chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all throughout the body; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 15:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts, family history of malignant hypothermia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. 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 right arm on 17Mar2021 at 03:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, the patient experienced rash all throughout the body. 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 event rash all throughout the body was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 46-years-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 12Apr2021, the patient experienced aches, fever (101.3 (units unspecified) at highest) and chills. The patient slept all day and night and felt better by next day afternoon. 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 reported events. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021, the patient underwent lab tests and procedures that included COVID-19 test (Nasal swab) and tested negative. The clinical outcome of the events aches, fever (101.3 at highest) and chills was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Pain
Clinical narrative: Sore arm; Fever; Chills; Body ache; Joint soreness; Headache; Generally felt like a very bad flu for 2days so far; 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: EW0151) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 51-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 17Apr2021 at 19:00, the patient experienced sore arm, fever, chills, body aches, joint soreness, headache and generally felt like a very bad flu for 2 days, but started to get better. 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 result of the events. The clinical outcome of the events sore arm, fever, chills, body aches, joint soreness, headache and generally felt like a very bad flu for 2 days were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Chills; Body ache; Joint soreness; Headache; Generally felt like a very bad flu for 2days so far; 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: EW0151) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 51-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 17Apr2021 at 19:00, the patient experienced sore arm, fever, chills, body aches, joint soreness, headache and generally felt like a very bad flu for 2 days, but started to get better. 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 result of the events. The clinical outcome of the events sore arm, fever, chills, body aches, joint soreness, headache and generally felt like a very bad flu for 2 days were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Migraine, Oral pain
Clinical narrative: Terrible migraine; Taste of metal in mouth; Severe mouth pain; This is a spontaneous report from a contactable consumer, the patient. A 26-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 19Apr2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included unspecified birth control medications, spironolactone (MANUFACTURER UNKNOWN), ambrosia artemisiifolia pollen (RAGWITEK) and escitalopram oxalate (LEXAPRO); all for an unknown indication since an unknown date 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 29Mar2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 16:30, 2.5 hours after the vaccination, the patient experienced terrible migraine, taste of metal was her in mouth. The patient looked it up and it was rare but she keeps experiencing severe mouth pain. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events terrible migraine and taste of metal in mouth was unknown and the clinical outcome of the event severe mouth pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 02Apr2021 at 10:30(at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced shingles to left flank. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles to left flank and included treatment with valtrex. The clinical outcome of the event shingles to left flank was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: Sore tongue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included melon allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. On an unknown date in 2021, the patient experienced sore tongue. The event did not result in doctor or other healthcare professional office/clinic, 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 sore tongue was unknown 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Malaise, Pain
Clinical narrative: Dizziness; Soreness; Feeling unwell; foggy head; This is a spontaneous report from a non-contactable consumer, the patient. An adolescent female patient received unknown 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. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced dizziness, soreness, foggy head and felt unwell. The clinical outcome of the events dizziness, soreness, foggy head and felt unwell were unknown at the time of  this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: Mild headache; Low grade fever; Mild chills; Lethargic; Swollen nodes in left armpit for about 4 days; This is a spontaneous report from a contactable consumer, the patient. A 67-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 10Feb2021 at 17:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had known allergies to cefoxitin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and celecoxib (CELEBREX); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021, 24 hours after second dose, the patient experienced mild headache, low grade fever, mild chills, lethargic which were gone the next day. On 11Feb2021, the patient had swollen nodes in left armpit for about 4 days and they too went away. The patient reported that nothing adverse since. 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 mild headache, low grade fever, mild chills and lethargic was recovered on 12Feb2021; while that of the swollen nodes in left armpit was recovered on 15Feb2021, after the duration of 4 days.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Pain and aches in left foot; Difficultymoving toes and walking.; Pain is moderate, but quite uncomfortable; Pain is moderate, but quite uncomfortable; around 5-6 on pain scale.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 18Apr2021 at 12:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included asthma, allergy to dust, molds and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The concomitant medications included salbutamol sulfate (ALBUTEROL SULFATE), fluticasone propionate (FLONASE) and unspecified allergy pill (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. On 18Apr2021 at 14:30, the patient experienced pain and aches in left foot, difficulty moving toes and walking, pain was moderate, but quite uncomfortable; around 5-6 on pain scale. 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. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and aches in left foot, difficulty moving toes and walking and pain was moderate, but quite uncomfortable was 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: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Broke out in rash and hives all over body; Broke out in rash and hives all over body; Itching; Swelling; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 16:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included dexlansoprazole (DEXILANT) for an unspecified indication from an unknown date and unknown if ongoing. On 16Apr2021 at 19:00, about two hours after vaccination, the patient broke out in rash and hives all over body and experienced itching and swelling. The event 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 the adverse events and included treatment with unspecified allergy medication. The clinical outcome of the events broke out in rash and hives all over body, itching and swelling was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 54-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 left arm in Mar2021 (at the age of 54-years old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, shingles, herbal allergy (chamomile), ragweed allergy and fruit allergy (melon). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. In Apr2021, a week after receiving the second dose, the patient begun to experience neuralgic pains similar to those which she had experienced when she had shingles in the past year. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, neuralgic pains was recovering at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Node - left clavicle; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included estrogen (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX) and melatonin (MANUFACTURER UNKNOWN); all from unknown dates, for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced swollen lymph node in the left clavicle. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph node in the left clavicle was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: During the night after 2nd dose felt flu like symptoms. The next day could not get out of bed. This lasted for another 24 hours.; During the night after 2nd dose felt flu like symptoms. The next day could not get out of bed. This lasted for another 24 hours.; Made me very weak and with a headache for the next 24 hours; Made me very weak and with a headache for the next 24 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 16Apr2021 at 14:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient previously took estrogens conjugated; medroxyprogesterone acetate (PREMPRO) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 (at the age of 76-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 17Apr2021 at 02:30, during the night after second dose the patient felt flu like symptoms. The next day on 17Apr2021, she could not get out of bed. This lasted for another 24 hours. It had made her very weak and with a headache for the next 24 hours. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events during the night after second dose felt flu like symptoms, the next day could not get out of bed, this lasted for another 24 hours, made her very weak and with a headache for the next 24 hours was resolved on 18Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Swollen tongue
Clinical narrative: Swollen tongue; Sore throat; Swollen lymph node near armpit under left arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Apr2021 at 09:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. 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 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 27Mar2021 at 09:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 11:00 the patient experienced swollen lymph node near armpit under left arm, swollen tongue and sore throat as well. 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 swollen lymph node near armpit under left arm, swollen tongue and sore throat were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 11:30 (at the age of 44-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 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 09:00 as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 03.00, the patient experienced low grade fever ~99.6 Fahrenheit, muscle aches, fatigue and sore arm for approximately 36hours; Injection site redness and itching starting about 2-3 days post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 13Apr2021 patient checked his body temperature and it was 99.6 Fahrenheit. 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 low grade fever ~99.6 Fahrenheit, muscle aches, fatigue and sore arm were recovered on unknown date in Apr2021. The clinical outcome of the event injection site redness and itching were recovered on 18Apr2021 (lasted until18Apr2021). No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 11:30 (at the age of 44-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 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 09:00 as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 03.00, the patient experienced low grade fever ~99.6 Fahrenheit, muscle aches, fatigue and sore arm for approximately 36hours; Injection site redness and itching starting about 2-3 days post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 13Apr2021 patient checked his body temperature and it was 99.6 Fahrenheit. 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 low grade fever ~99.6 Fahrenheit, muscle aches, fatigue and sore arm were recovered on unknown date in Apr2021. The clinical outcome of the event injection site redness and itching were recovered on 18Apr2021 (lasted until18Apr2021). No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Lymphadenopathy
Clinical narrative: Fever; joint aches; vomiting; tiredness; headache; muscle pain; nausea; feeling unwell; swollen lymph nodes; Sick for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 76-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 01Apr2021 at 00:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine, liothyronine (NP THYROID). 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 11Mar2021 at 00:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, the patient experienced fever, joint aches, vomiting, tiredness, headache, muscle pain, nausea, feeling unwell, swollen lymph nodes and sick for 2 days. Took 2 weeks to recover. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events fever, joint ache, vomiting, tiredness, headache, muscle pain, nausea, feeling unwell, swollen lymph nodes were recovering. The clinical outcome of the event sick was recovered on 06Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; joint aches; vomiting; tiredness; headache; muscle pain; nausea; feeling unwell; swollen lymph nodes; Sick for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 76-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 01Apr2021 at 00:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine, liothyronine (NP THYROID). 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 11Mar2021 at 00:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, the patient experienced fever, joint aches, vomiting, tiredness, headache, muscle pain, nausea, feeling unwell, swollen lymph nodes and sick for 2 days. Took 2 weeks to recover. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events fever, joint ache, vomiting, tiredness, headache, muscle pain, nausea, feeling unwell, swollen lymph nodes were recovering. The clinical outcome of the event sick was recovered on 06Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 02Apr2021 at 18:30 (at the age of 60-old-years) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) and atorvastatin calcium (MANUFACTURER UNKNOWN); both for unspecified indication and start date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 12Mar2021 at 19:30 (at the age of 60-old-years) as a single dose for COVID-19 immunisation. The patient did not have any allergies to any medications, food, or other products. On 02Apr2021, the patient experienced tinnitus. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. 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 tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Vaccination site rash
