chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Impaired work ability, Insomnia
Clinical narrative: The next day I couldnt do anything.; Joint pain; Muscle aches/Every joint in my body was burning and aching; Unable to sleep; Chills; Fever; Headache; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Apr2021 (at the age of 56-year-old) at 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergies to fluconazole. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown 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. Concomitant medications included estradiol (ESTROGEN), omeprazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN)-all for unknown indication. On 14Apr2021 at 21:00, the patient experienced joint pain, muscle aches started, unable to sleep, chills, fever and headache. The patient reported that she couldn't do anything on 15Apr2021 and unable to get relief. Therapeutic measures were taken as a result of event and included treatment with Tylenol and the patient reported as unrelieved by the Tylenol. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of joint pain, muscle aches, unable to sleep, chills, fever and headache were recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: The next day I couldnt do anything.; Joint pain; Muscle aches/Every joint in my body was burning and aching; Unable to sleep; Chills; Fever; Headache; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Apr2021 (at the age of 56-year-old) at 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergies to fluconazole. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown 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. Concomitant medications included estradiol (ESTROGEN), omeprazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN)-all for unknown indication. On 14Apr2021 at 21:00, the patient experienced joint pain, muscle aches started, unable to sleep, chills, fever and headache. The patient reported that she couldn't do anything on 15Apr2021 and unable to get relief. Therapeutic measures were taken as a result of event and included treatment with Tylenol and the patient reported as unrelieved by the Tylenol. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of joint pain, muscle aches, unable to sleep, chills, fever and headache were recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: "I seem to be having bad hot flashes at night. she is in menopause and since the first COVID shot my hot flashes seem to have gotten 3 times worse at night".; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 04Apr2021 at 15:15 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel and lactose intolerant. The patient had known allergies to medications, food or other products. Concomitant medications included vit d (MANUFACTURER UNKNOWN) of 1000 mg 1 pill pm and calcium carbonate, colecalciferol (CALTRATE) of 600 mg 1pill am, all from an unknown date for unknown indication. The patient did not receive any other vaccine 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 05Apr2021, the patient reported that she seemed to be having bad hot flashes at night, was in menopause and since the first COVID shot her hot flashes seemed to have gotten 3 times worse at night. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event "she seem to be having bad hot flashes at night. she is in menopause and since the first COVID shot her hot flashes seem to have gotten 3 times worse at night" was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in left arm (injection site); Pain in left arm (injection site); Mild headache that lingered most of the day (16 hours or so); Mild headache that lingered most of the day (16 hours or so) along with tiredness; Lack of energy; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the arm left on 03Apr2021 at 14:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration the left arm on 13Mar2021 at 17:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 04Apr2021, the patient woke up on the morning with pain in left arm (injection site), mild headache that lingered most of the day (16 hours or so) along with tiredness and lack of energy. The symptoms were gone by the next day. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events pain in left arm (injection site), mild headache, tiredness and lack of energy were recovered on the 05Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia
Clinical narrative: Chin, lips and tongue began in tingle; Slight bitter to bad taste formed in the back of throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 13Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included fluticasone propionate (FLONASE), zinc (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), pantothenic acid (MANUFACTURER UNKNOWN), antihistamine (MANUFACTURER UNKNOWN), yinviv ease tonic (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took naproxen (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 48-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 13Apr2021 at 13:30, the patient experienced chin and lips and tongue began in tingle and a slight bitter and bad taste formed in the back of throat. 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 chin and lips and tongue began in tingle and a slight bitter and bad taste formed in the back of throat was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period started one week early; 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: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant drugs include ethinylestradiol; norgestimate (TRI-LO SPRINTEC) for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Apr2021 at 14:30, the patient experienced her period which started one week early, an hour after she received her shot. The patient reported that her cycle was always the same, so it was strange for it to be irregular. The only thing different about routine was getting the first Pfizer shot. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event period started one week early was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: It kind of knocked 'me' out/fatigue; This is a spontaneous report from a contactable consumer reporting for a patient. An adult male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 12Apr2021, in an email to the reporter, the patient (vendor) mentioned that after getting second dose of vaccine it kind of knocked him out. The reporter took this to mean fatigue since the patient did not elaborate. The clinical outcome of the event It kind of knocked 'me' out/fatigue was unknown at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: I developed a red, swollen lump at theinjection site; swollen lump at the injection site; hot to touch; I developed a red, swollen lump at the injection site; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced a red, swollen lump at the injection site the day after receiving the vaccine. The swollen area was about 2 inches and was circular. The skin of the swollen area was very red and hot to touch. On an unknown date in Apr2021, the patient experienced the bump became itchy. 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 developed a red, swollen lump at the injection site, the skin of the swollen area was very red and hot to touch, bump became itchy was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Migraine, Sinus pain
