chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: Fatigue day 3 till now; Breast tenderness 2 days from shot date; Dizziness and nausea day 2 after injection/ feeling light headed day 2 till now; Dizziness and nausea day 2 after injection; Eye pain; Headaches come and go from day 2 till today; Severe arm pain in left arm around injection/ 2 hrs after injection lasting 3 days; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 07Jul2021 at 12:00 (at the age of 36-years-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. Concomitant medications included colecalciferol (VIT D3), cyanocobalamin (B12), meclozine hydrochloride (BONINE), cetirizine hydrochloride (ZYRTEC), birth control and sambucus nigra (ELDERBERRY) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 07Jul2021 at 14:00, the patient experienced severe arm pain in left arm around injection/2 hrs after injection lasting 3 days. On 09Jul2021, the patient experienced breast tenderness 2 days from shot date, dizziness and nausea day 2 after injection and continued till the time of reporting 18Jul2021, feeling light headed day 2 till the time of reporting, eye pain and headaches come and go from day 2 till the time of reporting. On 10Jul2021, the patient experienced fatigue day 3 till the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arm pain in left arm around injection/ 2 hrs after injection lasting 3 days was resolved on 10Jul2021, after the duration of 3 days whereas breast tenderness, dizziness and nausea/feeling light headed, eye pain, headaches and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Fatigue day 3 till now; Breast tenderness 2 days from shot date; Dizziness and nausea day 2 after injection/ feeling light headed day 2 till now; Dizziness and nausea day 2 after injection; Eye pain; Headaches come and go from day 2 till today; Severe arm pain in left arm around injection/ 2 hrs after injection lasting 3 days; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 07Jul2021 at 12:00 (at the age of 36-years-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. Concomitant medications included colecalciferol (VIT D3), cyanocobalamin (B12), meclozine hydrochloride (BONINE), cetirizine hydrochloride (ZYRTEC), birth control and sambucus nigra (ELDERBERRY) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 07Jul2021 at 14:00, the patient experienced severe arm pain in left arm around injection/2 hrs after injection lasting 3 days. On 09Jul2021, the patient experienced breast tenderness 2 days from shot date, dizziness and nausea day 2 after injection and continued till the time of reporting 18Jul2021, feeling light headed day 2 till the time of reporting, eye pain and headaches come and go from day 2 till the time of reporting. On 10Jul2021, the patient experienced fatigue day 3 till the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arm pain in left arm around injection/ 2 hrs after injection lasting 3 days was resolved on 10Jul2021, after the duration of 3 days whereas breast tenderness, dizziness and nausea/feeling light headed, eye pain, headaches and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Shoulder pain; Hand pain; Arm pain; Knee pain; Foot pain; Stiffness; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 01Jun2021 at 00:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis which is ongoing and also asthma, high cholesterol, osteoarthritis, high blood pressure (BPH), COVID-19 and known allergy of shellfish.  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 fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), morniflumate (FLOMAX) and acetylsalicylic acid (ASPIRIN); from an unknown start date for an unknown indication and unknown if ongoing. 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 right arm on 10May2021 at 00:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 22Jun2021 the patient experienced shoulder pain, hand pain, arm pain, knee pain, foot pain and stiffness.  It was far more significant than any arthritis pain prior to that. The patient's osteoarthritis was in remission with no pain. The events did not result in doctor or other health care 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 shoulder pain, hand pain, arm pain, knee pain, foot pain and stiffness were not recovered at the time of this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: The day after vaccination, I have horrible body aches,; Chills; Low fever; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 19Jul2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included fluoxetine hydrochloride (PROZAC) for an unknown indication and combination birth control pill; both from an unknown date and unknown if ongoing. 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: EW0191) via an unspecified route of administration in the left arm on 28Jun2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 20Jul2021 at 03:00, the day after vaccination, the patient experienced horrible body aches, chills, low fever, nausea, and diarrhea. It came on very suddenly at 03:00. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with over the counter (OTC) pain medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible body aches, chills, low fever, nausea, and diarrhea were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: After the shot, my periods have been out of wack.; I'm on day four, and it's just spotting; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy in 2006 and 2012 and removal of tubes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patients period had been normal for the past 20 years except for when she was pregnant in 2006 and 2012. On 28May2021, after the shot, her periods had been out of wack. The patient was on her third period since her second dose, and her period was acting just like the last two, so she knew something was wrong. Usually, her second day of menstruation was her heaviest and had always been like that. The patient was on day four, and it was just spotting. Her last two periods were the same. She would spot for about four days, and then her period would arrive for just three days. Her regular periods were intense for the second to fourth day then would end on day five or six. The patient was reporting this because something was up with her cycle. She wouldn't get pregnant because she had removed her