chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Extreme itching; This is a spontaneous report from a contactable healthcare professional, the patient.  A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an intramuscular route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid and anemia. The patient was allergic to latex and venom (wasp/bee). Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and azelastine (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021, the patient was experiencing hives and extreme itching. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with methylprednisolone (MANUFACTURER UNKNOWN) for the events hives and itching. The clinical outcomes of the events hives and itching were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Headache; Nauseated; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old non-pregnant 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 17Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included irregular heartbeat and gastroesophageal reflux disease (GERD). The patient had allergies to sulfa drugs (sulfonamide allergy). Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) all since an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient previously received ondansetron (ZOFRAN) from an unknown date for unknown indication and was allergic to it. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. On 17Mar2021, within 3 hours, the patient was nauseated. By the midnight, on 18Mar2021 the patient had body aches, fever, headache and continued nausea. All symptoms except headache were resolved after 24 hours and the headache lasted for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events nauseated, body aches, fever were resolved on 19Mar2021 and headache was resolved on 20Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, Poor quality sleep
Clinical narrative: Her left arm was hurting. Pain was so bad in patient arm; The pain prevented patient from sleeping well.; Patient couldn't lifther hand and couldn't lay on her sidewhen she went to bed.; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown), via an unspecified route of administration in the left arm on 24Mar2021 at 08:30 as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient received unspecified concomitant medications. Previously, the 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 03Mar2021 at 08:30 as a single dose for COVID-19 immunisation. It was not sure, if the patient had known allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021, at 14:00, the patient experienced pain in arm (vaccinated arm), sleep unwell and movements reduced. It was reported that the patient was contacted and patient shared her experience getting shot the previous week. The morning was fine but by the evening, her left arm was hurting. m sleeping well. The pain went away 48 hours later. She did not have any other side effects. The events did pain was so bad in her arm; patient could not lift her hand and could not lay on her side when she went to bed. 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 treatment for the events. The clinical outcome of the events pain in arm, sleep unwell and movements reduced was recovered on 26Mar2021 (48 hrs).   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: feeling extremly over tired; muscles ache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant 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 an unspecified date at 15:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had received other unspecified medications in two weeks of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021 at 15:00, the patient reported that for the last 2 days feeling extremely over tired and muscles ache. The patient reported that doesn't know if the problem was a result of the vaccine but wanted to check if it could be. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extremely fatigue and muscle ache was unknown at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Neck pain, Vaccination site pain
Clinical narrative: Site pain remains sending pain to shoulder and neck. Pain was 7 on a scale of 1-10; Site pain remains sending pain to shoulder and neck. Pain was 7 on a scale of 1-10; Site pain remains sending pain to shoulder and neck. Pain was 7 on a scale of 1-10; Neck movements limited in Turing to left; This is a spontaneous report from a contactable consumer (patient himself). A 54-years-old male patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207; Expiration Date: unknown, at age of vaccination 54 years) via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:45 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus. Patient was allergic to dye. Concomitant medication included dulaglutide (TRULICITY) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 the patient experienced site pain remains sending pain to shoulder and neck. pain was 7 on a scale of 1-10, neck movements limited in turning to left. Therapeutic measures were taken as a result of adverse events as patient received Motrin, Tylenol and Aleve. Motrin or Tylenol nor Aleve work to alleviate pain. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting; Diarrhea; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the left arm on 26Mar2021 at 08:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Mar2021 at 20:00, the patient experienced vomiting, diarrhea, chills and fever. 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 treatment for the events vomiting, diarrhea, chills and fever. The clinical outcomes of the events vomiting, diarrhoea, chills and fever were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: fever; sore; This is a spontaneous report from a contactable consumer. A 42-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on 28Mar2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 13:00, the patient experienced fever and sore. It was unknown if the patient received any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the fever and sore was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: 100F fever; muscle aches; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient reported no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 06:00, 18 hours after vaccination, the patient experienced 100-degree Fahrenheit fever, muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as the result of adverse events. The clinical outcome of the events pyrexia, myalgia and fatigue were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: light headed; Hives; itchiness; This is a spontaneous report from a contactable healthcare professional, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via unspecified route of administration in the left arm on 29Mar2021 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), postural orthostatic tachycardia syndrome (POTS) and fibro (unspecified). The patient received unspecified concomitant medications. The patient previously received cefdinir (MANUFACTURER UNKNOWN), levaquin (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced hives, itchiness and light headed. