chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Muscle tightness, Myalgia, Swelling
Clinical narrative: significant swelling and pain in left under arm; Pain in left under arm and moving into left pec; Tightness in surrounding muscles andinto bilateral upper traps; Pain in left under arm and moving into left pec; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included multivitamin (MANUFACTUER UNKNOWN), angelica polymorpha, atractylodes macrocephala, bupleurum falcatum, glycyrrhiza uralensis, mentha canadensis, paeonia lactiflora, poria cocos, zingiber officinale (XIAO YAO SAN) (herbal) and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:45 (at the age of 45-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 COVID-19 vaccine. On 31Mar2021 at 04:00, the patient experienced significant swelling and pain in left under arm, moving into left pec and tightness in surrounding muscles and into bilateral upper traps. The events resulted in the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events significant swelling and pain in left under arm, moving into left pec and tightness in surrounding muscles and into bilateral upper traps. The clinical outcomes of the events swelling, armpit pain, muscle tightness and muscle pain were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Paraesthesia
Clinical narrative: whole face started to tingle; had two more episodes of whole face tingling, mild but still not completely gone; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6027) via an unspecified route of administration in the right arm on 27Mar2021 at 10:45 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included heart murmur. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), sumatriptan (IMITREX), fish oil (MANUFACTURER UNKNOWN) and acetylsalicylic acid; caffeine; paracetamol (EXCEDRIN) and multivitamins (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy to both. 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 27Mar2021 at 11:15 (approximately after 30 minutes after shot), the patient experienced whole face started to tingle which lasted for 45 minutes and patient felt fine after that. On 31Mar2021, the patient had two more episodes of whole face tingling, one lasted about an hour, the next was severe and lasted for about four hours and had become mild (at the time of reporting) but still not completely gone away after 24 hours. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of face started to tingle and included monitoring of blood pressure and heart rate (unknown results). The patient had blood pressure and heart rate measurements on an unknown date and the results were unknown. The clinical outcome of the event tingling was recovered with sequalae with the date 27Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysstasia, Headache, Pyrexia
Clinical narrative: Headache; Hard to even stand; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFIB) and COVID-19. The patient had allergic to iodine. Concomitant medications included losartan (MANUFACTURER UNKNOWN), ELIQUIS, atorvastatin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19. On an unknown date, the patient underwent COVID-19 virus test, that resulted positive. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient underwent lab test and procedure which included body temperature and result was shown as 101(unspecified units). On 30Mar2021 at 17:00 the patient experienced extreme chills that rattled entire body and fever 101. The patient reported that this extreme body reaction made it hard to stand. On 31Mar2021 the next day the patient experienced a lingering headache. The patient did not receive any treatment for 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 chills, fever, headache and difficulty in standing was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache; Hard to even stand; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFIB) and COVID-19. The patient had allergic to iodine. Concomitant medications included losartan (MANUFACTURER UNKNOWN), ELIQUIS, atorvastatin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19. On an unknown date, the patient underwent COVID-19 virus test, that resulted positive. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient underwent lab test and procedure which included body temperature and result was shown as 101(unspecified units). On 30Mar2021 at 17:00 the patient experienced extreme chills that rattled entire body and fever 101. The patient reported that this extreme body reaction made it hard to stand. On 31Mar2021 the next day the patient experienced a lingering headache. The patient did not receive any treatment for 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 chills, fever, headache and difficulty in standing was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Lethargy, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; lathargic; stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 01Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history included common variable immunodeficiency and rheumatoid arthritis. The patient had latex allergy and sulfonamide allergy. The patient previously had drug allergy while taking Percocet (MANUFACTURER UNKNOWN) and oxycontin (MANUFACTURER UNKNOWN). Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), ethinylestradiol, levonorgestrel (AMETHIA), immunoglobulin human normal (HIZENTRA) and methylprednisolone (MANUFACTURER UNKNOWN) started on an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG207) via an unspecified route of administration in the arm left on 11Mar2021 at 18:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 at 08:00 the patient experienced fever, lethargy and stomach ache. On 03Mar2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any therapeutic measures for the adverse events. The clinical outcome of the events fever, lethargic and stomach ache were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Sneezing
Clinical narrative: Extreme fatigue; Sneezing; Congestion; Mild headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 10:00 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Medical history of the patient included depression and anxiety. The concomitant medications included welbutrin (MANUFACTURER UNKNOWN), celexa (MANUFACTURER UNKNOWN). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 was unknown. Since vaccination, the patient had not tested for COVID-19.  