chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Tiny red dots appeared on my stomach after the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Previously the patient was not on any drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 12:15, after the vaccination, the patient experienced tiny red dots on stomach. The clinical outcome of the event tiny red dots on stomach was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Horrible genital herpes outbreak; This is a spontaneous report from a contactable nurse, the patient. A 43-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 arm left on 27Jan2021(at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received PCN for unknown indication on an unknown date. 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 vaccine. On 10Feb2021, the patient experienced horrible genital herpes outbreak. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the treatment of reported events which included valacyclovir (VALTREX) and pain medications(unspecified). The clinical outcome of the event horrible genital herpes outbreak was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node tenderness; Lymph node under right arm became enlarged; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 20Apr2021 at 14:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known past drug history. Concomitant medications included lisinopril 10 mg (MANUFACTURER UNKNOWN) and omeprazole 20 mg (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 30Mar2021 at 14:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021 at 03:00,  the patient experienced lymph node  enlarged and lymph node pain. Its reported that the patient's lymph node under right arm became enlarged. This happened a day and a half later than the shot. It was tender and uncomfortable and lasted for 6 days. The clinical outcome of the events of lymph node enlarged and lymph node tenderness were recovered on 28Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Left under arm (lymph node) very sore; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 26Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluvoxamine maleate (LUVOX), lamotrigine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and proto from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced left underarm (lymph node) very sore. The clinical outcome of the event left underarm (lymph node) very sore was not recovered at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Vaccination site pain
Clinical narrative: Inflammation on the top of left elbow to the point that patient can barely use left arm. Inflammation in left shoulder and the injection site has become tender again. Now having some inflammation in knees and right elbow area; Injection site had become tender again; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534, Expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. The patient had no past drugs. Concomitant medications included esomeprazole sodium (NEXIUM), vitamin B (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and probiotic (MANUFACTURER UNKNOWN), all for unknown indications, on an unknown dates. 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, within 1 to 1.5 weeks after receiving the vaccine, the patient experienced inflammation on the top of left elbow to the point that the patient can barely use his left arm, now had inflammation in left shoulder and the injection site had become tender again. The patient also had some inflammation in knees and right elbow area. It was reported that the patient never had inflammation in joints; especially in the left arm/elbow joint until after he was vaccinated (2nd dose) and had no injuries or accidents, and prior to receiving the vaccine the patient did not have pain in these areas. Therapeutic measures were taken and included treatment with ice and ibuprofen (MANUFACTURER UNKNOWN) etc., with no relief. The clinical outcome of the events inflammation and injection site has become tender again was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Blistering at injection site; 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: ER8731) via an unspecified route of administration on 28Apr2021 at 14:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included occasional ibuprofen (MANUFACTURER UNKNOWN) and calcium supplement (MANUFACTURER UNKNOWN) both for an unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) on the arm left via an unspecified route of administration on 07Apr2021 at 15:30 (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 29Apr2021 at 10:00 the patient experienced blistering at injection site. The clinical outcome of the event blistering at injection site was unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling cold, Headache, Hot flush
Clinical narrative: Dizziness; Hot flashes; Cold flashes; So much sweating; Headache; Full body soreness; Vision started to get blurred; Felt weak when standing; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 17-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. On 28Apr2021 at 17:45, the patient experienced dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred at the dudes and felt weak when standing. It was reported that the patient had to take the day off school because she could not get out of bed. The patient received treatment with TYLENOL for the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred and felt weak when standing were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Vision blurred
Clinical narrative: Dizziness; Hot flashes; Cold flashes; So much sweating; Headache; Full body soreness; Vision started to get blurred; Felt weak when standing; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 17-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. On 28Apr2021 at 17:45, the patient experienced dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred at the dudes and felt weak when standing. It was reported that the patient had to take the day off school because she could not get out of bed. The patient received treatment with TYLENOL for the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred and felt weak when standing were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Urinary tract infection
