chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash on inside elbow of right arm for 10 days; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 16Apr2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, polycystic ovarian syndrome (PCOS) 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 19Mar2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced rash on inside elbow of right arm for 10 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. On 17Apr2021, the patient underwent  SARS-CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event rash on inside elbow of right arm for 10 days 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy back/ stomach; Red face; This is a spontaneous report from a contactable pharmacist. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 25Apr2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had medical history. It was unknown whether the patient had known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had concomitant medications. It was unknown whether the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. On 25Apr2021, the patient experienced itchy back and stomach, red face. 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. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events itchy back and stomach, red face was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on neck, both arms and abdomen; This is a spontaneous report from a contactable healthcare professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy pills from an unknown start date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 11:00, the patient experienced hives on neck, both arms and abdomen and they did not itch. The patient experienced hives after the first dose, but did not report because thought that would go away then the patient got more hives after the second dose. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the event hives on neck, both arms and abdomen were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 24Apr2021 at 10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones.  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 paracetamol (TYLENOL) and salicylamide/ caffeine/ acetylsalicylic acid (EXCEDRIN); both for an unknown indication from an unknown dates and unknown if ongoing. The patient previously took ciprofloxacin (CIPRO) and levofloxacin (LEVAQUIN) for an unknown indication on an unknown dates and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8730) via an unspecified route of administration in the left arm on 03Apr2021 at10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 11:45, the patient experienced severe headache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Extremely fatigued; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included oral contraceptives (unspecified) for an unknown indication, from an unknown date and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 17Apr2021, the patient felt extremely fatigued and dizzy every day and it had been 11 days post vaccine at the time of report. 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 extremely fatigued and dizzy was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Diarrhea for 4 days so far; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Apr2021, the patient underwent reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 via nasal swab and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination included curcuma longa rhizome (TURMERIC) for unknown indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced diarrhea, which was there for 4 days till the time of report. 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 been tested for COVID-19. On an unknown date in Apr2021, post vaccination the patient underwent test for COVID-19 and the result was not known. The clinical outcome of the event diarrhea for 4 days till the time of report was resolving 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: Loose stool; Really bad chills; High fever/erratic fever; Vomited twice; Strong fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0777) via an unspecified route of administration in the right arm on 23Apr2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heart beat and heart murmur. 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 ibuprofen (ADVIL) 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: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 00:00, night of second vaccine, the patient experienced really bad chills, high fever and vomited twice. On 24Apr2021, 1 day after the vaccination the patient had erratic fever and strong fatigue. On 25Apr2021, 2 days after the vaccination the patient experienced loose stool. 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 really bad chills, high fever, vomited twice, strong fatigue and loose stool were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pruritus, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: After I fell asleep I woke up around 2 am with fever and chills; After I fell asleep I woke up around 2 am with fever and chills; rash and itching on my abdomen, face, arms, and lower pelvis.; rash and itching on my abdomen, face, arms, and lower pelvis.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration on the right arm on 20Apr2021 at 09:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure (with medications blood pressure was normal then) and known allergy to latex. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) 150 mcg; lisinopril (MANUFACTURER UNKNOWN) and diltiazem (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 21Apr2021 at 02:00, the patient woke up with fever and chills, rash. The patient then went back to sleep and woke up with rash and itching on abdomen, face, arms and lower pelvis. On 25Apr2021 (reported as today), even with benadryl and hydrocortisone cream (prescribed by the doctor), the patient was still itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events rash and itching on abdomen, face, arms and lower pelvis and included treatment with diphenhydramine hydrochloride (BENADRYL) and hydrocortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had been tested for COVID-19. On 22Apr2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events fever, chills, rash and itching on abdomen, face, arms and lower pelvis was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Throat irritation, Urticaria
