chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Red, raised, itchy, hard bump at injection site; Red, raised, itchy, hard bump at injection site; Red, raised, itchy, hard bump at injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-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 10Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included history of blood clot and osteoporosis. The patient had no known allergies. Concomitant medications included enoxaparin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), calcium, vitamin d nos (CALCIUM;VITAMIN D NOS) and prenatal vitamins; all were taken on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation and the patient previously received Tdap shot 5 years ago on an unknown date in 2016 and experienced red, raised, itchy and hard bump at injection site. 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 12Apr2021 at 17:00, 48 hours post vaccination, the patient had red, raised, itchy, hard bump at injection site and it kept growing bigger. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events red, raised, itchy, hard bump at injection site were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue; Strong aches; Low fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER4733) via an unspecified route of administration in the left arm on 11Apr2021 at 10:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), sertraline hydrochloride (ZOLOFT) and metoprolol (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. On 11Apr2021 at 13:00, the patient experienced fatigue, strong aches, low fever and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, aches, low grade fever and headache was recovering 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: Fatigue, Muscle twitching, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Severe fatigue; Severe vertigo; Severe muscle aches; Lots of muscle twitching; Pain in arm; Pain of injection site; 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 right arm on 20Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included narcolepsy, diabetes, arthritis and peripheral neuropathy. The patient had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included exenatide (BYDUREON), glimepiride (MANUFACTURER UNKNOWN), pioglitazone (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and meloxicam (MELO); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26Mar2021 at 03:30, the patient experienced severe fatigue, severe vertigo, severe muscle aches, lots of muscle twitching and pain in arm of vaccination site. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events severe fatigue, severe vertigo, severe muscle aches, lots of muscle twitching and pain in arm of vaccination site were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe fatigue; Severe vertigo; Severe muscle aches; Lots of muscle twitching; Pain in arm; Pain of injection site; 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 right arm on 20Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included narcolepsy, diabetes, arthritis and peripheral neuropathy. The patient had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included exenatide (BYDUREON), glimepiride (MANUFACTURER UNKNOWN), pioglitazone (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and meloxicam (MELO); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26Mar2021 at 03:30, the patient experienced severe fatigue, severe vertigo, severe muscle aches, lots of muscle twitching and pain in arm of vaccination site. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events severe fatigue, severe vertigo, severe muscle aches, lots of muscle twitching and pain in arm of vaccination site were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Pruritus
Clinical narrative: Also, sore throat symptoms started 5 days after injection; Also coughing symptoms started 5 days after injection; Also, cold symptoms started 5 days after injection; Within 5 minutes after injection, sharp pain in right hand; Within 5 minutes after injection, itchy skin at 3 locations; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 05Apr2021 at 15:30 (at the age of 57-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 food, medication or other product. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE) both are started on unknown dates, for unspecified indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 15:15, 5 minutes after injection the patient experienced sharp pain in right hand and itchy skin at 3 locations. On 10Apr2021, 5 days after vaccination the patient experienced sore throat, coughing and cold symptoms. On 12Apr2021, the patient underwent lab test which included nasal swab (COVID -19 virus test) and the result was Negative.  Therapeutic measures were not taken as a result of the event(s). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pain in right hand, and itchy skin, sore throat, coughing and cold symptoms were not recovered, at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Also, sore throat symptoms started 5 days after injection; Also coughing symptoms started 5 days after injection; Also, cold symptoms started 5 days after injection; Within 5 minutes after injection, sharp pain in right hand; Within 5 minutes after injection, itchy skin at 3 locations; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 05Apr2021 at 15:30 (at the age of 57-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 food, medication or other product. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE) both are started on unknown dates, for unspecified indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 15:15, 5 minutes after injection the patient experienced sharp pain in right hand and itchy skin at 3 locations. On 10Apr2021, 5 days after vaccination the patient experienced sore throat, coughing and cold symptoms. On 12Apr2021, the patient underwent lab test which included nasal swab (COVID -19 virus test) and the result was Negative.  Therapeutic measures were not taken as a result of the event(s). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pain in right hand, and itchy skin, sore throat, coughing and cold symptoms were not recovered, at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body ache; Chills; Fever; Headache; Sore arm; 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 left arm on 30Mar2021 at 11:30 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the day of vaccination, the patient experienced sore arm and headache. On 12Apr2021 at 00:00, the patient started to experience body ache, headache, chills and fever. 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. On an unknown date, the patient underwent SARS-CoV-2 test (mouth swab) and the result was negative. The clinical outcome of events sore arm, body ache, headache, chills and fever were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body ache; Chills; Fever; Headache; Sore arm; 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 left arm on 30Mar2021 at 11:30 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the day of vaccination, the patient experienced sore arm and headache. On 12Apr2021 at 00:00, the patient started to experience body ache, headache, chills and fever. 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. On an unknown date, the patient underwent SARS-CoV-2 test (mouth swab) and the result was negative. The clinical outcome of events sore arm, body ache, headache, chills and fever were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Severe headache; Light headed; Nausea; Diarrhoea; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 76-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 08Apr2021 at 11:45 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and seasonal allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) all taken for an 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 09Apr2021 at 03:00, the patient experienced severe headache, light headed, nausea, tiredness and diarrhoea. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe headache, light headed, nausea, tiredness and diarrhoea was recovered with sequelae at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Myalgia
Clinical narrative: Muscle aches; Fatigue; Extremely heavy menstrual bleeding (abnormal).; This is a spontaneous report from a 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: EN6207) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 40-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-19 vaccination. On 12Apr2021, with the second dose of vaccine, the patient experienced muscle aches, fatigue and extremely heavy menstrual bleeding (abnormal). Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event's muscle aches, fatigue and extremely heavy menstrual bleeding (abnormal) were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 43-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP6955), at the age of 43, via an unspecified route of administration, left arm, on Mar 27, 2021, at 10:45, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included unspecified prenatal vitamins for unspecified indication (from unknown date and unknown if ongoing). Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Information on allergies to medications, food, or other products: not applicable. On Apr 12, 2021, at 15:00, patient found out in annual check-up her platelet count was low (108K/ul); normal range was 150- 450K/ul). Her previous platelet count was 198K/ul on unknown date in Feb 2021 (before the vaccination on Mar 27, 2021). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The outcome of low platelet count (108K/ul): unknown (at the time of report). No follow-up attempts needed. No further information expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headaches; joint pain; tiredness; fatigue; feeling in a haze/brain fog; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to strawberries. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took allopurinol and experienced drug allergy. 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 10Apr2021 at 14:00, the patient experienced headaches, joint pain, tiredness, fatigue and felt haze/brain fog. The events 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 events. The clinical outcome of the events headaches, joint pain, tiredness, fatigue and felt haze/brain fog were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male 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 12Apr2021 at 10:30(at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 13Apr2021 at 00:00, the patient experienced arm pain, headache and 100 degree fever. The patient did not receive any treatment for the adverse events. On 13Apr2021, the patient underwent body temperature test and the result was 100 degree(units unspecified). The clinical outcome of the event arm pain, headache and 100 degree fever were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Withdrawal bleed
Clinical narrative: started period last night consistently taken birth control and in the middle of the pack; This is a spontaneous report from a non-contactable consumer, the patient. A 22-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 12Apr2021 at 15:00(at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included graves disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included JUNEL FE 1/20 taken for birth control from an unknown date for unknown indication taken within two weeks of vaccination. 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 left arm in Mar2021 at 15:00 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 12Apr2021 at 22:00 the patient experienced start of period last night after consistently taken birth control and in the middle of the pack. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event started period last night after consistently taken birth control and in the middle of the pack was not recovered at the time of the report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Dizziness; Vertigo; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 08:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ibuprofen (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021, the patient experienced dizziness, vertigo and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with meclizine. The clinical outcome of the events dizziness, vertigo and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Paraosmia; Dysgeusia; This is a spontaneous report from a non-contactable physician. A male patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced parosmia and dysgeusia (metallic taste, sulfur smell). The clinical outcome of the event parosmia and dysgeusia (metallic taste, sulfur smell) were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Inappropriate schedule of product administration
