chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Caller is a nurse calling to report a temperature excursion involving PROQUAD and VARlCELLA.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 11-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided, lot number T021302 which has been verified to be valid, expiration date reported and validate as 19-DEC-2021), on an unknown date, the patient received varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). Both vaccines experienced a temperature excursion on 2 separate dates of -5 degrees Celsius (C) for 10 hours, and with a time frame of 20 hours, as recorded by a data logger. There was no additional previous temperature excursion reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Approximately 12 hours after the injection - started feeling that the L side of her face was numb and tingling.  Also started with nausea (no vomiting); headache (located in the back of her head) and fever (102.2).  She noted head felt very heavy and she had difficulty walking by herself (son was at her home to assist).  Facial numb ness resolved in ~3 hours.  She tried taking 800 mg ibuprofen but didn't have any relief so took Tylenol (this was  still on 12/24) and then took another dose of each at around 5:00am 12/25.  Fever was still coming/going (responded to the medicine but towards the end of that timeframe her temperature went up again).   Last fever was on 12/26 - no fever since (reporting this on 12/28).  Headache resolved on 12/27/2020.  She also noted that her injection site had small vessicles and was red/tender to touch - as of 12/28 vessicles have resolved and injection area appears back to normal.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site vesicles, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Approximately 12 hours after the injection - started feeling that the L side of her face was numb and tingling.  Also started with nausea (no vomiting); headache (located in the back of her head) and fever (102.2).  She noted head felt very heavy and she had difficulty walking by herself (son was at her home to assist).  Facial numb ness resolved in ~3 hours.  She tried taking 800 mg ibuprofen but didn't have any relief so took Tylenol (this was  still on 12/24) and then took another dose of each at around 5:00am 12/25.  Fever was still coming/going (responded to the medicine but towards the end of that timeframe her temperature went up again).   Last fever was on 12/26 - no fever since (reporting this on 12/28).  Headache resolved on 12/27/2020.  She also noted that her injection site had small vessicles and was red/tender to touch - as of 12/28 vessicles have resolved and injection area appears back to normal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: lightheaded, nauseous, feeling faint. Manual BP was taken as automatic BP was unable to be obtained; manual BP was 80/52 mmHg. Water provided, cold pack applied to  posterior neck. Patient recovered after 13 minutes and was walked out of building by RN.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, body aches, and fever
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Muscle spasms
Clinical narrative: Very painful injection site; overall fatigue; muscle cramps in my legs; This is a spontaneous report from a contactable healthcare professional.  A 50-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EH9899), intramuscular into the left arm on 16Dec2020 at 18:30 as single dose for COVID-19 immunization. Medical history included chronic bronchitis, asthma and hypertension from an unknown date.  Concomitant medication included losartan (MANUFACTURER UNKNOWN).  No allergies to medications, food, or other products were reported. The patient experienced very painful injection site, overall fatigue and " muscle cramps in my legs " on 17Dec2020, at 12:00. The events were not serious, and no treatment was required.  The outcome of very painful injection site, overall fatigue and " muscle cramps in my legs " was recovering.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Night sweats
Clinical narrative: Muscle aches,Migraine, night sweat; Muscle aches,Migraine, night sweat; Muscle aches,Migraine, night sweat; This is a spontaneous report from a contactable healthcare professional.  A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 16Dec2020 at 13:00 as single dose for COVID-19 immunization.  Medical history included fibromyalgia, degenerative bone disease from an unknown date.  The patient's concomitant medications were not reported.  No diagnosis of  COVID-19 was noted prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. The patient experienced muscle aches, migraine, night sweat on 16Dec2020, at  12:30, which was non-serious.  The outcome of muscle aches, migraine, night sweat  was recovered in Dec2020.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fatigue, Pain
