chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 22Mar2021 at 10:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown start date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. On 24Mar2021 at 09:00, the patient experienced swollen lymph node under left armpit. The patient did not receive any treatment for the event. The clinical outcome of the event swollen lymph node under left armpit was recovering at the time of report.      No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Genital herpes outbreak on the day after receiving the vaccine, which otherwise is quite rare for me.; 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: ER8727), via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications were not reported. The patient had known allergies to alendronate. 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 01Apr2021 at 17:00 (also reported as on the day after receiving the vaccine), the patient experienced genital herpes outbreak, which was quite rare for the patient. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event genital herpes was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: Blister in upper right corner of cheek inside the mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone acetate; ethinylestradiol; ferrous fumarate (MICROGESTIN FE 1.5/30) taken for an unspecified indication from an unspecified date. 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 01Apr2021, the patient had a blister in upper right corner of the cheek inside the mouth. The adverse event did not result in a doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event blister in the upper right corner of cheek inside the mouth was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Fatigue, Head discomfort, Hypoaesthesia
Clinical narrative: heavy head; muscle aches; Numbness aroundcheeks, face, bottom jawline; Numbness in throat; Tired; swallowing was little tight; Throat area felt tight; Throat area tender; Felt dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. The patient had allergies to pollen (otherwise do not know). 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 01Apr2021 at 16:15 (15 min after the shot), the patient experienced dizziness; at 16:30 (30 min after the shot), the patient felt heavy head, muscle aches, numbness around cheeks, face, bottom jawline, throat, felt tired, swallowing was little tight, throat area felt tight and tender (no difficulty in breathing). 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 reported events. The clinical outcome of the events felt dizziness, heavy head and muscle aches were recovering at the time of this report; whereas for events numbness around cheeks, face, bottom jawline, numbness in throat, tired, swallowing little tight, throat area felt tight and tender were resolved on 01Apr2021 (5 to 10 and 15 minutes later after the event started).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: heavy head; muscle aches; Numbness aroundcheeks, face, bottom jawline; Numbness in throat; Tired; swallowing was little tight; Throat area felt tight; Throat area tender; Felt dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. The patient had allergies to pollen (otherwise do not know). 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 01Apr2021 at 16:15 (15 min after the shot), the patient experienced dizziness; at 16:30 (30 min after the shot), the patient felt heavy head, muscle aches, numbness around cheeks, face, bottom jawline, throat, felt tired, swallowing was little tight, throat area felt tight and tender (no difficulty in breathing). 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 reported events. The clinical outcome of the events felt dizziness, heavy head and muscle aches were recovering at the time of this report; whereas for events numbness around cheeks, face, bottom jawline, numbness in throat, tired, swallowing little tight, throat area felt tight and tender were resolved on 01Apr2021 (5 to 10 and 15 minutes later after the event started).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on back of left calf; Red itchy rash on back of left calf; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the right arm on 16Mar2021 at 10:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and ondansetron (MANUFACTURER UNKNOWN) which were taken daily for unknown indications from 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 29Mar2021 at 13:00 (reported as started a few days ago), the patient experienced red itchy rash on back of left calf. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of red itchy rash on back of left calf which included treatment with doxycycline (MANUFACTURER UNKNOWN). The clinical outcomes of the events itchy rash and red rash were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: change in ear pressure; ringing noise; 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: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 16:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and celiac disease. Concomitant medications included levothyroxine sodium (SYNTHROID) 125 mcg, vitamin D (MANUFACTURER UNKNOWN) and cyanocobalamin (VITAMIN B12). 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 vaccine within four weeks prior to the vaccination. On 23Mar2021 a few minutes following the vaccination, the patient experienced a change in ear pressure (like experienced during a change in elevation) and the event lasted for about an hour. Then he developed a ringing noise which had lasted for the past 9 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of sensation of pressure in ear and ringing in ears, included treatment with CLARITIN and FLONASE. The clinical outcome of the event change in ear pressure (sensation of pressure in ear) lasted for about an hour and recovered on 23Mar2021. The clinical outcome of the event developed a ringing noise which had lasted for the past 9 days was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Rash at injection site; Rash at injection site, which itched and spread; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6200) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to sulfa drugs. Concomitant medications included escitalopram oxalate (LEXAPRO), nortriptyline hydrochloride (PAMELOR), metformin hydrochloride (GLUCOPHAGE), atenolol (TENORMIN) and others, all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the right arm on 02Mar2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, 5 days after second shot of Pfizer, the patient experienced rash at injection site, which itched and spread, was continuing as 5 days at the time of reporting. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the vaccination site rash and itchy were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears for 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 08:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, 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-19 vaccine. On 31Mar2021 at 11:45, the patient experienced ringing in ears for 24 hours. The adverse event did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event ringing in ears were recovered on 01Apr2021 at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Glare, Visual impairment
