chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: nausea; headache; palpitation; chills; Fatigued; took my temperature orally and ran a fever of 101.7; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; soreness/body aches; initially had injection site pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), intramuscularly on 05Jan2021 at 16:00 on Left arm at single dose for COVID-19 immunization in hospital. Medical history included Atopic Dermatitis and had Known allergies with Nickel, Cobalt, Dust Mites, Grass pollen. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) intramuscularly on 18Dec2020 at 12:30 PM on Left arm at single dose for COVID-19 immunization at age of 24-year-old. The patient initially had injection site pain and soreness on 05Jan2021. On 06Jan2021 she went to work and was fatigued with body aches, nausea, headache, palpitation and chills during her shift at 07:00 AM. She came home and took her temperature orally and ran a fever of 101.7 that evening on 06Jan2021. She took acetaminophen and managed to lower the fever. As of today 08Jan2021, current complaints were fatigue, body aches, and a headache. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event fever included acetaminophen. The outcome of the events fatigue, body aches and headache was not recovered; outcome of event Fever was recovered on 08Jan2021; outcome of the other events was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain, Palpitations, Pyrexia
Clinical narrative: nausea; headache; palpitation; chills; Fatigued; took my temperature orally and ran a fever of 101.7; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; soreness/body aches; initially had injection site pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), intramuscularly on 05Jan2021 at 16:00 on Left arm at single dose for COVID-19 immunization in hospital. Medical history included Atopic Dermatitis and had Known allergies with Nickel, Cobalt, Dust Mites, Grass pollen. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) intramuscularly on 18Dec2020 at 12:30 PM on Left arm at single dose for COVID-19 immunization at age of 24-year-old. The patient initially had injection site pain and soreness on 05Jan2021. On 06Jan2021 she went to work and was fatigued with body aches, nausea, headache, palpitation and chills during her shift at 07:00 AM. She came home and took her temperature orally and ran a fever of 101.7 that evening on 06Jan2021. She took acetaminophen and managed to lower the fever. As of today 08Jan2021, current complaints were fatigue, body aches, and a headache. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event fever included acetaminophen. The outcome of the events fatigue, body aches and headache was not recovered; outcome of event Fever was recovered on 08Jan2021; outcome of the other events was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: nausea; headache; palpitation; chills; Fatigued; took my temperature orally and ran a fever of 101.7; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; soreness/body aches; initially had injection site pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), intramuscularly on 05Jan2021 at 16:00 on Left arm at single dose for COVID-19 immunization in hospital. Medical history included Atopic Dermatitis and had Known allergies with Nickel, Cobalt, Dust Mites, Grass pollen. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) intramuscularly on 18Dec2020 at 12:30 PM on Left arm at single dose for COVID-19 immunization at age of 24-year-old. The patient initially had injection site pain and soreness on 05Jan2021. On 06Jan2021 she went to work and was fatigued with body aches, nausea, headache, palpitation and chills during her shift at 07:00 AM. She came home and took her temperature orally and ran a fever of 101.7 that evening on 06Jan2021. She took acetaminophen and managed to lower the fever. As of today 08Jan2021, current complaints were fatigue, body aches, and a headache. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event fever included acetaminophen. The outcome of the events fatigue, body aches and headache was not recovered; outcome of event Fever was recovered on 08Jan2021; outcome of the other events was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling on injection site; Redness and swelling on injection site; This is a spontaneous report from a non-contactable nurse (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medication included colecalciferol (VITAMIN D) and Estro-Aid. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), intramuscular in the right arm on 17Dec2020 at the age of 46-year-old for COVID-19 immunization and experienced mild cough. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 07Jan2021 20:00, the patient experienced redness and swelling on injection site. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old 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 and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; This is a spontaneous report from a contactable Other Health Professional(patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 06Jan2021 18:00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 07Jan2021 04:00 PM, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever. The patient did not receive any treatment. Outcome of events was recovering.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; This is a spontaneous report from a contactable Other Health Professional(patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 06Jan2021 18:00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 07Jan2021 04:00 PM, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever. The patient did not receive any treatment. Outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: I have latent TB and am diagnosed with herpes 1 and 2; I have latent TB and am diagnosed with herpes 1 and 2; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Patient had the first dose of the vaccine on 11Jan2021 and she/he had pre-existing conditions. A long time ago, she/he had 2 tachycardia episodes and was sensitive to epinephrine. Patient had latent TB and was diagnosed with herpes 1 and 2 in Jan2021. Outcome of events were unknown.  Information about lot/batch number has been requested.; Sender's Comments: The association between the events "latent PTB and Herpes 1 and 2" with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Lethargy
Clinical narrative: Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 07Jan2021 08:00, at single dose, for COVID-19 immunization, in the hospital. Medical history included Meniere's disease and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient had no other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 17Dec2020, for COVID-19 immunization. The patient experienced flu-like symptoms, lethargy, athralgias and fatigue on 08Jan2021 at 21:45. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Neck pain
