chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Paraesthesia, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Red swollen hands with a burning and tingling feeling; Red swollen hands with a burning and tingling feeling; Red swollen hands with a burning and tingling feeling; Red swollen hands with a burning and tingling feeling; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 12:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for unknown indication from an unknown start date and unknown if ongoing. The patient previously took pethidine hydrochloride (DEMEROL) for an unknown indication from an unknown date and experienced drug allergy. On 01Apr2021 at 17:00, the patient experienced every symptom listed as a possible side effect but the one that the patient had reached out was red swollen hands with a burning and tingling feeling. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test (Test type: Nasal swab) and the result was negative. The clinical outcome of the events red swollen hands with a burning and tingling feeling was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and gastro esophageal reflux disease (GERD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), esomeprazole (NEXIUM) and fexofenadine hydrochloride (ALLEGRA) for unknown indication from an unknown date and unknown if ongoing. On 13Apr2021, the patient experienced diarrhea onset 4 days after shot, diarrhea 4 plus times a 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity
Clinical narrative: Extended period bleeding; Severe arm pain; This is a spontaneous report from a contactable consumer, the patient. A 33-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 left arm on 30Mar2021 at 17:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. 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 escitalopram (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); both for unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced extended period bleeding and severe arm pain. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 extended period bleeding and severe arm pain were recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash
Clinical narrative: Watery diarrhea for 10 days; Rash on my chest and upper arms; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm  on 01Apr2021 at 16:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, migraine and depression. 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 received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Apr2021 at 20:00, the patient experienced watery diarrhea for 10 days and a rash on her chest and upper arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of watery diarrhea and rash on her chest and upper arms and included treatment with diphenhydramine hydrochloride (BENADRYL) and unspecified medication for diarrhea. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was  negative. The clinical outcome of the events watery diarrhea was recovered on 14Apr2021; while that of event rash on her chest and upper arms was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period started early mid cycle after both shots; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 06Feb2021 at 13:30 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9209) via an unspecified route of administration in the right arm on 27Feb2021 as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to sulfa, dairy and gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included medication for birth control (unspecified) and fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for unknown indication from an unknown date and unknown if ongoing. On 09Feb2021 at 07:00, the patient experienced period started early mid cycle after both shots. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event period started early mid cycle after both shots was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Initial sore arm, followed by 5-7 days (still ongoing) persistent low fever, nausea, headache, diarrhea (2 days), and significant joint pain. Occasional sore throat.; followed by 5-7 days (still ongoing) persistent low fever; Nausea; Headache; Diarrhea; Significant Joint pain; Occasional sore throat.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 08Apr2021 at 14:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included lupus and allergy to gluten. 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 included hydroxychloroquine sulfate (PLAQUENIL), alendronate sodium (ALENDRONATE), resveratrol (MANUFACTURER UNKNOWN), glutathione (MANUFACTURER UNKNOWN) and glyc (unspecified), all from unknown dates for unknown indications 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 on unknown date as a single dose for COVID-19 immunisation. On 09Apr2021, the patient experienced initial sore arm which was followed by 5-7 days (ongoing at the time of report) persistent low fever, nausea, headache, diarrhea (2 days), significant joint pain and occasional sore throat. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent rapid test (SARS-CoV-2 test) and the result was negative. The clinical outcome of the event diarrhea was recovered on 11Apr2021, while the clinical outcome of the events initial sore arm, persistent low fever, nausea, headache, significant joint pain and occasional sore throat was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Initial sore arm, followed by 5-7 days (still ongoing) persistent low fever, nausea, headache, diarrhea (2 days), and significant joint pain. Occasional sore throat.; followed by 5-7 days (still ongoing) persistent low fever; Nausea; Headache; Diarrhea; Significant Joint pain; Occasional sore throat.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 08Apr2021 at 14:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included lupus and allergy to gluten. 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 included hydroxychloroquine sulfate (PLAQUENIL), alendronate sodium (ALENDRONATE), resveratrol (MANUFACTURER UNKNOWN), glutathione (MANUFACTURER UNKNOWN) and glyc (unspecified), all from unknown dates for unknown indications 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 on unknown date as a single dose for COVID-19 immunisation. On 09Apr2021, the patient experienced initial sore arm which was followed by 5-7 days (ongoing at the time of report) persistent low fever, nausea, headache, diarrhea (2 days), significant joint pain and occasional sore throat. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent rapid test (SARS-CoV-2 test) and the result was negative. The clinical outcome of the event diarrhea was recovered on 11Apr2021, while the clinical outcome of the events initial sore arm, persistent low fever, nausea, headache, significant joint pain and occasional sore throat was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Electric shock sensation, Muscle spasms, Muscular weakness
