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: she tested positive for COVID yesterday at work; she tested positive for COVID yesterday at work/started to have a fever last night/now she has loss of sense of smell; This is a spontaneous report from a contactable nurse (patient). A 65 (age units: unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she received first dose of vaccine on Saturday approx. 9 days ago. The patient reported that she tested positive for COVID yesterday (on 24Jan2021) at work. The patient reported that she has started to have a fever last night (on 24Jan2021) and now she has loss of sense of smell (in Jan2021). The patient would like to know the efficacy of vaccine after first dose. The patient would like to know if she should get second dose after testing positive post first dose. Second dose scheduled for 10Feb. The events were reported as non-serious. The outcome of events was unknown.   Information about lot/batch number has been requested.; 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. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Only slight soreness at injection site for a day, but then I noticed 10 days later a red rash 3 inches wide and about 5 inches long extending from the injection site down my arm.  Very slightly itchy.  No fever, no chills, no systemic symptoms, no pain.  Today, on day 12, only 20% of the rash remains, and it is fading (now only slightly pink).  In other words, it is disappearing.  I noticed it on day 10, but don't know when it started-- probably a couple of days before that.  It wasn't there on day 2.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient).  A 60-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had pcr positive/tested positive in Jan2021 with outcome of unknown. She specified doing her test an hour and a half after vaccination. She then described doing two additional PCR tests, one that same night and the other the next day, and both came out negative. She added she "had no symptoms from the shot". She asked if the COVID-19 vaccine can cause a false positive PCR test.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain, Restlessness
Clinical narrative: Body aches; restless; no sleep; headaches; chills; This is a spontaneous report from a contactable other health professional reported for herself. A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 24Jan2021 14:00 at single dose at left arm for covid-19 immunization. The most recent COVID-19 vaccine was administered at Hospital. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 03Jan2021 at Left arm 14:00 for covid-19 immunization. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received 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 Body aches, restless, no sleep, headaches, chills on 25Jan2021 12:00 AM. The outcome of the event was not recovered. No treatment received for the adverse events.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness
Clinical narrative: Chills; weakness; a little light headed; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration in the left arm on 22Jan2021 10:30 at a single dose for covid-19 immunization. The patient's medical history included covid-19 from an unknown date and unknown if ongoing (prior to vaccination). The patient did not the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and did not received other vaccine in four weeks. Patient had no allergies to medications, food, and other products. On 22Jan2022 at 15:00, the patient experienced chills, weakness and a little light headed. The outcome of the event was recovered on an unknown date. The patient has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Erythema to face and chest starting at 8:15pm, about 4 hours after injection. Took Benadryl at 8:30pm. Redness mostly resolved by 10:30pm
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: low-grade fever; headache; nausea; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Yesterday (24Jan2021), the patient experienced a low-grade fever, headache, and nausea. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sore throat; runny nose; This is a spontaneous report from a contactable consumer (reported for herself) from a Pfizer-sponsored program. A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced runny nose on 20Jan2021 and had sore throat on 21Jan2021. Patient took 1st dose of covid vaccine on 04Jan2021, supposed to get 2nd one on 25Jan2021, but patient have a runny nose that started last Wednesday (20Jan2021) and sore throat on 21Jan2021. Patient asked if the second dose must be 3 weeks exactly, or can she take it later. Patient also asked for the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine and if she could receive it earlier or later than 3 weeks. The events were reported as not serious. The outcome of the events runny nose and sore throat was unknown.   Information on the Batch/Lot number has been requested.