chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Rash papular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Dry mouth; Rash on back and lower front stomach area. Small oblong slightly raised, itchy.; Rash on back and lower front stomach area. Small oblong slightly raised, itchy.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 30Mar2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 21Apr2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included citalopram hydrobromide (CELEXA) and thyroid (ARMOUR THYROID); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced rash on back and lower front stomach area, small oblong slightly raised, itchy and dry mouth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 21Apr2021, the patient underwent mouth swab and the result was negative. The clinical outcome of the events rash on back and lower front stomach area, small oblong slightly raised, itchy and dry mouth was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: 102 degree fever; Fatigue; Sever body aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL1283) via intramuscular route of administration in the left arm on 13Jan2021 at 15:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), vitamin k nos (VITAMIN K), rivaroxaban (XARELTO), simvastatin, ezetimibe (BIROW) and tiotropium bromide monohydrate (SPIRIVA) for unknown indication from an unknown date. The patient previously received aspirin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK5730) via intramuscular route of administration in the left arm on 11Dec2020 at 15:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 18:00, the patient experienced 102-degree fever (Unspecified units), fatigue and sever body aches for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of 102-degree fever, fatigue and sever body aches for 2 days were recovered on unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: sense of smell changed,  It's best described as a burnt scent when around fried foods (deep and saute), toothpaste, and mouthwash.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The medical history included ARVC (arrhythmogenic right ventricular cardiomyopathy), COVID-19 and penicillin allergy. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 11Apr2021, about 11 days after the first dose of the vaccine, the patient experienced sense of smell changed. It was best described as a burnt scent when around fried foods (deep and saute), toothpaste and mouthwash. Therapeutic measures were not taken as a result of the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sense of smell changed, it was best described as burned scent when around fried foods (deep and saute),toothpaste and mouthwash was unknown at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route of administration in the left arm on 28Apr2021 at 14:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node on my left side of neck near collarbone is sore and swollen.; Lymph node on my left side of neck near collarbone, is sore and swollen.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included citalopram hydrobromide (CELEXA), estrogens conjugated (PREMARIN) and ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY) for adults, all taken for unspecified indications from unknown dates. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and azithromycin (ZITHROMAX) and experienced drug allergy. Prior to the vaccination, it was unknown if 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 29Apr2021 at 13:00, the patient noticed that the lymph node on his left side of neck near the collarbone was sore and swollen. The patient did not seek any treatment, since research into possible side effects noted to swollen lymph nodes on the side where the vaccine was given. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event lymph node on left side of neck near collarbone was sore and swollen was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: Arm pain; Upset stomach; Nausea; Body aches; Fever; Insomnia; Shaking; This is a spontaneous report from a contactable consumer, the patient. A 23-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 29Apr2021 at 13:00(at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 13:00 (at the age of 23-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 vaccination. On 30Apr2021 at 01:00 the patient experienced arm pain, upset stomach, nausea, body aches, fever, insomnia and shaking. 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 events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events arm pain, upset stomach, nausea, body aches, fever, insomnia and shaking were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Arm pain; Upset stomach; Nausea; Body aches; Fever; Insomnia; Shaking; This is a spontaneous report from a contactable consumer, the patient. A 23-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 29Apr2021 at 13:00(at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 13:00 (at the age of 23-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 vaccination. On 30Apr2021 at 01:00 the patient experienced arm pain, upset stomach, nausea, body aches, fever, insomnia and shaking. 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 events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events arm pain, upset stomach, nausea, body aches, fever, insomnia and shaking were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash, similar to those of chickenpox for vaccinated people, rashes started around neck area, then arms, waist, legs; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 62-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 on 15Apr2021 at 14:45 (at an age of 62-years-old) as single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure, acid reflux and allergy to penicillin and bee sting. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient received other medications (unspecified) within 2 weeks of vaccination. On 18Apr2021, two days after the second vaccination, the patient got skin rash (similar to those of chickenpox for vaccinated people). They still stay there after two weeks, but became less itchy. The rashes started around neck area, then arms, waist and legs. Therapeutic measures were taken as a result of the events with allergy relief over the counter medication(unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of skin rash, similar to those of chickenpox for vaccinated people, rashes started around neck area, then arms, waist, legs and itchy were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever; Body ache/ pains; Headache; Eyes became swollen and very sore to touch; Eyes became swollen and very sore to touch; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8727) via an unspecified route of administration in the left arm on 28Apr2021 at 10:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mollusks and possibly latex (could not use latex gloves as the skin would react with rash). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0153) via an unspecified route of administration in the left arm on 10Apr2021 at 13:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 14:00 (about 27 hours after the second dose), the patient experienced low grade fever, body ache, pains, headache, eyes became swollen and were very sore to the touch. The patient was breathing fine. At the time of reporting, 45 hours after the second dose, eyes were still swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with over-the-counter (OTC) diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the events low grade fever, body ache/ pains, headache, eyes became swollen and very sore to touch were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: I have dermal fillers under my eyes and after the second dose my under eyes are swollen 2 days later.; This is a spontaneous report from a contactable consumer, the patient. A 36-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 16:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included derma fillers under the eye (Derma filler injection). Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. 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 arm left on 07Apr2021 at 15:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had dermal fillers under the eyes and after the second dose under eyes were swollen 2 days later on 30Apr2021 at 08:00. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event eye swollen which included treatment with lisinopril (MANUFACTURER UNKNOWN) 10 mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event under eyes were swollen was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema nodosum, Peripheral swelling
Clinical narrative: Swelling in bilateral legs; Erythema Nodosum; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via intramuscular route of administration on 13Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration on 23Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 the patient experienced swelling in bilateral legs that transformed into erythema nodosum over two weeks, on an unknown date in Apr2021. The reported events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of adverse events and included treatment with unspecified NSAIDS (MANUFACTURER UNKNOWN). The clinical outcome of the event swelling in bilateral legs and erythema nodosum was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vomiting; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01J1) via an unspecified route of administration in the left arm on 13Apr2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and sulfonamide allergy (Sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ustekinumab (STELARA) for unknown indication, on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 57-yeasr-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 23:30 the patient experienced vomiting and vertigo. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with Antivert. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting and vertigo was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Multiple menses per month; Excessive bleeding; Anemia; 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: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and lansoprazole (MANUFACTURER UNKNOWN) for unknown indication from unknown dates and unknown if ongoing. 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 an unknown date in Jan2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021 at 13:00, the patient experienced multiple menses per month, excessive bleeding and anemia diagnosis (Dx). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 16Feb2021, the patient underwent COVID test (navica test) via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events multiple menses per month, excessive bleeding and anemia were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Right arm lymphadenopathy; 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: EW0170) via an unspecified route of administration in the right arm on 28Apr2021 at 11:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 (at the age of 37-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. On 29Apr2021 at 16:00, the patient experienced right arm lymphadenopathy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymphadenopathy was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: not feeling well; tired; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient was not feeling well and tired. The clinical outcome of the event not feeling well and tired was unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hypokinesia, Pain
Clinical narrative: Shaking; Can not move right arm over head; Body aches; Chills; Headache; Fever of 102; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 29Apr2021 at 10:00 (at the age of 31-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 21:00, the patient experienced fever of 102 (unspecified units), body aches, chills, shaking uncontrollably, headache, cannot move right arm over her head. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 102 (unspecified units), body aches, chills, shaking uncontrollably, headache, cannot move right arm over her head were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking; Can not move right arm over head; Body aches; Chills; Headache; Fever of 102; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 29Apr2021 at 10:00 (at the age of 31-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 21:00, the patient experienced fever of 102 (unspecified units), body aches, chills, shaking uncontrollably, headache, cannot move right arm over her head. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 102 (unspecified units), body aches, chills, shaking uncontrollably, headache, cannot move right arm over her head were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity, Paraesthesia
Clinical narrative: leg pain, particularly in left leg; warmth in leg; tingling in leg; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 08:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and sumatriptan (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 08:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 27Apr2021 the patient experienced leg pain, particularly in left leg, warmth, tingling in leg and headache. No Therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events leg pain, warmth and tingling in leg and headache were recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, Fatigue
