chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female received first single dose of BNT162B2, (Pfizer, Solution for injection, Lot number: EK 9231, exp date not reported), intramuscular (anatomical location: arm left) on 29Dec2020 09:15 for immunization. Medical history included asthma, hypothyroid, high cholesterol, and allergies: latex and shellfish. The patient was diagnosed with COVID-19 Prior to vaccination.Concomitant medication (Other medications in two weeks) include: magnesium sulfate, ibuprofen, cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), simvastatin, and cimicifuga racemosa root, glycine max extract (BLACK COHOSH & SOY ISOFLAVONES). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. The patient experienced low grade temp 99.6, chills, was tired, and headache on 29Dec2020 19:00. No treatment was received. Patient was not Covid tested post vaccination. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the right arm on 28Dec2020 07:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes and blood pressure (BP) abnormal. The patient was not pregnant. Concomitant medications included losartan potassium (LOSATAN), metformin, and amlodipine besilate (NORVAC), clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Dec2020 19:00, the patient was sitting and both of her legs became completely numb for 20 minutes and then the symptoms went away. This never happen before. No treatment was received for the adverse event. Outcome of the event was recovered on 29Dec2020 19:20. The event was considered non-serious.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Neck pain
Clinical narrative: Severe Headache; muscle pain (neck and left shoulder); muscle pain (neck and left shoulder); joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration in the left arm on 30Dec2020 12:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes, hypothyroidism, hypercholesterolemia, and obesity. Concomitant medication included metformin hydrochloride (GLUCOPHAGE), metformin, semaglutide (OZEMPIC), fluoxetine hydrochloride (PROZAC), levothyroxine sodium (SYNTHROID). The patient previously took varenicline tartrate (CHANTIX) and experienced nightmare and allergies to varenicline tartrate. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 13:30, the patient experienced severe headache, muscle pain (neck and left shoulder), and joint pain. No treatment was received for the adverse event. Outcome of the event was recovered on Dec2020. The events were considered non-serious.  The following information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: high heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), 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 experienced high heart rate on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: Fever,  arm pain,  diarrhea
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Oropharyngeal pain, Polymerase chain reaction, Pyrexia
Clinical narrative: vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional .  A 41-years-old female patient  received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital.  Medical history included seasonal allergy.  No known allergies to medication, food or other products. The patient's concomitant medications were not reported.  On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14.   Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional .  A 41-years-old female patient  received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital.  Medical history included seasonal allergy.  No known allergies to medication, food or other products. The patient's concomitant medications were not reported.  On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14.   Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site erythema
Clinical narrative: Hives to opposite arm; redness to injection site; Itching; This is a spontaneous report from a contactable pharmacist.  A 33-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiry date not reported), intramuscular in 30Dec2020 09:00 at a single dose in the left arm as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient had no COVID prior vaccination and patient was not tested for COVID post vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 09:15, the patient experienced hives to opposite arm and redness to injection site, and itching. Started within 20 minutes, patient taken to the emergency room/department or urgent care for evaluation and medications. As treatment, patient received diphenhydramine, famotidine, prednisone in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the events hives to opposite arm and redness to injection site, and itching was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Feeling abnormal, Nausea, Paranoia
Clinical narrative: Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as "yesterday", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as "yesterday"), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as "yesterday", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as "yesterday"), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Full blood count, Headache, Metabolic function test, Photophobia
Clinical narrative: Patient received the Moderna COVID19 vaccine on 12/28/2020 approximately 10:00 AM.  By approximately 1830 patient noticed she was beginning to have some peripheral vision disturbances.  Patient noted to have slight head ache at the time.  Two mornings, on Wednesday, patient reports being unable to see when entering a lighted room.  Vision limitations being able to see minimally and what was able to be seen was very blurry with dark circles when squinting.  This visual disturbance improved after 30 seconds to a few minutes of being in dim light.  This occurred on Wednesday with headache developing later in the day.  Ibuprofen helped headache.  Has continued to have daily headaches since injection.  Patient states headaches seem to be improving some as the week has gone on.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual field defect, Visual impairment
Clinical narrative: Patient received the Moderna COVID19 vaccine on 12/28/2020 approximately 10:00 AM.  By approximately 1830 patient noticed she was beginning to have some peripheral vision disturbances.  Patient noted to have slight head ache at the time.  Two mornings, on Wednesday, patient reports being unable to see when entering a lighted room.  Vision limitations being able to see minimally and what was able to be seen was very blurry with dark circles when squinting.  This visual disturbance improved after 30 seconds to a few minutes of being in dim light.  This occurred on Wednesday with headache developing later in the day.  Ibuprofen helped headache.  Has continued to have daily headaches since injection.  Patient states headaches seem to be improving some as the week has gone on.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ear pain, Headache, Insomnia, Muscle tightness
Clinical narrative: extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Rash
Clinical narrative: now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 46-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiry date not reported), via an unspecified route of administration on 30Dec020 16:45 at a single dose in the left arm as Covid vaccine. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at the time of the vaccination. The patient previously took iodine and experienced allergies. The patient was not in other vaccine in four weeks. The patient had no prior COVID vaccination and was not tested for COVID post vaccination.  The patient experienced metallic taste almost immediately (30Dec2020 16:45) and now 2 hours (18:45) later patient have a rash on the belly. No treatments received in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The events metallic taste and rash on the belly was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: mild rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in Dec2020 at a single dose for Covid-19 Vaccine. The patient's medical history and concomitant medications were not reported.  Patient just had her covid vaccine shot a week ago (Dec2020) and was experiencing mild rash. Patient was asking if she was contagious. The outcome of the event mild rash was unknown.    Lot/Batch and Expiration date has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: "About 2 hours after vaccine administration experienced severe fatigue. Went home and took 2 hour nap. Was still somewhat fatigued through the evening. Felt fine when waking up the next day."