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received antihistamine (unspecified) as a treatment for the events. The clinical outcomes of the events hives, itchiness and light headed were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: mild headache; mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732), via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included atenolol (MANUFACTURER UNKNOWN), amlodipine besylate (MANUFACTURER UNKNOWN), budesonide (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced mild headache and mild fatigue. 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. The clinical outcome of mild headache and mild fatigue was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red swollen area around injection site  irritated; Red swollen area around injection site; Swollen injection site; Red swollen area around injection site itches; 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 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6202), via an unspecified route of administration in the left arm on 01Mar2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 13:00, the patient experienced red swollen area around injection site. Developed about a week after the injection. It was also itchy and irritated. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red swollen area around injection site, swollen injection site, red swollen area around injection site itches and red swollen area around injection site irritated was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Migraine, Pain
Clinical narrative: migraine; shooting pain from the top of the head to the injection site any time there was head move.; body ache; headache; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6206), via an unspecified route of administration in the right arm on 10Mar2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included lialda (MANUFUCTURER UNKNOWN), mercaptopurine (MANUFUCTURER UNKNOWN), sulfasalazine (MANUFUCTURER UNKNOWN), singular (MANUFUCTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6200), via an unspecified route of administration in the right arm on 15Feb2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to tree nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 (first day), the patient underwent tab test and procedure which included body temperature and result was shown as 102 (unspecified units). On 11Mar2021, on the first day, the patient experienced fever, chills, body aches and headache. On 12Mar2021 on second day, the patient experienced migraine on the right side of the body, shooting pain from the top of the head to the injection site any time there was head movement. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the events. The clinical outcome of the events fever, chills, pain, headache, migraine and shooting pain was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: migraine; shooting pain from the top of the head to the injection site any time there was head move.; body ache; headache; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6206), via an unspecified route of administration in the right arm on 10Mar2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included lialda (MANUFUCTURER UNKNOWN), mercaptopurine (MANUFUCTURER UNKNOWN), sulfasalazine (MANUFUCTURER UNKNOWN), singular (MANUFUCTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6200), via an unspecified route of administration in the right arm on 15Feb2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to tree nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 (first day), the patient underwent tab test and procedure which included body temperature and result was shown as 102 (unspecified units). On 11Mar2021, on the first day, the patient experienced fever, chills, body aches and headache. On 12Mar2021 on second day, the patient experienced migraine on the right side of the body, shooting pain from the top of the head to the injection site any time there was head movement. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the events. The clinical outcome of the events fever, chills, pain, headache, migraine and shooting pain was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry constant Barky cough; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the left arm on 28Mar2021 at 15:45 as a single dose (at the age of 38-year-old) for COVID-19 immunisation. The medical history of the patient included liver disease, barrettes oesophagus, diabetic and tachycardia. The patient had known allergies to morphine, dilatid and nubane. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), flonase (MANUFACTURER UNKNOWN), BENADRYL, aspirin (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not tested for COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 13:30, the patient experienced dry constant barky cough. Patient was treated with ALBUTEROL inhaler for the event dry constant barky cough. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dry constant barky cough was not recovered at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: The arm in which she received the vaccination was extremely sore through the night.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 11:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had experienced extremely sore arm in which she received the vaccination through the night on 22Mar2021 at 13:00. It was further reported that the pain subsided in the next day. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) on 23Mar2021 and the result found to be negative. The clinical outcome of the event the arm in which she received the vaccination was extremely sore through the night was resolved on 23Mar2021. No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report from a Pfizer sponsored Program. A contactable female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Caller wanted to know if it is okay for her to take the second dose, due tomorrow while she is having high blood pressure and took medications for it on unspecified date. Treatment was received by patient for hypertension. Patient underwent lab test and procedures include blood pressure measurement result include high. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Skin exfoliation, Swelling face, Swelling of eyelid