Clinical narrative: Fever - 103 F; Urine Infection; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced fever-103 F and urine infection. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever-103 F and urine infection and included treatment with unspecified antibiotics. The outcomes of the fever-103 F and urine infection were recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: episodes of hives(torso, arms and legs), severe hives for a few days.  Subsequent weeks I have had occasional hive/red itchy bumps.; This is a spontaneous report from a contactable consumer, the patient. A 51-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 the arm left on 02Apr2021 at 12:30(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, blood pressure high, hay fever, and vitiligo. The patient did not take any concomitant medication.  The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 12Mar2021 at 12:30 (at the age of 51-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, the patient experienced episodes of hives (torso, arms and legs). The event started 3 or so days after vaccine, severe hives for a few days. Subsequent weeks he had occasional hive and red itchy bumps through previous day. Total 10-12 days' worth of episodes. It was reported that he had not had episode of hives in as long as he could remember, maybe 20+ years and never recurring. Therapeutic measures were taken as a result of reported event and included treatment with Zyrtec. The events resulted in doctor or other healthcare professional office/clinic visit, The clinical outcome of the events hives and red itchy bumps were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: pain in hands and at the base of thumbs; pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles; This is a spontaneous report from a contactable consumer, the patient. A 59-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 arm left on 24Mar2021 at 17:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included depression and obesity on unknown dates. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), omeprazole (PROTONIX) and ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, cholecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER) from an unknown dates taken for an unknown indications. 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 previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles (muscle pain) and also the patient experienced pain in hands and at the base of thumbs (pain in extremity). The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events (pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles and pain in hands and at the base of thumbs) and included treatment with X-rays, physical therapy (PT) and unspecified medications on unknown dates. The clinical outcome of the events pain in hands and at the base of thumbs and pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK8736) via an unspecified route of administration in the right arm on 29Apr2021 at 07:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, allergy to eggs, dairy, peppers, pineapple, walnut. Concomitant medications included enalapril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) from an unknown date for an unspecified 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. On 29Apr2021 at 08:30 the patient experienced dizziness. The clinical outcome of the event dizziness was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes under both arms, around both sides of neck and in groin; 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: ER8731) via an unspecified route of administration in the arm left on 16Apr2021 at 13:00 (at the age of 56-years-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: EN6199) via an unspecified route of administration in the arm left on 10Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patient previously received DTaP vaccine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced rash and severe lymph node reaction (not specified). 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 vaccine. On 17Apr2021 at 09:00, the patient experienced swollen lymph nodes under both arms, around both sides of neck and in groin. The clinical outcome of the events swollen lymph nodes under both arms, around both sides of neck and in groin were not recovered 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: Arthralgia, Fatigue, Feeling hot, Headache, Pyrexia
Clinical narrative: Feeling hot; Loud high pitched ringing in ears; Extreme pain in joints-caused severe pain from lumbar surgical site to return,; Vomiting; Extreme exhaustion; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 28Apr2021 at 11:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, multiple disabling back conditions with surgeries and rheumatoid arthritis. The patient received other medications within two weeks of vaccination. Past drug history includes sulfa and penicillin. 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 28Apr2021 at 14:00 the patient experienced vomiting, extreme exhaustion, felt hot, fever, extreme pain in joints-caused severe pain from lumbar surgical site to return, headache and loud high-pitched ringing in ears. The clinical outcome of the events vomiting, extreme exhaustion, felt hot, fever, extreme pain in joints-caused severe pain from lumbar surgical site to return, headache, loud high pitched ringing in ears were not recovered 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: Tinnitus, Vomiting
Clinical narrative: Feeling hot; Loud high pitched ringing in ears; Extreme pain in joints-caused severe pain from lumbar surgical site to return,; Vomiting; Extreme exhaustion; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 28Apr2021 at 11:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, multiple disabling back conditions with surgeries and rheumatoid arthritis. The patient received other medications within two weeks of vaccination. Past drug history includes sulfa and penicillin. 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 28Apr2021 at 14:00 the patient experienced vomiting, extreme exhaustion, felt hot, fever, extreme pain in joints-caused severe pain from lumbar surgical site to return, headache and loud high-pitched ringing in ears. The clinical outcome of the events vomiting, extreme exhaustion, felt hot, fever, extreme pain in joints-caused severe pain from lumbar surgical site to return, headache, loud high pitched ringing in ears were not recovered 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: Blood pressure increased, Blood pressure measurement, Headache, Pain
