chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Pain
Clinical narrative: Rapid heart rate (120-150); Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 21-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 29Apr2021 at 14:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, depression and bladder spasms. The patient had no known allergy. The patient received unspecified other concomitant medication within 2 weeks of the vaccination. 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 01Apr2021 at 17:00 (at the age of 21-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 30Apr2021 at 10:00, the day after vaccination, the patient experienced rapid heart rate (120-150), headache and body aches.  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 visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events rapid heart rate (120-150), headache and body aches were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: 3 weeks after the second Pfizer shot at 10:38 pm my smell and taste came back almost 100%.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via intramuscular route of administration in the right arm on 09Jan2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included olmesartan medoxomil (BENICAR) and nebivolol hydrochloride (BYSTOLIC) both for unknown indications, from an unknown dates and unknown if ongoing. The patient previously received ZICAM (nasal spray) on an unknown date in 1998 and experienced loss of smell and loss of taste. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 19Dec2020 at 13:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient reported that she had once used in late 1998 over the counter nasal spray ZICAM. Since then, she had lost smell and taste. On 29Jan2021, at 22:38 three weeks after the second Pfizer shot, her smell and taste came back almost 100%. She had lost some smell and taste but continued to have what had been gone. She would pay for a shot like this to continue to smell and taste. 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 three weeks after the second Pfizer shot, her smell and taste came back almost 100% was unknown 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: Arthralgia, Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Numbness on both feet and hands; Tight feel on the face; Tingling on the whole body; Sore on both shoulders, legs; Sore on both shoulders, legs; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9809) via an unspecified route of administration in the right arm on 14Feb2021 at 09:00 (at the age of 39-years-old)  and the patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the right arm on 15Mar2021 at 15:00 (at the age of 39-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 known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Feb2021 at 18:00 the patient experienced numbness on both feet and hands, tight feel on the face, tingling on the whole body and sore on both shoulders and legs. The event resulted in doctor or other healthcare professional office/clinic visit. 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 numbness on both feet and hands; tight feel on the face, tingling on the whole body and sore on both shoulders and legs were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel well after shot; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received 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. Medical history and concomitant medications were not reported. On an unknown date, the patient did not feel well after the shot. The clinical outcome of the event did not feel well after the shot was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; This is a spontaneous report from a non-contactable consumer. A female patient of an unknown age 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 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm and headache. The clinical outcome of the events sore arm and headache were 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Have ringing in my ears. Dr. diagnosed me with tinnitus. I never had ringing in my ears before; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfur antibiotic, gold and sunscreen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took nickel sulfate (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient received other vaccines within 4 weeks prior to the COVID vaccine and included tetanus vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 for an unknown indication. Concomitant medications included estrogens conjugated (PREMARIN) and muscle relaxer (MANUFACTURER UNKNOWN), both for unknown indications on unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9267) via an unspecified route of administration in the left  arm on an unknown date, as a single dose for COVID-19 immunisation. On 08Mar2021, the patient experienced ringing in ears and the doctor diagnosed the patient with tinnitus. The patient reported that she never had ringing in the ears before. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and was reported as cleaned ear wax out of ear. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph node under right arm; This is a spontaneous report from a contactable consumer, the patient. An unspecified aged non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 00:00 as 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. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 29Apr2021, the patient had swollen lymph node under right arm a week later where the injection was given. Since the vaccination, the patient had not been tested for COVID-19. The event 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 reported events. The clinical outcome of event swollen lymph node under right arm was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Chest discomfort, Heart rate
Clinical narrative: Pounding racing heart of over 111; fever of 102 degrees; ringing in both ears off and on; body ache; heavy chest; blood pressure went from 116/68 to 96/67; pain in arm; 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: EW0172; Expiration date: 31Aug2021) via an unspecified route of administration in the left arm on 28Apr2021 at 13:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxyzine hydrochloride (HYDROXIZINE) for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received codeine (MANUFACTURER UNKNOWN) and oseltamivir phosphate (TAMIFLU); both for unspecified indication from unknown date and experienced drug allergy and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729; Expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. On 29Apr2021 at 01:00, the patient experienced pounding racing heart of over 111 (unspecified units) while resting for 7 hours straight, fever of 102 degrees, ringing in both ears off and on, body ache, heavychest, blood pressure went from 116/68 (unspecified units) to 96/67 (unspecified units) and pain in arm that felt absolutely horrible. 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 pounding racing heart of over 111 while resting for 7 hours straight, fever of 102 degrees, ringing in both ears off and on, bodyache, body ache, heavychest blood pressure went from 116/68 to 96/67 and pain in arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia, Tinnitus
