chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Face oedema, Liver function test, Oedema peripheral, Renal function test, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable physician. A 53-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number pfel0410) on his left arm, intramuscular on 04Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 (first dose). It was reported that about 1 week after 2nd dose, the patient had diffuse edema of face, hands and legs. After edema resolved, skin on fingertips peeled off; all on 11Jan2021. Labs for kidney, liver and thyroid were checked and everything normal. No treatment was received for the events. The outcome of the events was recovered with sequel.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: This is a spontaneous report from a contactable physician. A 53-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number pfel0410) on his left arm, intramuscular on 04Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 (first dose). It was reported that about 1 week after 2nd dose, the patient had diffuse edema of face, hands and legs. After edema resolved, skin on fingertips peeled off; all on 11Jan2021. Labs for kidney, liver and thyroid were checked and everything normal. No treatment was received for the events. The outcome of the events was recovered with sequel.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient (not pregnant, age at vaccination reported as 61-years-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (left arm), on 02Feb2021, at single dose, for covid-19 immunization. Medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), for covid-19 immunization. The patient felt flu like symptoms the day after the second vaccination dose on 03Feb2021. Symptoms have resolved on the second day after vaccination. The patient recovered from the adverse event on 04Feb2021. No treatment was received for the adverse event. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 20Jan2021 01:15 at SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure (abnormal) from an unknown date. The patient was taking unspecified concomitant medications within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered at a hospital. 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. No allergies to medications, food or other products. The patient experienced dizziness, vertigo, falling on 20Jan2021 02:30. Treatment was not received. Outcome of the event was recovered with sequelae on an unspecified date. The reporter considered the events as non-serious.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via intramuscular route of administration on 25Jan2021 at 14:30 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular on 04Jan2021 at 11:30 am (age: 54-years) on the left arm for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 02Feb2021, the patient experienced numbness in arms, hands, legs and feet. The patient did not receive any treatment for the reported event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Pain in extremity
Clinical narrative: left index finger feels like it was jammed; finger was in a lot of pain when moving left or right, even when washing his hands; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 03Feb2021 at 19:45 at a single dose on the arm left for COVID-19 immunization. Medical history included patient was diagnosed with COVID-19. Concomitant medications included naproxen sodium (ALEVE) and biotin. On 04Feb2021 at 03:00, the patient stated that his left index finger feels like it was jammed. The patient also stated that his finger was in a lot of pain when moving left or right, even when washing his hands. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable Other health care professional (patient). A 35-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 16Jan2021 at 09:00 AM (at age of 35-year-old) as a single dose for COVID-19 immunisation, lot number: unknown. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included rhamnus cathartica, rhamnus purshiana, senna spp. (HERBAL) teas, cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER), fluoxetine. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient caught covid on 30Jan2021 and she was unable to get second vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. It was also reported that since the vaccination, the patient had been tested for COVID-19. She underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 03Feb2021. Patient was recovering from the event, at the time of the report. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: He came down with covid; This is a spontaneous report from a contactable Consumer (patient)  A male patient received frist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 20Jan2021 at SINGLE DOSE for covid-19 immunization .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient stated he came down with covid on 01Feb2021. Lab data included sars-cov-2 antibody test (01Feb2021): came down with covid (postitive) .The reporter added he received antibodies and was told not to take the second shot for 90 days. Outcome of the event was unknown. Information on the lot/ batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain and swelling in my lymph node in left armpit; Pain and swelling in my lymph node in left armpit; On 30Jan2021, the patient received the second dose BNT162B2 and first dose was received on 13Jan2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL8982), via an unspecified route of administration at the left arm on 30Jan2021 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. The patient has no other medical history. There were no concomitant medications. The patient was not pregnant at the time of vaccination. Historical vaccine includes 1st dose of BNT162B2 for COVID-19 immunization, on 13Jan2021 12:00PM at the left arm, lot number: EL3246 at the age of 43 years. On 30Jan2021, the patient received the second dose BNT162B2 and first dose was received on 13Jan2021. On 01Feb2021 06:00 AM, the patient experienced pain and swelling in her lymph node in left armpit. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received 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. The events pain and swelling in my lymph node in left armpit recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cold sweat, Decreased appetite, Dizziness
Clinical narrative: lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Presyncope
Clinical narrative: lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: itchy eyes; This is a spontaneous report from a non-contactable physician (patient). This physician reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age (reported as age: 79, unit unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer vaccine on 26Jan2021. Patient had itchy eyes that day and day after, then subsided. The next shot is scheduled for 26Feb2021, patient was struggling in making a decision on the second shot. Patient asked for any information on this side effect. The outcome of the event itchy eyes was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) :  same reporter/drug/AE, different patient.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hypoaesthesia, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization.  Medical history was none. 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 workplace clinic. 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 included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of  numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization.  Medical history was none. 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 workplace clinic. 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 included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of  numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiry date unknown), intramuscular in the left arm, on 05Jan2021 17:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included asthma and high cholesterol. The patient has no allergy to medications, foot or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included atorvastatin (LIPITOR) and ethinylestradiol, norgestrel (CRYSELLE). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced upper left swollen lymph nodes (4) on 08Jan2021 13:30. The patient postponed 2nd shot until this is resolved. Ultrasound was done and was told biopsy was needed next. Therapeutic measures were taken as a result of upper left swollen lymph nodes (4) included ultrasound (as reported) on an unspecified date with unknown results. The event resulted to "doctor or other healthcare professional office/clinic visit". The outcome of the event was not resolved.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 approximately 2 weeks after receiving her second dose of vaccine; Tested positive for COVID-19 approximately 2 weeks after receiving her second dose of vaccine; This is a spontaneous report from a contactable consumer. A 93-year-old female patient not pregnant received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date in Jan2021 (at age of 93-year-old) as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. It was unknown if patient received other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was tested positive for COVID-19 approximately two weeks after receiving her second dose of vaccine, onset date 30Jan2021. Event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatments were administered. The patient underwent laboratory tests and procedures which included sars-cov-2 test: positive on 30Jan2021. Patient had not recovered at the time of the report.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Breast pain, Mammogram, Ultrasound breast
Clinical narrative: my left breast started draining clear/white fluid; there is associated pain radiating down towards the nipple from the top of the breast and along the left side of the breast; This is a spontaneous report from a contactable nurse who reported for herself   This  44-years-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3247 in the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic.Age at vaccination 44 years.The patient received the first dose of the same vaccine from Lot # EL1284 on 29Dec2020 via intramuscular , on the Left arm .Tthe patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypothyroidism , gestational diabetes ,Allergies: Bees (anaphylaxis) , Allergy: shrimp (gastrointestinal) .Concomitant medication included levothyroxine ,  alprazolam  , procaterol hydrochloride (PRO-AIR), chlorphenamine maleate (CHLOR)  and vitamin d . The patient reported as follows :"On 22Jan2021 18:00 my left breast started draining clear/white fluid. Additionally there was associated pain radiating down towards the nipple from the top of the breast and along the left side of the breast that has lasted two weeks and continues".Lab data included mammogram (2021): unknown results .ultrasound left breast (2021): unknown results.The adverse event result in Doctor or other healthcare professional office/clinic visit.Events were treated (I have had to have a mammogram and ultrasound of left breast and am awaiting an MRI.Levaquin ).Events reported as non serious.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.Outcome of the events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mental fatigue