Clinical narrative: Series of migraine flares; Hot flashes combined with ear; Sinus pain on day 4, 5, 6; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gliclazide (CLARITIN), vitamins nos (MULTIVITAMIN) and mefenamic acid (ADVIL), all from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 09:00, the patient experienced series of migraine flares, hot flashes and sinus pain on day 4, 5, 6. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, hot flashes and sinus pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Light headache; Light Body pain; Light fever; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 12Apr2021 at 09:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 09:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient experienced light headache, light body pain and light fever. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. The clinical outcomes of the events, light headache, light body pain and light fever was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Malaise
Clinical narrative: Sore armpit; Felt unwell; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 12:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced sore armpit and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events, The clinical outcome of the event sore armpit and felt unwell were recovered on an unknown date in Apr2021, at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives on torso; Rash and hives on torso; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 15Apr2021 at 10:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 21:00, the patient experienced rash and hives on torso. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash and hives on torso were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Paraesthesia oral, Swollen tongue
Clinical narrative: very dizzy on day 3 and 4 of vaccine; Within 90 mins of the vaccine mymouth started to tingle; tongue started to swell; My lymph nodes under mychin were also a little swollen andwent down after a day; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 13:30 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient did not receive any medication within two weeks of vaccination. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on unknown date for unspecified indications and experienced drug allergy. 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 tested for COVID-19. On 26Mar2021, within 90 mins of the vaccine, the patient's mouth started to tingle, tongue started to swell, though it did not cut off breathing it was noticeable for 4 hours. On 26Mar2021, the patient's lymph nodes under chin were also a little swollen and went down after a day. On 28Ma2021, day 3 and 4 after vaccine, the patient was very very dizzy. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mouth started to tingle and tongue started to swell was recovered on 26Mar2021, and of the event little swollen lymph nodes under chin was recovered on 27Mar2021, and of the event very very dizzy was recovering, at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Headache lasting more than 7 days; Itching entire body; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, anxiety, hypothyroidism and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), vitamin b complex (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN); all from unknown dates for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Hepatitis b vaccine and experienced allergy to the vaccine. On 08Apr2021 at 15:15, the patient experienced headache lasting more than 7 days and itching entire body. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovering while that of the itching entire body was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Vaccine given in same arm and same location arm feels weak.; Arm tingling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not receive any other medications within two weeks. On 13Apr2021 at 06:00, 8 days after vaccination, the patient had experienced weak arm and tingling as if it was sleeping in the same location in same arm of vaccine given. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events weak arm and tingling was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Myalgia, Nausea, Pyrexia
Clinical narrative: severe muscle pain surrounding injection site; inflammation; fever; minor hives; nausea; fatigue; Severe muscle pain surrounding injection site; This is a spontaneous report from a contactable consumer, the patient. A 24-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  left arm on 13Apr2021 at 16:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, stomach upset and major depressive disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and chlorhexidine towelette (MANUFACTURER UNKNOWN)  on an unspecified date for an unknown indication and experienced drug allergy. The patient had no known allergies to medications, food or other products. Concomitant medications included drospirenone (MANUFACTURER UNKNOWN) from 13Apr2021 at 16:45 and ethinylestradiol (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced severe muscle pain surrounding injection site, inflammation, mild fever, minor hives surrounding injection site, nausea, and fatigue all within 2 days of receiving the vaccine. Hives developed 2 days later, muscle pain receding. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the event severe muscle pain surrounding injection site, inflammation, fever, minor hives, nausea and fatigue was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: severe muscle pain surrounding injection site; inflammation; fever; minor hives; nausea; fatigue; Severe muscle pain surrounding injection site; This is a spontaneous report from a contactable consumer, the patient. A 24-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  left arm on 13Apr2021 at 16:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, stomach upset and major depressive disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and chlorhexidine towelette (MANUFACTURER UNKNOWN)  on an unspecified date for an unknown indication and experienced drug allergy. The patient had no known allergies to medications, food or other products. Concomitant medications included drospirenone (MANUFACTURER UNKNOWN) from 13Apr2021 at 16:45 and ethinylestradiol (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced severe muscle pain surrounding injection site, inflammation, mild fever, minor hives surrounding injection site, nausea, and fatigue all within 2 days of receiving the vaccine. Hives developed 2 days later, muscle pain receding. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the event severe muscle pain surrounding injection site, inflammation, fever, minor hives, nausea and fatigue was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Left lymph node under armpit has swelled significantly; 100.8-101.2 fever; Strong headache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and psoriatic arthritis. The patient was allergic to penicillin (PCN). Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 42-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 four weeks prior to the vaccination. On 13Apr2021 at 08:00, 20 plus hours after the vaccination, the patient had fever of 100.8 to 101.2, strong headache and on 13Apr2021 at 18:00, 30 hours after the vaccination, the patient experienced that the lymph node under armpit had swelled significantly and the patient was unable to put the arm down. The patient did not seek treatment and wanted to reevaluate next morning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, strong headache and left lymph node under armpit had swelled were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 39, via unspecified route of administration,  left arm, on Mar 11, 2021, at 10:00; and received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 39, via unspecified route of administration, left arm on Apr 1, 2021, at 13:30, single dose, for COVID-19 immunisation. Medical history reported as not available. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 12, 2021, at 18:00, patient experienced tinnitus after first shot, which was significantly stronger tinnitus after second shot and there was no prior known tinnitus. Since the vaccination, patient has not tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the event. The outcome of the tinnitus after first shot, which was significantly stronger tinnitus after second shot: not recovered at the time of this report. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site rash