Clinical narrative: Pounding racing heart of over 111; fever of 102 degrees; ringing in both ears off and on; body ache; heavy chest; blood pressure went from 116/68 to 96/67; pain in arm; 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: EW0172; Expiration date: 31Aug2021) via an unspecified route of administration in the left arm on 28Apr2021 at 13:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxyzine hydrochloride (HYDROXIZINE) for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received codeine (MANUFACTURER UNKNOWN) and oseltamivir phosphate (TAMIFLU); both for unspecified indication from unknown date and experienced drug allergy and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729; Expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. On 29Apr2021 at 01:00, the patient experienced pounding racing heart of over 111 (unspecified units) while resting for 7 hours straight, fever of 102 degrees, ringing in both ears off and on, body ache, heavychest, blood pressure went from 116/68 (unspecified units) to 96/67 (unspecified units) and pain in arm that felt absolutely horrible. 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 pounding racing heart of over 111 while resting for 7 hours straight, fever of 102 degrees, ringing in both ears off and on, bodyache, body ache, heavychest blood pressure went from 116/68 to 96/67 and pain in arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Nausea, Taste disorder
Clinical narrative: An hour after felt flush; An hour after felt flush and nauseated; Weird taste; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 12:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks of COVID-19 vaccine. The patient did not receive other medications within 2 weeks of COVID-19 vaccine. The patient had no known allergies. On 30Apr2021 at 13:15, 30 minutes after the vaccine, the patient had weird taste in mouth which was more noticeable when drinking water. On 30Apr2021 at 13:45, an hour after the vaccine, the patient felt flushed and nauseated. No therapeutic measures were taken as a result of the reported 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 weird taste in mouth, felt flush and nauseated were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Fatigue, Muscle tightness, Pain
Clinical narrative: Intense lower back pain; Upset stomach; Muscle tightness; Very thirsty for first day; Total body soreness; Soreness at injection site; Soreness through upper left arm; Exhaustion; Brief tingling in hands and feet.; 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: UNKNOWN) via intramuscular route of administration in the left arm on 28Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, GERD, allergic to paw paws, onions, sensitive to soy, tomatoes, and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), pseudoephedrine hydrochloride (SUDAFED) and omeprazole (MANUFACTURER UNKNOWN) and collagen supplements; all since an unknown date for unknown indication and unknown if ongoing. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via intramuscular route of administration in the left arm on 31Mar2021 at 12:30 (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 COVID vaccine. On 28Apr2021 at 16:30, the patient experienced soreness at injection site and through upper left arm, total body soreness and muscle tightness followed. The patient experienced exhaustion and was very thirsty for the first day, had brief tingling in hands and feet, intense lower back pain at end of day 2 of symptoms, and an upset stomach. The patient reported the symptoms started at 16:30 on the day of injection, lasted through next day and the symptoms were worse on day 2. 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 visit, and 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 adverse events. The clinical outcome of the events intense lower back pain, upset stomach, muscle tightness, very thirsty for first day, total body soreness, soreness at injection site, soreness through upper left arm and exhaustion and brief tingling in hands and feet was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Thirst, Vaccination site pain
Clinical narrative: Intense lower back pain; Upset stomach; Muscle tightness; Very thirsty for first day; Total body soreness; Soreness at injection site; Soreness through upper left arm; Exhaustion; Brief tingling in hands and feet.; 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: UNKNOWN) via intramuscular route of administration in the left arm on 28Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, GERD, allergic to paw paws, onions, sensitive to soy, tomatoes, and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), pseudoephedrine hydrochloride (SUDAFED) and omeprazole (MANUFACTURER UNKNOWN) and collagen supplements; all since an unknown date for unknown indication and unknown if ongoing. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via intramuscular route of administration in the left arm on 31Mar2021 at 12:30 (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 COVID vaccine. On 28Apr2021 at 16:30, the patient experienced soreness at injection site and through upper left arm, total body soreness and muscle tightness followed. The patient experienced exhaustion and was very thirsty for the first day, had brief tingling in hands and feet, intense lower back pain at end of day 2 of symptoms, and an upset stomach. The patient reported the symptoms started at 16:30 on the day of injection, lasted through next day and the symptoms were worse on day 2. 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 visit, and 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 adverse events. The clinical outcome of the events intense lower back pain, upset stomach, muscle tightness, very thirsty for first day, total body soreness, soreness at injection site, soreness through upper left arm and exhaustion and brief tingling in hands and feet was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph nodes above collar bone on left shoulder, side of vaccination site.; Swollen, painful lymph nodes above collar bone on left shoulder, side of vaccination site.