Clinical narrative: Visual disturbance; Blocked out partial vision; Large moving floating/glare in left visual field.; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 01Apr2021 at 15:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 20:30, the patient experienced visual disturbance, six hours post vaccination, large moving floating/glare in left visual field which lasted 15-20 minutes. The patient was also unable to focus and had blocked out partial vision in only left peripheral field. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for visual disturbance, partial visual loss and glare. The clinical outcome of the event visual disturbance and glare were resolved on 01Apr2021, while that of the event partial visual loss was resolved 1n Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on my lowerneck and upper chest.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER-8732) via an unspecified route of administration in the left arm on 28Mar2021 at 13.45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient previously took 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 07Mar2021 at 13.45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After 3 days of injection, on 31Mar2021, the patient experienced slightly itchy rash on lower neck and upper chest. It was about 2inches x 3inches and spread further upper chest. No therapeutic measures were taken as a result of the reported events.  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 the events slightly itchy, rash on lower neck and upper chest was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Skin reaction, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Local skin reaction,; swelling in throat.; swelling at site; very itchy at point of injection.; This is a spontaneous report from a contactable consumer. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 5318) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00(at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history included latex allergy and sulfa medicine allergy (sulfonamide allergy). Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 16:15, the patient experienced local skin reaction, swelling at site and in throat and felt very itchy at point of injection. 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 events. The clinical outcome of the events local skin reaction, throat swelling, vaccination site swelling and vaccination site pruritis were recovered on unknown date of 2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red whelp at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included factor's deficiency, ulcerative Colitis, rheumatoid arthritis, deep vein thrombosis and multi-modular thyroid. The patient had known allergy to contrast dye for MRI. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 09Mar2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified concomitant medications from an unknown date for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. . On 30Mar2021 at 16:00, the patient experienced red welp at and around the injection site after second injection. The patient did not receive any therapeutic treatment for the adverse event. The adverse 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 clinical outcome of the event red welp at and around the injection site was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymph node pain
Clinical narrative: Fatigue; Headache; muscle pain; chills; joint pain; fever; injection site swelling; nausea; painful lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Mrna, Lnp-s, Pf) in the right arm on 09Mar2021 at 10:30 (at the age of 57-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Mrna, Lnp-s, P) in the right arm on 30Mar2021 at 10:45 (at the age of 57-years-old) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included disc degeneration, arthritis, essential tremor, neuropathy, fibromyalgia and COVID-19. Concomitant medications included primidone (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), omeprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN). The patient had the history of allergy to Lyrica. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been had tested for COVID-19. On an unspecified date in 2021, the patient experienced fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea and painful lymph nodes. Adverse 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 treatment for the reported events. The clinical outcome of the events fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea and painful lymph nodes were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Fatigue; Headache; muscle pain; chills; joint pain; fever; injection site swelling; nausea; painful lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Mrna, Lnp-s, Pf) in the right arm on 09Mar2021 at 10:30 (at the age of 57-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Mrna, Lnp-s, P) in the right arm on 30Mar2021 at 10:45 (at the age of 57-years-old) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included disc degeneration, arthritis, essential tremor, neuropathy, fibromyalgia and COVID-19. Concomitant medications included primidone (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), omeprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN). The patient had the history of allergy to Lyrica. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been had tested for COVID-19. On an unspecified date in 2021, the patient experienced fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea and painful lymph nodes. Adverse 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 treatment for the reported events. The clinical outcome of the events fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea and painful lymph nodes were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site itching; 20 hours later a large lump startedappearing; Injection site red; Injection site warmth; Initial pain at injection site; Injection site tenderness; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8727) via an unspecified route of administration in the left arm on 27Mar2021 at 18:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was allergy to pineapple. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 6Mar2021 at 18:30 (at the age of vaccination 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 00:00 the patient experienced initial pain at injection site but after 14:45 (about 20 hours later) a large lump started appearing, it was very red and warm to the touch, it grew to about a 3-inch diameter on 29Mar2021 at 18:45 (over the next 48 hours) and started to itch. The patient did not receive any treatment for the event.  The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain at injection site, injection site red, injection site warmth and injection site itching were resolving (redness and itch started to go down after about 2 days); whereas for event injection site large lump and injection site tenderness were not resolved (still a hard bump with the diameter a little larger than a dime and it is tender to touch) at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: Weakness; Shaking all over; Very Tired; Fever; Terrible flu; Getting up to go to the bathroom was difficult.; Nausea; Left arm was numb; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 at 20:15 (at the age of 49 years)  as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration in the left arm on 03Mar2021  at 10:00 (at the age of 49 years), as a single dose for COVID-19 immunisation and aspirin on unknown date for unknown indication and experienced bruises. 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 4 weeks prior to the COVID vaccine.  On 25Mar2021, the patient experienced her left arm was numb. On 26Mar2021, at 9:30 the patient experienced shaking all over, very tired, could not sit, and at afternoon fever above 102, left like she had a terrible flu, getting up to go to the bathroom was difficult and nausea. On 27March2021, the patient experienced weakness and tiredness persisted. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment herself with ibuprofen. The clinical outcome of the events numbness upper arm, shaking, fever above 102, terrible flu, difficulty walking to bathroom, nausea, weakness and tiredness was recovered on 28March202.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nausea, Pyrexia, Tremor
Clinical narrative: Weakness; Shaking all over; Very Tired; Fever; Terrible flu; Getting up to go to the bathroom was difficult.; Nausea; Left arm was numb; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 at 20:15 (at the age of 49 years)  as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration in the left arm on 03Mar2021  at 10:00 (at the age of 49 years), as a single dose for COVID-19 immunisation and aspirin on unknown date for unknown indication and experienced bruises. 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 4 weeks prior to the COVID vaccine.  On 25Mar2021, the patient experienced her left arm was numb. On 26Mar2021, at 9:30 the patient experienced shaking all over, very tired, could not sit, and at afternoon fever above 102, left like she had a terrible flu, getting up to go to the bathroom was difficult and nausea. On 27March2021, the patient experienced weakness and tiredness persisted. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment herself with ibuprofen. The clinical outcome of the events numbness upper arm, shaking, fever above 102, terrible flu, difficulty walking to bathroom, nausea, weakness and tiredness was recovered on 28March202.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Nausea, Vaccination site pain
Clinical narrative: Bloating; diarrhea; nausea; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to foods and environmental (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (ADVIL) and paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 04:00, about 16 hours after vaccination, the patient experienced bloating, diarrhea, nausea and sore injection site (vaccination site pain). The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events bloating, diarrhea, nausea and sore injection site were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; chills; joint ache; fatigue; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 19:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, 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, the patient experienced headache, chills, joint ache, fatigue and had injection site pain. Therapeutic measures were taken as a result of the events headache, chills, joint ache, fatigue and injection site pain which included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events headache, chills, joint ache, fatigue and injection site pain were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Skin exfoliation
Clinical narrative: Blistering of fingers; Peeling of fingers; This is a spontaneous report from a contactable physician. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via intramuscular route of administration on 16Feb2021(at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes and hypertension from an unknown date. The patient was allergic to penicillin. The patient previously received celecoxib (CELEBREX), gabapentin (MANUFACTURER UNKNOWN) and experienced drug allergy. It was unknown if patient had received any other medication within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via intramuscular route of administration on 26Jan2021(at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 the patient experienced blistering and peeling of fingers that started approximately 5 weeks after vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with topical triamcinolone. The clinical outcome of the event blistering and peeling of fingers were recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain  at the injection site; Swollen lymph node left armpit; swelling at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8932) via an unspecified route of administration in the left arm on 28Mar2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 16:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 the patient experienced pain and swelling at the injection site, swollen lymph node left armpit. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the events pain at the injection site, swelling at the injection site and swollen lymph node left armpit was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: pain in my kidneys on both sides; Fever of 103, usually averages around 96.7 to 97 degrees; Chills; body aches; horrible headache; vomiting; diarrhea; nausea; The arm that received the shot was extremely sore; Still feeling weak and exhausted after day 5; Still feeling weak and exhausted after day 5; Kidney infection; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 26Mar2021 at 09:00 (at the age of 39-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), generalized anxiety disorder (GAD), atrial fibrillation, and psoriasis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine, birth control, propranolol, escitalopram oxalate (LEXAPRO), naproxen (naproxen sodium), and loratadine (CLARITIN) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 08Mar2021 at 11:30 as a single dose in the left arm for COVID-19. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) from an unknown date and experienced allergy. On 26Mar2021 at 09:00 (as reported), the patient experienced fever of 103, usually averages around 96.7 to 97 degrees, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore. These symptoms lasted over 3 days. The patient was still feeling weak and exhausted after day 5 (30Mar2021). The patient had pain in her kidneys on both sides that started on day 4 after getting the vaccine (29Mar2021). The patient visited a doctor as a result of the event. The patient received treatment for a kidney infection. The patient's symptoms started within 3 hours of the second shot and continued for over 3 full days. The outcomes of fever, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore, weak, exhausted, kidney infection, and kidney pain were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Kidney infection, Nausea, Pain, Pain in extremity
Clinical narrative: pain in my kidneys on both sides; Fever of 103, usually averages around 96.7 to 97 degrees; Chills; body aches; horrible headache; vomiting; diarrhea; nausea; The arm that received the shot was extremely sore; Still feeling weak and exhausted after day 5; Still feeling weak and exhausted after day 5; Kidney infection; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 26Mar2021 at 09:00 (at the age of 39-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), generalized anxiety disorder (GAD), atrial fibrillation, and psoriasis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine, birth control, propranolol, escitalopram oxalate (LEXAPRO), naproxen (naproxen sodium), and loratadine (CLARITIN) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 08Mar2021 at 11:30 as a single dose in the left arm for COVID-19. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) from an unknown date and experienced allergy. On 26Mar2021 at 09:00 (as reported), the patient experienced fever of 103, usually averages around 96.7 to 97 degrees, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore. These symptoms lasted over 3 days. The patient was still feeling weak and exhausted after day 5 (30Mar2021). The patient had pain in her kidneys on both sides that started on day 4 after getting the vaccine (29Mar2021). The patient visited a doctor as a result of the event. The patient received treatment for a kidney infection. The patient's symptoms started within 3 hours of the second shot and continued for over 3 full days. The outcomes of fever, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore, weak, exhausted, kidney infection, and kidney pain were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal pain, Vomiting
Clinical narrative: pain in my kidneys on both sides; Fever of 103, usually averages around 96.7 to 97 degrees; Chills; body aches; horrible headache; vomiting; diarrhea; nausea; The arm that received the shot was extremely sore; Still feeling weak and exhausted after day 5; Still feeling weak and exhausted after day 5; Kidney infection; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 26Mar2021 at 09:00 (at the age of 39-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), generalized anxiety disorder (GAD), atrial fibrillation, and psoriasis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine, birth control, propranolol, escitalopram oxalate (LEXAPRO), naproxen (naproxen sodium), and loratadine (CLARITIN) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 08Mar2021 at 11:30 as a single dose in the left arm for COVID-19. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) from an unknown date and experienced allergy. On 26Mar2021 at 09:00 (as reported), the patient experienced fever of 103, usually averages around 96.7 to 97 degrees, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore. These symptoms lasted over 3 days. The patient was still feeling weak and exhausted after day 5 (30Mar2021). The patient had pain in her kidneys on both sides that started on day 4 after getting the vaccine (29Mar2021). The patient visited a doctor as a result of the event. The patient received treatment for a kidney infection. The patient's symptoms started within 3 hours of the second shot and continued for over 3 full days. The outcomes of fever, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore, weak, exhausted, kidney infection, and kidney pain were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased
Clinical narrative: Brain fog; rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 14:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, thyroidectomy and obesity. Concomitant medication included ARMOUR THYROID and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication. The patient had a history of allergy to penicillin, steroids and sulfonamides. Prior to the vaccination, patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 7:00, the patient experienced brain fog and rapid heart rate (five days post vaccine). The patient did not receive any treatment for the events. The clinical outcome of the events brain fog and rapid heart rate were ongoing at the time of reporting.  No follow up attempts are possible. Information about batch number cannot be obtained.