chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: she had large raised, red area around injection site, today looks less swollen; she had large raised, red area around injection site, today looks less swollen/left arm swollen; left arm hard; caller is thinking the vaccine was admistered subcutaneously and not in the muscle/felt like the injection did not go into her muscle; This is a spontaneous report from a contactable consumer(patient) via a Pfizer Sponsored Program Support.  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number:ER8731) subcutaneous, administered in Arm Left on 16Apr2021 07:50(at the age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included overweight, migraine. Concomitant medication included naproxen sodium, sumatriptan succinate (TREXIMET) taken for migraine, start and stop date were not reported.  The patient previously received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number:ER8727) Injection administered on Arm left on 23Mar2021 for COVID-19 immunisation and imitrex for migraine. Patient had the second vaccine Pfizer on Friday and when she was given injection she jumped. The patient is thinking the vaccine was administered subcutaneously and not in the muscle Stated that it did not feel like it went into her muscle at the time. Patient had large raised, red area around injection site Stated that since Friday it was swollen. Stated that it was swollen Friday, Saturday and Sunday and has went down a little bit. Stated that she is afraid it went in subcutaneously. Clarified that it is her left arm that was affected and stated again that she is afraid if the second dose did not go in correctly that she is not fully protected. Stated that she did not feel the same kind of expansion like the first dose. Patient took Imitrex injections and has the same type reaction. Stated that she does not think that it goes into the skin. It was more than five years ago that she had this happen and was taking them. Stated that she stopped taking Imitrex. Stated that she takes a different medication now because she is scared of the shot. Later stated that she still takes Imitrex but that it has something added to it and is called Treximate now. Patient Stated that she put ice on her arm and took some Tylenol. The outcome of the events Incorrect route of product administration was not recovered and for Vaccination site erythema unknown and for all other events recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (19Apr2021): This is a follow-up spontaneous report from a contactable consumer includes: age, age at vaccination, historical vaccine, past drug, concomitant medication and new event(Pain in extremity) were added.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site pain
Clinical narrative: Pain at injection site for 48+ hours; Slight swelling of face; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0171) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and heart disorder. The patient had no known allergies to medications, food or other products not to his knowledge. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received other unspecified medications in two weeks of vaccination. On 19Apr2021 at 16:00, the patient experienced pain at injection site for 48+ hours and slight swelling of face. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site for 48+ hours and slight swelling of face were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: Eye was swollen; Lips were swollen; Itching really bad to where it burned; Hives all over body; Two days later the welts continued; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient has no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and trazodone (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 16:00, two days after the first dose of vaccination the patient experienced itching really bad to where it burned and that night had hives all over the body. On 19Apr2021, the welts continued and patient 's eye was swollen and that night lips were swollen. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prednisone  (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), and famotidine (PEPCID)  till it cleared up. The clinical outcome of the event itching really bad to where it burned, hives all over body, the welts continued, eye was swollen and lips were swollen was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: Heart palpitations; Tightness in chest; Shortness of breath; Fever; Chills; Headache; Nausea; 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: Ew0169) via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and had known allergies to wheat and gluten. 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 vaccination. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN), vitamin B (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), levoglutamide (L GLUTAMINE) and iron (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication and unknown if ongoing. On 16Apr2021, the first two days, the patient experienced fever, chills, headache and nausea, felt fine but had these symptoms again. On 21Apr2021 at 03:00 (about 6 days after vaccination), the patient woke up with heart palpitations, tightness in chest and shortness of breath. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, nausea, heart palpitations, tightness in chest and shortness of breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Heart palpitations; Tightness in chest; Shortness of breath; Fever; Chills; Headache; Nausea; 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: Ew0169) via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and had known allergies to wheat and gluten. 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 vaccination. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN), vitamin B (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), levoglutamide (L GLUTAMINE) and iron (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication and unknown if ongoing. On 16Apr2021, the first two days, the patient experienced fever, chills, headache and nausea, felt fine but had these symptoms again. On 21Apr2021 at 03:00 (about 6 days after vaccination), the patient woke up with heart palpitations, tightness in chest and shortness of breath. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, nausea, heart palpitations, tightness in chest and shortness of breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up; rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up; rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and known allergy to penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. On 21Apr2021 at 01:00, about 12 hours after receiving the second dose of vaccine, the patient experienced a rapid onset of aches and chills that in the beginning caused fairly violent shivering as a fever built up. The patient took multiple readings as he bundled up and turned up the heat with temperature climbing to 100.3. 12 hours later symptoms continued although were improving. The patient once had a similar reaction to a flu shot in the past. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 21Apr2021, the patient underwent body temperature test and the result was 100.3 (unspecified unit). Therapeutic measures were taken as a result of events and included treatment with 400mg of ibuprofen from 21Apr2021 and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, chills and fever were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Achy; Chills; Fever; Fatigue; This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously received unspecified vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 for immunisation. On an unknown date in Apr2021, the patient experienced achy, chills, fever and fatigue. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events achy, chills, fever and fatigue were resolved on an unknown date in Apr-2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up in the night with chills, shakes, and feverish symptoms; Woke up in the night with chills, shakes, and feverish symptoms; Woke up in the night with chills, shakes, and feverish symptoms; Soreness of the body; Headache; Slight soreness of the arm; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 21-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.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously 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 30Mar2021 at 11:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced slight soreness of the arm later in that day. On 21Apr2021 at 03:00, the patient woke up in the night with chills, shakes, feverish symptoms, soreness of the body and headache. 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 event slight soreness of the arm was resolved on an unknown date in Apr2021 and of the events woke up in the night with chills, shakes, feverish symptoms, soreness of the body and headache was resolved on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Woke up in the night with chills, shakes, and feverish symptoms; Woke up in the night with chills, shakes, and feverish symptoms; Woke up in the night with chills, shakes, and feverish symptoms; Soreness of the body; Headache; Slight soreness of the arm; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 21-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.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously 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 30Mar2021 at 11:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced slight soreness of the arm later in that day. On 21Apr2021 at 03:00, the patient woke up in the night with chills, shakes, feverish symptoms, soreness of the body and headache. 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 event slight soreness of the arm was resolved on an unknown date in Apr2021 and of the events woke up in the night with chills, shakes, feverish symptoms, soreness of the body and headache was resolved on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Hot flush
Clinical narrative: Intense chills; 101 degree fever; Muscle pain; Headache; Nausea; Intense dizziness; Skin pain; Tooth pain; Hot flashes; 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: ew0150) via an unspecified route of administration in the left arm on 19Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. It was reported that the patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram hydrobromide (CELEXA) 40mg taken for an unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 20Apr2021 at 05:00, the patient experienced intense chills, 101 degree fever, headache, nausea, intense dizziness, muscle pain, skin pain, tooth pain, hot flashes and scared to hold her newborn child. 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 intense chills, 101 degree fever, headache, nausea, intense dizziness, muscle pain, skin pain, tooth pain and hot flashes was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain of skin, Pyrexia, Toothache
Clinical narrative: Intense chills; 101 degree fever; Muscle pain; Headache; Nausea; Intense dizziness; Skin pain; Tooth pain; Hot flashes; 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: ew0150) via an unspecified route of administration in the left arm on 19Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. It was reported that the patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram hydrobromide (CELEXA) 40mg taken for an unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 20Apr2021 at 05:00, the patient experienced intense chills, 101 degree fever, headache, nausea, intense dizziness, muscle pain, skin pain, tooth pain, hot flashes and scared to hold her newborn child. 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 intense chills, 101 degree fever, headache, nausea, intense dizziness, muscle pain, skin pain, tooth pain and hot flashes was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faecal calprotectin, Faecal calprotectin increased, Fatigue, Gastroenteritis viral
