chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: I have been tired; dizzy on and off since I got my vaccine, 5 days ago; Today I realized I got my period a full week early.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00(at the age of 37-year-old) as a single dose for COVID-19immunisation. Medical history included asthma, gluten intolerance and sulfonamide allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00(at the age of 36-year-old) as a single dose for COVID-19immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021 at 09:30 the patient experienced that she had been tired (fatigue) and dizzy on and off since she got her vaccine, 5 days ago. She realized she got her period a full week early (menstruation abnormal) .Therapeutic measures were taken as a result of the adverse events and included treatment with acetaminophen (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN). On 31Mar2021, the patient underwent Nasal Swab test for COVID-19 and the result was Negative. On 03Apr2021, the patient underwent Nasal Swab test for COVID-19 and the result was Negative. The clinical outcome of the events she had been tired(fatigue) and dizzy on and off since she got her vaccine, 5 days ago, she realized that she got her period a full week early (menstruation abnormal)  were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Anovulatory cycle
Clinical narrative: No period after 64 days and counting,; no ovulation; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included alprazolam (XANAX) from unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Feb2021 the patient experienced no period after 64 days and counting and no ovulation either. The events did not result in doctor or other healthcare professional office/clinic visit.  Therapeutic measures were not taken as the result of adverse events.  The clinical outcome of the events no period after 64 days and counting and no ovulation either were not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Episodic left arm pit pain; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 07Apr2021 at 17:15 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included lung lobectomy in 2008 to address pulmonary sequestration. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 17Mar2021 at 17:15 (at the age of 53-year-old), as a single dose for COVID-19 immunisation and took Clarithromycin, Amoxicillin and Clindamycin; all on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 02:00, the patient experienced episodic left arm pit pain. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event episodic left arm pit pain was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Dizziness; Headache; Bleeding 6 days later; Another period; This is a spontaneous report from a contactable consumer, the patient. A 35-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 26Mar2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, chronic allergies, asthma, premenstrual syndrome (PMS) and ovulation pain. The patient had no known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC), DIM supplement and prenatal vitamins from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 10:00, the patient experienced dizziness and headache, was not sure if the events were the result of the vaccine until the patient was supposed to ovulate the 11 days later (the patient felt ovulation and always cramp with ovulation), the patient started with another period and was still bleeding 6 days later while the patient has had 4 day cycles the entirety of 24 years of menstruating. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, headache, cramp with ovulation, bleeding 6 days later and another period was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Maternal exposure during pregnancy
Clinical narrative: her nose and tremendous amount of blood came out,; pregnant; This is a spontaneous report from a contactable consumer, the patient. This is a maternal report. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTCH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 07Apr2021 as dose 1, single for covid-19 immunisation. Medical history included was None. The patient concomitant medications were not reported. Patient was 39 weeks pregnant and got the first dose of the vaccine 07Apr2021. Patient said she blew her nose and a tremendous amount of blood came out, asking if that was normal.   Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Started with chills; Tiredness; 100 degree fever; Headache; Faster heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er 8737), via an unspecified route of administration in the left arm on 08Apr2021 at 17:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included extra heartbeat, COVID-19 and sulfonamide allergy.  Concomitant medications included Alive multi-vit, 2 calcium pills (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and biotin (MANUFACTURER UNKNOWN); all from an unknown date for unspecified indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:00, next afternoon the patient experienced started with chills, tiredness and then 100-degree fever with headache, faster heartbeat. The patient took an ibuprofen & slept most of the afternoon/evening and rest of night, and felt better next day. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 09Apr2021 at 15:00, the patient underwent lab test and procedure which included body temperature and result was shown as 100-degree. The clinical outcome of the events chills, tiredness and then 100-degree fever with headache, faster heartbeat were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started with chills; Tiredness; 100 degree fever; Headache; Faster heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er 8737), via an unspecified route of administration in the left arm on 08Apr2021 at 17:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included extra heartbeat, COVID-19 and sulfonamide allergy.  Concomitant medications included Alive multi-vit, 2 calcium pills (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and biotin (MANUFACTURER UNKNOWN); all from an unknown date for unspecified indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:00, next afternoon the patient experienced started with chills, tiredness and then 100-degree fever with headache, faster heartbeat. The patient took an ibuprofen & slept most of the afternoon/evening and rest of night, and felt better next day. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 09Apr2021 at 15:00, the patient underwent lab test and procedure which included body temperature and result was shown as 100-degree. The clinical outcome of the events chills, tiredness and then 100-degree fever with headache, faster heartbeat were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Heart rate increased, Lymphadenopathy
Clinical narrative: slow labored breathing; rapid heartbeat; blurry vision; swollen lymph nodes; fever; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 05Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma, attention deficit hyperactivity disorder (ADHD) and pollen allergy. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:30, the patient experienced extreme fatigue, chills, fever, slow labored breathing, rapid heartbeat, swollen lymph nodes and blurry vision. Therapeutic measures were taken as a result of adverse events and included treatment with ibuprofen on day two and three of adverse effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 05Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event extreme fatigue, chills, fever, slow labored breathing, rapid heartbeat, swollen lymph nodes and blurry vision was recovered with lasting effects on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vision blurred