Clinical narrative: The day after I am feeling very tired, achy and weak with a temp of 100.1.; The day after I am feeling very tired, achy and weak with a temp of 100.1.; The day after I am feeling very tired, achy and weak with a temp of 100.1.; The day after I am feeling very tired, achy and weak with a temp of 100.1.; This is a spontaneous report from a contactable healthcare professional.  A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 17Dec2020 at 14:00 as single dose for covid-19 immunization.  Medical history included hypertension and being pre-diabetic from an unknown date and unknown if ongoing. No known food or drug allergies noted.  Concomitant medication included metformin (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC), metoprolol succinate (TOPROL).  The patient reported " the day after I am feeling very tired, achy and weak with a temp of 100.1" on 18Dec2020. No other vaccines within 4 weeks prior to the COVID vaccine were administered.  No treatment received for the adverse events. No diagnosed of COVID-19 was noted before or after vaccination. Vaccine Facility information available. The outcome of " the day after I am feeling very tired, achy and weak with a temp of 100.1" was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Pain, Respiratory tract congestion
Clinical narrative: Sneezing, intermittent cough, congestion, body aches, fatigue, loss of appetite.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Sneezing, intermittent cough, congestion, body aches, fatigue, loss of appetite.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache, body aches (specifically to back), fatigue; Headache, body aches (specifically to back), fatigue; Headache, body aches (specifically to back), fatigue; This is a spontaneous report from non-contactable consumer, the patient.  A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 20:00 (at the age of 26-years-old) in the right arm as a single dose for COVID-19 immunization.   The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included omeprazole (PRILOSEC) and fexofenadine hcl (ALLEGRA); both for unknown indications from unknown dates and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously took azithromycin (ZITHROMAX) from an unknown date to an unknown date for an unknown indication and experienced drug allergy.  On 18Dec2020 at 04:00, the patient experienced headache, body aches (specifically to back), and fatigue; all reported as non-serious. The patient did not receive any treatment for the events. The clinical outcomes of headache, body aches (specifically to back), and fatigue were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Woke up with hive-like bumps that itch; This is a spontaneous report from a non-contactable healthcare professional. A 32-year-old female patient received bnt162b2 (BNT162B2; lot number: EK5730; expiration date: unknown), intramuscular left arm on 17Dec2020 17:00 at single dose for immunization. Medical history included hives a few weeks ago. She is not pregnant. The patient's concomitant medications were not reported. The patient stated that she woke up on 18Dec2020 07:00 AM with hive-like bumps that itch. There was no treatment given. The patient added that it maybe unrelated as she had hives, a few weeks ago. The vaccine was given in a hospital. The patient did not have other vaccine in the last 4 weeks. The patient was not diagnosed with COVID-19 prior to the vaccination and was not COVID tested post vaccination. The outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Injection site pain
Clinical narrative: Approximately 2 hours post injection, I began to feel fatigued and achy. At 3 hours post injection, I had a headache, muscle & joint aches.  I also had slight nausea & a moderately severe stomach ache.  These symptoms began to subside approximately 10 hours post injection with the stomach ache taking an additional 2 hours to resolve (12 hours total).   The injection site was painful the day following the vaccine and did not resolve until 2 days post administration.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Approximately 2 hours post injection, I began to feel fatigued and achy. At 3 hours post injection, I had a headache, muscle & joint aches.  I also had slight nausea & a moderately severe stomach ache.  These symptoms began to subside approximately 10 hours post injection with the stomach ache taking an additional 2 hours to resolve (12 hours total).   The injection site was painful the day following the vaccine and did not resolve until 2 days post administration.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, sore arm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Employee has history of anaphylaxis and was in the 30 min observation. C/O dizziness. Sits on gurney at 45 degree angles. No sob, chest pain or hives. VS obtained and employee hypertensive. Under observation of RN. Able to sip on water, but continues to have HTN and dizziness. Taken to the ED for further evaluation of symptoms.