chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore throat; Cough; Chills; Headache; Body aches; Joint pain; Arm pain; Swollen lymph node (left under arm), Swollen lymph nodes in neck; Fever; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Ew0172), via an unspecified route of administration in left arm on 29Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Medical history included asthma, depression and insomnia/sleep disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA ALLERGY), mometasone furoate (FLONASE) and vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation; iodine and experienced drug allergy. On 30Apr2021 at 20:00, the patient experienced chills, headache, body ache, joint pain, arm pain, swollen lymph node (left under arm), swollen lymph nodes in neck, fever (99-101 while taking paracetamol (TYLENOL)), severe fatigue. Started on 02May2021, patient experienced sore throat and cough, continued fatigue, continued fever, swollen lymph nodes in neck. As of 05May2021, sore throat, cough, fatigue, swollen lymph nodes in neck and fever were still present. Cough had worsened. 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. Therapeutic measures were taken as result of fever included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of the events sore throat, cough, fatigue, swollen lymph nodes in neck and fever was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Skin infection
Clinical narrative: My skin start infection rash.; My skin start infection rash, itching, stining, all over my neck, ear, face and arm,; My skin start infection rash, itching, stining, all over my neck, ear, face and arm,; My skin start infection rash, itching, stining, all over my neck, ear, face and arm,; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's past drug history was reported as unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Mar2021 at 08:00, the patient experienced skin infection with rash, itching, stinging all over neck, ear, face, arm and was very painful. The event resulted in emergency room/department or urgent care. The clinical outcome of the events skin infection, rash, itching and stinging were not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling cold, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: bright yellow rash or bruising lasting for a few hours on non-vaccinated arm; Vaccinated arm significantly colder than the other arm; Numbing of vaccinated right arm, then right leg, then left leg hour; This is a spontaneous report from a contactable consumer, the patient. A 24-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 16Apr2021 at 18:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications included levonorgestrel (MIRENA) from an unknown date taken for birth control. Prior to the vaccination, it was unsure if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 21Apr2021, the patient underwent PCR test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced numbing of vaccinated right arm, then right leg, then left leg hour after vaccination for several hours after vaccination. Next day (17Apr2021), vaccinated arm significantly colder than the other arm. On 04May2021, the patient experienced bright yellow rash or bruising lasting for a few hours on non-vaccinated arm. The clinical outcome of the events of numbness and coldness  was recovered on an unknown date in Apr2021 while the clinical outcome of the event of bruising of arm was recovered on 04May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Soreness in the arm at shot area; Fatigue; feverish; This is a spontaneous report from a contactable consumer, the patient. An 67-year-old male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 08Mar2021 at 13:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient no known allergies. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, day after the shot in the morning, the patient felt symptoms of soreness in the arm at shot area, fatigue and feverish, one day after shot was administered. The patient was fine till the symptoms started. The clinical outcome of the event soreness in the arm at shot area, fatigue and feverish were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: Rt arm site of administered very COLD / Cool to touch; Normal hurt/ discomfort; Nausea; Frontal headache; lightheaded; strange sensation of NUMBNESS started exterior side of right thumb & rt thumb pad. Numbness moved to involve entire rt thumb. Numbness to lesser degree tip to palm of rt index finger rt middle finger, rt ring finger & rt pinkie.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0173) via an unspecified route of administration in the right arm on 04May2021 at 10:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included long term chronic autoimmune diseases and syndrome and on &off sensitive reactions. Concomitant medications included estradiol (ESTRADIOL TRANSDERMAL SYSTEM) and fentanyl (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in the right arm on 13 Apr2021 at 10:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 10:00, the patient experienced numbness, On 05May2021 the patient experienced nausea, discomfort, frontal headache, lightheaded and feeling cold. It was reported that within few minutes of 2nd Dose administered, strange sensation of NUMBNESS started exterior side of right thumb and rt thumb pad. Numbness moved to involve entire rt thumb. Numbness to lesser degree tip to palm of rt index finger rt middle finger, rt ring finger & rt pinkie. Almost immediately started flexing massaging and moving thumb & fingers Made certain to keep right arm moving/ in motion Rt fingers hand wrist arm flexed massaged moved. On & off for hours. Rt thumb remains semi numb on 05/05/2021. Numbness diminished in rt fingers, but semi numb rt finger tips. Failed to tell. Messaged online care provider & Pfizer on 05/05/2021. NOTE: Rt arm site of administered Pfizer 2 Dose very COLD / Cool to touch for 24+ hours. Normal hurt/ discomfort. Less than 60 after Pfizer 2 started normal/ common side effects...Nausea, frontal headache, lightheaded History of long-term autoimmune disease & syndromes. