chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Chills; Low grade fever (never got above 99); ZERO appetite; Tingly body; Odd nausea "ie". I didn't feel it in my stomach but in the back of my throat, verge of being sick and and knew that if had anything solid, would not digest it.; Mild sleepiness; Lethargy; Swollen lymph nodes; Illusive headache; Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 32-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 left arm on 20Apr2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergic to sulfa antibiotics and lactose intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D) and montelukast sodium (SINGULAIR); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation.  On 20Apr2021 at 18:30, the patient experienced chills, low grade fever (never got above 99) , zero appetite, tingly body, odd nausea where she didn't felt it in her stomach but in the back of her throat and it was like on the verge of being sick and knew that if it had anything solid which would not digest it, mild sleepiness and lethargy, swollen lymph nodes, illusive headache and insomnia. She also reported that most of that was immediately after the shot and only lasted a few hours. On the same day, the patient underwent body temperature test and the result was below 99 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, low grade fever (never got above 99), zero appetite, tingly body, odd nausea, mild sleepiness and lethargy, swollen lymph nodes, illusive headache and insomnia was recovering at the time of this report.     No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Chills; Low grade fever (never got above 99); ZERO appetite; Tingly body; Odd nausea "ie". I didn't feel it in my stomach but in the back of my throat, verge of being sick and and knew that if had anything solid, would not digest it.; Mild sleepiness; Lethargy; Swollen lymph nodes; Illusive headache; Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 32-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 left arm on 20Apr2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergic to sulfa antibiotics and lactose intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D) and montelukast sodium (SINGULAIR); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation.  On 20Apr2021 at 18:30, the patient experienced chills, low grade fever (never got above 99) , zero appetite, tingly body, odd nausea where she didn't felt it in her stomach but in the back of her throat and it was like on the verge of being sick and knew that if it had anything solid which would not digest it, mild sleepiness and lethargy, swollen lymph nodes, illusive headache and insomnia. She also reported that most of that was immediately after the shot and only lasted a few hours. On the same day, the patient underwent body temperature test and the result was below 99 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, low grade fever (never got above 99), zero appetite, tingly body, odd nausea, mild sleepiness and lethargy, swollen lymph nodes, illusive headache and insomnia was recovering at the time of this report.     No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Swelling of lower lip on the left side/ upper left lip swelled; Overnight "I" was awoken by a torturous rash; Urticaria; Itch; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 12Mar2021 at 19:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and the patient was fine on the first shot. On 09Apr2021, after the second vaccination, the patient was awoken overnight by a torturous rash, which appeared to be urticaria and included swelling of her lower lip on the left side. After looking online, the patient took Benadryl, which helped the itch and took subsequent courses of Benadryl throughout the day. The next night, the patient's upper left lip was swelled. For the next 10 days, the rash would come back upon her rising, though it was not nearly as severe as the initial one. There was no itch for 2 days, then the last night (on 20Apr2021), the rash came back at what the patient could say was 70 percent of the original rash. The patient took Benadryl, but it took far longer to take effect than it previously had. The patient had no additional lip swelling after the first two events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lower lip on the left side/ upper left lip swelled was resolved on an unknown date in Apr2021. The clinical outcome of the events overnight "I" was awoken by a torturous rash, urticaria and itch was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: Headache; Body aches; Felt like "they" had fever (temperature was normal); This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient had no known allergies to medications, food, or other products (reported as not applicable (NA)). 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. Concomitant medication included fluoxetine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 21Apr2021 at 03:00, the patient experienced headache, body aches and felt like they had fever (temperature was normal). The events did not result in doctor or other healthcare professional office/clinic visit, 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 headache, body aches and felt like "they" had fever (temperature was normal) was resolved on 21Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Rash maculo-papular, Skin lesion
Clinical narrative: Macropapular rash occurring on back, upper extremities and thighs with flesh colored papules; Macropapular rash occurring on back,upper extremities and thighs w/ flesh colored papules; lesions that have lasted for greater than 3 weeks; This is a spontaneous report from a contactable nurse. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). 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. Concomitant medications included prenatal pills (MANUFACTURER UNKNOWN) and fiber supplement (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took nifedipine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration in the left arm on 23Feb2021 at 15:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. In Mar2021 (reported as 15Mar2021 at 00:00), the patient experienced macropapular rash occurring on back, upper extremities and thighs with flesh-colored papules and lesions that have lasted for greater than 3 weeks. Therapeutic measures were not taken as a result of the event. 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 event macropapular rash occurring on back, upper extremities and thighs with flesh-colored papules and lesions that have lasted for greater than 3 weeks was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Depression, Fatigue, Headache, Pain