Clinical narrative: significant muscle aches; chills; joint pain; Neck pain with headache that night; Neck pain with headache that night; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID 19 vaccine; unknown lot number and expiration date), intramuscular right arm on 06Jan2021 14:00 [02:00 PM] at a single dose for covid-19 vaccination. Medical history included breast cancer and had covid-19 prior vaccination. The patient has no known allergies. Concomitant medication included tamoxifen (TAMOXIFEN). The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her most recent COVID-19 vaccine in a hospital. The patient experienced neck pain with headache that night (06Jan2021 22:00 [10:00 PM]) then next day (07Jan2020), significant muscle aches and chills with joint pain for another day and a half. The events were considered as non-serious. It was unknown if treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; Information about Lot/Batch could not be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever (T-Max was 100.9); body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 at 10:30 (at the age of 37-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not receive any other mediations within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (temperature maximum (T-Max) was 100.9), body aches, and fatigue on 18Dec2020 at 13:30. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: T-Max of 100.9 on 18Dec2020 and nasal swab: negative on 04Jan2021. The patient did not receive any treatment for the events. The clinical outcome of fever (T-Max was 100.9), body aches, and fatigue was recovered on 19Dec2020 at 22:30.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Mild cough after 1 week of vaccine; This is a spontaneous report from a non-contactable nurse. A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscular (anatomical location: arm right) from 17Dec2020 07:45 to 17Dec2020 07:45, single dose for covid-19 immunisation.  Medical history was reported as none. Concomitant medication included ergocalciferol (VIT D). On 23Dec2020 at 08:00, The patient experienced mild cough after 1 week of vaccine. The patient did not received any treatment for the event. Outcome of the event was recovering.    No follow up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection sight; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 40113/ej1686), via an unspecified route of administration (anatomical location: left arm) from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE for an COVID-19 immunisation.  Medical history included diabetes, asthma and overweight. The patient's concomitant medications were not reported. On 04Jan2021, the patient experienced soreness at injection sight. Outcome of the event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Rhinalgia, Vaccination site pain
Clinical narrative: Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; This is a spontaneous report from a contactable other health care professional. A 45-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose (lot number: EH9899); via an unspecified route of administration on 17Dec2020 14:00 at single dose at arm left; second dose (lot number: EK9231) via an unspecified route of administration on 08Jan2021 00:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic back pain, Allergies to medications, food, or other products: Avocado. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), celecoxib (CELEBREX), pregabalin (LYRICA), triamcinolone acetonide (NASACORT), omeprazole. On 08Jan2021 09:00, the patient experienced Headache, pain at injection site, nasal congestion, nasal pain. The events were assessed as non-serious. There was no treatment received for the events. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pharyngeal swelling, Tongue pruritus
Clinical narrative: Glands in throat swelling after eating, possibly of new food that she ate. However with the throat swelling she also had tongue itchiness; Glands in throat swelling after eating, possibly of new food that she ate. However with the throat swelling she also had tongue itchiness; headache; This is a spontaneous report from a contactable nurse. A 25-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (anatomical location: arm left) from 08Jan2021 12:30 to 08Jan2021 12:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included OCD, anxiety, depression and Known Allergies: Mushrooms. Concomitant medication included fluvoxamine maleate (LUVOX), trazodone, clonidine, diphenhydramine hydrochloride (BENADRYL) and melatonin. The patient previously took cogentin and experienced known allergies. The patient had first vaccination with bnt162b2 from 21Dec2020 to 21Dec2020 for covid-19 immunisation. On 08Jan2021 at 16:00, the patient stated that she had glands in throat swelling after eating, possibly of new food that she ate. however with the throat swelling she also had tongue itchiness and the patient had headache. Therapeutic measures were taken as a result of tongue pruritus and pharyngeal swelling included Benadryl. The patient did not received any treatment for the event headache. Outcome of the events tongue pruritus and pharyngeal swelling was recovered on an unspecified date in Jan2021 while outcome of the event headache was unknown.   Information Requested on Lot/ Batch number.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever; Cough; Ear pain; This is a spontaneous report from a contactable consumer (medical assistant and patient herself). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration 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 received BNT162B2 vaccine last Monday (04Jan2021). However, the patient started having symptoms of chills, fever, cough, and ear pain today (08Jan2021). The patient already did the rapid test twice, but tested negative on both tests. The patient wanted to know if it is normal to experience these symptoms even if it has been 5 days already since she received the vaccine. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: chills; extremely painful injection site and was unable to lift affected arm over head easily; extremely painful injection site and was unable to lift affected arm over head easily.; This is a spontaneous report from a contactable nurse. A 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (anatomical location: arm left) from 07Jan2021 18:00 to 07Jan2021 18:00 at SINGLE DOSE for an unspecified indication. Medical history included known allergies: PCN. There were no concomitant medications. On 08Jan2021 at 12:00, The patient experienced extremely painful injection site and was unable to lift affected arm over head easily and then chills. The patient did not received any treatment for the events. Outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; This is a spontaneous report from a contactable nurse. A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (anatomical location: arm right) from 07Jan2021 14:00 to 07Jan2021 14:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, pancreatitis, If-covid-prior-vaccination: Yes and allergies sulfa meds. Concomitant medication included paracetamol (TYLENOL) and metoprolol. The patient previously took codeine for allergies. The patient had first vaccine of BNT162B2 from 18Dec2020 to 18Dec2020 for COVID-19 immunization. On 08Jan2021 at 16:30, the patient had painful, very enlarged lymph nodes in right axilla, collarbone area, right side of neck and right breast. extremely painful and swollen. Started approx 26 hours after injection - came on suddenly. Outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Tachyphrenia