Clinical narrative: Approx 12 hours after receiving vaccine, developed hives on chest and stomach, itchy throat, itchy eyes.; Itchy throat; Itchy eyes; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 13Apr2021 at 10:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known seasonal 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 lithium (MANUFACTURER UNKNOWN) and prazosin (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. On 13Apr2021 at 22:15, approximately 12 hours after receiving vaccine, the patient developed hives on chest and stomach, itchy throat and itchy eyes. 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. Therapeutic measures were taken as a result of hives on chest and stomach, itchy throat and itchy eyes and included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the events hives on chest and stomach, itchy throat and itchy eyes was recovered on an unknown date on Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Sore left arm; fever; nausea with 1 vomit occurrence; nausea with 1 vomit occurrence; headache; chills; tiredness; aches; This is a spontaneous report from a contactable consumer, the patient. A 46-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 left arm on 23Apr2021 at 16:45 (at the age of 46-year-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. The patient did not receive any concomitant medications within two weeks prior to the COVID-19 vaccine. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP9533) via an unspecified route of administration in the left arm on 02Apr2021 at 16:00 as a single dose for COVID-19 immunisation. On 23Apr2021 (also reported as at 02:00), the patient experienced sore left arm (getting better), fever up to 101.5 degrees (climbing to 101.5 currently), nausea with 1 vomit occurrence (no longer present), headache (somewhat better), chills (better), tiredness (somewhat better) and aches (still existed). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included self-treatment with paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea with 1 vomit occurrence was recovered on an unknown date in Apr2021. The clinical outcome of the events sore left arm, headache, chills and tiredness were recovering while that of the event fever and aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Sore left arm; fever; nausea with 1 vomit occurrence; nausea with 1 vomit occurrence; headache; chills; tiredness; aches; This is a spontaneous report from a contactable consumer, the patient. A 46-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 left arm on 23Apr2021 at 16:45 (at the age of 46-year-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. The patient did not receive any concomitant medications within two weeks prior to the COVID-19 vaccine. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP9533) via an unspecified route of administration in the left arm on 02Apr2021 at 16:00 as a single dose for COVID-19 immunisation. On 23Apr2021 (also reported as at 02:00), the patient experienced sore left arm (getting better), fever up to 101.5 degrees (climbing to 101.5 currently), nausea with 1 vomit occurrence (no longer present), headache (somewhat better), chills (better), tiredness (somewhat better) and aches (still existed). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included self-treatment with paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea with 1 vomit occurrence was recovered on an unknown date in Apr2021. The clinical outcome of the events sore left arm, headache, chills and tiredness were recovering while that of the event fever and aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: Sick after 2nd Covid vacinne and need to go to the emergency room; This is a spontaneous report based on the information received by Health Authority (MFR Control No. 2021US001298). A contactable 55-year-old female consumer (patient) reported for herself. A 55-year-old adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 (Therapy Dates reported as 29Mar2021/29Mar2021 and therapy duration: 1 day) (Age at vaccination: 55-year-old) as DOSE 2, SINGLE for COVID-19 immunization, it was mentioned that, product used for unknown indication and abaloparatide (TYMLOS), via an unspecified route of administration from an unspecified date (Batch/Lot Number: RT02101; Expiration Date: Jan2023) unknown route of administration and ongoing, at 80 ug, daily for an unspecified indication. Therapy Dates: Ongoing and therapy duration was unknown. Medical history included ongoing osteoporosis and coagulopathy (Clotting disorder and Taking blood thinners). Concomitant medication was not reported. On 29Mar2021 sick after 2nd COVID vaccine and need to go the emergency room. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Migraine
Clinical narrative: Severe migraine; Medicine taste in back of throat; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 25Apr2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergy to bee venom. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included biotin (MANUFACTURER UNKNOWN), B-12 (MANUFACTURER UNKNOWN) and methadone (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Apr2021 at 10:30, the patient experienced severe migraine (all day, so far) and medicine taste in back of throat. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events migraine and medicine taste in back of throat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Heavy menstrual bleeding, Menstruation irregular, Oligomenorrhoea, Oral herpes
Clinical narrative: Heavy menstrual cycle; Longer menstrual cycle.; Then one week later another menstrual cycle; Tender breasts; Cold sore on mouth; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second 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 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cold sores on mouth 10 years ago. The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6285) via an unspecified route of administration in the left arm on 01Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced heavy menstrual cycle, longer menstrual cycle, and one week later, she had another menstrual cycle. The patient also reported tender breasts and cold sore on mouth (had not had a cold sore in 10 years). 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events longer menstrual cycle/heavy menstrual cycle, another menstrual cycle a week later, tender breasts and cold sore on mouth was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Herpes simplex, Intermenstrual bleeding