Clinical narrative: Lost all my taste and smell; Lost all my taste and smell; now everything taste like metal or rotten; was tired for 4 days; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient did not have any known allergies to food medications or other products. The patient did take any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient lost all his taste and smell. He had a super great sense of smell and taste, now everything tasted like metal or rotten, hard to describe. He was tired for 4 days, the lack of smell and taste was strange to him as he felt he had a strong sense of smell. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lost all taste and smell, everything taste like metal or rotten and tired for 4 days were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Probable shingles in upper right chest, upper right back, and back of right arm (vaccination in left arm); This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levonorgestrel (MIRENA), vitamin d nos (VITAMIN D) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, the patient experienced probably shingles in upper right chest, upper right back, and back of right arm (vaccination in left arm). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with valtrex. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event probably shingles in upper right chest, upper right back, and back of right arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart Palpitations; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Jan2021, the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart palpitations was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report from a contactable consumer. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 06Apr2021 at 09:00  (at the age of 17-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 22:00, the patient experienced headache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events headache and chills were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Large swollen area in left arm pit (lymph node?), tender to touch.; Large swollen area in left arm pit (lymph node?), tender to touch.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 28Apr2021 at 15:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, at 08:00 the patient experienced large swollen area in left arm pit (lymph node?), tender to touch. Noticed 2nd morning after 2nd dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large swollen area in left arm pit (lymph node?), tender to touch were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm was sore; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient 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 27Apr2021 at 15:30(at the age of 48-year-old) as a single dose for COVID-19immunisation. Medical history included asthma, obesity, anemia, autoimmune disorder, ehlers-danlos syndrome, POTTS .The patient previously took amoxicillin (MANUFACTURER UNKNOWN) ,codeine (MANUFACTURER UNKNOWN), topamax (MANUFACTURER UNKNOWN), agave syrup (MANUFACTURER UNKNOWN) and experienced drug allergy for the following medications . Concomitant medications included phentermine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date, excedrin (MANUFACTURER UNKNOWN) for migraine on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19 . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 19:00 the patient experienced left arm sore. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm sore was recovered after 3 days of vaccine.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: did not feel well; fever; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Mar2021. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other medications within two weeks of taking COVID-19 vaccine. On an unknown date in Apr2021, the patient experienced did not feel well and developed a fever for approximately 1 day. It was reported that the patient felt fine, but for the subject period his symptoms were similar to when he had COVID-19 in approximately Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events did not feel well and developed a fever for approximately 1 day was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Developed shingles; Right chest wall involvement with post herpetic neuralgia; This is a spontaneous report from a contactable physician, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration in the left arm on 29Dec2020 at 19:00 (at the age of 54-years-old) as single dose for COVID-19 immunisation. The patients' medical history included HTN (hypertension), GERD (gastroesophageal reflux disease) and seasonal allergies. The patient had no known drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccination. On 27Mar2021, the patient developed shingles. The patient reported that it was a moderate case. On 27Mar2021, the patient also experienced right chest wall involvement with post herpetic neuralgia. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with valacyclovir (VALTREX) 1000 mg TID (three times a day) for 7 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of shingles and right chest wall involvement with post herpetic neuralgia were resolved with lasting effects on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Nausea, SARS-CoV-2 test
Clinical narrative: Metal taste; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-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 27Apr2021 at 09:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation as other vaccine within four weeks prior to the COVID vaccine. On 29Apr2021 at 02:00, the patient experienced metal taste, dizziness & nausea. Since the vaccination, the patient had been tested for COVID-19. On 29Apr2021, the patient underwent lab test and procedure which included COVID-19 virus test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event metal taste, dizziness and nausea was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis, Petechiae
Clinical narrative: Petechiae on upper arms, chest; Mottling of thighs and legs; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 03Apr2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid issues, insulin resistance, PCOS and iron deficiency anemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and inositol (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. On 03Apr2021 at 22:00, the patient experienced petechiae on upper arms, chest; mottling of thighs and legs which cleared up after 48 hours. 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. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events petechiae on upper arms, chest; mottling of thighs and legs was recovered on 05Apr2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 24Apr2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash that has spread from shoulder to lower extremities including buttocks, top of feet and ankles and legs.; This is a spontaneous report from a contactable pharmacist. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration in the right arm on 05Apr2021 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had no known drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via intramuscular route of administration in the right arm on 13Mar2021 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced rash that had spread from shoulder to lower extremities including buttocks, top of feet, ankles and legs. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event rash that spread from shoulder to lower extremities including buttocks, top of feet, ankles and legs was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.