Clinical narrative: Calprotectin level was at 3,000 mcg; acute diarrhea (6-10 times a day); thought it was the stomach flu; fatigue; This is a spontaneous report from a contactable consumer or other non-HCP. A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 20Mar2021 as dose 2, single (at the age of 40-years-old) for COVID-19 immunization. Medical history included BRCA1+ (BRCA1 gene mutation) from an unknown date and unknown if ongoing, chronic migraine and known allergies to Sulpha. Concomitant medications/ other medications the patient received within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA); armodafinil; levothyroxine; omeprazole (PRILOSEC [OMEPRAZOLE]). Facility where the most recent COVID-19 vaccine was administered mentioned as Health Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 07:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. On 03Apr2021 10:00 the patient experienced acute diarrhea (6-10 times a day). At first patient thought it was the stomach flu, fatigue. After 10 days patient did a stool sample and my Calprotectin level was at 3,000 mcg on 13Apr2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the Adverse events. The patient underwent lab tests and procedures which included stool sample/Calprotectin level (faecal calprotectin): 3000 ug on 13Apr2021; SARS-CoV-2 RNA (COVID-19), Qualitative, NAAT (sars-cov-2 test): Negative Nasal Swab on 04Apr2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Calprotectin level was at 3,000 mcg; acute diarrhea (6-10 times a day); thought it was the stomach flu; fatigue; This is a spontaneous report from a contactable consumer or other non-HCP. A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 20Mar2021 as dose 2, single (at the age of 40-years-old) for COVID-19 immunization. Medical history included BRCA1+ (BRCA1 gene mutation) from an unknown date and unknown if ongoing, chronic migraine and known allergies to Sulpha. Concomitant medications/ other medications the patient received within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA); armodafinil; levothyroxine; omeprazole (PRILOSEC [OMEPRAZOLE]). Facility where the most recent COVID-19 vaccine was administered mentioned as Health Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 07:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. On 03Apr2021 10:00 the patient experienced acute diarrhea (6-10 times a day). At first patient thought it was the stomach flu, fatigue. After 10 days patient did a stool sample and my Calprotectin level was at 3,000 mcg on 13Apr2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the Adverse events. The patient underwent lab tests and procedures which included stool sample/Calprotectin level (faecal calprotectin): 3000 ug on 13Apr2021; SARS-CoV-2 RNA (COVID-19), Qualitative, NAAT (sars-cov-2 test): Negative Nasal Swab on 04Apr2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: Severe dizziness and nausea appeared suddenly three (3) days after getting the first vaccine; Severe dizziness and nausea appeared suddenly three (3) days after getting the first vaccine; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 10Apr2021 at 17:00, 3 days after getting the first vaccine, the patient suddenly experienced severe dizziness and nausea. The symptoms lasted for over 11 days and were still going at the time of this report. Dizziness was less severe at day 11 but was still there. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified nausea and dizziness medications. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent SARS-CoV-2 RNA, QL, RT PCR test and the result was found to be negative. The clinical outcome of the events severe dizziness and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever; Tiredness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from on an unknown date in Feb2021 and ended on 20Feb2021. The patient had no known allergies to food, medications or other products. 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 vaccination. On 10Apr2021, the patient had fever, tiredness and fatigue since the day patient took the first shot of vaccine. It had been 12 days and still the patient had fever up to 101.6. The patient had COVID-19 during the month of Feb2021 and quarantine ended on 20Feb2021 and therefore felt chances of having corona were highly unlikely. On an unknown date in Apr2021, the patient underwent body temperature and the result was up to 101.6 (units unspecified). No therapeutic measures were taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The clinical outcome of the events fever, tiredness and fatigue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, SARS-CoV-2 test
Clinical narrative: Cough; By the afternoon after the 2nd vaccine, flu-like symptoms started-flu-like symptoms started -body aches, chills, fatigue, earache, headache.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (COMIRNATY; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 15:00, the patient experienced by the afternoon after the 2nd vaccine, flu-like symptoms started which included body aches, chills, fatigue, earache and headache. These lasted 48 hours. The headache, fatigue and body aches continued. On 13Apr2021, the patient experienced cough. It had been 22 days now and still have cough and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of flu-like symptoms started-body aches, chills, fatigue, earache and headache and included treatment with antibiotics. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events flu-like symptoms started-body aches, chills, fatigue, earache, headache and cough was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Started period week early; Have been bleeding very heavily like never before; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0151) via an unspecified route of administration in the right arm on 16Apr2021 (both at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), tizanidine (MANUFACTURER UNKNOWN) and hydrocodone bitartrate/ paracetamol (NORCO); all on an unknown date for unknown indication and unknown if ongoing. On 13Apr2021, the patient period started week early, had been bleeding very heavily like never before. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period started week early and had been bleeding very heavily like never before were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Premenstrual syndrome