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site x 36 hrs.; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK5730), via an unspecified route of administration on 16Dec2020 18:00 at single dose (right arm) for Covid-19 immunisation. Medical history included seasonal allergies, depression, elevated cholesterol and pollen and dust allergies only. The patient had no allergies to medications and food. Concomitant medications included fluoxetine, loratadine, Montelukast sodium (SINGULAIR), fluticasone and mul (as reported). On 16Dec2020 19:00, the patient experienced pain at injection site x 36 hrs. The patient was vaccinated at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Reports dizziness started evening of 12/24/20 and ongoing. Reports dizziness is much better today and feels it has almost resolved. Is following up with PCP today, 12/28/20 . no other symptoms reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt verbalized he felt dizzy. Pt was sitting down at this time. The patient verbalized that the dizziness resolved after a duration of 30 seconds. No epinephrine or diphenhydramine was required for recovery. Pt denied distress or SOA.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tachycardia
Clinical narrative: Pt had Covid vaccine. 5 minutes after vaccine complained of tachycardia. HR initially to palpation was in the 220s. Pt assisted supine. Code Blue called per protocal. Dr. to room. Pts BPs were 160/80, 144/90, 140/84, and 138/80. HR 140, 134, and 123 bpm. O2 sat the whole time was 100% on RA. Pt c/o nausea and dizziness. Assisted to stretcher and brought to ER for evaluation. Pt state she had a previous history of Covid and anxiety but this experience felt different to her then her previous panic attacks. No rash, wheezing, oral swelling, pruitis.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hot flush
Clinical narrative: Flushing and hot flashes that have persisted 2 hours after vaccine.; Flushing and hot flashes that have persisted 2 hours after vaccine.; Notable feeling of dizziness; This is a spontaneous report from a contactable consumer (patient) and physician.  A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch # EH9899), via an unspecified route of administration on the left arm on 18Dec2020 11:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history reported as none. The patient had no allergies to medications, food, or other products. There were no concomitant medications. Prior to vaccination, the patient not diagnosed with COVID-19 and the patient has not been tested for COVID-19 since the vaccination. On 18Dec2020 11:30, the patient experienced flushing and hot flashes that have persisted 2 hours after vaccine.  The patient also had notable feeling of dizziness. No treatment was received for the adverse events. Outcome of the events were not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Migraine, Pain, Pyrexia
Clinical narrative: Reporting on behalf of staff member. She received covid vaccine on 12/24. The following day, she experienced extreme weakness/fatigue, migraine, low grade fever, body aches, and tachycardia. She went to the ER, they gave her IV fluids, pain meds and tylenol with no relief. She was monitored for awhile and then sent home to rest and recover. 3 days later (12/27) she says she feels significantly better, but still a little tired.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Reporting on behalf of staff member. She received covid vaccine on 12/24. The following day, she experienced extreme weakness/fatigue, migraine, low grade fever, body aches, and tachycardia. She went to the ER, they gave her IV fluids, pain meds and tylenol with no relief. She was monitored for awhile and then sent home to rest and recover. 3 days later (12/27) she says she feels significantly better, but still a little tired.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Exposure to SARS-CoV-2, Injection site pain, No adverse event
Clinical narrative: No adverse events reported as of yet after patient was vaccinated in right deltoid except a sore arm; pregnant patient was vaccinated yesterday with the COVID-19 vaccine; pregnant patient was vaccinated yesterday with the COVID-19 vaccine; pregnant patient was vaccinated yesterday with the COVID-19 vaccine; This is a spontaneous report from a contactable physician via Medical information team. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, in right deltoid via an unspecified route of administration on 17Dec2020 10:30 at single dose for routine vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. It was reported that patient pregnant was vaccinated yesterday with the COVID-19 vaccine. She received vaccine while pregnant on 17Dec2020 which was non serious per report. The patient was an MD and her age was 35 years old. She was vaccinated yesterday with COVID 19 vaccine and she was pregnant. She was able to speak to Pfizer Drug Safety. The patient was a frontline Healthcare provider and there was no prescriber for the vaccine. She thinks there should be a pregnancy registry so she wanted to get on it so Pfizer can use her data. Her next dose will be on 07Jan2021. The reason she got it was because she was high risk and a front line healthcare worker. The patient was 21 weeks pregnant. She assumed this was going to be a normal pregnancy and normal delivery. The patient had the vaccination in the hospital. No additional vaccines administered on same date.  No adverse events reported as of yet after patient was vaccinated in right deltoid except a sore arm. Onset time of arm being sore was 5pm (17:00) yesterday, 17Dec2020. This did not require a visit to the ER or physician's office. No prior vaccinations within 4 weeks. No AE for prior vaccinations and no medical history or family medical history relevant and no relevant test. The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysgeusia, Fatigue, Headache, Nausea