Clinical narrative: Rash around injection site; Headache; Hot flashes; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included cyclic vomiting syndrome and hepatitis c with 0 viral load. Concomitant medications included naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 11:45 the patient experienced rash around injection site, headache and hot flashes. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events rash around injection site, headache and hot flashes were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Vaccine side swollen lymph nodes near collar bone; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Other medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced vaccine side swollen lymph nodes near collar bone. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaccine side swollen lymph nodes near collar bone was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Herpes zoster, Rash
Clinical narrative: Got small rash on left side of abdomen; Was tested for antibodies to varicella/shingles.Received call 4/19/21 for highy elevated antibodies probably being shingles.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome and varicella. Concomitant medications included norethisterone (ERRIN) and ibuprofen (MANUFACTURER UNKNOWN). The patient did not have any allergies to medications, food, or other products. 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 received other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 22Mar2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00, the patient got small rash on left side of abdomen. Went to the clinic on 18Apr2021 for advice on what to use on it. The patient had a history of varicella as a child but no known stress or unusual circumstances that would trigger a reaction and no history of shingles previously. The patient was tested for antibodies to varicella/shingles and was diagnosed with highly elevated antibodies probably being shingles on 19Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of small rash on left side of abdomen and highly elevated antibodies probably being shingles which included treatment with Medrol (Pak). The clinical outcome of the event small rash on left side of abdomen and highly elevated antibodies probably being shingles was resolving 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: Rash
Clinical narrative: Rash similar to what patient got after viralinfection started on Monday 4/19; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, penicillin allergy and sulfur drug sensitivity. 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 vaccine. Concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 21:00, the patient experienced rash similar to what the patient got after viral infection. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash similar to what the patient got after viral infection was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Rash macular
Clinical narrative: Swelling of lips within one minute.; Red blotches on face and neck; tingling in tongue and palate; This is a spontaneous report from a contactable physician, the patient. A 60-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 18Apr2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension (HTN), lipids increased (reported as elevated lipids). The patient previously had shellfish and experienced shellfish allergy. The patient also had tree nuts previously and experienced allergy to nuts. The patient previously took fluvastatin sodium (LESCOL) and levofloxacin(LEVAQUIN), both on unknown date for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included amlodipine besilate (NORVASC), formoterol fumarate, mometasone furoate (DULERA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA) and vitamin d nos (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swelling of lips within one minute on 18Apr2021 at 15:45. On 18Apr2021 at 15:45 the patient also experienced red blotches on face and neck. She also had tingling in tongue and palate. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of swelling of lips within one minute, red blotches on face and neck, tingling in tongue and palate and included treatment at site, Benadryl 50milligram, next at emergency room, Solumedrol/Ben. The clinical outcome of the events swelling of lips within one minute, red blotches on face and neck, tingling in tongue and palate was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: first 24 hours: fever, fatigue, headache, body ache; Body rash from neck down to groin including A-P trunk; mild under-eye swelling; first 24 hours: fever; first 24 hours: fever, fatigue; first 24 hours: fever, fatigue, headache; This is a spontaneous report from a non-contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had unspecified known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of the vaccination. On 17Apr2021, in first 24 hours, the patient experienced  fever, fatigue and headache. On 18Apr2021, 2 days after vaccination, the patient experienced body ache, body rash from neck down to groin including A-P trunk, ongoing headache and fatigue, mild under-eye swelling and these symptoms are ongoing and unresolved at that time. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, fatigue, headache, body ache, body rash from neck down to groin including A-P trunk and mild under-eye swelling was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: first 24 hours: fever, fatigue, headache, body ache; Body rash from neck down to groin including A-P trunk; mild under-eye swelling; first 24 hours: fever; first 24 hours: fever, fatigue; first 24 hours: fever, fatigue, headache; This is a spontaneous report from a non-contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had unspecified known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of the vaccination. On 17Apr2021, in first 24 hours, the patient experienced  fever, fatigue and headache. On 18Apr2021, 2 days after vaccination, the patient experienced body ache, body rash from neck down to groin including A-P trunk, ongoing headache and fatigue, mild under-eye swelling and these symptoms are ongoing and unresolved at that time. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, fatigue, headache, body ache, body rash from neck down to groin including A-P trunk and mild under-eye swelling was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.