Clinical narrative: Intense headaches for 2 weeks off and on throughout the day.; Fatigue; Joint pain; Depression; Body aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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. Concomitant medications were not reported. On 01Apr2021 at 00:00, the patient experienced intense headaches for 2 weeks off and on throughout the day, that got better but still battling with frequent headaches. The patient also reported for fatigue, joint pain, depression and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense headaches for 2 weeks off and on throughout the day, fatigue, joint pain, depression and body aches was resolved with sequelae on an unknown date Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash around injection site with swelling; Rash around injection site; Fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30 (at the age of 36-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisdexamfetamine mesilate (VYVANSE) and escitalopram oxalate (LEXAPRO); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 29Mar2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced rash around injection site with fever and swelling. 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 rash around injection site with fever and swelling was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered.; patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered.; patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered.; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: ER2613), via an unknown route, administration in upper left arm on 20Apr2021 at 10:30 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization at workplace clinic. No COVID prior vaccination. The patient had no medical history and no known allergies. Concomitant medication was not reported. No other vaccine in four weeks. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: EJ1685), via an unknown route, administration in left arm on 30Mar2021 at 10:30 (at the age of 37-years-old) as historical vaccine as dose 1, single for COVID-19 immunization at workplace clinic. On 20Apr2021 at 10:30, after vaccination immediately after needle was removed, the patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered. Adverse event was not resulted to visit emergency room and physician office. No COVID tested post vaccination. No treatment received. The outcome of events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal oedema, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 02:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 01:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 00:00, the patient experienced swelling nose and face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling nose and face was not recovered 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin disorder
Clinical narrative: Bumps on the upper right under arm; Itches off and on or when clothes are touching; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old female patient 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 09Apr2021 at 14:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes in her family, but not to the patient. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. On 10Apr2021, the patient experienced bumps on the upper right under arm and they sometimes got bigger and smaller. They itched off and on or when clothes were touching. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bumps on the upper right under arm and they itched 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Right shoulder pain; It feels heavy and swollen, tight; It feels heavy and swollen, tight; It feels heavy and swollen, tight; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulpha drugs. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient received unspecified multivitamins within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Apr2021, the patient experienced right shoulder pain, it felt heavy and swollen and tight. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event right shoulder pain, it felt heavy and swollen and tight was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Sleeplessness around 4-21 @ 12AM.; Nausea day of; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 20Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 17:00, the patient experienced nausea day of vaccination. Around 21Apr2021 at 00:00, the patient experienced fever, chills and sleeplessness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea day of, fever, chills and sleeplessness were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Vaccination site pain
Clinical narrative: Swelling underneath the eyes; Itchy underneath the eyes; Red irritation underneath the eyes; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL); since unknown date, for unknown indication and unknown if ongoing. The patient previously took sulfur (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, at 11:00. the patient experienced swelling underneath the eyes, itchy underneath the eyes, red irritation underneath the eyes and soreness at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the adverse events and included treatment with diphenhydramine hydrochloride (BENADRYL) every 4 hours. The clinical outcome of the event swelling underneath the eyes, itchy underneath the eyes, red irritation underneath the eyes and soreness at the injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Menstruation irregular, Nausea
Clinical narrative: Haven't had menstrual cycle for over 9 months and had a 3 day period last week; Experienced headache for 3 weeks; Pain in arm for 2 days; Fatigue, nausea, anxiety on and off last 3 weeks.; Fatigue, nausea, anxiety on and off last 3 weeks.; Fatigue, nausea, anxiety on and off last 3 weeks.; 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: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included diltiazem (CARDIZEM), colecalciferol (VITAMIN D3), progesterone (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unknown indication from unknown date and unknown if ongoing. The patient previously took cefalexin (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 31Mar2021 at 16:00, the patient experienced headache for 3 weeks, pain in arm for 2 days, fatigue, nausea, anxiety on and off from 3 weeks prior to report. The patient hadn't had menstrual cycle for over 9 months and had a 3 day period the week before reporting on an unknown date in Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event experienced headache for 3 weeks was resolving, while that of pain in arm for 2 days was resolved on 02Apr2021. The clinical outcome of the events fatigue, nausea, anxiety on and off last 3 weeks prior to report and had a 3 day period the week before reporting was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Haven't had menstrual cycle for over 9 months and had a 3 day period last week; Experienced headache for 3 weeks; Pain in arm for 2 days; Fatigue, nausea, anxiety on and off last 3 weeks.; Fatigue, nausea, anxiety on and off last 3 weeks.; Fatigue, nausea, anxiety on and off last 3 weeks.; 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: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included diltiazem (CARDIZEM), colecalciferol (VITAMIN D3), progesterone (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unknown indication from unknown date and unknown if ongoing. The patient previously took cefalexin (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 31Mar2021 at 16:00, the patient experienced headache for 3 weeks, pain in arm for 2 days, fatigue, nausea, anxiety on and off from 3 weeks prior to report. The patient hadn't had menstrual cycle for over 9 months and had a 3 day period the week before reporting on an unknown date in Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event experienced headache for 3 weeks was resolving, while that of pain in arm for 2 days was resolved on 02Apr2021. The clinical outcome of the events fatigue, nausea, anxiety on and off last 3 weeks prior to report and had a 3 day period the week before reporting was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria, Wheezing