Clinical narrative: headaches,  back pain, fatigue, nausea, foul taste in mouth
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: headaches,  back pain, fatigue, nausea, foul taste in mouth
Age: 62.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Mobility decreased
Clinical narrative: not able to lift arm
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Syringe issue, Underdose
Clinical narrative: after the administration of the first dose of the Covid Vaccine presented a leakage of about 2-3ml; the patient was administered Subcutaneously instead of Intramuscularly/maybe the product had been injected Subcutaneous rather than Intramuscular; This is a spontaneous report from a contactable physician.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneous at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient after the administration of the first dose of the Covid vaccine presented a leakage of about 2-3ml, the patient was administered subcutaneously instead of intramuscularly/maybe the product had been injected subcutaneous rather than intramuscular.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dizziness, Headache, Lip swelling
Clinical narrative: I'm not sure this is entirely vaccine related, but I wanted you to be aware. I occasionally experience unexplained swelling of my lips. It has been investigated by an allergist, but the cause is unknown -- doesn't appear to be a food allergy (no trigger foods identified, and it has never appeared immediately after eating), and may not even be histamine related.     It could be something immune-system related, and my experience this weekend might support that.     I had normal, expected symptoms on Friday evening (chills, headache). Those resolved Saturday. Saturday night, my lower lip swelled dramatically. Swelling spread into the upper lip as well. I have seen this before, but this was one of the more severe instances I have experienced.     Lips remained swollen overnight. When I woke up Sunday morning and went to the restroom, I became suddenly lightheaded and passed out. That's a symptom I have never experienced before. I consulted with my primary care doctor and took it very easy the rest of Sunday. He and I will follow up to further asses what happened. No further light-headedness on Sunday or today. Lips eventually resolved late in the afternoon.     This is all about 72 hours after the vaccine, so I can't be sure it is related, but I do wonder if it is related to having my immune system revved up by the vaccine. I reported it on the CDC check-in app and my primary care physician is noting it on his side as well.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: I'm not sure this is entirely vaccine related, but I wanted you to be aware. I occasionally experience unexplained swelling of my lips. It has been investigated by an allergist, but the cause is unknown -- doesn't appear to be a food allergy (no trigger foods identified, and it has never appeared immediately after eating), and may not even be histamine related.     It could be something immune-system related, and my experience this weekend might support that.     I had normal, expected symptoms on Friday evening (chills, headache). Those resolved Saturday. Saturday night, my lower lip swelled dramatically. Swelling spread into the upper lip as well. I have seen this before, but this was one of the more severe instances I have experienced.     Lips remained swollen overnight. When I woke up Sunday morning and went to the restroom, I became suddenly lightheaded and passed out. That's a symptom I have never experienced before. I consulted with my primary care doctor and took it very easy the rest of Sunday. He and I will follow up to further asses what happened. No further light-headedness on Sunday or today. Lips eventually resolved late in the afternoon.     This is all about 72 hours after the vaccine, so I can't be sure it is related, but I do wonder if it is related to having my immune system revved up by the vaccine. I reported it on the CDC check-in app and my primary care physician is noting it on his side as well.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral coldness, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever of 38.6; cold fingers all day; very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm; very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm; very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the right arm on 16Dec2020 at 18:15 at 48-years-old at a single dose for COVID-19 immunization; administered in a hospital.  Medical history included Vertigo, chronic pruritus from Apr2020 to Jul2020 (Vertigo, chronic pruritus (treated and recovered with gabapentin).  