On 30Mar2021 at 12:00, the patient experienced extreme fatigue and some mild cold symptoms like sneezing, congestion, and mild headache. The patient did not received any treatment for the events. The clinical outcome of the events extreme fatigue, sneezing, congestion and mild headache was recovering at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Woke up with a rash and itchy chest; Itchy chest; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 30Mar2021 at 11:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), guaifenesin; pseudoephedrine hydrochloride (SUDAFED), estradiol (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unspecified indications from on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021 at 08:00, the patient woke up with a rash and itchy chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the rash and itchy. The clinical outcomes of the events rash and itchy were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Body ache; Fever of 100 for 12 hours; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-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 25Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) received on unspecified date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 26Mar2021 at 01:00, the patient experienced fever of 100 (unspecified units) for 12 hours, chills, headache, body ache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the reported events. The clinical outcome of the event fever was resolved on 26Mar2021 at 13:00 (for 12 hours) while that of the events chills, headache, body ache and fatigue was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body ache; Fever of 100 for 12 hours; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-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 25Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) received on unspecified date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 26Mar2021 at 01:00, the patient experienced fever of 100 (unspecified units) for 12 hours, chills, headache, body ache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the reported events. The clinical outcome of the event fever was resolved on 26Mar2021 at 13:00 (for 12 hours) while that of the events chills, headache, body ache and fatigue was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Feeling hot, Flushing, Malaise
Clinical narrative: soreness at injection site; Neck felt stiff; Flushed face/face felt hot; Flushed face/face felt hot; Felt "off"; "Off" feeling was a bit foggy-brained; weakness; Injection site swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERE737) via an unspecified route of administration on 01Apr2021 at 11.30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had history of known allergies to insect bites (slight reaction to insect bites, no EPI pen needed/used). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, 20 minutes after vaccination, the patient experienced flushed face, face felt hot and felt off. That off feeling was a bit foggy-brained, weakness but was not so much that she had to stop what she was doing. Neck felt stiff about 30 minutes after vaccine. These symptoms lasted about an hour and Injection site was swollen for first 8 hours or so. Day after vaccination, only minor soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcomes of flushed face, face felt hot, felt off, foggy-brained, weakness, neck felt stiff, Injection site swollen were recovered on 01Apr2021 and of the soreness at injection site was recovered on 02Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at injection site; Neck felt stiff; Flushed face/face felt hot; Flushed face/face felt hot; Felt "off"; "Off" feeling was a bit foggy-brained; weakness; Injection site swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERE737) via an unspecified route of administration on 01Apr2021 at 11.30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had history of known allergies to insect bites (slight reaction to insect bites, no EPI pen needed/used). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, 20 minutes after vaccination, the patient experienced flushed face, face felt hot and felt off. That off feeling was a bit foggy-brained, weakness but was not so much that she had to stop what she was doing. Neck felt stiff about 30 minutes after vaccine. These symptoms lasted about an hour and Injection site was swollen for first 8 hours or so. Day after vaccination, only minor soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcomes of flushed face, face felt hot, felt off, foggy-brained, weakness, neck felt stiff, Injection site swollen were recovered on 01Apr2021 and of the soreness at injection site was recovered on 02Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pain in extremity, Thirst
Clinical narrative: Headache; Arm soreness; Mild body aches; Light headedness/ got dizzy easily; Thirst; Got dizzy easily; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 01Apr2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. No concomitant medications were taken by the patient. 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 did not receive any other medications within 2 weeks of vaccination. On 01Apr2021 at 13:00 the patient experienced headache, arm soreness, mild body aches, light headedness, got dizzy easily and thirst. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, arm soreness, mild body aches, light headedness, got dizzy easily and thirst were recovered on an unspecified date in Apr-2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Headache, Myalgia
Clinical narrative: joint pains; muscle aches; Headache; feeling of being cold (not chills); This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male 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 01Feb2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included pro-inflammatory state. It was reported that patient had started a weight training program on the same day as the vaccination and suspected that it might have induced a pro-inflammatory state. Allergies to medications, food, or other products was reported as not to the patient's knowledge. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), cholecalciferol (VITAMIN D3), glucosamine (MANUFACTURER UNKNOWN) and chondroitin sulfate (MANUFACTURER UNKNOWN) all for unknown indications and since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021 at 08:00, the patient experienced joint pain, muscle aches, headache and feeling of being cold (not chills). Therapeutic measures were taken as a result of joint pain, muscle ache, headache and feeling cold included treatment with naproxen for the next 3 days. It was reported that these symptoms had continued despite the treatment with naproxen for 3 days. The clinical outcome of the events joint pain, muscle aches, headache and feeling cold were recovered (reported as-by day 5 post-injection the symptoms had gone) at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in fingers on both hands; pins and needles sensation in hands; This is a spontaneous report from a contactable consumer, the patient. A 79-years-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 in the left arm on 24Feb2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications of the patient were not reported. Patient had no known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not tested for COVID-19. On 04Mar2021 at 07:00 the patient experienced numbness in fingers on both hands, pins and needles sensation in hands. The patient did not receive any treatment for events. Clinical outcome of the events numbness in fingers and pins and needles was unknown at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal
Clinical narrative: Foggy headedness; difficulty concentrating; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was reported as none. The patient was allergic to fruits and nuts. Concomitant medications included ibuprofen (ADVIL) taken for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 02Apr2021, at 09:30, the patient experienced foggy headedness and difficulty concentrating. 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 foggy headedness and difficulty concentrating was recovering 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: Blepharitis, Gingival pain, Headache, Pain, Swelling face