Clinical narrative: General body fatigue; mental fatigue (moderate); This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at single dose for COVID-19 immunisation at the age of 32-year-old. Medical history was none. Concomitant medications were unknown. On 05Feb2021 at 05:30, the patient experienced general body fatigue and mental fatigue (moderate). The outcome of the events was unknown. 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 lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Coccidioidomycosis, Pneumonia, SARS-CoV-2 test
Clinical narrative: she was diagnosed with pneumonia; Valley fever; This is a spontaneous report from a Pfizer Sponsored Program, Pfizer First Connect. A contactable female consumer of unspecified age (patient) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, 2 days after vaccination, the patient was diagnosed with pneumonia and Valley fever. The patient was tested negative for the COVID virus on an unknown date. Her second BNT162B2 dose was scheduled for 15Feb2021. Events outcome was unknown. Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 24-year-old female patient at same age receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), intramuscular in left arm on 03Feb2021 12:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscular soreness for 24 hours (04Feb2021 12:00), fatigue for 6 hours (03Feb2021 18:00), nausea 12 hours (04Feb2021 00:00) after injection, lasting for 6 hours. The outcomes of events were unknown. The patient was not pregnant at the time of vaccination. The patient was not received 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, patient has not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 26Jan2021,14:45 (lot number: EL3247), at the age of 51-years via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient did not receive other vaccines within four weeks. The patient had no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was tested after the vaccination for COVID-19. The patient experienced tested positive for COVID-19 on 04Feb2021. The adverse events required doctor or other healthcare professional office/clinic visit. The patient did not received treatment. The patient underwent COVID-19 (Nasal Swab) test on 04Feb2021 which was positive. The consumer assessed the events as non-serious. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A lot of pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration on the left arm on 04Feb2021 09:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure and coronary artery (disease). Concomitant medication included valsartan, rosuvastatin calcium (ROSUVASTIN) and acetylsalicylic acid (BABY ASPIRIN). On 04Feb2021 14:30 the patient experienced a lot of pain at the injection site. No treatment was received for the event. Event was reported as non-serious: 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. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovering.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine with aura
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3248; expiration date: unknown), via an unspecified route of administration right arm on 04Feb2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3248; expiration date: unknown) at the vaccination age of 52-year-old via an unspecified route of administration left arm on 14Jan2021 08:45 AM at a single dose for covid-19 immunization. On 04Feb2021 04:45 PM, the patient reported that he believed he experienced an ocular migraine in his left eye approximately 9 hours after getting the second shot. He took 2 acetaminophen 500 mg tablets and the symptoms cleared up in 20-30 minutes. He has never experienced this sort of sensation before so he figures it could possibly be related. He woke up with a mild headache at the start of this second day (05Feb2021), as well. The events were non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event ophthalmic migraine was recovered on 04Feb2021 while headache was recovered on Feb2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 07:45 at single dose in left arm for COVID-19 immunisation at the age of 25-year-old. Lot number was EL9264. Pregnant was not pregnant at the time of vaccination. Medical history included asthma, allergies, anxiety, frequent bronchitis. Concomitant medications included mefenamic acid (ADVIL), sertraline hydrochloride (ZOLOFT), fluticasone propionate (ARMONAIR), fexofenadine hydrochloride (ALLEGRA), ipratropium bromide (IPRATROPIUM BROM). The patient experienced Injection site tenderness on 04Feb2021 at 13:00; the patient was not treated for the event. The patient recovered from the event. 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. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Muscle and joint pain; Muscle and joint pain; fever; severe chills; nausea; vomiting; fatigue; severe headache; injection site pain; severe feeling of sickness; This is a spontaneous report from a contactable nurse reported for himself that:  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) form LOT# EJ1685 on left arm on 22Dec2020 10:00 at SINGLE DOSE for covid-19 immunization.Age at vaccination: 69 Years Medical history included flu (almost 43 years ago).  