Concomitant medications included ergocalciferol (VIT D), krill oil (MANUFACTURER UNKNOWN), niacin (MANUFACTURER UNKNOWN), guaifenesin (MUCINEX), loratadine (CLARITIN); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination).  The patient previously took ketoconazole and experienced Known allergies, gabapentin for pruritus and vertigo; all from an unspecified date to an unspecified date. On 16Dec2020, the patient experienced: very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm. On 17Dec2020, the patient experienced: cold fingers all day (non-serious). On 17Dec2020 at 17:50, the patient experienced: fever of 38.6 (non-serious). Prior to the vaccination, the patient was diagnosed with COVID-19; and since the vaccination, the patient had been tested for COVID. The patient underwent lab tests and procedures which included body temperature: 38.6 on 17Dec2020, Oral Throat Swab PCR (polymerase chain reaction): positive on 22Nov2020, Oral Throat Swab PCR: negative on 10Dec2020.  Therapeutic measures were taken as a result of cold fingers all day, fever of 38.6, very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm. The clinical outcome of the events: cold fingers all day, fever of 38.6, was recovered on an unspecified date. The clinical outcome of the event, very sore deltoid area from the night of 12/16 thru 12/17 was recovered on 17Dec2020. The clinical outcome of the event, cant raise my right arm, was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA;  Generalized Itchy rash with hives all over body not relieved by benadryl, zyrtec, claritin and pepcid.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Head discomfort, Headache, Magnetic resonance imaging
Clinical narrative: feels sluggish; had a little bit of fever yesterday; Warm feeling shooting in head; developed a warm feeling in his head that turned into a headache; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9899), via an unspecified route of administration (arm left) on 16Dec2020 at single dose for precaution for front line worker. The patient's medical history included blood pressure abnormal, blood cholesterol abnormal, diabetes, enlarged prostate, sleep disorder, on anticoagulant therapy, and migraine. Concomitant medications included lisinopril, simvastatin, metformin hcl, tamsulosin, dutasteride, zolpidem, aspirin [acetylsalicylic acid], and melatonin. It was reported that the patient experienced warm feeling shooting in head on 16Dec2020. It was further reported that the patient developed a warm feeling in his head that turned into a headache on 16Dec2020. The patient also experienced slight fever on 1Dec2020. The patient received the vaccine on Wednesday afternoon (16Dec2020). The patient stated, "initially it felt weird; for a couple of minutes, it felt ok and then he felt a warm feeling shooting in his head, like when you take strong medications or do MRI. It gives you that strong feeling. It was cold or warm but shoots in head. He felt it, so he went to occupational health and it went away. He went home early and did not finish his shift. Then he got a headache and it did not go away and it is not severe. He feels sluggish and had a little bit of fever yesterday and took Tylenol and it went away. He still had a headache and it bothers him. He cannot remember the name of the medication that he got the warm feeling shooting in his head, but he believed it was when they did a dye for an MRI. He does not have the name and did not have a lot or expiration. He works at a hospital but not as a healthcare provider. He got the vaccine a few day ago and later stated it was Wednesday, 16Dec2020 warm feeling started an hour after getting the vaccine. As soon as he went to occupational health, it went away and improved. He did not have the headache yet. He did not work his full shift. He got home at night and felt not too bad of a headache. He has a history of migraines and he can feel somehow, he is starting to have a headache. It is not severe though. The headache started that night and it is still there. It is not so severe, but it bothers him. When he had a slight fever, it is gone after taking Tylenol. He never actually checked his temperature, he just felt warm. He takes medications every day, so he took medications the night before and did not take other medications since then. He wanted to find out if there was any interaction with the vaccine before taking them again. The outcome of event fever was recovering, events warm feeling shooting in head and headache was not recovered, and the event feels sluggish was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: feels sluggish; had a little bit of fever yesterday; Warm feeling shooting in head; developed a warm feeling in his head that turned into a headache; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9899), via an unspecified route of administration (arm left) on 16Dec2020 at single dose for precaution for front line worker. The patient's medical history included blood pressure abnormal, blood cholesterol abnormal, diabetes, enlarged prostate, sleep disorder, on anticoagulant therapy, and migraine. Concomitant medications included lisinopril, simvastatin, metformin