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nasal congestion, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Arm soreness; stuffy nose/congestion; tired; knee pain; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on the left arm on 29Dec2020 12:30 at single dose for covid-19 immunisation. Medical history included tree fruit allergy. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient experienced arm soreness, stuffy nose/congestion, tired and knee pain on 29Dec2020 17:30. The patient did not receive treatment for the reported events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: pending on 29Dec2020. Outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in arm at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date not given), intramuscular on 29Dec2020 18:00 at a single dose in the left arm as Covid Vaccine. Medical history included hypothyroid, low adrenal cortex and allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medication included fluoxetine. The patient had no vaccine in four weeks. The patient previously took amoxycillin and experienced allergies. On 29Dec2020 (reported as at 5:30 AM and 5:00 AM; pending clarification), the patient experienced pain in arm at injection site. Since the vaccination, the patient has not been tested for COVID-19. The event reported was not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the event pain in arm at injection site was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Pyrexia
Clinical narrative: Within 1 hour, increasing dizziness and vertigo like symptoms, loss of appetite, followed by fatigue weakness and febrile episodes by 10pm that evening.  These persisted until 0300AM on the 19th.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Within 1 hour, increasing dizziness and vertigo like symptoms, loss of appetite, followed by fatigue weakness and febrile episodes by 10pm that evening.  These persisted until 0300AM on the 19th.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Autoimmune disorder, Chronic spontaneous urticaria, Swollen tongue, Urticaria
Clinical narrative: chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 28Dec2020 10:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole (PROTONIX), naproxen sodium (ALEVE), and birth control. 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 30Dec2020 16:00, the patient have a chronic auto immune response in the form of urticaria and angioedema. The symptoms of hives as well as swollen tongue was maintained with antihistamines. Outcome of the events was not recovered. The events were considered non-serious.  The following information on the batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events chronic autoimmune response in the form of urticaria and angioedema 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: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Palpitations, Panic attack
Clinical narrative: Patient started feeling week, dizzy, panicky, and like her heart was racing immediately after leaving the room after receiving the shot. She sat down and then I had her lie down on the floor.  She was given a bottle of water and then after about 1 min lying down on the floor she decided she felt ok to sit back up.  After a couple of minutes sitting (<5 min) she felt ok to stand back up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: bit achy and she can definitely tell where the injection was administered; This is a spontaneous report from contactable consumer. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration, at the left shoulder on 29Dec2020 around 3:00-4:00pm at single dose for immunisation .  Medical history included ongoing Sjogren'ssyndrome, Raynaud's disease, antiphospholipid antibody syndrome, two other conditions which the patient cannot remember, was on blood thinner, immunocompromised or on medication that compromises your immune system-all of which apply to her.  Concomitant medication included hydroxychloroquine (PLAQUENIL), warfarin, aspirin all from about 15-20 years ago as a blood thinner. On 29Dec2020, patient felt like the vaccine has affected her a bit as she was feeling a bit achy and she can definitely tell where the injection was administered because sometime last night she rolled over and thought well she won't be sleeping on that left arm after getting the vaccine injection in her left shoulder. She was not sure if her feeling a bit achy is just the day, or related to the vaccine. Patient did not read the product paperwork until last night when she got home after having been administered the vaccine. She was given an approximate date of her second scheduled dose around 19Jan2021; that is not necessarily the date she will get the second dose; that depends on the next clinic date at the county health department. No plan to change dose unless advised to. The patient has not yet recovered from the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vertigo
Clinical narrative: she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 29Dec2020 09:00 at a single dose in the left arm as COVID-19 vaccine. Medical history included blood pressure high (diagnosed a while ago at the time of the report), and she has been taking a medication for it for years. There were no concomitant medications. Patient said she had no new medications or other vaccinations administered with this vaccine. On 29Dec2020 22:00, he patient had a reaction where the room was spinning and she got very dizzy. She would like to know is that normal, since she has to go back for a second shot. She was given the vaccine by a nurse at the hospital she works as technician at which is not a military hospital. She said that the hospital is giving the vaccine to its employees. She got the vaccine yesterday morning around or after 09:00AM, and she was ok during the day. She said that the room spinning started before she went to bed at about 10:00PM, and when she got to her room she noticed everything was moving around. She said then she fell asleep, and it was better today, the room was not moving, she just felt very weak now (30Dec2020). Patient said as her treatment for room was spinning and she got very dizzy was that she fell asleep. The events room was spinning and she got very dizzy were recovering. The outcome of the event felt very weak was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Cough, Fatigue, Hypertension