Clinical narrative: Diarrhea/stomach cramps (72 hours); Diarrhea/stomach cramps (72 hours); Fatigue and sore arm (24 hours); Fatigue and sore arm (24 hours); HSV2 outbreak (1 week); Menstrual spotting; Hormonal mood swings; This is a spontaneous report from a 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:  EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 07:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex. The patient had known allergies to amoxicillin and pine nut. 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 not received any medication within two weeks of vaccination. On 01Apr2021 at 12:00, the patient experienced diarrhea/stomach cramps (72 hours), fatigue and sore arm (24 hours), HSV2 outbreak (1 week), menstrual spotting and hormonal mood swings (first instance of spotting in history of menstrual cycle). The event resulted in doctor or other healthcare professional office/clinic visit. 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, fatigue and sore arm was recovered on 02Apr2021. The clinical outcome of the events stomach cramps/diarrhea was recovered on 04Apr2021. The clinical outcome of the event HSV2 outbreak was recovered on 08Apr2021. The clinical outcome of the events, menstrual spotting and hormonal mood swings was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mood swings, Pain in extremity
Clinical narrative: Diarrhea/stomach cramps (72 hours); Diarrhea/stomach cramps (72 hours); Fatigue and sore arm (24 hours); Fatigue and sore arm (24 hours); HSV2 outbreak (1 week); Menstrual spotting; Hormonal mood swings; This is a spontaneous report from a 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:  EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 07:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex. The patient had known allergies to amoxicillin and pine nut. 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 not received any medication within two weeks of vaccination. On 01Apr2021 at 12:00, the patient experienced diarrhea/stomach cramps (72 hours), fatigue and sore arm (24 hours), HSV2 outbreak (1 week), menstrual spotting and hormonal mood swings (first instance of spotting in history of menstrual cycle). The event resulted in doctor or other healthcare professional office/clinic visit. 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, fatigue and sore arm was recovered on 02Apr2021. The clinical outcome of the events stomach cramps/diarrhea was recovered on 04Apr2021. The clinical outcome of the event HSV2 outbreak was recovered on 08Apr2021. The clinical outcome of the events, menstrual spotting and hormonal mood swings was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: The heaviest and most painful menstrual period of my life.; The heaviest and most painful menstrual period of my life.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 lisinopril (MANUFACTURER UNKNOWN), colestipol (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for unknown indications from an unknown date and unknown if ongoing. On 21Apr2021 at 12:00, the patient experienced heaviest and most painful menstrual period in life. 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 heaviest and most painful menstrual period of in life was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test
Clinical narrative: ''My'' period was 8 days late with multiple negative pregnancy tests. ''My'' cycle usually runs 28 days like clockwork and ''my'' period was due on the 17th but did not start until the 25th making ''my'' cycle 36 day; 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: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 18:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 17Apr2021, the patient experienced her period was 8 days late with multiple negative pregnancy tests. Her cycle usually run 28 days like clock-work and her period was due on the 17Apr2021 but did not start until the 25Apr2021 making her cycle 36 days. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. On an unknown date in Apr2021, the patient underwent pregnancy test multiple times and the results were negative. The clinical outcome of the event period was 8 days late was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Body aches; Intense muscle pain in right arm, unable to lift more than half way up; Temperature reached a maximum of 101.8 degrees F; Headache; Swollen lymph nodes under right arm; Bruising at inject site; Tenderness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 23Apr2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The medical history included reactive airways disease, allergies to certain trees, weeds, grasses, molds, rodents and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 31Mar2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 20:00, the patient experienced body aches, intense muscle pain in right arm, unable to lift more than half way up, temperature reached a maximum of 101.8 degrees F, headache, swollen lymph nodes under right arm, bruising at inject site and tenderness at injection site. On the same day, the patient underwent body temperature test and the result was 101.8 degrees fahrenheit. The adverse events did not result 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 reported events which included treatment with acetaminophen (MANUFACTURER UNKNOWN) according to the direction given. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, intense muscle pain in right arm, unable to lift more than half way up, temperature reached a maximum of 101.8 degrees F, headache, swollen lymph nodes under right arm, bruising and tenderness at injection site were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site bruising, Vaccination site pain