hcl, tamsulosin, dutasteride, zolpidem, aspirin [acetylsalicylic acid], and melatonin. It was reported that the patient experienced warm feeling shooting in head on 16Dec2020. It was further reported that the patient developed a warm feeling in his head that turned into a headache on 16Dec2020. The patient also experienced slight fever on 1Dec2020. The patient received the vaccine on Wednesday afternoon (16Dec2020). The patient stated, "initially it felt weird; for a couple of minutes, it felt ok and then he felt a warm feeling shooting in his head, like when you take strong medications or do MRI. It gives you that strong feeling. It was cold or warm but shoots in head. He felt it, so he went to occupational health and it went away. He went home early and did not finish his shift. Then he got a headache and it did not go away and it is not severe. He feels sluggish and had a little bit of fever yesterday and took Tylenol and it went away. He still had a headache and it bothers him. He cannot remember the name of the medication that he got the warm feeling shooting in his head, but he believed it was when they did a dye for an MRI. He does not have the name and did not have a lot or expiration. He works at a hospital but not as a healthcare provider. He got the vaccine a few day ago and later stated it was Wednesday, 16Dec2020 warm feeling started an hour after getting the vaccine. As soon as he went to occupational health, it went away and improved. He did not have the headache yet. He did not work his full shift. He got home at night and felt not too bad of a headache. He has a history of migraines and he can feel somehow, he is starting to have a headache. It is not severe though. The headache started that night and it is still there. It is not so severe, but it bothers him. When he had a slight fever, it is gone after taking Tylenol. He never actually checked his temperature, he just felt warm. He takes medications every day, so he took medications the night before and did not take other medications since then. He wanted to find out if there was any interaction with the vaccine before taking them again. The outcome of event fever was recovering, events warm feeling shooting in head and headache was not recovered, and the event feels sluggish was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Wheezing
Clinical narrative: patient received the vaccination and within a few minutes she developed sore throat, wheezing; patient received the vaccination and within a few minutes she developed sore throat, wheezing; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at 08:30 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 18Dec2020 at 08:30, the patient experienced sore throat and wheezing; within a few minutes she developed sore throat, wheezing. Facility where the COVID-19 vaccine was administered was workplace clinic. The adverse events resulted in Emergency room/department visit or urgent care. The patient received "RT" treatments. It was unknown if prior to vaccination the patient was diagnosed with COVID-19 and it was unknown if she was tested for COVID-19 since the vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysarthria, Glossodynia, Oral discomfort, SARS-CoV-2 test negative
Clinical narrative: a "funny" feeling in my mouth/A sore sensation; a "funny" feeling in my mouth/A sore sensation; It felt as if it had been burned; slurred speech; loss of taste; This is a spontaneous report from a contactable consumer.  A 32-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Dec2020 09:30 for immunization, administered at hospital.  Medical history included asthma, allergies: aluminum, pet dander, trees/weeds/grass, seasonal allergy. She had not Covid prior vaccination. Concomitant medication included montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D [COLECALCIFEROL]), received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  On 17Dec2020 14:30, the patient experienced a funny feeling in my mouth/a sore sensation, it felt as if it had been burned, slurred speech, loss of taste. Course of events: Within 5 hours of injection she started noticing a "funny" feeling in her mouth. A sore sensation. By 19:30 her tongue was very sore. It felt as if it had been burned. she had nothing hot to eat that day and nothing new to eat. The soreness increased. She also had some slurred speech and loss of taste. The patient underwent lab tests: Sars-cov-2 test (Rapid nasopharyngeal, nasal swab): negative on 18Dec2020. She received no treatment. The symptoms have stayed steady and have not gotten better. The outcome of events was not recovered. The case was assessed as non-serious.   Information on the lot/ batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: a "funny" feeling in my mouth/A sore sensation; a "funny" feeling in my mouth/A sore sensation; It felt as if it had been burned; slurred speech; loss of taste; This is a spontaneous report from a contactable consumer.  A 32-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Dec2020 09:30 for immunization, administered at hospital.  