chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Vaccination site pain
Clinical narrative: fatigue; chills; mild persistent headache (checked but, no fever); severe arm soreness at injection site/could not lift arm; severe arm soreness at injection site/could not lift arm; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, levonorgestrel (ALESSE) for birth control, ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) and cetirizine. The patient previously received BNT162B2 (COVID Pfizer) first dose in Dec2020 for COVID-19 immunization. On 09Jan2021, the patient experienced fatigue, chills, mild persistent headache (checked but, no fever), severe arm soreness at injection site and could not lift arm. Symptoms began about 12 hours after vaccination. The patient did not receive treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jan2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Joint swelling, Muscle spasms, Pain, Peripheral swelling
Clinical narrative: Swelling of neck,shoulder, and arm; Swelling of neck,shoulder, and arm; Swelling of neck,shoulder, and arm; Temperature of 101; Body aches; Spasms in both legs; This is a spontaneous report from a contactable nurse (patient). A non-pregnant adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5519), intramuscular in right arm, on 28Jan2021 at 15:30 (03:30 PM), at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish and dyes or derivative. The patient's concomitant medication included losartan. The patient previously took the first dose of BNT162B2 (Lot Number: EL3246) on 07Jan2021 at 04:00 PM for COVID-19 immunization (intramuscular in right arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a workplace clinic facility. On 29Jan2021 at 01:00 AM, the patient experienced swelling of neck, shoulder, and arm; temperature of 101; body aches; and spasms in both legs. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling of neck,shoulder, and arm; Swelling of neck,shoulder, and arm; Swelling of neck,shoulder, and arm; Temperature of 101; Body aches; Spasms in both legs; This is a spontaneous report from a contactable nurse (patient). A non-pregnant adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5519), intramuscular in right arm, on 28Jan2021 at 15:30 (03:30 PM), at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish and dyes or derivative. The patient's concomitant medication included losartan. The patient previously took the first dose of BNT162B2 (Lot Number: EL3246) on 07Jan2021 at 04:00 PM for COVID-19 immunization (intramuscular in right arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a workplace clinic facility. On 29Jan2021 at 01:00 AM, the patient experienced swelling of neck, shoulder, and arm; temperature of 101; body aches; and spasms in both legs. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aptyalism, Poor quality sleep
Clinical narrative: her adverse event as having absolutely no saliva at all about 2-3 minutes later after getting the COVID-19 vaccine; did not have a good night's sleep; anxious; This is a spontaneous report from a contactable consumer reporting for herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown reported as "EL9281 or EL9261" as the reporter cannot tell, pending clarification, expiry date: 31May2021), via an unspecified route of administration on 28Jan2021 12:00 at SINGLE DOSE (first dose) for covid-19 immunisation.  Medical history included COPD from an unspecified date (not taking any medication for COPD) and she was 5'5 and has gotten a little bit tinier on an unspecified date. The patient's concomitant medications were not reported. On 28Jan2021, the patient stated everything was perfect and she was made to sit there for 15 minutes. The patient reported her adverse event as having absolutely no saliva at all about 2-3 minutes later after getting the COVID-19 vaccine. Her mouth stopped producing the saliva almost immediately and it was total. She stated she never had anything like that before. She stated it did not make her feel ill. She was still breathing alright, so she did not tell anybody.  She did not have a good night's sleep and anxious about whether she won't be able to breathe with this experience. At 07:00 the next day, everything went back to normal and it was very noticeable for her. She was concerned about taking the second shot in 3 weeks considering her experience with the first shot. The patient stated afterwards that the information provided to her helped her to be relived and be confident about taking the second shot. Outcome of the event was recovered on 29Jan2021 07:00.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, SARS-CoV-2 test
Clinical narrative: Wrist bone is swollen on the right arm where she received  vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 29Jan2021 16:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 29Jan2021 19:00, the patient experienced that wrist bone was swollen on the right arm where she received vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 14Dec2020. No therapeutic measure was taken as a result of the events. Clinical outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: Wheezing; Dry cough at rest or while talking; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, in Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included Cichorium intybus extract/ Embelia ribes powder/ Glycyrrhiza glabra extract/ Operculina turpethum extract/ Senna occidentalis extract/ Solanum nigrum extract/ Terminalia chebula extract/ Zingiber officinale powder (HERBOLAX), levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), and ezetimibe (ZETIA). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a public health clinic. On 13Jan2021 at 07:00 PM (19:00), the patient experienced wheezing within 2 to 3 days and dry cough at rest or while talking. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Epistaxis, Facial discomfort, Facial pain
Clinical narrative: chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color,  not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none.  She then had copious amounts of thin nasal drainage to her left sinus/nostril.  Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine.  Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning.  She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia, Rhinorrhoea, Toothache