Clinical narrative: Spasms; Paresthesia; Fever; Diarrhea; Nervous system issues; Weakness as legs could barely move; Nervous zapping in my brain and body; This is a spontaneous report from a contactable consumer, the patient. A 46-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 left arm on 24Mar2021 at 10:00 (at the age of 46-years-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 included antibiotics from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 08:00, the patient experienced spasms, paresthesia, fever, diarrhea, nervous system issues, weakness as legs could barely move, nervous zapping in brain and body. On an unknown date in 2021, the patient underwent blood test and the result was unknown. On 13Apr2021, the patient underwent COVID test (nasal swab) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient received any treatment for the events. The patient reported that nobody knew what to do. They were doing blood work. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events spasms, paresthesia, fever, diarrhea, nervous system issues, weakness as legs could barely move, nervous zapping in brain and body 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Spasms; Paresthesia; Fever; Diarrhea; Nervous system issues; Weakness as legs could barely move; Nervous zapping in my brain and body; This is a spontaneous report from a contactable consumer, the patient. A 46-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 left arm on 24Mar2021 at 10:00 (at the age of 46-years-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 included antibiotics from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 08:00, the patient experienced spasms, paresthesia, fever, diarrhea, nervous system issues, weakness as legs could barely move, nervous zapping in brain and body. On an unknown date in 2021, the patient underwent blood test and the result was unknown. On 13Apr2021, the patient underwent COVID test (nasal swab) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient received any treatment for the events. The patient reported that nobody knew what to do. They were doing blood work. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events spasms, paresthesia, fever, diarrhea, nervous system issues, weakness as legs could barely move, nervous zapping in brain and body 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Extreme body ache; Tiredness; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 36-years-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. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 09:30, the patient experienced extreme body ache, fever, chills, tiredness and injection site pain. 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 and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme body ache, fever, chills, tiredness and injection site pain was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Gastrointestinal pain
Clinical narrative: Woke up to bad stomach pain almost like IBS; Liquid diarrhea; Gut pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history includef high blood pressure (Hbp). 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 taken within two weeks of vaccination were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 01:00, the patient woke up to bad stomach pain almost like IBS, liquid diarrhea and gut pain. 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 bad stomach pain, liquid diarrhea and gut pain was not resolved 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Swelling of eyelid
Clinical narrative: 4/14 around 11 AM had 5 minutesshortness of breath / cough.; 4/14 around 11 AM had 5 minutes shortness of breath / cough.; Around 11:30 to 12 started noticing eye lids started swelling half inches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. 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 levothyroxine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 as a single dose for COVID-19 immunisation. On 14Apr2021, around 11: 00, the patient experienced shortness of breath and cough for 5 minutes. Around 11:30 to 12 started noticing eye lids started swelling half inches. No itchy or water leak. The events did not result in doctor or other healthcare professional office or clinic visit or emergency visit. No therapeutic measures were 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 shortness of breath and cough was recovered on 14Apr2021, while the event eye lids started swelling half inches were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: Muscle fasciculations in chest, abdomen, hands, arms, and face; This is a spontaneous report from a contactable consumer, the patient. A 20-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 14Apr2021 at 11:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma, migraines, anxiety, depression, obsessive-compulsive disorder (OCD), chronic left ankle pain, hypertension, seborrheic dermatitis and sulfonamide allergy (allergy to sulfa drugs in bulk). 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 montelukast (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), ethinylestradiol; norethisterone (ALYACEN) and hydrochlorothiazide (HYDROCHLOROTH); all taken from unknown dates for unknown indications 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 24Mar2021 at 12:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 15:30, the patient experienced muscle fasciculations in chest, abdomen, hands, arms, and face. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle fasciculations in chest, abdomen, hands, arms, and face was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Extreme fatigue for 24 hours; Extreme fatigue for 24 hours then stomach upset 3 days later, over a month later, still having regular upset stomach; Extreme fatigue for 24 hours then nausea 3 days later, over a month later, still having nausea; Extreme fatigue for 24 hours then dizziness 3 days later; Extreme fatigue for 24 hours then diarrhea 3 days later, over a month later still having diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 37-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 right arm on19Mar2021 at 18:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, penicillin allergy and iodine 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 budesonide/formoterol fumarate (SYMBICORT), sertraline (MANUFACTURER UNKNOWN); norethisterone acetate/ethinylestradiol (AUROVELA) and fexofenadine hydrochloride (ALLEGRA); all taken for an unknown indication from an unknown dates 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 26Feb2021 at 18:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced extreme fatigue for 24 hours then stomach upset, nausea, dizziness and diarrhea 3 days later. Over a month later, still she had regular upset stomach, nausea and diarrhea. The 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue was recovered on an unknown date in Mar2021, while the events stomach upset, nausea, diarrhea were not recovered and the event dizziness 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Overnight after shot developed aches and significant chills; Overnight after shot developed aches and significant chills; May have had other flu-like symptoms; This is a spontaneous report from a contactable consumer, the parent. A 23-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 07Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control to help with cystic acne, celiac disease and known allergies to some fruit/nut allergy (mild). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medication. 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 17Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 23:30, overnight after shot, the patient developed aches and significant chills and other flu like symptoms. The patient tried long hot showers, baths, blankets and by 05:30 took an Advil and continued to take Advil as per label at times day after shot. The patient reported that by second day after shot, seemed like symptoms had mostly cleared. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL), hot showers and blanket. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, chills and flu like symptoms were resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy break through bleeding. I was on my regular menstrual cycle last week, so this period is not normal.; Heavy break through bleeding. I was on my regular menstrual cycle last week, so this period is not normal.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 14Apr2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) for birth control 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: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 05:00, the patient experienced heavy break through bleeding, she was on her regular menstrual cycle last week, so this period was not normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy break through bleeding, she was on her regular menstrual cycle last week, so this period was not normal was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Inappropriate schedule of product administration, Lethargy
Clinical narrative: Lethargy; Fever ranging from 99-101; Diarrhea; Nausea; Headache; Minor arm swelling; Dose 1: 22Feb2021Dose 2: 12Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 12Apr2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included bradycardia episode, minor osteoarthritis, osteoporosis and anxiety. 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 lorazepam (MANUFACTURER UNKNOWN) for anxiety from an unknown date and unknown if ongoing. The patient previously took lidocaine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy (reported as tested and confirmed). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 22Feb2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, within 12 hours of vaccination, the patient experienced minor arm swelling. On 13Apr2021 at 02:00, the patient experienced lethargy, fever ranging from 99-101 (unspecified units), diarrhea, nausea 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 minor arm swelling, lethargy, fever ranging from 99-101, diarrhea, nausea and headache was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Lethargy; Fever ranging from 99-101; Diarrhea; Nausea; Headache; Minor arm swelling; Dose 1: 22Feb2021Dose 2: 12Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 12Apr2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included bradycardia episode, minor osteoarthritis, osteoporosis and anxiety. 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 lorazepam (MANUFACTURER UNKNOWN) for anxiety from an unknown date and unknown if ongoing. The patient previously took lidocaine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy (reported as tested and confirmed). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 22Feb2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, within 12 hours of vaccination, the patient experienced minor arm swelling. On 13Apr2021 at 02:00, the patient experienced lethargy, fever ranging from 99-101 (unspecified units), diarrhea, nausea 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 minor arm swelling, lethargy, fever ranging from 99-101, diarrhea, nausea and headache was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Nausea, Pain
