chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: took an entire bottle of Tylenol PM. I wanted to die; emotionally unstable even suicidal; emotionally unstable even suicidal; Emotions became violently unable to control/a day where I was PURE rage; feel sick and run down; feel sick and run down; Throwing up; unable to eat; The dreams of my ex abuser I escaped are prominent in my mind and dream's again now too; I genuinely feel the vaccine did something to my brain/chemical balance/emotional state; Other vaccine same date product: Covid-19/moderna, 06Sep2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history was reported as none. No COVID prior to vaccination. Not tested for COVID post vaccination. No known allergies. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 07Sep2021 03:00, the patient took an entire bottle of Tylenol PM reporting that "I wanted to die." At the same time, the patient became emotionally unstable even suicidal, emotions became violently unable to control, there was a day where I was pure rage, feel sick and run down, throwing up everyday for no reason, unable to eat for days, had dreams of my ex abuser I escaped are prominent in my mind and dream's again now too and the patient genuinely feel the vaccine did something to her brain/chemical balance/emotional state. The patient added that "I know it sounds crazy but there's no other correlation, nothing else odd happened to me. Can a shot do that to me?" The patient considered the events as life threatening and have case disability or permanent damage. The events required emergency room visit. No treatment was given for the events. It was also reported that other vaccine same date product: covid-19/Moderna on 06Sep2021. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got COVID 19 September 3,2021, 4 months after vaccinated it doesn't protect me at all.; I got COVID 19 September 3,2021, 4 months after vaccinated it doesn't protect me at all.; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EWO167 and expiration date was not reported), first dose via an unspecified route of administration, administered in left arm on 06May2021 at 15:00 (at the age of 67-year-old) as single for COVID-19 immunization. The patient had no medical history and no known allergies. The patient did not receive any other vaccine in four weeks. Patient had no Covid prior vaccination and patient was tested Covid post vaccination. The patient received herbal medications in two weeks. On 03Sep2021 at 19:30, the patient experienced COVID 19. The patient reported that, she got vaccinated on 06May2021 and got COVID 19 on 03Sep2021, 4 months (3 months 28 days) after vaccination and it doesn't protect at all. The patient had drug ineffectiveness. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab) and the results were: positive on 03Sep2021 and negative on 15Sep2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit and considered event as life threatening illness (immediate risk of death from the event). The patient did not receive ant treatment for events. On an unspecified date in 2021, the patient recovered with sequelae (Recovered with lasting effects).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on shoulder and neck worsened; This is a spontaneous report from a contactable consumer (patient). A 86-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN9581; expiration date: 31May2021), via an unspecified route of administration, administered in right arm on 01Feb2021 16:30 (at the age of 86 years) as dose 2, single for COVID-19 immunization. The patients medical history included ongoing gout diagnosed two or three years ago and ongoing palpitation of the heart. The patient started Eliquis at 2.5mg tablet twice a day and then he found out he was bleeding to death, clarifies he was bleeding internally in his small intestine, so he cut his Eliquis in half, stated the doctor did not like that he cut his dose in half, but he stopped bleeding internally after about a week. He was left-handed, so he got the injection in his right arm. Concomitant medications included apixaban (ELIQUIS, formulation: tablet, strength: 2.5mg) for palpitation of the heart that he had very often taken half tablet by mouth twice daily; diltiazem hydrochloride (DILTIAZEM XR, formulation: capsule, strength: 240mg) for an unspecified indication taken once a day by mouth. Both recommended by patients cardiologist. The patient also took febuxostat (ULORIC, formulation: tablet, strength: 80mg) for gout taken half tablet once a day by mouth. The patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiration date: Apr2021), via an unspecified route of administration, administered in right arm on 07Jan2021 around 10:30am (at the age of 86 years) as dose 1, single for COVID-19 immunization and experienced rash on shoulder and neck. The events at the time of last observation were not recovered and ongoing. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) were none except the first dose of COVID vaccine. On an unspecified date the patient mentioned the rash on shoulder and neck worsened. He also stopped using his laundry soap since he was not sure if it was his laundry soap the rash symptoms. AE did not result in visit to physician office or emergency room. On an unspecified date the patient took pantoprazole 40mg (oval yellow tablet, delayed release, lot number: QASB2000 (thinks the last digit was a 0, not sure), expiration date: Feb2023) as a therapeutic measure. He read the one of the side effects of long-term use was a rash so he confirms he stopped taking it but the rash was still there. He was putting Eucerin for the rash and it seems to soothe it over somewhat. Outcome of event was not recovered patient stated it was hard to tell, he thinks it was getting a little worse.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Tired; Arm was more sore; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 24Feb2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included fluticasone propionate; salmeterol xinafoate (ADVAIR DISKUS 250/50) and eletriptan hydrobromide (RELPAX); both from an unknown start date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Feb2021 at 05:00, the patient experienced headache, tired and the arm was more sore that day than the previous day. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, tired and the arm was more sore was not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, SARS-CoV-2 test, Vomiting
Clinical narrative: Headache; Vomit; Upset stomach; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 09:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 10:00, the patient experienced headache, vomit, upset stomach and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 25Feb2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events headache, vomit, upset stomach and diarrhea were unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 03Feb2021 at 10:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced nausea, headache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, nausea and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Dull headache; Extra tired; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via an unspecified route of administration in the left arm on 17Feb2021 at 10:45 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included ministroke two and a half years ago and blood cholesterol abnormal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and ubidecarenone (COQ10); all for an unknown indication on an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration in the left arm on 27Jan2021 at 10:45 (at the age of 68-year-old) as a single dose for COVID-19 immunisation and no bad adverse events were noticeable after the dose. The patient also received unspecified cholesterol medication to lower the cholesterol. On 18Feb2021 at 20:30 the patient experienced only dull headache and extra tired, the evening of the second day after the second dose. The reported events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dull headache and extra tired were resolved on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Upper-airway cough syndrome, Vaccination site pain