Clinical narrative: Body aches; Intense muscle pain in right arm, unable to lift more than half way up; Temperature reached a maximum of 101.8 degrees F; Headache; Swollen lymph nodes under right arm; Bruising at inject site; Tenderness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 23Apr2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The medical history included reactive airways disease, allergies to certain trees, weeds, grasses, molds, rodents and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 31Mar2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 20:00, the patient experienced body aches, intense muscle pain in right arm, unable to lift more than half way up, temperature reached a maximum of 101.8 degrees F, headache, swollen lymph nodes under right arm, bruising at inject site and tenderness at injection site. On the same day, the patient underwent body temperature test and the result was 101.8 degrees fahrenheit. The adverse events did not result 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 reported events which included treatment with acetaminophen (MANUFACTURER UNKNOWN) according to the direction given. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, intense muscle pain in right arm, unable to lift more than half way up, temperature reached a maximum of 101.8 degrees F, headache, swollen lymph nodes under right arm, bruising and tenderness at injection site were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Joint pain; Chills; Shaking; Nausea; Fatigue; Foggy thinking; Diarrhea/loose stools; Weakness; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 at the age of 52-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 and allergy to night shades. Concomitant medications included PROTEASE and TILACTASE 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 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8728) via an unspecified route of administration in the left arm on an 26Mar2021 at 10:15 at the age of 52-years-old as a single dose for COVID-19 immunisation. On 16Apr2021 at 18:00, the patient experienced joint pain, chills, shaking, nausea, fatigue, foggy thinking, diarrhea, loose stools, weakness, and injection site pain. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events joint pain, chills, shaking, nausea, fatigue, foggy thinking, diarrhea, loose stools, weakness, and injection site pain was resolved with sequelae on an unknown date in Apr2021.                 No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Thinking abnormal, Tremor, Vaccination site pain
Clinical narrative: Joint pain; Chills; Shaking; Nausea; Fatigue; Foggy thinking; Diarrhea/loose stools; Weakness; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 at the age of 52-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 and allergy to night shades. Concomitant medications included PROTEASE and TILACTASE 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 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8728) via an unspecified route of administration in the left arm on an 26Mar2021 at 10:15 at the age of 52-years-old as a single dose for COVID-19 immunisation. On 16Apr2021 at 18:00, the patient experienced joint pain, chills, shaking, nausea, fatigue, foggy thinking, diarrhea, loose stools, weakness, and injection site pain. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events joint pain, chills, shaking, nausea, fatigue, foggy thinking, diarrhea, loose stools, weakness, and injection site pain was resolved with sequelae on an unknown date in Apr2021.                 No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Chills, Diarrhoea
Clinical narrative: Headache; Joint pain; Muscle pain; Diarrhea; High fever (103.2); Chills; Pain in armpits; Pain in armpits and groin; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0175) via an unspecified route of administration in the left arm on 28Apr2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  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: EW 0150) via an unspecified route of administration in the left arm on 07Apr2021 at 14:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021 at 21:00, the patient experienced headache, joint pain, muscle pain, diarrhea, high fever (103.2), chills, pain in armpits and groin. On same day, the patient underwent body temperature test and the result was 103.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, joint pain, muscle pain, diarrhea, high fever (103.2), chills, pain in armpits and groin was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Joint pain; Muscle pain; Diarrhea; High fever (103.2); Chills; Pain in armpits; Pain in armpits and groin; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0175) via an unspecified route of administration in the left arm on 28Apr2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  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: EW 0150) via an unspecified route of administration in the left arm on 07Apr2021 at 14:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021 at 21:00, the patient experienced headache, joint pain, muscle pain, diarrhea, high fever (103.2), chills, pain in armpits and groin. On same day, the patient underwent body temperature test and the result was 103.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, joint pain, muscle pain, diarrhea, high fever (103.2), chills, pain in armpits and groin was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Heart rate
Clinical narrative: Migraine; Nausea; Severe muscle spasms on right side of body; Dizziness; Weakness; Heartbeat elevated 20 bpm; Pain and swelling at injection site; Swelling at injection site; Chills; Vomiting; Loss of appetite; 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: ER8732) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 43-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included Polycystic Ovarian Syndrome (PCOS) and chronic inflammation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), low-dose naltrexone (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021 at 04:30, 12 hours after the shot, the patient experienced migraine, nausea, severe muscle spasms on right side of the body every 30 seconds, dizziness, weakness, heartbeat elevated 20 beats per minute (bpm), pain and swelling at injection site and chills. On an unknown date in Apr2021, 20 hours after the shot, the patient experienced muscle spasms right side, vomiting, chills, loss of appetite and migraine. 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 events migraine, nausea, severe muscle spasms on right side of body, dizziness, weakness, heartbeat elevated 20 bpm, pain and swelling at injection site, chills, vomiting and loss of appetite was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.