Clinical narrative: chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color,  not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none.  She then had copious amounts of thin nasal drainage to her left sinus/nostril.  Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine.  Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning.  She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Ear pain, Epistaxis, Eye pruritus, Facial pain
Clinical narrative: chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color,  not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none.  She then had copious amounts of thin nasal drainage to her left sinus/nostril.  Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine.  Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning.  She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Impaired work ability, Jaw disorder, Lymphadenopathy, Parosmia
Clinical narrative: chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color,  not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none.  She then had copious amounts of thin nasal drainage to her left sinus/nostril.  Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine.  Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning.  She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea, Secretion discharge, Tenderness
Clinical narrative: chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color,  not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none.  She then had copious amounts of thin nasal drainage to her left sinus/nostril.  Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine.  Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning.  She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura
Clinical narrative: suffered ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration at the left arm on 25Jan2021 09:30 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient suffered ocular migraine on 26Jan2021 22:00. No treatment was received for the adverse event. Clinical outcome of the event was recovered on an unspecified date.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Mild sore arm; muscle ache into shoulder blade and neck for 36 hours; muscle ache into shoulder blade and neck for 36 hours; muscle ache into shoulder blade and neck for 36 hours; mild fatigue for 72 hours at minimum; low grade headache for 48 hours; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E132495121, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included food allergy (garlic, oatmeal, turkey, chickpeas/garbanzo beans). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included vitamin d nos (VITAMIN D). On 27Jan2021 17:00, the patient experienced mild sore arm and muscle ache into shoulder blade and neck for 36 hours, mild fatigue for 72 hours at minimum, low grade headache for 48 hours. The patient underwent lab tests and procedures which included SARS-COV-2 test with pending result since 29Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Mild sore arm; muscle ache into shoulder blade and neck for 36 hours; muscle ache into shoulder blade and neck for 36 hours; muscle ache into shoulder blade and neck for 36 hours; mild fatigue for 72 hours at minimum; low grade headache for 48 hours; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E132495121, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included food allergy (garlic, oatmeal, turkey, chickpeas/garbanzo beans). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included vitamin d nos (VITAMIN D). On 27Jan2021 17:00, the patient experienced mild sore arm and muscle ache into shoulder blade and neck for 36 hours, mild fatigue for 72 hours at minimum, low grade headache for 48 hours. The patient underwent lab tests and procedures which included SARS-COV-2 test with pending result since 29Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Peripheral coldness, Vaccination site pain
Clinical narrative: Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9265, expiry date: unknown), via an unspecified route of administration in the left arm, on 28Jan2021, at single dose, for covid-19 immunization, at an urgent care center. Medical history included known allergies to seafood. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included metformin, and hydrochlorothiazide, telmisartan. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced cold hands and feet, chills, back of the head aches and stinging in injection arm on 28Jan2021. No treatment was given for the events. The patient was recovering from the events. The events were assessed as non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Cough, Fatigue
Clinical narrative: Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. 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 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache.  These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. 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 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache.  These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. 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 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache.  These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Chills, Diarrhoea
Clinical narrative: Extreme fatigue; headache; diarrhea; stomach pain; joint pain; chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date not reported), via an unspecified route of administration in the left arm on 29Jan2021 18:15 at single dose for COVID-19 immunization. Medical history included COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown, expiry date not reported) in the left arm on 08Jan2021 07:15 PM at single dose for COVID-19 immunization. On 30Jan2021 13:00, the patient experienced extreme fatigue, headache, diarrhea, stomach pain, joint pain, chills, and upset stomach. No therapeutic measure was taken as result of the events. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Extreme fatigue; headache; diarrhea; stomach pain; joint pain; chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date not reported), via an unspecified route of administration in the left arm on 29Jan2021 18:15 at single dose for COVID-19 immunization. Medical history included COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown, expiry date not reported) in the left arm on 08Jan2021 07:15 PM at single dose for COVID-19 immunization. On 30Jan2021 13:00, the patient experienced extreme fatigue, headache, diarrhea, stomach pain, joint pain, chills, and upset stomach. No therapeutic measure was taken as result of the events. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Erythema, Joint swelling, Pruritus