Clinical narrative: Headache; Fatigue; Arm soreness at site of injection; Postnasal drainage; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 20Feb2021 at 17:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergies, obesity, depression, anxiety and attention deficit hyperactivity disorder (ADHD). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (ACETAMINOPHEN), cetirizine (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); all from an unknown start date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021, the day after the vaccination, the patient experienced headache, fatigue and arm soreness at site of injection. Few days later in Feb2021, the patient experienced postnasal drainage and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fatigue, arm soreness at site of injection, postnasal drainage and sore throat was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: Fatigue; Ache at injection site; Headache; Foggy; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021, the patient experienced fatigue, ache at injection site, headache, foggy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, ache at injection site, headache, foggy was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Malaise, Pain
Clinical narrative: Dizzy/ dizziness; Site pain; Tiredness; Chills; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 62-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 16:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN) taken for unknown indication from unknown dates and unknown if ongoing. On 26Feb2021 at 06:30, the next day after the vaccine the patient felt very dizzy, it was reported that dizziness was not described on the side effects. Also, the patient had other effects which included site pain, tiredness, chills, and feeling unwell. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy/dizziness, site pain, tiredness, chills, and feeling unwell was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Tenderness, Vaccination site swelling
Clinical narrative: Swelling at injection site (approx 2.5 inches across); redness; muscle pain; tenderness; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 13:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tocopherol (VITAMIN E), probiotics (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 09:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 10:00, the patient experienced swelling at injection site (approximately 2.5 inches across), redness, muscle paint and tenderness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling at injection site, redness, muscle pain and tenderness were recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Vaccination site pain
Clinical narrative: also ankle swollen; When i got up today also left right side of thigh above the knee and knee on same side also ankle swollen; Injection site, pain on 2/26; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 25Feb2021 at 17:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Feb2021, the patient experienced injection site pain and on 27Feb2021 when she got up that day also left right side of thigh above the knee and knee on same side also ankle swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, left right side of thigh above the knee and knee on same side also ankle swollen were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm starting on day of vaccine and still somewhat sore 3 days later; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore arm starting on day of vaccine and still somewhat sore 3 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event sore arm starting on day of vaccine and still somewhat sore 3 days later was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: "Click in left ear which is intermittent and goes on all through the day and night. This continued and got worse on the day of second vaccine"; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Jan2021 at 09:00 (at the age of 73-years-old) as a single dose and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient had no known allergies to medication, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included balsalazide (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN) and azathioprine (MANUFACTURER UNKNOWN); all 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. On 22Jan2021 at 15:00, on the day of her first Pfizer vaccine, the patient started to get a click in her left ear which was intermittent and goes on all through the day and night, this continued and got worse on the day of her second vaccine. The clicking has continued for 5 weeks. The patient will be having an MRI on 01Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with removal of ear wax, steroid ear drops and prednisone; from unknown start dates to unknown stop dates. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "Click in left ear which is intermittent and goes on all through the day and night. This continued and got worse on the day of second vaccine" was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Tongue disorder
Clinical narrative: Third day after vaccine a purplish large bump or sore appeared on tongue was sensitive; Third day after vaccine a purplish large bump or sore appeared on tongue was sensitive; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 at 11:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received levofloxacin (LEVAQUIN) on an unknown date and experienced drug allergy. On 15Feb2021 at 11:00, third day after the vaccine, a purplish large bump or sore appeared on the patient's tongue which was sensitive and was almost completely gone in 24 hours and totally gone in 48 hours. The patient reported that he had a picture. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event purplish large bump or sore appeared on tongue which was sensitive was resolved on 17Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion, vaccine was exposed to temp as high as 55 degrees F unmixed for a 6 hour period prior to getting vaccine; Temperature excursion, vaccine wasexposed to temp as high as 55 degrees F unmixed for a 6 hour period prior to getting vaccine; This is a spontaneous report from a contactable nurse. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the left arm on 24Feb2021 at 07:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Feb2021 at 07:00, the patient experienced temperature excursion where vaccine was exposed to temp as high as 55 degrees F which was unmixed for a 6 hours period prior to vaccination. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event temperature excursion where vaccine was exposed to temp as high as 55 degrees F which was unmixed for a 6 hours period prior to vaccination was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 25Feb2021 at 10:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure (CHF) and atrial fibrillation (AFIB). The patient had no known allergies. Concomitant medications included apixaban (ELIQUIS), atorvastatin calcium (LIPITOR), isosorbide mononitrate (IMDUR), metoprolol (MANUFACTURER UNKNOWN), furosemide (LASIX) and potassium (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced vomiting on 27Feb2021 at 13:30 and also on 28Feb2021 (at the time of this report) in the afternoon. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Body aches; Head ache; This is a spontaneous report from a non-contactable consumer. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3247 ) via an unspecified route of administration in the left arm on 17Feb2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3247) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to vaccination. On 18Feb2021, the patient experienced body aches and headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events body aches and headache was recovered on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Parosmia