Medical history included asthma, allergies: aluminum, pet dander, trees/weeds/grass, seasonal allergy. She had not Covid prior vaccination. Concomitant medication included montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D [COLECALCIFEROL]), received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  On 17Dec2020 14:30, the patient experienced a funny feeling in my mouth/a sore sensation, it felt as if it had been burned, slurred speech, loss of taste. Course of events: Within 5 hours of injection she started noticing a "funny" feeling in her mouth. A sore sensation. By 19:30 her tongue was very sore. It felt as if it had been burned. she had nothing hot to eat that day and nothing new to eat. The soreness increased. She also had some slurred speech and loss of taste. The patient underwent lab tests: Sars-cov-2 test (Rapid nasopharyngeal, nasal swab): negative on 18Dec2020. She received no treatment. The symptoms have stayed steady and have not gotten better. The outcome of events was not recovered. The case was assessed as non-serious.   Information on the lot/ batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: thinks it is COVID toe; thinks it is COVID toe; an itchy toe/Her toe started itching. It is very red; an itchy toe/Her toe started itching. It is very red; This is a spontaneous report from a contactable nurse, the patient.  A 49-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 on 16Dec2020 at 07:15 (at the age of 49-years-old) as a single dose for COVID-19 immunization.  Medical history was not reported.  Concomitant medications included zingiber officinale root (GINGER ROOT), clonazepam (KLONOPIN), progesterone (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), spironolactone (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), and zinc (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing.   On 18Dec2020 at 02:00, the patient experienced an itchy toe/her toe started itching and it was very red, reported as non-serious. The clinical course was as followed: the patient was at work on the night of 18Dec2020 and was having trouble with her toe. Her toe started itching. It was very red. She wondered if it was "COVID toe" as the picture she found looked exactly the same. The physician she worked with did not know what it was. She took a diphenhydramine hydrochloride (BENADRYL) and sprayed freezing agent on it to stop the itching. The clinical outcomes of the itchy toe, red toe, and "COVID toe" were not recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a possibility that the events are related to BNT162 vaccine. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes virus infection, Neuralgia, Stress
Clinical narrative: herpes flair-up; herpes flair-up; I nerve pain, it happends all the time when I am under stress She mentioned this happened last night; I nerve pain, it happends all the time when I am under stress  She mentioned this happened last night; This is a spontaneous report from a contactable Nurse reporting for herself.  A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9809, Expiry Date: Mar2021), intramuscular on 17Dec2020 at single dose for covid-19 immunisation (front line worker). Medical history included herpes treated with acyclovir (manufacturer: Calrsbad Tech), oral at 400 mg, as needed. The patient's concomitant medications were not reported. The patient experienced herpes flair-up on 17Dec2020 with outcome of not recovered. On 17Dec2020 (last night) the patient had nerve pain, it happened all the time when she was under stress with outcome of unknown. The patient took acyclovir as treatment and wanted to know if there's any drug interaction with the covid 19 vaccine and if she will be eligible to get her second dose of Covid 19 vaccine while taking Acyclovir.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Emotional distress
Clinical narrative: lightheadedness/feeling lightheaded/felt herself going backwards and caught herself; disappointed and upset; This is a spontaneous report from a contactable consumer (patient) who reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was allergic to aspirin, if she takes it her eyes will come out of her head and quite a few other things will happen to her. Patient reported that she got the COVID-19 Vaccine on 17Dec2020 and it was like 1 hour after (also reported within 1 hour) she got the vaccine that she started feeling lightheaded which she had never experienced before, even today. Patient is an environmental service worker, she had so many discharges and so many COVID rooms to wipe down that she just kept pushing herself because they are just short staffed; but at one point she felt herself going backwards and caught herself, she decided to sit down and drink a water and continued to feel lightheaded. No one was available to relieve her yesterday (17Dec2020), she had to stay at the hospital until midnight and continue her activities with lightheadedness (pending clarification). Patient said, almost a day later, lightheadedness persists, she was still feeling the lightheadedness today (18Dec2020). Her concern is it's like 3-4 days afterwards that you will feel some effects. She wanted to know if this is what they are talking about, if