Clinical narrative: My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1283), at age 45 years, intramuscular on the right arm, on 29Jan2021 09:00 at single dose, for COVID-19 immunisation. Medical history included allergy to red wasp bee stings. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. On 30Jan2021 01:00, patient's ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them. Patient soaked her ankles and took some diphenhydramine (BENADRYL) and ibuprofen (MOTRIN). She also applied triamcinolone acetonide cream usp. and oatmeal (EUCERIN ECZEMA RELIEF BODY CREAM). She mentioned that it is not resolved by Tuesday, she will visit urgent care. Facility where the most recent COVID-19 vaccine was administered was at a hospital. Since the vaccination, the patient has not been tested for COVID-19. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was not recovered. Case was reported as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Headache, Hypoaesthesia, Insomnia
Clinical narrative: Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic  The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pruritus, Pyrexia, Vaccination site pruritus
Clinical narrative: Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic  The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Product use issue
Clinical narrative: Joint pain; had liquid diarrhea; Stomach not crampy but urgency when it happens; Medical history include coeliac disease; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included essential tremor, coeliac disease, high blood pressure, and allergies to wheat and dairy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included enalapril (ENALAPRIL), venlafaxine hydrochloride (EFFEXOR), propranolol and hydrochlorothiazide (HCT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported for about a week, she has had liquid diarrhea. The patient also has joint pain, stomach not crampy but urgency when it happens and no fever. The patient did not received treatment for the adverse events and the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The onset of the events was on 26Jan2021 and the outcome of the events was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphagia, Lymphadenopathy, Pyrexia
Clinical narrative: Fever over 100 degrees; swollen lymph nodes; unable to swallow; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 30Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included an unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced "fever over 100 degrees and swollen lymph nodes causing me to be unable to swallow" on 30Jan2021 at 22:00. No treatment was received for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruise on left arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 25Jan2021 08:15 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history was none. The patient has no known allergies to medications, food, or other products. Concomitant medications included iron, birth control, prenatal vitamins. On 26Jan2021, the patient experienced bruise on left arm. No treatment was received for the events. Outcome of the event was not recovered. The reporter assessed the events as non-serious. Since the vaccination, the patient not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: Dry cough; Fatigued; Bitemporal headache 4/10 with 10 being the worst; Fever started within 6 hours after the vaccine/The next day temp increased to 100.3; This is a spontaneous report from a contactable physician. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 29Jan2021 09:45 at a single dose for covid-19 immunization. Medical history included Rheumatoid Arthritis, Menieres disease and history of 6 pneumonia episodes 4 during childhood 2 as an adult. The patient previously took bactrim, augmentin and malarone; all of which the patient had allergies to. It was reported that Fever started within 6 hours after the vaccine. Initially 99.8 in the evening of the day I was vaccinated. Also, dry cough which lasted about 5 hours and was gone after that. The next day temp increased to 100.3. This lasted until 24 hours after vaccination when it abruptly ended. However, patient continued to be very fatigued. Also, several hours after vaccination, bitemporal headache 4/10 with 10 being the worst which ended approximately 24 hrs after vaccination; all on 29Jan2021 at 3:00PM. The patient receive acetaminophen for the events. The outcome of the event dry cough recovered in 29Jan2021, headache recovered on 30Jan2021, not recovered for event fatigue, while recovering for fever.  Information on lot/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Skin irritation, Urticaria
Clinical narrative: skin irritation and discoloring; skin irritation and discoloring; severe hives; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (right arm) on Jan2021 at single dose for Covid-19 immunization. The patient's medical history included Heart (heart disorder), diabetes, and allergy: life long allergies. The patient concomitant medication includes unspecified medication. The patient previously took Zocor, Cardura, Accupril, Niacin, Clonidine HCl; all tabs and experienced allergies. In Jan2021, the patient experienced skin irritation and discoloring starting the day of vaccine and increasing into severe hives the following days. Currently on day 6 with no relief.  The patient did not received treatment for the events. The outcome of the events was not recovered. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Information on the Lot/Batch number has been requested