Clinical narrative: Approximately 5 minutes after shot during 15 min wait time, a hot flush came over my body with sensitivity to smells and lightheadedness.; Approx 5 min after shot during 15 min wait time, a hot flush came over my body with sensitivity to smells and lightheadedness; Approx 5 min after shot during 15 min wait time, a hot flush came over my body with sensitivity to smells and lightheadedness; Headache for remainder of the day.; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19262) via an unspecified route of administration in the left arm on an unknown date in Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer, atrial fibrillation (AFib), and lumbar spine compression fracture (compression fx L1). The patient previously took neomycin sulfate; polymyxin b sulfate; gramicidin (NEOSPORINE) and epinephrine (MANUFACTURER UNKNOWN); both for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, approximately 5 minutes after vaccination, during 15 minutes wait time, the patient had a hot flush that came over her body with sensitivity to smells, light headedness and headache for remainder of the day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hot flush came over her body, sensitivity to smells, light headedness and headache were resolved on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Throat irritation, Throat tightness
Clinical narrative: Sore arm; Slight headache; Congestion in throat; Slight tickle in throat; Slightly spacey; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 24Feb2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included QT prolonged, heart failure, fruit allergy to kiwi fruit, dairy allergy, gluten sensitivity, food allergy to potatoes, tomatoes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included nadolol (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 24Feb2021 at 11:00, the patient experienced sore arm, slight headache, congestion and slight tickle in throat and slightly spacey. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event slight headache was recovered on 24Feb2021 while that of the event sore arm was recovered on 26Feb2021. The clinical outcome of the events congestion in throat, slight tickle in throat and slightly spacey was recovering at the time of this report  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Strong body aches; Headache; Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9267) via an unspecified route of administration in the right arm on 22Feb2021 at 14:45 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis, gastroesophageal reflux disease (GERD), high cholesterol and penicillin allergy (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), vitamin (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM); all unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, the next AM, the patient experienced a slight sore arm. On 26Feb2021 at 03:00, Thursday night the patient woke up with strong body aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight sore arm and strong body aches was resolved on an unknown date in 2021 while that of the event headache was resolved on 01Mar2021, after the duration of 3 days.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Feb2021 at 10:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and Intravenous (IV) contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 21:30, the patient experienced muscle spasms in left arm, lower back and eye. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms in left arm, lower back and eye was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Malaise, Night sweats
Clinical narrative: "I"was shivering, actually shaking for 3 hrs during the first night; "I" was shivering, actually shaking for 3 hrs during the first night.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; The next day "I "didn't feel good with an upsetstomach, didn't want to eat.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 18Feb2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Feb2021, the patient experienced night sweats as she had gotten out of a pool. On 19Feb2021 at 02:30, the patient experienced shivering and shaking for 3 hours during the first night. On 19Feb2021,the next day, the patient did not feel good with an upset stomach and did not want to eat. The adverse events did not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events night sweats, did not feel good with an upset stomach, did not want to eat and shivering were resolved on an unknown date in Feb2021, while the event shaking was resolved on 19Feb2021 at 05:30, after the duration of 3 hours.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: "I"was shivering, actually shaking for 3 hrs during the first night; "I" was shivering, actually shaking for 3 hrs during the first night.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; The next day "I "didn't feel good with an upsetstomach, didn't want to eat.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 18Feb2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Feb2021, the patient experienced night sweats as she had gotten out of a pool. On 19Feb2021 at 02:30, the patient experienced shivering and shaking for 3 hours during the first night. On 19Feb2021,the next day, the patient did not feel good with an upset stomach and did not want to eat. The adverse events did not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events night sweats, did not feel good with an upset stomach, did not want to eat and shivering were resolved on an unknown date in Feb2021, while the event shaking was resolved on 19Feb2021 at 05:30, after the duration of 3 hours.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: Site injection moderate pain; Site injection discomfort; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported.  On 26Feb2021 at 06:00, the patient experienced site injection moderate pain and discomfort for 2 days, tolerable, not need of pain killers. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event site injection moderate pain and discomfort was resolved on 28Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 13Feb2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient had no known allergies to medication food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient took unspecified medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 23Jan2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 16Feb2021, the patient experienced pityriasis rosea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pityriasis rosea was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.