The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced  muscle and joint pain, fever, severe chills, severe shivering, nausea, vomiting, fatigue, severe headache, injection site pain and a severe feeling of sickness. This severe feeling of sickness was the worst feeling of sickness that I have had in my life, only equal to the most sick I have felt in my life, which was the last time I had the flu, which was almost 43 years ago. This began about 9 hours after I got my second vaccine shot. This lasted about 36 hours, the worst of it about 4 hours. Lab data sars-cov-2 test (unknown date): negative. No treatment received. Events were reported as non-serious. Outcome of the events was recovered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Muscle and joint pain; Muscle and joint pain; fever; severe chills; nausea; vomiting; fatigue; severe headache; injection site pain; severe feeling of sickness; This is a spontaneous report from a contactable nurse reported for himself that:  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) form LOT# EJ1685 on left arm on 22Dec2020 10:00 at SINGLE DOSE for covid-19 immunization.Age at vaccination: 69 Years Medical history included flu (almost 43 years ago).  The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced  muscle and joint pain, fever, severe chills, severe shivering, nausea, vomiting, fatigue, severe headache, injection site pain and a severe feeling of sickness. This severe feeling of sickness was the worst feeling of sickness that I have had in my life, only equal to the most sick I have felt in my life, which was the last time I had the flu, which was almost 43 years ago. This began about 9 hours after I got my second vaccine shot. This lasted about 36 hours, the worst of it about 4 hours. Lab data sars-cov-2 test (unknown date): negative. No treatment received. Events were reported as non-serious. Outcome of the events was recovered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Muscle and joint pain; Muscle and joint pain; fever; severe chills; nausea; vomiting; fatigue; severe headache; injection site pain; severe feeling of sickness; This is a spontaneous report from a contactable nurse reported for himself that:  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) form LOT# EJ1685 on left arm on 22Dec2020 10:00 at SINGLE DOSE for covid-19 immunization.Age at vaccination: 69 Years Medical history included flu (almost 43 years ago).  The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced  muscle and joint pain, fever, severe chills, severe shivering, nausea, vomiting, fatigue, severe headache, injection site pain and a severe feeling of sickness. This severe feeling of sickness was the worst feeling of sickness that I have had in my life, only equal to the most sick I have felt in my life, which was the last time I had the flu, which was almost 43 years ago. This began about 9 hours after I got my second vaccine shot. This lasted about 36 hours, the worst of it about 4 hours. Lab data sars-cov-2 test (unknown date): negative. No treatment received. Events were reported as non-serious. Outcome of the events was recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Lymphadenopathy
Clinical narrative: Lymph node swelling on collar bone area; Excessive belching without other potential trigger; This is a spontaneous report from a contactable pharmacist.  A 35-year-old female pharmacist reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318), intramuscular into the left arm on 02Feb2021 at 04:30 PM at single dose for COVID-19 immunization. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Concomitanr drugs were unknown.  The patient experienced excessive belching without other potential trigger days 1 and 2 after vaccination and lymph node swelling on collar bone area 3 days after vaccination.  No treatment was received. the outcome of the events was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 02Feb2021 08:45 at single dose for COVID-19 immunization. Medical history included stage 4 prostate cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications were not reported. The patient previously took celecoxib (CELEBREX) and experienced allergies. On 04Feb2021, the patient experienced extreme soreness on side where injection was given, also had malaise and tiredness. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results (COVID test result Pending) on 05Feb2021. No treatment was received for the adverse events. Clinical outcome of the events was recovered/resolved with sequel (reported as recovered with lasting effects).  Information on the lot/batch number has been requ
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (not pregnant) received the first dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 05Feb2021 08:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included colorectal cancer and thyroid cancer. She had allergies to sulfur. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient experienced her lips felt swollen and numb for about one hour after the dose was administered (non-serious) on 05Feb2021. No treatment was given. The outcome of events was recovered on unspecified date in Feb2021.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number expiry date not reported), via an unspecified route of administration in left arm on 05Feb2021 00:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood pressure abnormal and chronic kidney disease. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram, diltiazem, amlodipine, calcitriol and iron. The patient experienced cold sweat, slight fever and chills (all non-serious) on 06Feb2021 03:00, no treatment. The outcome of events was unknown. Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Severe pain and swelling at injection site; Severe pain and swelling at injection site; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration (right arm) on 05Feb2021 12:00 (at the age of 51years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247) on 15Jan2021 (10:00AM) (at the age of 51years) at right arm for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Feb2021, the patient experienced severe pain and swelling at injection site. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Product administration error