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events of numbness, nausea, discomfort, frontal headache, lightheaded and feeling cold was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Rt arm site of administered very COLD / Cool to touch; Normal hurt/ discomfort; Nausea; Frontal headache; lightheaded; strange sensation of NUMBNESS started exterior side of right thumb & rt thumb pad. Numbness moved to involve entire rt thumb. Numbness to lesser degree tip to palm of rt index finger rt middle finger, rt ring finger & rt pinkie.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0173) via an unspecified route of administration in the right arm on 04May2021 at 10:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included long term chronic autoimmune diseases and syndrome and on &off sensitive reactions. Concomitant medications included estradiol (ESTRADIOL TRANSDERMAL SYSTEM) and fentanyl (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in the right arm on 13 Apr2021 at 10:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 10:00, the patient experienced numbness, On 05May2021 the patient experienced nausea, discomfort, frontal headache, lightheaded and feeling cold. It was reported that within few minutes of 2nd Dose administered, strange sensation of NUMBNESS started exterior side of right thumb and rt thumb pad. Numbness moved to involve entire rt thumb. Numbness to lesser degree tip to palm of rt index finger rt middle finger, rt ring finger & rt pinkie. Almost immediately started flexing massaging and moving thumb & fingers Made certain to keep right arm moving/ in motion Rt fingers hand wrist arm flexed massaged moved. On & off for hours. Rt thumb remains semi numb on 05/05/2021. Numbness diminished in rt fingers, but semi numb rt finger tips. Failed to tell. Messaged online care provider & Pfizer on 05/05/2021. NOTE: Rt arm site of administered Pfizer 2 Dose very COLD / Cool to touch for 24+ hours. Normal hurt/ discomfort. Less than 60 after Pfizer 2 started normal/ common side effects...Nausea, frontal headache, lightheaded History of long-term autoimmune disease & syndromes. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events of numbness, nausea, discomfort, frontal headache, lightheaded and feeling cold was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Taste disorder
Clinical narrative: Felt like baseball in left armpit, very sore; Felt like baseball in left armpit, very sore; Taste sensation like Sucrets on the tongue; This is a spontaneous report from a non-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: UNKNOWN) via an unspecified route of administration in the arm left on 15Apr2021 at 11:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, penicillin allergy and sulfonamide allergy(sulfa). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 26Mar2021at 13:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced immediate taste sensation like sucrets on the tongue for 5-10 min. On 18Apr2021, 2 days later the patient felt like baseball in left armpit and very sore. The clinical outcome of the events taste altered, lymphadenopathy axillary and armpit pain were recovered on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Severe body ache; Chills; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on an unknown date (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced severe body ache 1 day after the 2nd dose, chills 1 day after the 2nd dose and tiredness during 3 days after the 2nd dose. Therapeutic measures were taken as a result of body ache, chills, tiredness and included treatment with tylenol. The clinical outcome of the events severe body ache, chills and tiredness were all resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles covered left side of forehead, eye, and nose; Shingles covered left side of forehead, eye, and nose; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 16:00 (Batch/Lot Number: ER8729) as a single dose (at the age of 38 years old) for COVID-19 immunisation.  Medical history included overactive bladder. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received dose 1 of BNT162b2 (at the age of 38 years old) on 19Mar2021 at 4:00 PM (batch/lot number: ER8727) in Right arm. On 23Apr2021, at 06:00 PM, the patient broke out into shingles. Shingles covered left side of forehead, eye, and nose. The event resulted in an Emergency room/department or urgent care visit and the patient received treatment with antiviral medication. The events were reported as non-serious by the patient. The patient was recovering from the shingles. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Fatigue, Gastrointestinal disorder, Migraine
Clinical narrative: increased GI issue; joint inflammation; Sinus issue; weakness in arms and legs; heart palpitations; Migraine; lightheadedness; fatigue; burning at injection site; muscle cramping/soreness/weakness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8734) in the arm left on 09Apr2021 at 13:00(at the age of 31-year-old) as a dose for COVID-19 immunisation. Medical history included mast cell activation syndrome. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 13:00 the patient experienced weakness in arms, heart palpitation, migraine, light headeness, fatigue and burning at injection site. On 10Apr2021 the patient experienced increased GI and sinus issues and joint inflammation. The patient reported after 5 - 15 minutes of injection: burning at injection site, weakness in arms, heart palpitations. 1 - 2 hours after injection: weakness in arms and legs, heart palpitations, migraine, lightheadedness, fatigue. 5 hours after injection: immense fatigue, muscle cramping/soreness/weakness. Next day (10Apr2021) : increased GI and sinus issues, immense fatigue, muscle weakness, joint inflammation, migraine, lightheadedness. Next 5 days: fatigue and muscle weakness continued. The clinical outcome of the event weakness in arms, heart palpitation, migraine, lightheadedness, burning at injection site increased GI and sinus issues, fatigue and joint inflammation were recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Palpitations, Sinus disorder, Vaccination site pain