Clinical narrative: eye lids where swollen; around eyes was burning; skin waspeeling all over face; cheek swelling; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old adult non-pregnant 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 23Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus. Concomitant medications included multi vitamin gummies (MANUFACTURER UNKNOWN), B12 gummies (MANUFACTURER UNKNOWN), vitamin D3 gummies (MANUFACTURER UNKNOWN) and vitamin C gummies (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient was allergic to nickel. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, at 11:00, after 2 hours of receiving the vaccination, the patients lower half of right cheek started to swell. On 24Mar2021, on the next day, both eye lids were swollen and the area under eyes were also swollen, skin around eyes was burning and skin was peeling all over face. Therapeutic measures were taken as the result of adverse events, which include treatment with antihistamines (FENISTIL). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of burning sensation, cheek swelling, eye lid swelling and skin peel was recovered on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen armpit on left arm.  The shot was given into the left arm; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732); via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date received within 2 weeks of vaccination. The patient was allergic to shellfish, cats and dogs. The patient had not received any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 00:00, the patient experienced swollen armpit on left arm. 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 the result of adverse events. The clinical outcome of swollen armpit on left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Joint pain; Fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 22Mar2021 (in appropriate schedule of vaccine administered) at 14:00 (at the age of 71-year-old), as a single dose for COVID-19 immunisation. The patients medical history included arthritis. The patients concomitant medications included paracetamol (TYLENOL), hydrochlorothiazide (MANUFACTURER UNKNOWN) and meloxicam (MANUFACTURER UNKNOWN) for arthritis, since unspecified dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 08Mar2021 at 14:00 (at the age of 71-year-old), as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient experienced joint pain and fatigue on 23Mar2021 at 13:00. No therapeutic measures were taken for the reported events. The clinical outcome of events joint pain and fatigue was resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Been getting nausea every night after the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Mar2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse. The patient had known allergy to penicillin, seafood and shellfish. Concomitant medications included TRI SPRINTEC. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 19:00 , the patient experienced nausea. She had been getting nausea every night after the vaccine. The adverse event 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 event. The clinical outcome of nausea was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis
Clinical narrative: Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 40- year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included allergies to apples. Concomitant medication included atorvastatin calcium (LIPITOR) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021 at 03:00, when patient's 04-year-old daughter woke him up, the patient was sweating. It was not hot in the room. The patient did not take the temperature as the patient was tired and went back to sleep. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events sweating and tiredness was recovered on 05Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Taste disorder
Clinical narrative: Stiff neck; funny taste in mouth; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant 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 29Mar2021 at 14:30 (at an age of 51-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 16:00 the patient experienced stiff neck, headache, and taste altered (funny taste in mouth). No therapeutic measures were taken by the patient. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of stiff neck, headache, and a funny taste in mouth was unknown at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Pain in extremity
Clinical narrative: Chest pains; Shortness of breath; Back pains; Arm pains; This is a spontaneous report received from a non-contactable consumer, the patient. A female patient of unspecified age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 16:15, as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (PCN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00, the patient experienced chest pains, shortness of breath, back pains and arm pains. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and PEPCID. The clinical outcome of the events chest pains, shortness of breath, back pains and arm pains were resolving at the time of this report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: big red lump on side of right foot; Swelling over the bank of the ankle; Big red lump on side of right foot hurts to even touch. Left foot severe pain; Big red lump on side of right foot; Severe foot and leg pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. The patient was allergic to doxycycline and sulfa drugs. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), trazadone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and buspar (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administartion in the left leg on 26Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021 at 07:00, 4 days after the vaccination, the patient had severe foot and leg pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as a result of severe foot and leg pain included tylenol (MANUFACTURER UNKNOWN), anti-inflammatory drugs (MANUFACTURER UNKNOWN) and zpak (MANUFACTURER UNKNOWN). The pain eased for a couple of days but then was back again, worse than before. On an unknown date, the patient had a big red lump on side of right foot which hurt even to touch, left foot had severe pain and swelling over back of ankle. The clinical outcome of the events severe foot and leg pain, big red lump on side of right foot which hurts, left foot severe pain and swelling over back of ankle was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site swollen; Injection site painful; Injection  site warm to touch; difficult to move  arm around; This is a spontaneous report from a contactable nurse, the patient. A 55-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the arm left on 25Mar2021 at 16:30 (age at the vaccination was 55-years-old) as a single dose for COVID-19 Immunisation. Medical history included controlled high blood pressure from an unspecified date. Concomitant medications were not reported. 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 arm right on 04Mar2021 at 16:30 (age at the vaccination was 55-years-old) as a single dose for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no allergies to medications, food, or other products.  on 25Mar2021 at 04:45, the patient experienced vaccination site swelling, vaccination site pain, vaccination site warmth, and arm discomfort which sometimes which makes her difficult to move the arm around. Patient also stated ''Believe the administration may have been given subconsciously instead of intramuscular. Another 2nd dose of vaccine necessary due to possible improper site administration? Do vaccines improperly administered effective enough to provide immunity? Should she be concerned?''. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of vaccination site swelling, vaccination site pain, vaccination site warmth, arm discomfort was not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Aches; sore arm; Extremity tingling feeling; Fatigue; This is a spontaneous report from a non-contactable consumer. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced aches, sore arm, extremity tingling feeling and fatigue. The clinical outcomes of the events aches, sore arm, extremity tingling feeling and fatigue were recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Device expulsion, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: bleeding heavily (menstrual); the Mirena IUD that I had for about a year and a half, dislodged from my uterus (It fell out.); This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8732) via an unspecified route of administration on 25Mar2021 at 15:00 (at the age of 55-years-old) in left arm as a single dose for covid-19 immunization. Medical history included anaemia, thalassaemia, narcolepsy, and bipolar disorder all from an unknown date and unknown if ongoing. The patient previously took Compazine and experienced allergy. Prior to vaccination, the patient was not diagnosed with covid-19. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Concomitant medications received within 2 weeks of vaccination included levonorgestrel (MIRENA IUD); oxcarbazepine (OXCARBAZEPINE); quetiapine (QUETIAPINE) and methylphenidate hydrochloride (CONCERTA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced bleeding heavily (menstrual) around 38 hours after the vaccination on 27Mar2021 at 06:00. She mentioned about 24 hours after that, the Mirena IUD that she had for about a year and a half, dislodged from her uterus (It fell out). Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Tranexamic acid to control the bleeding. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test (saliva) with pending result on 29Mar2021. The outcome of the events was not resolved.  Follow-up attempts are possible. Further information is requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: neck and chest rash; Felt dizzy and spacey; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on 01Mar2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medication was not reported. The patient was allergic to sulfur drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 03Mar2021, patient experienced neck and chest rash about 4-5 days after vaccination and continued for 3 weeks, at 3 weeks patient developed a light rash on left arm from shoulder to forearm and about 3 days after the vaccination she felt dizzy and spacey. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatments received for the events rash and dizziness was unknown. The clinical outcome of events rash and dizziness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swelling under arm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the right arm on 22Mar2021 at 10:00 for COVID-19 immunisation. Medical history included diabetes and COVID-19. The patient had a history of allergy to Reglan. Concomitant medications included vitamin d, rosuvastatin and cabergoline (MANUFACTURER UNKNOWN); all for unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 7:00 following day after injection, the patient began to feel swelling under arm, lymph node was swollen and was currently as big as a lemon. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling under arm and swollen lymph nodes was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Chills; Fever; Nausea; Headache; General body pain / Body aches; Extreme tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history, however, the patient had allergies to penicillin, sulfonamide, codeine and clindamycin. The concomitant medications include red yeast rice (MANUFACTURER UNKNOWN), zyrtec (MANUFACTURER UNKNOWN), CoQ10 (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) all for an unspecified indication from an unspecified date. 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 03Mar2021 at 12:00 (at the age of 60-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-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 04:30, the patient experienced chills, fever, nausea, headache, general body pain (body aches) and extreme tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of the events chills, fever, nausea, headache, general body pain (body aches), extreme tiredness was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.