tubes, so it was not a pregnancy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events after the shot, periods had been out of wack, was on day four, and it was just spotting, last two periods were the same, she would spot for about four days, and then her period would arrive for just three days was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I was expecting my period end of April and I missed having a period then and the next month. I had a period end of June. So I missed my period for two month; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 14Apr2021 at 18:00 (at the age of 47-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. The patient did not receive any concomitant medications. On 28Apr2021, the patient expecting her period end of April and she missed having a period then and the next month. The patient had period at end of June. So, she missed her period for two month. It was also reported that highly unusual since she has been regular most of her life and does not suspect peri menopausal symptom. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 'I was expecting my period end of April and I missed having a period then and the next month. I had a period end of June. So I missed my period for two month' was unknown at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Adnexa uteri pain, Breast enlargement, Breast pain, Constipation
Clinical narrative: My menstrual cycle is all messed up. I am usually extremely regular and My periods have been coming late; My periods have been coming late, coming VERY heavy; Unusual ovarian pain; I am getting PMS symptoms like enlarged and painful breasts; I am getting PMS symptoms like enlarged and painful breasts; Bloating; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 06May2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone propionate (FLONASE) from an unknown date for an unknown indication. On 08May2021, the patient experienced menstrual cycle all messed up. The patient usually was extremely regular and periods had been coming late and very heavy, felt unusual ovarian pain, she was getting PMS symptoms like enlarged and painful breasts, bloating and constipation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle late, very heavy periods, unusual ovarian pain, enlarged and painful breasts, bloating and constipation was unknown at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: My menstrual cycle is all messed up. I am usually extremely regular and My periods have been coming late; My periods have been coming late, coming VERY heavy; Unusual ovarian pain; I am getting PMS symptoms like enlarged and painful breasts; I am getting PMS symptoms like enlarged and painful breasts; Bloating; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 06May2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone propionate (FLONASE) from an unknown date for an unknown indication. On 08May2021, the patient experienced menstrual cycle all messed up. The patient usually was extremely regular and periods had been coming late and very heavy, felt unusual ovarian pain, she was getting PMS symptoms like enlarged and painful breasts, bloating and constipation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle late, very heavy periods, unusual ovarian pain, enlarged and painful breasts, bloating and constipation was unknown at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Breast swelling, Breast tenderness, Dysmenorrhoea, Premenstrual syndrome
Clinical narrative: 3 Phantom periods in July. where I have all the premenstral symptoms and get intense mental cramps, but never get my period; 3 Phantom periods in July.   where I have all the premenstral symptoms and get intense mental cramps, but never get my period.; My breasts have been swollen and tender for at least 4 weeks....; breasts have been swollen and tender for at least 4 weeks; premenstral symptoms; 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: EW0217) via an unspecified route of administration in the left arm on 10Jun2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0182) via an unspecified route of administration in the arm right on 08May2021 (at the age of 40-year-old) 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 30Jun2021, the patient experienced three phantom periods in Jul2021, where the patient had all the premenstral symptoms and got intense menstrual cramps, but never got period. The patient's breasts had been swollen and tender for at least four weeks at the time of this report. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had been tested for COVID-19. On 02Jun2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 16Jun2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 08Jul2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 14Jul2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the event three phantom periods where the patient had all the premenstral symptoms and got intense menstrual cramps, but never got period, breasts had been swollen and tender for at least four weeks, was not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: 3 Phantom periods in July. where I have all the premenstral symptoms and get intense mental cramps, but never get my period; 3 Phantom periods in July.   where I have all the premenstral symptoms and get intense mental cramps, but never get my period.; My breasts have been swollen and tender for at least 4 weeks....; breasts have been swollen and tender for at least 4 weeks; premenstral symptoms; 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: EW0217) via an unspecified route of administration in the left arm on 10Jun2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0182) via an unspecified route of administration in the arm right on 08May2021 (at the age of 40-year-old) 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 30Jun2021, the patient experienced three phantom periods in Jul2021, where the patient had all the premenstral symptoms and got intense menstrual cramps, but never got period. The patient's breasts had been swollen and tender for at least four weeks at the time of this report. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had been tested for COVID-19. On 02Jun2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 16Jun2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 08Jul2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 14Jul2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the event three phantom periods where the patient had all the premenstral symptoms and got intense menstrual cramps, but never got period, breasts had been swollen and tender for at least four weeks, was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Periods have been horrible; Very upset; This is a spontaneous report from a contactable consumer. An adult female patient in her 40's (as reported) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown that patient did 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: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 23Jul2021 at 12:00, reporter was food shopping and a lady came up to the reporter because reporter was wearing her Pfizer Mask and abruptly yelled that on an unknown date, patient's periods had been horrible ever since she received the Pfizer vaccine and patient was very upset and then she stormed off and left the store. The reporter had no information just that patient looked in her 40's and short dark hair. The reporter had no other information to give. It was unknown whether any therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events periods have been horrible and very upset was unknown 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; Lightheaded; Anxious; Vomiting; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 23Jul2021at 16:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, allergy to nickel and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included daily vitamins (unspecified), azithromycin (MANUFACTURER UNKNOWN) and guaifenesin (MUCINEX) for unknown indications from an unknown date and unknown if ongoing. The patient previously took promethazine hydrochloride / dextromethorphan hydrobromide (PROMETHAZINE DM) and amoxicillin / clavulanic acid (AUGMENTIN) for unknown indications on an unknown date and experienced drug allergy. On 23Jul2021 at 16:45, the patient experienced diarrhea, nausea, lightheaded, anxious and vomiting. 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 diarrhea, nausea, lightheaded, anxious and vomiting were recovered on unknown date in Jul2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Hot flush, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Hot flashes; Sore throat; Nasal drip; Difficulty concentrating; This is a spontaneous report from a non-contactable consumer, the patient. A 42-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 19Jul2021 at 16:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN), all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 19Jul2021 at 23:15, the patient experienced hot flashes, sore throat, nasal drip and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events experienced hot flashes, sore throat, nasal drip and difficulty concentrating was 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; Aches; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 19-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 29Jul2021 at 08:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Jul2021 at 09:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Jul2021 at 21:00, the patient experienced chills, aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches and headache was unknown 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Pain
Clinical narrative: Widespread body aches; Irregular menstrual cycles; Heavy menstrual bleeding; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 27Jul2021 at 10:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. On 28Jul2021, the patient experienced widespread body aches, irregular menstrual cycles and heavy menstrual bleeding. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event widespread body aches, irregular menstrual cycles and heavy menstrual bleeding were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle affected; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Jun2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 an unknown date in 2021, the patient's menstrual cycle affected. The clinical outcome of the event menstrual cycle affected was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Got urticaria after 4 days when got Pfizer vaccination; 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: EW0173) via an unspecified route of administration in the right arm on 24Jul2021 at 16:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received tetanus vaccine (MANUFACTURER UNKNOWN) and experienced allergy to vaccine (reported as allergies to tetanus needles). On 28Jul2021 at 16:30, 4 days after getting the Pfizer vaccination, the patient experienced urticaria. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with cetirizine (ZYRTEC). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event urticaria was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Neuralgia, Vaccination site pain
Clinical narrative: I had nerve pain down my left arm; Injection site pain; Face numbness; I also still have a headache that has not gone away 3 days later.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on an unknown date in Jul2021 at 19:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included mild cerebral palsy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/norgestimate (SPRINTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received cefaclor (CECLOR) for an unknown indication on an unknown date and experienced drug allergy. On 29Jul2021 at 00:00, after first dose, the patient experienced nerve pain down her left arm, injection site pain, face numbness and also still had a headache that had not gone away 3 days later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain down her left arm, injection site pain, face numbness and also still had a headache that had not gone away 3 days later was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: Extreme headache; Sick; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on an unknown date in Jul2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and 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 escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown start date and unknown if ongoing. On an unknown date in Jul2021, about 10 mins after receiving the first dose, the patient experienced extreme headache. It was making the patient sick and was right behind the ears and the patient had never had a headache here before and that bad. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme headache and sick was not recovered at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Occasionally, joint swelling occurs with the pain.; Moderate to severe full-body joint pain for 24 hours, followed by long term, followed by long term, intermittent mild to moderate joint pain, primarily in hands and arms (but can occur in any joint); This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6198) via an unspecified route of administration in the left arm on 27Feb2021 at 08:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, acid reflux, migraine, hyperacusis and known allergies to penicillin and its relatives. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 28Feb2021 at 18:30, the patient experienced moderate to severe full-body joint pain for 24hours, followed by long term, intermittent mild to moderate joint pain primarily in hands and arms (but can occur in any joint) that persisted till the time of reporting. Occasionally, joint swelling occurred with the pain. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the events. The clinical outcome of the event moderate to severe full-body joint pain for 24hours, followed by long term, intermittent mild to moderate joint pain primarily in hands and arms (but can occur in any joint), occasionally, joint swelling occurred with the pain was resolved with sequelae on unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Magnetic resonance imaging, Neck pain
Clinical narrative: my right knee that caused excruciating pain, extreme swelling; My right knee that caused excruciating pain/shoulder area started hurting; left shoulder/neck area started hurting.; This is spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- 8731) via an unspecified route of administration in left arm on 14Apr2021 13:00 as dose 2, single (at the age of 65-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/Drug store. The patient was not pregnant at time of vaccination. The patient had no COVID prior vaccination, was not COVID tested post vaccination. The patient took no other vaccine in four weeks. Patient medical history included sinus issues, allergies to penicillin. The concomitant medications included amlodipine besylate, pramipexole, estradiol patch all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 6955) via an unspecified route of administration in left arm on 24Mar2021 at 14:45 as dose 1, single for COVID-19 immunization. The patient stated that an arthritic attack in her right knee that caused excruciating pain, extreme swelling on 01May2021. She never had knee pain before nor any arthritis. About a month later her left shoulder/neck area started hurting on 01May2021 (as reported). Was not sure what that was and still it hurted. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated for the adverse events were treated with MRI, 4 weeks PT, steroid shot in knee. The patient underwent lab test and procedure which included MRI with unknown result on an unspecified date. The outcome of the events resolved with sequel on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, Emotional disorder
Clinical narrative: Swollen face; Sudden fever; Dizziness; Chest pain; Difficulty breathing deep; Coughing when breathing deep; Overly emotional; All around feeling ill; Tired/sleeping a lot; Tired/sleeping a lot; Severe arm pain; Legs feeling heavy/throbbing; Legs feeling heavy/throbbing; This is a spontaneous report from a non-contactable consumer, the patient. A 12-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 01Aug2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of 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 in the left arm on 11Jul2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. On 02Aug2021 at 09:15, the patient experienced swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing. 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 and included treatment with diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing was 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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Limb discomfort, Malaise, Pain in extremity
Clinical narrative: Swollen face; Sudden fever; Dizziness; Chest pain; Difficulty breathing deep; Coughing when breathing deep; Overly emotional; All around feeling ill; Tired/sleeping a lot; Tired/sleeping a lot; Severe arm pain; Legs feeling heavy/throbbing; Legs feeling heavy/throbbing; This is a spontaneous report from a non-contactable consumer, the patient. A 12-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 01Aug2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of 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 in the left arm on 11Jul2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. On 02Aug2021 at 09:15, the patient experienced swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing. 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 and included treatment with diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing was 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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: Swollen face; Sudden fever; Dizziness; Chest pain; Difficulty breathing deep; Coughing when breathing deep; Overly emotional; All around feeling ill; Tired/sleeping a lot; Tired/sleeping a lot; Severe arm pain; Legs feeling heavy/throbbing; Legs feeling heavy/throbbing; This is a spontaneous report from a non-contactable consumer, the patient. A 12-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 01Aug2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of 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 in the left arm on 11Jul2021 at 14:30 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. On 02Aug2021 at 09:15, the patient experienced swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing. 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 and included treatment with diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen face, sudden fever, dizziness, chest pain, difficulty breathing deep, coughing when breathing deep, overly emotional, all around feeling ill, tired/sleeping a lot, severe arm pain and legs feeling heavy/throbbing was 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.