Clinical narrative: increased GI issue; joint inflammation; Sinus issue; weakness in arms and legs; heart palpitations; Migraine; lightheadedness; fatigue; burning at injection site; muscle cramping/soreness/weakness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8734) in the arm left on 09Apr2021 at 13:00(at the age of 31-year-old) as a dose for COVID-19 immunisation. Medical history included mast cell activation syndrome. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 13:00 the patient experienced weakness in arms, heart palpitation, migraine, light headeness, fatigue and burning at injection site. On 10Apr2021 the patient experienced increased GI and sinus issues and joint inflammation. The patient reported after 5 - 15 minutes of injection: burning at injection site, weakness in arms, heart palpitations. 1 - 2 hours after injection: weakness in arms and legs, heart palpitations, migraine, lightheadedness, fatigue. 5 hours after injection: immense fatigue, muscle cramping/soreness/weakness. Next day (10Apr2021) : increased GI and sinus issues, immense fatigue, muscle weakness, joint inflammation, migraine, lightheadedness. Next 5 days: fatigue and muscle weakness continued. The clinical outcome of the event weakness in arms, heart palpitation, migraine, lightheadedness, burning at injection site increased GI and sinus issues, fatigue and joint inflammation were recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder
Clinical narrative: Strong episodes of brain fog resembling a marijuana high a couple of days apart; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications included PROPECIA from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 04:00, the patient experienced strong episodes of brain fog resembling a marijuana high a couple of days apart. No therapeutic measures were taken as a result of the event. The clinical outcome of the event strong episodes of brain fog resembling a marijuana was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on feet, under right arm, on right side of arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 03May2021 at 16:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 19:45, the patient experienced rash on feet, under right arm, on right side of arm. The clinical outcome of the event rash on feet, under right arm, on right side of arm was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate decreased
Clinical narrative: Dizziness; Drop in heart rate; Extreme tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 12Apr2021 at 12:15(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles, eczema and blood pressure high. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and chlortalidone (CHLORTHALIDONE); all from unknown dates for unspecified indication. The patient previously received sulfa (unspecified) on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 07:00, the patient experienced dizziness, drop in heart rate and extreme tiredness. The clinical outcome of the event dizziness, drop in heart rate, extreme tiredness was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Premenstrual syndrome
Clinical narrative: Delayed period by 6 days; Heavy menstrual bleeding; Extended pms symptoms; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169), via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history included tonsillectomy, appendectomy and kidney stones. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (ACETAMINOPHEN) for an unknown indication from an unspecified date. The patient's past drug included nitrofurantoin (MACROBID) for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced delayed period by 6 days, heavy menstrual bleeding and extended premenstrual syndrome (PMS) symptoms. The clinical outcome of the event delayed period, bleeding menstrual heavy and premenstrual syndrome was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chromaturia, Influenza like illness, Pain, Palpitations
Clinical narrative: Flu-like; Aches all over; Red urine; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 49-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 04May2021 at 13:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 unspecified date in Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021, the patient experienced flu-like symptoms, aches all over, red urine and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events flu-like symptoms, aches all over, red urine and heart palpitations was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Flu-like; Aches all over; Red urine; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 49-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 04May2021 at 13:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 unspecified date in Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021, the patient experienced flu-like symptoms, aches all over, red urine and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events flu-like symptoms, aches all over, red urine and heart palpitations was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urine analysis
Clinical narrative: Flu-like; Aches all over; Red urine; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 49-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 04May2021 at 13:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 unspecified date in Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021, the patient experienced flu-like symptoms, aches all over, red urine and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events flu-like symptoms, aches all over, red urine and heart palpitations was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed today both sides; This is a spontaneous report from a contactable consumer, the patient. A 45-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 24Apr2021 at 14:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. Concomitant medications included lithium (MANUFACTURER UNKNOWN) and quetiapine (MANUFACTURER UNKNOWN). The patient had no past drug. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 09:00 the patient experienced nose bleed both sides. The clinical outcome of the event nose bleed both sides was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting x 6; nausea; This is a spontaneous report from a contactable consumer, the patient. A 24-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 arm left on 05May2021 at 14:15 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to crab. The patient received unknown birth control within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 02:15 (as mentioned in the source document), the patient experienced vomiting and nausea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown if the patient received any treatment for adverse event. The clinical outcomes of the events vomiting and nausea was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tiredness; Soreness in arm; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 03May2021 at 17:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient previously received no medication. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021, the patient experienced tiredness and soreness in arm. The clinical outcome of the events tiredness and soreness in arm was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left arm/ in armpit area; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. Past drug included latex. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 10Apr2021 11:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 17:00, the patient experienced swollen lymph node under left arm/ in armpit area. The clinical outcome of the event swollen lymph node under left arm/ in armpit area was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Epistaxis, Fatigue, Gingival bleeding
Clinical narrative: Sharp stomach pain; Gum bleeding (more than normal).; Minor nose bleed; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 05May2021 at 12:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) taken for an unknown indication from an unknown date, escitalopram oxalate (LEXAPRO) taken for an unknown indication from an unknown date and lamotrigine (LAMICTAL) taken for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 07Apr2021 at 13:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05May2021, the patient experienced a sharp stomach pain which started within 30 minutes of the vaccine and lasted several hours (at the time of this report), minor nose bleed, gum bleeding (more than normal) when brushing teeth and exhaustion. The clinical outcome of the events sharp stomach pain, gum bleeding, minor nose bleed, exhaustion was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears that varied in intensity but usually mild; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 17Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high which was normal with medicines and high cholesterol from unknown dates. Concomitant medications included atorvastatin calcium (LIPITOR), esomeprazole (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19. On 19Apr2021 at 00:00, the patient experienced ringing in the ears that varied in intensity but usually was mild. It was constant and the patient, could hear it through ambient noise (tinnitus). This started only after the second dose. The patient's hearing was still normal otherwise and could hear every sound. The clinical outcome of the event ringing in the ears that varied in intensity but usually mild was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Lump in left shoulder at injection site fairly hard and about 3 inches long; Injection site was red.; Injection site was warm; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 27Apr2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications included lisinopril (LISINOPRIL), acetylsalicylic acid (BABY ASPIRIN) and vitamins nos; minerals nos (CENTRUM) taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021, the patient experienced a lump in left shoulder at injection site which was fairly hard, about 3 inches long and was red and warm. The event resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcome of the event lump in left shoulder at injection site which was fairly hard, about 3 inches long and was red and warm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sweating; Vomiting; Dizziness; Fever; Nausea; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8730) via an unspecified route of administration in the arm left on 05May2021 at 15:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included montelukast sodium (SINGULAIR) and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) both taken for unspecified indication from an unknown date. The patient previously took morphine and experienced allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 07Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 20:00, the patient experienced sweating, vomiting, dizziness, fever, nausea and pain in arm. The clinical outcome of the events sweating, vomiting, dizziness, fever, nausea and pain in arm were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sweating; Vomiting; Dizziness; Fever; Nausea; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8730) via an unspecified route of administration in the arm left on 05May2021 at 15:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included montelukast sodium (SINGULAIR) and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) both taken for unspecified indication from an unknown date. The patient previously took morphine and experienced allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 07Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 20:00, the patient experienced sweating, vomiting, dizziness, fever, nausea and pain in arm. The clinical outcome of the events sweating, vomiting, dizziness, fever, nausea and pain in arm were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, SARS-CoV-2 test
Clinical narrative: had significant muscle pain around left shoulder blade; muscle pain even on the side of left body near chest; I had significant muscle pain around my left shoulder blade.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 01May2021 at 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 10Apr2021 at 12:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02May2021 at 07:30, the patient experienced significant muscle pain around the left shoulder blade and even on the side of the left body near chest. The clinical outcome of the events significant muscle pain around the left shoulder blade and even on the side of the left body near chest was recovered on 03May2021. The patient underwent a lab test on 05May2021 which included nasal swab test and the result was pending.  No follow-up attempts are needed. No further information is expected.