Clinical narrative: Whole body aching; Headache; Blood pressure elevated; This is a spontaneous report from a contactable nurse, the patient. A 29-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 arm left on 28Apr2021(at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) from an unknown date. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021(at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient previously took peanut on an unknown date. 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 vaccine. On 29Apr2021 at 00:00, the patient experienced whole body aching, headache and blood pressure elevated. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events whole body aching, headache and blood pressure elevated was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Premenstrual syndrome
Clinical narrative: Menstruated one week early; Menstruated one week early with increased pre-menstruated symptoms; This is a spontaneous report from a contactable consumer, the patient. A 38-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 arm left on 10Apr2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT) for unknown indication on an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 20Mar2021 at 15:00 (at the age of 38-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 29Apr2021 at 00:00, the patient experienced menstruated one week early with increased pre-menstruated symptoms. Therapeutic measures taken were not reported. The clinical outcome of the events menstruated one week early with increased pre-menstruated symptoms was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in the mouth, that has so far lasted two days.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received treatment with hydrocodone bitartarate, paracetamol (VICODIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 12:00 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 28Apr2021, the patient experienced metallic taste in the mouth, that has so far lasted two days. The clinical outcome of the event metallic taste in the mouth, that has so far lasted two days was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Pyrexia
Clinical narrative: loose cough; chills; slight increase in temp (no higher than 100.8) for 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 24Apr2021 at 11:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergy, sinus infection (Chronic sinus infections) and upper respiratory disorder (chronic upper respiratory issues). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), acetylsalicylic acid, caffeine (BAYER BACK & BODY PAIN) and acetylsalicylic acid (ASPRIN) from unknown dates taken for unknown indications. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 03Apr2021 at 13:45 (at the age of 61-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 COVID vaccine. On 25Apr2021 at 07:30, the patient experienced incredible chills, slight increase in temp (no higher than 100.8) for 24 hours, and a cough. It had been 5 days and the patient still had a loose cough that the patient was concerned about and the patient would like to talk to someone before making an appointment with her physician to discuss a course of treatment and need to know about medications that her physician normally prescribes for upper respiratory problems vs. vaccine ingredients. The clinical outcome of the event loose cough was not recovered at the time of this report.  The clinical outcome of the event slight increase in temp (no higher than 100.8) for 24 hours and chills was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Fatigue, SARS-CoV-2 test
Clinical narrative: Apathetic; Fatigued; Tired; Exhausted; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164), via an unspecified route of administration in the left arm on 19Apr2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medication within two weeks of the COVID-19 vaccination. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and CECLOR from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 11:30 (at the age of 38-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 13:00, the patient felt tired, fatigued, exhausted and apathetic. On 28Apr2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. The clinical outcome of the events felt tired, fatigued, exhausted and apathetic was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 27Apr2021 at 13:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15 (at the age of 38-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 28Apr2021 at 01:00, within 12 hours of vaccination, the patient experienced chills and  body aches. The clinical outcome of the events chills and body aches was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Loud tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant 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 21Apr2021 at 11:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included unidentified autoimmunity issues. The patient did not receive any other medication within two weeks of vaccination. The patient previously took gluten, tree nuts and some antibiotics. The patient previously received varicella zoster vaccine rge (CHO) (SHINGRIX) on an unknown date for immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 60-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. On 22Apr2021, the patient experienced loud tinnitus. The clinical outcome of the event loud tinnitus was not resolved 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: Rash pruritic