Clinical narrative: Moderate  joint pain in both knees; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male 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 30Mar2021 at 13:30 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included rivaroxaban (XARELTO) from an unknown date for an unknown indication. 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 23Mar2021 at 13:30 (at the age of 67-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. The patient experienced no effect after the first dose. On 11Apr2021 at 15:00, 12 days after second vaccination, the patient experienced moderate joint pain in both knees. The patient still enduring moderate pain at the 15-day point. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event joint pain in both knees. On an unknown date, the patient underwent lab test and procedure which included blood test and the result was no indicated problems or abnormalities found. The clinical outcome of the event joint pain in both knees was not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache that lasted about 8 hours; This is a spontaneous report from a non-health care professional. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the right arm on 27Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration on 06Mar2021, 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 28Mar2021, the patient experienced mild headache that lasted about 8 hours. The event 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.  The clinical outcome of the event mild headache that lasted about 8 hours was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: soreness at injection site; Fatigue; Chills; This is a spontaneous report from a non-contactable consumer, the patient.  A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 12Apr2021(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 12Apr2021 the patient experienced soreness at injection site, fatigue and chills. 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 event. The clinical outcome of the event soreness at injection site, fatigue and chills was recovered on unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches, headache; headache; This is a spontaneous report from a contactable consumer. A female patient of unspecified age 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 27Mar2021 as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, on the day after the second shot for about 8-12 hours, the patient experienced body aches and headache. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event body aches and headache was recovered on unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Tremor
Clinical narrative: Legs began to shake/whole body shaking uncontrollably. Minutes later whole body was shaking uncontrollably.; involuntary muscle spasms throughout body butconcentrated in limbs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as n/a. 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 19:30, about 8 hours after receiving the vaccine, the patient noticed his legs began to shake, and minutes later whole body was shaking uncontrollably. This was not shivering from chills but instead intense involuntary muscle spasms throughout body but concentrated in limbs. This lasted for approximately 45 minutes and then ceased. The patient had never experienced anything like this and had not had any neurological issues. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events legs began to shake and minutes later whole body was shaking uncontrollably and intense involuntary muscle spasms throughout body, which lasted for approximately 45 minutes and then ceased was recovered on 12Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Decreased appetite, SARS-CoV-2 test
Clinical narrative: Intense abdominal pain on the right side of my body/ The abdominal pain (came and went) but lasted nearly 6 days and was very severe at times (like being stabbed); I also started to lose my appetite and became very weak; I also started to lose my appetite and became very weak; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 31Mar2021 at 09:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00, day 4 after the first jab the patient began to feel intense abdominal pain on the right side of the body. The patient also started to lose appetite and became very weak. The abdominal pain (came and went) but lasted nearly 6 days and was very severe at times like being stabbed. Pain medications (Tylenol and Advil) helped mitigate some of the side effects. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with acetaminophen (TYLENOL) and ibuprofen (ADVIL). On 07Apr2021, the patient underwent rapid COVID-19 nasal swab test and the result was negative. The clinical outcome of the events intense abdominal pain on the right side of body like being stabbed, lose appetite and became very weak was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 08:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol high. The patient had no known allergies to medications, food or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and pseudoephedrine hydrochloride (SUDAFED) from an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other medications within four weeks prior to the COVID vaccine. 