Clinical narrative: Insomnia; Racing thoughts; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included chronic migraines, high blood pressure, and known allergies to tree nuts. The patient's concomitant medications were not reported. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021 at 16:00, the patient experienced insomnia and racing thoughts, which were assessed as non-serious. The patient did not receive any treatment for the adverse events (AE). The patient recovered from both the events on an unspecified date in Jan2021.  Information on the batch/lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Headache; fever; chills; shaking; underarm swelling; arm pain; muscles pain; fatigue; lighheadness; This is a spontaneous report from a non-contactable Other Health Professional (patient).  A 25-year-old female patient (not pregnant at the time of vaccineation) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration at left arm on 07Jan2021 12:00 at single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 08Jan2021 01:00, the patient experienced headache, fever, "chills/shaking", underarm swelling, arm pain, muscles pain, fatigue, and "lighheadness". The above mentioned events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering. The reporter considered the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Swelling, Tremor
Clinical narrative: Headache; fever; chills; shaking; underarm swelling; arm pain; muscles pain; fatigue; lighheadness; This is a spontaneous report from a non-contactable Other Health Professional (patient).  A 25-year-old female patient (not pregnant at the time of vaccineation) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration at left arm on 07Jan2021 12:00 at single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 08Jan2021 01:00, the patient experienced headache, fever, "chills/shaking", underarm swelling, arm pain, muscles pain, fatigue, and "lighheadness". The above mentioned events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering. The reporter considered the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash macular, Tachycardia
Clinical narrative: Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek9231, expiration date was unknown), intramuscularly on the left arm on 08Jan2021 (at 11:00 PM as reported; pending clarification) at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included that the patient had known allergies to medications, food, or other products, but was not specified. Concomitant medications included ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), curcuma longa (TURMERIC) as supplement, and an unspecified multivitamin. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021 (at 11:15 AM as reported; pending clarification), the patient experienced lightheaded, tachycardia, and blotchy rash, which resulted in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of lightheaded, tachycardia, and blotchy rash, which included diphenhydramine (BENADRYL) and steroid. The patient was recovering from all the events.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Breath sounds abnormal, Dizziness, Dyspnoea, Headache
Clinical narrative: difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Stridor
Clinical narrative: difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Eye swelling, Headache, Lip swelling
Clinical narrative: difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Paraesthesia, Pharyngeal swelling, Stridor, Swelling face
Clinical narrative: difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swelling face, Swollen tongue
Clinical narrative: difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over trunk of my body; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the left arm on 16Dec2020 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 and had not been tested for COVID-19 since the vaccination. On 08Jan2021, the patient experienced rash over trunk of her body. Therapeutic measures were taken as a result of rash over trunk of her body and included treatment with diphenhydramine (BENADRYL). Outcome of the event was recovering. The event was considered non-serious by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported a side effect on the COVID-19 vaccine. On an unspecified date, she experienced shortness of breath within 24 hours and asked if it was an expected side effect or if she should consult her healthcare provider (HCP). The patient considered the event as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Nausea
Clinical narrative: not feeling well; headache; nausea; joint pain; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not a healthcare professional (HCP), but she works in a healthcare facility. She had received the COVID-19 vaccine on 07Jan2021 and she was not feeling well on an unspecified date. The patient was also asking what could she take for the headache, nausea, and joint pain on an unspecified date. She also asked if her regular doctor would answer her concerns considering she had been given the vaccine at the hospital. The outcome of the events "not feeling well, headache, nausea, and joint pain" was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lymphadenopathy, Pruritus, Pyrexia
Clinical narrative: flu like symptoms; right arm pit (hard and itching) swollen; right arm pit (hard and itching) swollen; fever; swollen lymph; chills; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age (reported as 45, unit unknown) received the first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had question about getting 2nd vaccination/dose. At end of Oct2020/beginning of Nov2020, she was positive for COVID. After a month and 1/2 after COVID19, she got the vaccine. After first vaccination, 18 hours later patient had the flu like symptoms and right arm pit (hard and itching) swollen. She had fever, swollen lymph nodes at 10 or 11 O'clock. Patient had chills, fever, flu like symptoms. 18 days after, the lump was there. Outcome of the events was unknown. Patient was asking if it was okay to get the 2nd shot.  Information of lot/batch number has been requested.