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG200) via an unspecified route of administration in the left arm on 27Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to penicillin (MANUFACTURER UNKNOWN), and sufla drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously 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 06Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021 at 12:00, the patient experienced swollen, painful lymph nodes above collar bone on left shoulder, side of vaccination site. 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 visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events swollen, painful lymph nodes above collar bone on left shoulder were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Widespread rash; This is a spontaneous report from a contactable consumer, the patient. A 27-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 26Apr2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included atopic dermatitis. The patient had known allergies to peanut, tree nuts, coconut and stone fruit allergy (peaches, apricots). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced widespread rash. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of event widespread rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fatigue; 103 degree fever; This is a spontaneous report from a contactable consumer. A male patient of unknown age received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 the patient experienced fatigue and 103 degree fever. Therapeutic measures were taken as a result of fatigue and 103 degree fever included treatment with acetaminophen (MANUFACTURER UNKNOWN). On 30Apr2021, the patient underwent body temperature and the result was 103 degree fever. The clinical outcome of the events fatigue and 103 degree fever was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about the lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information:Patient's Initials updated as unknown, Country captured,Supplier to safety updated to measurable supplier other and Protect Confidentiality unticked in general tab.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Red itchy, splotchy rash on hands; Red itchy, splotchy rash on hands; Red itchy, splotchy rash on hands; This is a spontaneous report from a contactable consumer, the patient. A 35-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 25Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); taken for 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. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Apr2021, the patient experienced red itchy, splotchy rash on hands approximately 4 days after vaccine and were continuing still at the time of this report. 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 red itchy, splotchy rash on hands were not resolved 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: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Rash, SARS-CoV-2 test
Clinical narrative: Rash all over my body appeared within 24h-48; Intense joint pain; Intense fatigue; Felt very weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included asthma, known allergies to dust and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021, the patient experienced a rash all over the body which appeared within 24h-48, intense joint pain, intense fatigue and the patient felt very weak. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On an unspecified date in 2021, the patient underwent a nasal swab test and the result was unknown. The clinical outcome of the events rash all over body that appeared within 24h-48, intense joint pain, intense fatigue and felt very weak was not resolved 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: Urticaria
Clinical narrative: hives on my neck and scalp that I cannot seem to line up with a food or medication; This is a spontaneous report from a contactable healthcare professional. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 13Apr2021 at 17:30 (at the age of 29-year-old) as a single dose for COVID-19immunisation. The medical history included autoimmune reaction to gluten(not celiac), chronic gastro intestinal (GI) issues (GERD (Gastroesophageal reflux disease), chronic gastritis, bile reflux, SIBO (Small intestinal bacterial overgrowth)) and allergic to soybean oil. 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 concomitant medications included eszopiclone (LUNESTA), alprazolam (XANAX), ondansetron (ZOFRAN), probiotic (unspecified), hyoscyamine sulfate (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. On 28Apr2021 at 21:00, the patient experienced hives on her neck and scalp,  that she cannot seem to line up with a food or medication. The patient received treatment for the reported event which included Benadryl. The adverse event 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 event hives on the neck and scalp was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Tinnitus
Clinical narrative: Chronic loud tinnitus began a few days after the first dose and had continued until today; Vaccine administered at inappropriate site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right leg on 02Apr2021 at 12:30 (at the age of 64-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 27Apr2021 at 16:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included none. 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 COVID-19 vaccine. Concomitant medications were not reported. On 02Apr2021 at 12:30, the patient experienced "chronic loud tinnitus began a few days after the first dose and had continued until today". The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "chronic loud tinnitus began a few days after the first dose and had continued until today" was not recovered 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: Erythema, Pruritus, Rash
Clinical narrative: broke out into a full body rash ~30 hours after vaccination.; Mild to moderate itching around non-raised groups redness. Mostly upper body, sparse in lower body.; Mild to moderate itching around non-raised groups redness. Mostly upper body, sparse in lower body.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 29Apr2021 at 16:00 (at the age of 27-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 dexamfetamine sulfate, amfetamine sulfate, dexamfetamine saccharate, amfetamine aspartate (reported as ADDERALL Generic) and bupropion hydrochloride (reported as WELLBUTRIN Generic); both from unknown date for unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 20:30, approximately 30 hours after vaccination, the patient broke out into a full body rash, mild to moderate itching around non-raised groups redness mostly upper body, sparse in lower body. The patient was still experiencing, now 4 days after vaccination, but it seemed to be fading in severity. The patient had no other recent changes in food, clothing, medications, or settings. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events full body rash, mild to moderate itching around, non-raised groups redness mostly in upper body and sparse in lower body was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen bump that is painful at base of skull/ Swollen neck lymph node; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EW0175) via an unspecified route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 16-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 diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 02May2021, the patient experienced swollen bump that is painful at base of skull three days after shot assumed that a lymph node and swollen neck lymph node all on same side as that of 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 visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events swollen bump that is painful at base of skull three days after shot assumed it's a lymph node and swollen neck lymph node all same side as that of the shot were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: next morning I had a slight headache; I experienced symptoms within the first 6 hours of getting my second shot. I felt fatigued, body aches, and a low fever (99). The next morning I had a slight headache but took Tylenol and was fine all; felt fatigued, body aches, and a low fever (99); a low fever (99); This is a spontaneous report from a contactable consumer. A 21-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 arm left on 21Apr2021 at 13:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The medical history included anxiety, depression and ADHD (Attention-deficit hyperactivity disorder). 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 concomitant medications included escitalopram (MANUFACTURER UNKNOWN) of 10 mg,  XR (unspecified) of 15 mg, folic acid (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. 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 arm left on 31Mar2021 at 13:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 19:00, within the first 6 hours of getting second shot, the patient felt fatigue, body aches and a low fever (99). On 22Apr2021, the next morning, the patient had a slight headache but the patient took Tylenol and was fine all day. It was reported that the next day(on 23Apr2021) was the same thing (slight headache and fever/body aches at night). It was been 8 days (at the time of report) since her second shot and had a low fever(always around 99)/body aches almost every night. On 21Apr2021, the patient underwent body temperature test and tested with a temperature of 99 (unspecified unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events body ache, slight headache and fever which included Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches, fatigue, low fever and headache was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nasal congestion, Pain in extremity, Productive cough
Clinical narrative: Sore arm; Mild fatigue and tiredness for a couple days.; A couple swollen lymph nodes after the first shot (still lingering).; Perhaps congestion and phlegm (that could have been allergies too though but it did seem increased for 2 days after the shot); Perhaps congestion and phlegm (that could have been allergies too though but it did seem increased for 2 days after the shot); This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 01Apr2021 at 16:00 (at the age of 33-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on 22Apr2021 at 16:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D3), vitamin e nos (VITAMIN E) and ascorbic acid (VITAMIN C) and multi-vitamins (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. 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 02Apr2021, the patient experienced sore arm, mild fatigue and tiredness for a couple days. A couple swollen lymph nodes after the first shot (still lingering). Perhaps congestion and phlegm (that could have been allergies too though but it did seem increased for 2 days after the shot). 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 sore arm, mild fatigue, tiredness, swollen lymph nodes after the first shot (still lingering), perhaps congestion and phlegm were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: Headache; Swollen Lymph node in right armpit; General fatigue; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 27Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), vortioxetine hydrobromide (TRINTELIX), verapamil hydrochloride (CALAN) and pantoprazole sodium sesquihydrate (PROTONIX); all since an unknown date for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 06Apr2021 at 13:30 (at the age of 46-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 28Apr2021, the patient experienced headache, swollen lymph node in right armpit, general fatigue and injection site pain. 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, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, swollen lymph node in right armpit, general fatigue and injection site pain were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pyrexia, Vomiting
Clinical narrative: Back pain; Fever; Joint aches; Vomiting, not able to keep water or crackers down for 8 hours; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route in the left arm on 28Apr2021 at 16:00 hours (at the age of 43-years-old) as single dose for COVID-19 immunisation. Medical history of the patient included asthma. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other medications within 2 weeks of the vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route in the left arm on an unknown date as single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks of COVID vaccine. On 29Apr2021 at 05:30 hours, the patient had fever, back pain, joint aches and vomiting, and was not able to keep water or crackers down for 8 hours.  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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events of fever, back pain, joint aches and vomiting were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: felt very weak and tired; felt very weak and tired; body aches; Nausea; Chills; headache; swollen lymphnode under clavicle; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BW0170) via an unspecified route of administration in the left arm on 23Apr2021 at 18:15 (at the age of 35-years-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. The patient previously 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 01Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Apr2021, the next day of the second shot, the patient felt very weak, tired, had body aches, nausea and chills. The next couple of days, the patient had a headache and also seemed to have a swollen lymph node under her clavicle. 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 felt very weak and tired, body aches, nausea, chills , headache and swollen lymph node under clavicle were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.