Clinical narrative: LEFT SIDE OF FACE WASSWOLLEN; Headache; Pain; LEFT EYELID  DIAGNOSED WITH BLEPHARITIS; GUM AND TEETH PAIN.; GUM AND TEETH PAIN.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), in the right arm on 22Mar2021 at 10:30 (at the age 0f 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced face swelling on left side with headache and pain and also diagnosed with blepharitis in left eyelid. The patient had also experienced swelling in upper eyelid and itchy and also gum and teeth pain. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as result of events which included antibiotics and ointment for both eyes. The clinical outcome of the events left side of face swollen, headache, pain, left eyelid diagnosed with blepharitis, gum and teeth pain was 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: Toothache
Clinical narrative: LEFT SIDE OF FACE WASSWOLLEN; Headache; Pain; LEFT EYELID  DIAGNOSED WITH BLEPHARITIS; GUM AND TEETH PAIN.; GUM AND TEETH PAIN.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), in the right arm on 22Mar2021 at 10:30 (at the age 0f 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced face swelling on left side with headache and pain and also diagnosed with blepharitis in left eyelid. The patient had also experienced swelling in upper eyelid and itchy and also gum and teeth pain. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as result of events which included antibiotics and ointment for both eyes. The clinical outcome of the events left side of face swollen, headache, pain, left eyelid diagnosed with blepharitis, gum and teeth pain was resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pyrexia, Vaccination site pain
Clinical narrative: Gout in the left leg triggered.; injection site pain; mildtemperature rise; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7533) via unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included gout and colitis that had been in remission for the last 7 years. 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 COVID vaccination. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (unspecified) (MANUFACTURER UNKNOWN) and diosmin, herperidin (DIOSMIN COMPLEX) for unknown indication from unknown date. On 01Apr2021 at 22:00, the patient had gout in the left leg which was triggered (gout aggravated) in the evening after the vaccination. He was prescribed with indomethacin and COLCRYS and had mild effects after 14 hours of first symptoms. On the same day, the patient had very little pain at injection site (vaccination site pain) and also experienced a mild temperature rise in the first 24 hours. Therapeutic measures were taken as a result of injection site pain, mild temperature rise and included treatment with indomethacin and COLCRYS. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of event gout in the left leg triggered which was resolving, while the injection site pain and mild temperature rise was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate increased
Clinical narrative: Elevated blood pressure; Elevated blood pressure and heart rate.; This is a spontaneous report from a contactable consumer, the patient. A 58-years-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 arm left on 31Mar2021 at 15:15 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included left bundle branch block, hypertension and COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included rabeprazole sodium (ACIPHEX), atorvastatin (MANUFACTURER UNKNOWN), irbesartan (AVAPRO), ascorbic acid (VITAMINS C), zinc (MANUFACTURER UNKNOWN) and B; from unknown dates for unknown indication. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 16:00, the patient experienced elevated blood pressure and heart rate. The events resulted in visit to emergency room/department or urgent care. The patient did not receive any treatment for the elevated blood pressure and heart rate. The clinical outcomes of the events elevated blood pressure and heart rate were resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Fairly severe lymph node swelling in armpit area of left arm (injection site); Hours after second dose causing significant pain/discomfort, persisting for multiple days; Hours after second dose causingsignificant pain/discomfort; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 10Mar2021 at 17:45 (at the age of 20-years-old) and a second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 31Mar2021 at 14:45 (at the age of 20-years-old), each as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. Concomitant medications included birth control pill for an unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Mar2021, 2 weeks after dose 1, the patient experienced lymph node swelling in armpit area of left arm (injection site) with less severity which caused significant pain/discomfort. On 01Apr2021 at 01:00, the patient experienced the same reaction after the second dose which was fairly severe and persisted for multiple days. The patient did not receive any treatment for the reported events. The events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the lymph node swelling in armpit, significant pain/discomfort was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigued; Aches/pains in arms, lower back, and legs; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date in Mar2021(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to zithromax, ceclore, budesonide. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, 24 hours after receiving the second dose the patient experienced very fatigue and experienced aches and pains in her arms, lower back and legs. It was reported that it continued (especially the fatigue) for four days total. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events fatigue, aches and pains in arms, lower back, and legs was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swollen tongue, Urticaria
Clinical narrative: I remained at center for 30 minutes. After leaving, I developed hives within 10 minutes. The insides of my nostrils and to tongue swelled.; nostrils swelled; tongue swelled; This is a spontaneous report received from a contactable consumer, the patient. A 49-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 in the right arm on 19Mar2021 at 16:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included asthma, penicillin and all variants allergy, latex allergy, plastic bags like grocery store allergy, pumpkins allergy.  Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 16:45 (as reported), the patient remained at centre for 30 minutes. After leaving, experienced hives within 10 minutes, the insides of nostrils and to tongue swelled. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome for the events hives, nostrils swelling and tongue swelling was resolved on an unknown date in 2021.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Crying, Decreased appetite, Depression
Clinical narrative: caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021.  Information on batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait inability, Gingival swelling, Headache
Clinical narrative: caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021.  Information on batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021.  Information on batch/lot number has been requested.