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 11Apr2021 at 18:00, the patient experienced strong metallic taste in mouth. The patient reported of strong metallic taste in mouth, the patient had shot on wednesday morning and taste appeared on sunday evening and had gone stronger on monday, as of tuesday that was still present. No therapeutic measures were taken as a result of reported 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 event strong metallic taste in mouth was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: Itchiness all over chest and arms 1 week later; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 05Apr2021 at 11:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication, started from unknown date, unknown if ongoing. The patient previously received clarithromycin (BIAXIN) on unknown date for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 09Apr2021, the patient underwent lab tests and procedures which included rapid nasal swab test, and the result was negative. On 11Apr2021 at 12:00, the patient experienced itchiness all over chest and arms 1 week later. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event itchiness all over chest and arms was 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: Body temperature, Chills, Feeling hot, Flushing, Headache
Clinical narrative: Body aches; cant sleep well; body is so hot; I feel chilled; Rash is itchy all over; Headache; Nausea; low-grade fever (99.5); skin started to feel flush; "a rash starting to form. The next day, I had a severe full-body rash"; This is a spontaneous report from a contactable consumer, the patient. A 28-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 06Apr2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included sulfamethoxazole (MANUFACTURER UNKNOWN) 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 been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 11Apr2021 at 15:00, 5 days after the vaccine, the patient got a headache, nausea, and a low-grade fever (99.5). The patient's skin started to feel flush, and noticed a rash starting to form. The next day on 12Apr2021, the patient had a severe full-body rash, body aches, and a continued headache. The patient couldn't sleep well because her body was so hot, yet felt chilled, and the rash was itchy all over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 12Apr2021, the patient underwent nasal swab test for COVID-19 and result was found to be negative and the patient also underwent saliva test for COVID-19 and result was pending. Therapeutic measures were taken as a result of the reported events and included treatment with unspecified antibiotic medications. The clinical outcome of the events headache, nausea, low-grade fever (99.5), skin started to feel flush, "a rash starting to form. The next day, the patient had a severe full-body rash", body aches, could not sleep, body was so hot, feel chilled, rash was itchy all over were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Poor quality sleep, Pyrexia, Rash
Clinical narrative: Body aches; cant sleep well; body is so hot; I feel chilled; Rash is itchy all over; Headache; Nausea; low-grade fever (99.5); skin started to feel flush; "a rash starting to form. The next day, I had a severe full-body rash"; This is a spontaneous report from a contactable consumer, the patient. A 28-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 06Apr2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included sulfamethoxazole (MANUFACTURER UNKNOWN) 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 been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 11Apr2021 at 15:00, 5 days after the vaccine, the patient got a headache, nausea, and a low-grade fever (99.5). The patient's skin started to feel flush, and noticed a rash starting to form. The next day on 12Apr2021, the patient had a severe full-body rash, body aches, and a continued headache. The patient couldn't sleep well because her body was so hot, yet felt chilled, and the rash was itchy all over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 12Apr2021, the patient underwent nasal swab test for COVID-19 and result was found to be negative and the patient also underwent saliva test for COVID-19 and result was pending. Therapeutic measures were taken as a result of the reported events and included treatment with unspecified antibiotic medications. The clinical outcome of the events headache, nausea, low-grade fever (99.5), skin started to feel flush, "a rash starting to form. The next day, the patient had a severe full-body rash", body aches, could not sleep, body was so hot, feel chilled, rash was itchy all over were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: Body aches; cant sleep well; body is so hot; I feel chilled; Rash is itchy all over; Headache; Nausea; low-grade fever (99.5); skin started to feel flush; "a rash starting to form. The next day, I had a severe full-body rash"; This is a spontaneous report from a contactable consumer, the patient. A 28-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 06Apr2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included sulfamethoxazole (MANUFACTURER UNKNOWN) 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 been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 11Apr2021 at 15:00, 5 days after the vaccine, the patient got a headache, nausea, and a low-grade fever (99.5). The patient's skin started to feel flush, and noticed a rash starting to form. The next day on 12Apr2021, the patient had a severe full-body rash, body aches, and a continued headache. The patient couldn't sleep well because her body was so hot, yet felt chilled, and the rash was itchy all over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 12Apr2021, the patient underwent nasal swab test for COVID-19 and result was found to be negative and the patient also underwent saliva test for COVID-19 and result was pending. Therapeutic measures were taken as a result of the reported events and included treatment with unspecified antibiotic medications. The clinical outcome of the events headache, nausea, low-grade fever (99.5), skin started to feel flush, "a rash starting to form. The next day, the patient had a severe full-body rash", body aches, could not sleep, body was so hot, feel chilled, rash was itchy all over were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.