Clinical narrative: Strong PMS symptoms; Extremely heavy periods; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 08Mar2021 at 09:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and rosemary allergy. The patient did not receive any medication within two weeks of vaccination. 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 an unknown date in Mar2021, the patient experienced strong Premenstrual  symptoms (PMS) for three for three days after each dose, and on top of regular PMS for the month and also, extremely heavy periods after each dose, had to change out pads every four hours instead of eight. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 event strong PMS symptoms was recovered on an unknown date in Mar2021. The clinical outcome of the event extremely heavy periods was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Pain
Clinical narrative: Shoulder pain/ Joint pain; Body ache; Stomach upset; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PF12ERER8729) via an unspecified route of administration in the right arm on 05Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included clinical hyperthyroidism and allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal teas (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: BFEBNTEP6955) via an unspecified route of administration in the right arm on 18Mar2021 at 08:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced shoulder pain, body ache, joint pain and stomach upset. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shoulder pain/ joint pain, body ache and stomach upset was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Inappropriate schedule of product administration, Nausea, Somnolence
Clinical narrative: Headache; Nausea; Vomiting; Diarrhea; Drowsiness; Dose 1: 22Mar2021, Dose 2: 05Apr2021; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis. The patient had no known allergies to food, medications or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient 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 on 22Mar2021 at 13:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 05:00, the patient experienced headache, nausea, vomiting, diarrhea and drowsiness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, vomiting, diarrhea and drowsiness was resolving at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Nausea; Vomiting; Diarrhea; Drowsiness; Dose 1: 22Mar2021, Dose 2: 05Apr2021; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis. The patient had no known allergies to food, medications or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient 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 on 22Mar2021 at 13:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 05:00, the patient experienced headache, nausea, vomiting, diarrhea and drowsiness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, vomiting, diarrhea and drowsiness was resolving at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Sore at injection site; All over body aches; Slight fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO164) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received ibuprofen; diphenhydramine citrate (ADVIL PM) and experienced drug allergy with the blue dye present in it; glutamate sodium (MONOSODIUM GLUTAMATE) and also experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 16:00, the patient experienced sore at injection site, all over body aches, slight fever and fatigue. 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 sore at injection site, all over body aches, slight fever and fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Tinnitus
Clinical narrative: Extreme ringing in ears.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Mar2021 at 14:00 (at the age of 58-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 10Mar2021 at 14:00, the patient experienced extreme ringing in ears. CATSCAN revealed nothing except extreme ringing in ears. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient underwent CATSCAN, revealed nothing except extreme ringing in ears. Therapeutic measures were taken as a result of the event which included tests to figure out what was going on. The clinical outcome of the event extreme ringing in ears was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweats; chills; muscle aches; Joint pain; Headaches; Fatigue; Insomnia; Mouth sores; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 15:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:00, the patient experienced sweats, chills, muscle aches, joint pain, headaches, fatigue, insomnia and mouth sores. 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 event sweats, chills, muscle aches, joint pain, headaches, fatigue, insomnia and mouth sores was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Stomatitis
Clinical narrative: Sweats; chills; muscle aches; Joint pain; Headaches; Fatigue; Insomnia; Mouth sores; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 15:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:00, the patient experienced sweats, chills, muscle aches, joint pain, headaches, fatigue, insomnia and mouth sores. 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 event sweats, chills, muscle aches, joint pain, headaches, fatigue, insomnia and mouth sores was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.