Clinical narrative: slow labored breathing; rapid heartbeat; blurry vision; swollen lymph nodes; fever; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 05Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma, attention deficit hyperactivity disorder (ADHD) and pollen allergy. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:30, the patient experienced extreme fatigue, chills, fever, slow labored breathing, rapid heartbeat, swollen lymph nodes and blurry vision. Therapeutic measures were taken as a result of adverse events and included treatment with ibuprofen on day two and three of adverse effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 05Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event extreme fatigue, chills, fever, slow labored breathing, rapid heartbeat, swollen lymph nodes and blurry vision was recovered with lasting effects on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: tired; headache; joint pain; couldnt lift my arm; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number El9267) on 20Feb2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included atorvastatin, metoprolol, and losartan from unknown dates for unknown indications. The patient previously received warfarin (COUMADIN) from an unknown date and experienced allergy. On an unspecified date the patient experienced joint pain severe for 14 days, tired for 14 days, headache for 14 days, and couldn't lift his arm for 3 days. The events were reported as non-serious. The patient was not hospitalized for the events. The outcomes of joint pain severe, tired, headache, and couldn't lift arm were unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021400134 Same patient and drug, different dose/events
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Deep vein thrombosis, Pain in extremity, Peripheral swelling
Clinical narrative: 2 "DVTs" in left leg; 7 days later left leg and arm swelled up; inside left thigh very sore burns when I walk since the 17th of march; inside left thigh very sore; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration on 10Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included atorvastatin, metoprolol, and losartan from unknown dates for unknown indications. The patient previously received warfarin (COUMADIN) from an unknown date and experienced allergy. The patient received dose 1 of bnt162b2 (lot number El9267) on 20Feb2021 at 11:00 as a single dose in the left arm for COVID-19 immunization and experienced joint pain severe 14 days, tired 14 days, headache 14 days, and couldn't lift his arm for 3 days. With dose 2 the patient had no pain, tiredness, or headache. Seven days later (on 17Mar2021) the patient experienced left leg and arm swelled up, had 2 "DVTS" in left leg. The swelling was down but inside left thigh was very sore and burned when he walked since 17Mar2021. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited a doctor or other healthcare professional office/clinic and emergency room./department or urgent care as a result of the events. The patient received treatment with rivaroxaban for clots. The outcomes of had 2 "DVTs," inside left thigh was very sore and burned when he walked were not recovered. The outcome of left leg and arm swelled up was recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021400070 Same patient and drug, different dose/events
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on left side under arm and on top of my breast; This is a spontaneous report from a non-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: El3302) via an unspecified route of administration in the left arm on 12Mar2021 at 11:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021, the patient experienced swollen lymph nodes on left side under arm and on top of the breast. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph nodes on left side under arm and on top of the breast was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: severe migraine; This is a spontaneous report from a contactable consumer, the patient. A 55-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 07Apr2021 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, asthma, chronic back pain, thyroid nodules, allergy to sulfa drugs and penicillin allergy. Concomitant medications included levocabastine hydrochloride (ZYRTEC), duloxetine hydrochloride (CYMBALTA), erenumab (AIMOVIG), trazodone hydrochloride (DEPRAX) and vitamin d (MANUFACTURER UNKNOWN); all from unknown start dates for unknown indications. 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 17Mar2021 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation and also had known allergies to ibuprofen (MOTRIN), morphine (MANUFACTURER UNKNOWN) and oseltamivir phosphate (TAMIFLU). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 07Apr2021 at 14:30, the patient felt fine walking in to get vaccine but within minutes experienced a severe migraine. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event severe migraine was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tension, Tremor
Clinical narrative: "Uncontrollable shaking and tenseness"; "Uncontrollable shaking and tenseness"; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) and paracetamol (TYLENOL). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, the patient experienced uncontrollable shaking and tenseness and chills. 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 which included treatment with TYLENOL. The clinical outcome of the events "uncontrollable shaking and tenseness" and chills were recovering 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: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Nausea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0151) via an unspecified route of administration on 08Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced sore arm, fatigue, nausea and headache. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. The clinical outcome of the events sore arm, fatigue, nausea and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Neck pain, Pruritus, Somnolence
Clinical narrative: Drowsiness; pain at the injection site; skin itching; slight neck pain; lightheaded; felt hot; 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: Ewolso) via an unspecified route of administration in the left arm on 07Apr2021 at 18:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included contact dermatitis, asthma, skin allergies hypothyroidism, depression, anxiety, year-round allergies and was allergic to gluten and soy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced drowsiness, pain at the injection site, skin itching, slight neck pain, lightheaded and felt hot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events drowsiness, pain at the injection site, skin itching, slight neck pain, lightheaded and felt hot was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Drowsiness; pain at the injection site; skin itching; slight neck pain; lightheaded; felt hot; 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: Ewolso) via an unspecified route of administration in the left arm on 07Apr2021 at 18:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included contact dermatitis, asthma, skin allergies hypothyroidism, depression, anxiety, year-round allergies and was allergic to gluten and soy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced drowsiness, pain at the injection site, skin itching, slight neck pain, lightheaded and felt hot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events drowsiness, pain at the injection site, skin itching, slight neck pain, lightheaded and felt hot was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling
Clinical narrative: Swollen ankles in the week following administration.; Disruptive headache in the 24 hours following administration.; This is a spontaneous report from a contactable consumer. An unspecified aged non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. Medical history included nephrectomy (1 kidney) and history of cancer. 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 in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 04Apr2021, 24 hours following administration, the patient experienced disruptive headache and on 08Apr2021, swollen ankles in the week following administration. On an unknown date the patient underwent for unknown lab tests. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events which included lab tests. The clinical outcome of disruptive headache and swollen ankles were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Large red swollen splotch (hot and itchy) by injection 2 days later; Large red swollen splotch (hot and itchy) by injection 2 days later; Large red swollen splotch (hot and itchy) by injection 2 days later; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 13:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and hypercortisolism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was allergic to grass and shrimp. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 14Mar2021 at 10:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 12:00, two days after the vaccination, the patient experienced large red swollen splotch (hot and itchy) by injection. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events large red swollen splotch (hot and itchy) was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: left face cheek got tingly feeling; Left hand, left foot got tingly feeling; Very sore and throbbing arm where vaccine was/ forearm and top of hand had pain off and on all day; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 09:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 11:45, 2 hours after the vaccination, the patient left hand and left foot and left face cheek got a tingly feeling. Face tingling went away about 7 hours later. Hand and foot tingly next day. On the same day, the patient also experienced a very sore and throbbing arm where the vaccine was and the patient forearm and top of hand had pain off and on all day. The vaccine was taken on tuesday morning and by friday was pretty much gone. Just a little sore arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event face tingling resolved on 06Apr2021, after the duration of 7 hours. The clinical outcome of the event left hand and left foot tingly feeling was resolved on 07Apr2021. The clinical outcome of the event very sore and throbbing arm where the vaccine was/ forearm and top of hand had pain off and on all day was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Painful left arm; Swelling and heat on left arm; Fatigue; Chills; Low grade fever; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8737) via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021, the patient experienced painful swelling and heat on left arm >2 days after injection, fatigue, chills, low grade fever and general malaise for at least 2 days (at the time of reporting). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event painful swelling and heat on left arm, fatigue, chills, low grade fever and general malaise was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Painful left arm; Swelling and heat on left arm; Fatigue; Chills; Low grade fever; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8737) via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021, the patient experienced painful swelling and heat on left arm >2 days after injection, fatigue, chills, low grade fever and general malaise for at least 2 days (at the time of reporting). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event painful swelling and heat on left arm, fatigue, chills, low grade fever and general malaise was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Golf ball sized bump at injection site; Soreness at injection site; red itchy rash at injection site; red itchy rash at injection site; red itchy rash at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 27Mar2021 at 08:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 06Mar2021 at 08:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00, the patient experienced golf ball sized bump at injection site(vaccination site lump), red itchy rash at injection site and soreness at injection site. The patient did not receive any treatment for the reported events. The clinical outcome of the events bump at injection site, red itchy rash at injection site and soreness at injection site were recovered on an unknown date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Heartburn; This is a spontaneous report from a non-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: unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) and ceftriaxone sodium (ROCEPHIN) for unknown indication and on unknown date and experienced drug allergy. Concomitant medications included birth Control (MANUFACTURER UNKNOWN) and daily multi-vitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021, the patient experienced heartburn. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event heartburn was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Headache; Arm soreness; Body aches; Sore throat; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 12:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 12:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 05:00, the patient experienced headache, arm soreness, body aches and sore throat. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events headache, arm soreness, body aches and sore throat were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling of tongue; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in left arm on 06Apr2021 at 09:30 (at the age of 63 years) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in right arm on 16Mar2021 at 09:30 as single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 at 19:00, patient experienced swelling of tongue. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event swelling of tongue was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Not feeling well; Aches and pains all over; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medications within two weeks of the COVID-19 vaccination. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021, the patient reported that he did not feel well and had aches and pains all over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events not feeling well and aches and pains all over was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness/ feeling extremely tired; Headache; Muscle pain; Injection site swelling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6204) via an unspecified route of administration in the left arm on 02Mar2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes II, high cholesterol, Obese, HBP (blood pressure high) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient received doxycycline (MANUFACTURER UNKNOWN) and metaxalone (SKELAXIN) on unknown date for an unspecified indication and experienced drug allergy. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 09:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, nausea and feeling extremely tired. 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 reported event. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, injection site swelling, nausea and feeling extremely tired were recovered on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.