Clinical narrative: Itchy rash on cheek bones (small bumps), later spread to chest, under eyebrows and behind ears; This is a spontaneous report from a contactable consumer. A 47-year-old 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 arm left on 23Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and seasonal allergies. The patient has taken unspecified concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 14:30 (at the age of 47-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. On 27Apr2021, the patient experienced itchy rash. It was reported that the patient experienced itchy rash on cheek bones (small bumps), later spread to chest, under eyebrows and behind ears. The patient has taken benadryl (MANUFACTURER UNKNOWN) as a treatment for the adverse event. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itchy rash was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: right upper arm is not functioning properly and cannot lift the right arm above the waist.; tingling in wrist and hand as well; This is a spontaneous report from a contactable consumer, the patient. A 63-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 05Apr2021 at 16:00 (at the age of 63-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: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 16:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021 at 14:00, the patient experienced right upper arm was not functioning properly, cannot lift right arm above the waist and had some tingling in the wrist and hand. The clinical outcome of the events right upper arm was not functioning properly, cannot lift right arm above the waist and had some tingling in the wrist and hand was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Little red acne-like bumps that are painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drugs were unknown. 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. On 16Apr2021 at 00:00, the patient experienced little red acne-like bumps that are painful to touch which lasted for 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event red acne-like bumps that are painful was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Blood test, Inappropriate schedule of product administration, Ultrasound scan
Clinical narrative: In my arm pit of my left arm it swelled up; In my arm pit of my left arm it swelled up and was very painful; Dose 1 Start date: 20210203/ Dose 2 Start date: 20210218; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 18Feb2021 at 13:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included low thyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation (The vaccine was administered outside the range of 19-42 days (15 days) resulting in Inappropriate schedule of vaccine administered and medication error). The patient past drug therapy included lisinopril (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. Prior to 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 4 weeks prior to the COVID vaccine. On 21Feb2021 at 03:00, the patient's arm pit of the left arm swelled up and was very painful. Her doctor put her on steroids and the pain went away but the swelling has not totally gone away and is sometimes painful. The patient went back to her doctor 6 weeks later with the complaint that it was still swollen and sometime painful. The doctor ordered an ultrasound and blood test but all was negative. It was still swollen and sometimes painful that has not gone away yet. On an unknown date, patient underwent lab tests and procedures which included ultrasound and blood test and the results were negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with steroids. The clinical outcome of the events arm pit of the left arm swelled up and was very painful was not resolved 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: Cervical polyp, Lip haemorrhage, Ultrasound pelvis, Vaginal haemorrhage
Clinical narrative: Blood spotting on toilet paper after urinating, apparently coming from vagina. I am menopausal.; pimple on my lip that was bleeding; polyp in my cervix; This is a spontaneous report from a contactable consumer.  This 55-year-old (non-pregnant) female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0161) intramuscularly into the right arm on 26Apr2021 at 11:00 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient medical history included hypothyroidism from 1987 and ongoing, thyroid disease, dermatitis contact from an unknown date and unknown if ongoing. Known allergies to Novocain, beauty products. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder and vitamin d3 (VITAMIN D3) taken for an unspecified indication, both from an unspecified start date and ongoing. The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0178) intramuscularly into the left arm on 04Jun2021 at 11:30 AM as single dose for COVID-19 immunisation. The patient previously took novocain and experienced drug hypersensitivity. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Apr2021, at around 12:00 PM, the patient experienced blood spotting on toilet paper after urinating, apparently coming from vagina. She was menopausal. She experienced pimple on her lip that was bleeding and polyp in her cervix. Events required visit to physician office. 3 days after vaccine, she had a pimple on her lip that was bleeding. At the same time, she had one or two drops of blood on toilet paper after urination. She knew it came from her vagina because she pressed into it with the toilet paper. After she saw some pink on the paper. When she pressed it was very red, but just one little drop. She called the doctor and he told she could have endometrial cancer and sent her for an ultrasound and biopsy. She insisted it had only been one/two drops to no avail. After the ultrasound on 18May2021, she was seen by an obgyn who informed that the ultrasound was normal and she did not need a biopsy. He observed a polyp in her cervix. He thinks that was what bleed. Bleeding never happened before or again. Treatment received was pelvic ultrasound. Device Date was reported to be 29Apr2021. Outcome was resolved on 29Apr2021 for all the events.  No Follow-up attempts needed. No further information expected.  Follow-up (25Jun2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included clinical course of events, dose 2 details.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Blotching dry spots all over body, scalp, chest, arms, face; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 18:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and past drug history were reported as not applicable and no respectively. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Apr2021, the patient experienced blotching dry spots all over body, scalp, chest, arms, face. It was unknown whether the patient the received treatment for the events. It was unknown whether the event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blotching dry spots all over body, scalp, chest, arms, face was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.