Clinical narrative: Severe pain radiating from neck on side of injection, down into arm and to hand.; Blood pressure elevated; Movement of hand or arm causessevere pain; Nausea; Dizziness; minor visible swelling; Redness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, minor non-rheumatoid arthritis. The patient previously received acetylsalicylic acid (ASPIRIN), on an unspecified date for an unknown indication and experienced drug allergy (also reported as Aspirin family allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), paracetamol (TYLENOL) and zolpidem tartrate (AMBIEN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 20:00, the patient experienced severe pain radiating from neck on side of injection, down into arm and to hand, blood pressure is elevated. Any movement of hand or arm causes severe pain, nausea, and dizziness due to pain. Some minor visible swelling and redness at injection site. No fever, some general body aches and on same day, the patient underwent test for blood pressure and the result was elevated. The events did not result in doctor or other healthcare professional office/clinic, 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 severe pain radiating from neck on side of injection, down into arm and to hand, blood pressure elevated, movement of hand or arm causes severe pain, nausea, dizziness, minor visible swelling, redness at injection site and general body aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site erythema
Clinical narrative: Severe pain radiating from neck on side of injection, down into arm and to hand.; Blood pressure elevated; Movement of hand or arm causessevere pain; Nausea; Dizziness; minor visible swelling; Redness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, minor non-rheumatoid arthritis. The patient previously received acetylsalicylic acid (ASPIRIN), on an unspecified date for an unknown indication and experienced drug allergy (also reported as Aspirin family allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), paracetamol (TYLENOL) and zolpidem tartrate (AMBIEN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 20:00, the patient experienced severe pain radiating from neck on side of injection, down into arm and to hand, blood pressure is elevated. Any movement of hand or arm causes severe pain, nausea, and dizziness due to pain. Some minor visible swelling and redness at injection site. No fever, some general body aches and on same day, the patient underwent test for blood pressure and the result was elevated. The events did not result in doctor or other healthcare professional office/clinic, 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 severe pain radiating from neck on side of injection, down into arm and to hand, blood pressure elevated, movement of hand or arm causes severe pain, nausea, dizziness, minor visible swelling, redness at injection site and general body aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: A-typical spotting mid-menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 19:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) from an acupuncturist, taken for an unspecified indication from an unknown date and unknown if ongoing. On 13Apr2021, beginning 3 to 4 days after first dose, the patient experienced a-typical spotting mid-menstrual cycle and the spotting was continuing until 15Apr2021, the sixth day and had not stopped at the time of this report. The patient typically had regular periods with no spotting and the period had just ended 7 days prior to the spotting (4 days before the shot). The event did not result in a visit to the doctors 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 spotting mid-menstrual cycle was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: being miserable; This is a spontaneous report from a contactable nurse and consumer (patient) received from a Pfizer-sponsored program. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), via oral from Jan2020 (Batch/Lot number: unknown, Expiration Date: 30Jan2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis.  The patient's medical history and concomitant medications were not reported.  The patient experienced being miserable in Mar2021. The patient was advised by her medical doctor (MD) that tofacitinib citrate was held for one month (Mar2021), while getting COVID vaccine. It was reported that the patient was being measurable when off for that month (Mar2021). The action taken in response to the event for tofacitinib citrate was post-therapy. The outcome of being miserable was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: Pain under injection arm; Fever/shivering; Fever/Shivering; Nausea; Headache; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 02Feb2021 at 16:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypercholesterolemia and seasonal 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 COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), simvastatin (SIMVASTIN), colecalciferol (VITAMIN D3), calcium (MANUFACTURER UNKNOWN) and mult (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 13Jan2021 at 15:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021 at 06:00, the patient experienced pain under injection arm, fever/shivering, nausea, headache and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures not 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 pain under injection arm, fever/shivering, nausea, headache and muscle aches were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain under injection arm; Fever/shivering; Fever/Shivering; Nausea; Headache; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 02Feb2021 at 16:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypercholesterolemia and seasonal 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 COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), simvastatin (SIMVASTIN), colecalciferol (VITAMIN D3), calcium (MANUFACTURER UNKNOWN) and mult (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 13Jan2021 at 15:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021 at 06:00, the patient experienced pain under injection arm, fever/shivering, nausea, headache and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures not 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 pain under injection arm, fever/shivering, nausea, headache and muscle aches were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.