Clinical narrative: Wheezing; Hives; Swelling of lips; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and low hemoglobin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 22:00, the patient experienced wheezing, hives and swelling of lips. 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 methylprednisolone (MEDROL) dose pack. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events wheezing, hives and swelling of lips were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath within 30 minutes of receiving the vaccine; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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. Concomitant medications were not reported. On 31Mar2021 at 14:15, the patient experienced shortness of breath within 30 minutes of receiving the vaccine, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness of breath, headache and fatigue were resolved on an unknown date 2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Pyrexia
Clinical narrative: Fatigue; Fever; Chills; Elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 16:00, the patient experienced fatigue, fever, chills and elevated heart rate. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, fever, chills and elevated heart rate were resolving 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: Chills, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Body aches; Night sweats; Swollen lymph nodes on the left sideof body; Chills; Fever; Headache; Arm soreness; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shrimp and nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. 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: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:00, the patient experienced body aches, night sweats, swollen lymph nodes on the left side of body, chills, fever, headache, arm soreness, nausea and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. 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 body aches, night sweats, swollen lymph nodes on the left side of body, chills, fever, headache, arm soreness, nausea and fatigue were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches; Night sweats; Swollen lymph nodes on the left sideof body; Chills; Fever; Headache; Arm soreness; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shrimp and nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. 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: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:00, the patient experienced body aches, night sweats, swollen lymph nodes on the left side of body, chills, fever, headache, arm soreness, nausea and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. 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 body aches, night sweats, swollen lymph nodes on the left side of body, chills, fever, headache, arm soreness, nausea and fatigue were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electric shock sensation, Fatigue, Pain
Clinical narrative: Ache all over; Unable to breath well; Felt faint; Felt like an electrical shock from heart; Exhausted; This is a spontaneous report from a contactable consumer, the patient. A 63-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 00:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, pre-diabetes and reflux. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole magnesium (NEXIUM), losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), nicotinic acid (niacin) (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN) started on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, 7 days after first vaccine, the patient experienced ache all over, unable to breath well, felt faint, felt like an electrical shock from heart, exhausted which lasted 3 to 4 days. The patient had made an appointment with cardiologist and not getting second vaccine with cardiologist approval. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event ache all over, unable to breath well, felt faint, felt like an electrical shock from heart and exhausted was resolved in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Hypersensitivity, Inflammation, Nausea, Vomiting
Clinical narrative: Adverse allergic reaction across face, arms, hands and rectum; severe nausea; vomiting; inflammation in colitis; inflammation in colitis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 37-year-old female patient received BNT162b2 (COMIRNATY, Lot/batch number: ER8733, expiry date: not reported, Age at vaccination: 37-year-old) via an unspecified route of administration in left arm on 02Apr2021 12:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. Patient medical history included allergy from amoxicillin. The concomitant medications were not reported. On 02Apr2021, patient experienced adverse allergic reaction across face, arms, hands and rectum, severe nausea, vomiting, inflammation in colitis (Inflammation and colitis). Treatment was received as antibiotic (Augmentin) for adverse event. No other vaccine in four weeks. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No COVID present prior vaccination. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Severe vomiting; Chills; Fever; Sweats; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 08:15 (at the age of 40-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 to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The 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. On 20Apr2021 at 22:30, the patient experienced severe vomiting, chills, sweats and fever. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vomiting, chills, sweats and fever 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on upper torso, noticed it on Monday evening. It spread a little to above panty line the next day. It's not particularly itching but some.; Rash on upper torso, noticed it on Monday evening. It spread a little to above panty line the next day. It's not particularly itching but some.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received the vaccine (unspecified) within four weeks prior to the vaccination. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), both were taken for unspecified indication from an unknown date. 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 unspecified date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced rash on upper torso, noticed it on Monday evening. It spread a little to above panty line the next day. It was not particularly itching but some. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on upper torso, noticed it on monday evening, it spread a little to above panty line the next day, it was not particularly itching but some were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Insomnia, Pain, Pyrexia
Clinical narrative: Unable to sleep; Body aches; Fever; Cough; Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 16:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and penicillin allergy. The patient previously received acetylsalicylic acid (ASPIRIN) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. 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 25Mar2021 at 17:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. On 20Apr2021 at 21:00, the patient reported that she was unable to sleep, had body aches, fever, cough and chest pain. 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 unable to sleep, body aches, fever, cough and chest pain was recovered on an unknown date in  Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.