Clinical narrative: they gave him 6 times the amount of the regular dosage; pharmacist made a mistake.; This is a spontaneous report from a contactable consume reported on behalf of (her fiancee). A 25-years-old male patient (medical student) received  the first dose of bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on  05Feb2021 as a Single Dose  for covid-19 immunisation.  The patient had no known medical history.  There were no concomitant medications. Reporter does not have his vaccine card with her therefore could not provide the Lot Number or Expiration Date. On 05Feb2021, the patient experienced they gave him 6 times the amount of the regular dosage. The patient received a call from (Specialty Pharmacy name) informing him  they gave him 6 times the normal dose. They said '1.8 and 0.3 was what he was supposed to get'. The patient was not given any details about how this occurred they just said the pharmacist made a mistake. The patient feels fine but customer service at (Specialty Pharmacy name) did not provide the patient with a lot of information. Consumer inquired Do they basically just monitor him? The reporter was unsure if (Specialty Pharmacy name) reported this incident to Pfizer.  The clinical outcome of the event accidental overdose and product administration error was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: PNC13
Symptoms: Cough, Wheezing
Clinical narrative: Coughed and wheezed for 5 years after Prevnar shot; Coughed and wheezed for 5 years after Prevnar shot; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient coughed and wheezed for 5 years after PREVNAR shot. Said stopped wheezing after heavy antibiotics, Ciprofloxacin and Cefazolin duplex. It was reported that event took place after use of product. The outcome of wheezing was recovered while another event was unknown.  Information regarding lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Feeling abnormal, Movement disorder
Clinical narrative: This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt faint; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single  dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient felt faint for less than a minute after receiving the shot, on an unspecified date. Final outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood creatinine, Blood creatinine increased, Red blood cell sedimentation rate, Red blood cell sedimentation rate abnormal
Clinical narrative: Markers for ESR and CR were more than double what they should be; Markers for ESR and CR were more than double what they should be; This is a spontaneous report from a contactable nurse reporting for herself. A 71-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9269), via an unspecified route of administration, on 02Feb2021, at single dose, for COVID-19 immunisation and methotrexate sodium (unknown manufacturer) (exp date 12Nov2021) tablet, via an unspecified route of administration, from 2014 and ongoing, at 7 DF weekly (it was 17.5 mg), for rheumatoid arthritis. Medical history included pain and ongoing rheumatoid arthritis. Concomitant medication included folic acid (unknown manufacturer). The patient experienced markers for ESR and CR were more than double what they should be (red blood cell sedimentation rate abnormal) in Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood creatinine: more than double in Feb2021, red blood cell sedimentation rate: abnormal in Feb2021. The action taken in response to the events for methotrexate sodium was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: C-reactive protein increased, Condition aggravated, Pain, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Markers for ESR and CR were more than double what they should be; Markers for ESR and CR were more than double what they should be; This is a spontaneous report from a contactable nurse reporting for herself. A 71-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9269), via an unspecified route of administration, on 02Feb2021, at single dose, for COVID-19 immunisation and methotrexate sodium (unknown manufacturer) (exp date 12Nov2021) tablet, via an unspecified route of administration, from 2014 and ongoing, at 7 DF weekly (it was 17.5 mg), for rheumatoid arthritis. Medical history included pain and ongoing rheumatoid arthritis. Concomitant medication included folic acid (unknown manufacturer). The patient experienced markers for ESR and CR were more than double what they should be (red blood cell sedimentation rate abnormal) in Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood creatinine: more than double in Feb2021, red blood cell sedimentation rate: abnormal in Feb2021. The action taken in response to the events for methotrexate sodium was unknown.