Clinical narrative: Rash started at injection site and went down to a scar which was due to a tuberculosis vaccine administered to me as an infant; little redness only at scar one week later; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 16Mar2021 at 15:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer on 2006, lumpectomy, radiation treatments, allergies to crafting and allergies to sulfa 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. Concomitant medications included atorvastatin 10 mg (MANUFACTURER UNKNOWN), metagenics bone builder forte (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient previously received tuberculosis vaccine which was administered as an infant in Italy. On 17Mar2021 at 12:00, the patient experienced rash which developed within 24 hours which started at injection site and went down to a scar which was due to a tuberculosis vaccine administered to her as an infant in Italy where she was born. The rash got better each day but at the time of report the patient had little redness only at scar one week later. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event rash started at injection site and redness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: Dizziness; Weakness; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included heart failure. Concomitant medications were not reported. The patient had known allergies to pecan, cats and cefzil. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Apr2021 at 02:00, the patient experienced dizziness, weakness, fever and chills. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events- dizziness, weakness, fever and chills was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Very heavy period days after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to a couple antibiotics. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021, the patient experienced very heavy period days after vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event very heavy period days after vaccine was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision in left eye for past 4 weeks. started day after second dose.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 16Mar2021 at 20:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), valaciclovir hydrochloride (VALTREX), vitamin b (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) all from unknown date for an unknown indication and unknown if ongoing. 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  tested for COVID-19. On 17Mar2021 at 14:00,day after second dose, the patient experienced blurry vision in left eye for past 4 weeks. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of blurry vision in left eye was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever over 101 F; Chills; Nausea; Muscle ache; Fatigue; Sore throat; Headache; Neck pain; This is a spontaneous report from a contactable healthcare professional. A 22-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 13Apr2021 at 19:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), vitamin B12 (MANUFACTUREER UNKNOWN) and colecalciferol (vitamin D3) (MANUFACTUREER UNKNOWN) from unknown dates, for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 19:00 (at the age of 22-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 vaccine. On 14Apr2021 at 03:30, the patient experienced fever over 101 (Fahrenheit), chills, nausea, muscle ache, fatigue, sore throat, headache and neck pain. The patient underwent lab tests and procedures, which included Body temperature on 14Apr2021 at 03:30 and resulted 101 (Fahrenheit). Therapeutic measures were taken as a result of the events which included treatment with acupuncture. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events fever over 101 (Fahrenheit), chills, nausea, muscle ache, fatigue, sore throat, headache and neck pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever over 101 F; Chills; Nausea; Muscle ache; Fatigue; Sore throat; Headache; Neck pain; This is a spontaneous report from a contactable healthcare professional. A 22-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 13Apr2021 at 19:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), vitamin B12 (MANUFACTUREER UNKNOWN) and colecalciferol (vitamin D3) (MANUFACTUREER UNKNOWN) from unknown dates, for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 19:00 (at the age of 22-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 vaccine. On 14Apr2021 at 03:30, the patient experienced fever over 101 (Fahrenheit), chills, nausea, muscle ache, fatigue, sore throat, headache and neck pain. The patient underwent lab tests and procedures, which included Body temperature on 14Apr2021 at 03:30 and resulted 101 (Fahrenheit). Therapeutic measures were taken as a result of the events which included treatment with acupuncture. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events fever over 101 (Fahrenheit), chills, nausea, muscle ache, fatigue, sore throat, headache and neck pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Intense chills,; fever; nausea; headache; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8734) via an unspecified route of administration on 20Mar2021(at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 00:00 the patient experienced Intense chills, fever, nausea, headache, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events Intense chills, fever, nausea, headache, fatigue were recovered with sequelae on an unknown date in Apr2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on 10Apr2021(at the age of 33-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Nausea
Clinical narrative: Nausea; tiredness; leg cramp; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 13Apr2021 at 12:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included fibromyalgia, tachycardia, dysrhythmias. The patient's allergies included sulfonamide allergy, penicillin allergy, pollen allergy, amoxicillin allergy, dairy allergy, grass allergy, trees allergy and mold allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date 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 13Apr2021 at 16:30 the patient experienced nausea and tiredness and leg cramp. The patient had the worst leg cramp from the top of the leg right up into the groin, they continued all the way down to my ankle. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events nausea and tiredness and leg cramp were recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Muscle pain; Tiredness; Pain in my left arm where vaccinated; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 14:45 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient has allergy to pollen, mould, avocado, nuts and few others food products. Concomitant medications include cetirizine hydrochloride (ZYRTEC) for unspecified indication from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 the patient experienced muscle pain, tiredness and pain in my left arm where vaccinated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, tiredness and pain in my left arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.