this is expected. Patient initially reported being a healthcare professional (HCP), but clarified her profession is Environmental Service, working at (Institution name). Patient is allergic to aspirin, she wondered if the COVID-19 vaccine contains aspirin. Patient was suggested contacting her doctor to find out if she is allergic to any of the components in the vaccine. Patient was reminded it is possible to consult the ingredients as part of the Vaccine Fact Sheet on (Website name). Patient was disappointed and upset for experiencing lightheadedness after receiving the vaccine (Dec2020). She wishes she hadn't received it. As indicated in previous requests, was referred to an HCP for guidance after experiencing lightheadedness. Outcome of lightheadedness was not recovered, outcome of disappointed and upset was unknown.   Information on the Lot/Batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Headache, Pyrexia
Clinical narrative: Fever, mild cough, headache & light-headedness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac telemetry, Dizziness, Electrocardiogram, Laboratory test, Nausea
Clinical narrative: nausea; dizziness; Progressed to tachycardia; heart rate from 60-120; This is a spontaneous report from a contactable consumer.   A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 18Dec2020 at 07:45, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient, approximately 15 minutes after shot, experienced mild nausea and dizziness. Progressed to tachycardia, heart rate from 60-120. Felt it racing and pounding. Went to emergency room for evaluation. The patient underwent lab tests and procedures which included heart rate: 60-120.  Therapeutic measures were taken as a result of the events and included electrocardiogram (EKG) and telemetry monitoring.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: nausea; dizziness; Progressed to tachycardia; heart rate from 60-120; This is a spontaneous report from a contactable consumer.   A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 18Dec2020 at 07:45, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient, approximately 15 minutes after shot, experienced mild nausea and dizziness. Progressed to tachycardia, heart rate from 60-120. Felt it racing and pounding. Went to emergency room for evaluation. The patient underwent lab tests and procedures which included heart rate: 60-120.  Therapeutic measures were taken as a result of the events and included electrocardiogram (EKG) and telemetry monitoring.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Extreme Vertigo and Dizziness 20 minutes following vaccination. Patient began to slowly feel better.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac flutter, Chest discomfort, Cough, Electrocardiogram abnormal
Clinical narrative: Right neck pain radiates from shoulder blade to occiput.; Tightness of chest and fluttering in chest that made me cough persistently; Tightness of chest and fluttering in chest that made me cough persistently; BP elevated 150/90; I had EKG report read occasional PVC.; This is a spontaneous report from a contactable nurse reporting for herself.  A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 18Dec2020 10:15 at single dose for covid-19 immunisation at hospital. Medical history included asthma, eczema, allergies to PCN (penicillin), whey, glutamate, gluten, sulfites. Concomitant medication included isosorbide mononitrate (FLO). On 18Dec2020 at 10:45 the patient experienced right neck pain radiates from shoulder blade to occiput. Tightness of chest and fluttering in chest that made her cough persistently. BP elevated 150/90, no prior history of hypertension. In ED for check-up, the patient had EKG report read occasional PVC. Labs all within normal limits and symptoms and BP better within 1.5 hours so discharged to home. The patient was not treated for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Neck pain, Pain, Ventricular extrasystoles
Clinical narrative: Right neck pain radiates from shoulder blade to occiput.; Tightness of chest and fluttering in chest that made me cough persistently; Tightness of chest and fluttering in chest that made me cough persistently; BP elevated 150/90; I had EKG report read occasional PVC.; This is a spontaneous report from a contactable nurse reporting for herself.  A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 18Dec2020 10:15 at single dose for covid-19 immunisation at hospital. Medical history included asthma, eczema, allergies to PCN (penicillin), whey, glutamate, gluten, sulfites. Concomitant medication included isosorbide mononitrate (FLO). On 18Dec2020 at 10:45 the patient experienced right neck pain radiates from shoulder blade to occiput. Tightness of chest and fluttering in chest that made her cough persistently. BP elevated 150/90, no prior history of hypertension. In ED for check-up, the patient had EKG report read occasional PVC. Labs all within normal limits and symptoms and BP better within 1.5 hours so discharged to home. The patient was not treated for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.  Information on the lot/batch number has been requested.