Clinical narrative: Heart palpitations; Fatigue; Severe stomach cramping; High blood pressure; Cough; This is a spontaneous report from a contactable other HCP (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose (lot number: EK5730) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient said she had a list of reported side effects that she was having from the COVID Vaccine. The patient received COVID-19 vaccine on 23Dec2020 (not clarified), and since then she had been having symptoms. She had been to the doctor about it and she was currently going to treatment for it. But she had been experiencing heart palpitations, fatigue, severe stomach cramping, high blood pressure and cough. That was all she got. Outcome of all events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; Fatigue; Severe stomach cramping; High blood pressure; Cough; This is a spontaneous report from a contactable other HCP (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose (lot number: EK5730) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient said she had a list of reported side effects that she was having from the COVID Vaccine. The patient received COVID-19 vaccine on 23Dec2020 (not clarified), and since then she had been having symptoms. She had been to the doctor about it and she was currently going to treatment for it. But she had been experiencing heart palpitations, fatigue, severe stomach cramping, high blood pressure and cough. That was all she got. Outcome of all events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Moderate difficulty breathing for about 36 hours, relieved somewhat by Albuterol Inhaler.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Burning when the medication was injected; Injection was given under the shoulder bone instead of the deltoid muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration under the shoulder bone (arm), on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included use of multivitamin for a healthy lifestyle. The patient's concomitant medication included ongoing unspecified multivitamin. The patient received the COVID-19 vaccine this morning (30Dec2020) as she works in a COVID unit. The injector put it under her shoulder bone and not in the deltoid muscle; injection was given under the shoulder bone instead of the deltoid muscle. The patient complained of it burning - started when the medication was injected. The patient also asked if this was good enough and if it will it be effective. The patient was recovering from the event.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Having ringing in her ear today; This is a spontaneous report from a contactable consumer.  A female patient (Age: 67; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), 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 had ringing in her ear on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Gait disturbance, Headache
Clinical narrative: she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications.  It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oropharyngeal discomfort, Pyrexia, Somnolence
Clinical narrative: she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications.  It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications.  It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: pt reported a swallowing arm at the site of injection, recommended to use Benadryl
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Joint swelling, Oral viral infection, Pulmonary oedema, SARS-CoV-2 test positive
Clinical narrative: Covid 19 test: Nasal Swab Result: Positive; Covid 19 test: Nasal Swab Result: Positive; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; This is a spontaneous report from a contactable Other HCP (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 24Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included juvenile idiopathic arthritis (JRA). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included imipramine, nebivolol hydrochloride (BYSTOLIC), and topiramate (TOPAMAX). The patient received other vaccine within 4 weeks prior to the COVID vaccine which is J&J cv trial. The patient experienced severe joint swelling, oral viral sores, and left lung fluid exhaustion on 25Dec2020 06:00; it was reported that no treatment was given for these. The patient tested for COVID-19 post vaccination. The COVID-19 test post vaccination was a Nasal Swab (Abbott Binax) on 27Dec2020. The COVID-19 test result was positive. Outcome of the events severe joint swelling, oral viral sores, and left lung fluid exhaustion was recovering; for the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 test positive) with BNT162b2 can not be fully excluded. Based on the close temporal relationship, the association between the event left lung fluid exhaustion with BNT162b2 can not be fully 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: Covid 19 test: Nasal Swab Result: Positive; Covid 19 test: Nasal Swab Result: Positive; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; This is a spontaneous report from a contactable Other HCP (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 24Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included juvenile idiopathic arthritis (JRA). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included imipramine, nebivolol hydrochloride (BYSTOLIC), and topiramate (TOPAMAX). The patient received other vaccine within 4 weeks prior to the COVID vaccine which is J&J cv trial. The patient experienced severe joint swelling, oral viral sores, and left lung fluid exhaustion on 25Dec2020 06:00; it was reported that no treatment was given for these. The patient tested for COVID-19 post vaccination. The COVID-19 test post vaccination was a Nasal Swab (Abbott Binax) on 27Dec2020. The COVID-19 test result was positive. Outcome of the events severe joint swelling, oral viral sores, and left lung fluid exhaustion was recovering; for the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 test positive) with BNT162b2 can not be fully excluded. Based on the close temporal relationship, the association between the event left lung fluid exhaustion with BNT162b2 can not be fully 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: I had a high fever 102.2. I had nausea and diarrhea.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Dyspnoea
Clinical narrative: blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation.  Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination.  Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT).  The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "blood pressure went up to 150/101" with BNT162b2 can not fully 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.