chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Thirst, Vomiting
Clinical narrative: 20 hours - 28 hours after vaccination, all of the above and headache and nausea; 20 hours - 28 hours after vaccination, all of the above and headache and nausea; Around 28 hours after vaccination, vomited 5 times; Approximately 10 hours after vaccination, arm pain; Approximately 10 hours after vaccination, arm pain, chills and fatigue; Approximately 10 hours after vaccination, arm pain, chills and fatigue; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3247) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within two weeks of vaccination was not reported. It was not reported whether the patient received 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: 3247) via an unspecified route of administration in the left arm on 05Feb2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 20:00, approximately 10 hours after vaccination, the patient experienced arm pain, chills and fatigue. On 26Feb2021, 14 hours - 20 hours after vaccination, the patient experienced arm pain, chills, body aches, thirst, fatigue, difficulty sleeping. On 27Feb2021, 20 hours - 28 hours after vaccination, all of these and headache and nausea. On 27Feb2021, around 28 hours after vaccination, the patient vomited 5 times. In 30-36 hours symptoms started to subside and 48 hours after vaccine, symptoms were mostly gone except for sore arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue, body aches, thirst, difficulty sleeping, headache and nausea, vomiting was resolved on an unknown date in 2021, while that of arm pain was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Extremely swollen under arm lymph nodes, and painful area. On left side same as injection side.; Extremely swollen under arm lymph nodes, and painful area. On left side same as injection side.; Very small swelling on opposite under arm right.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 04Mar2021 at 09:30 (at the age of 72-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and neuropathy. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide, triamterene (MAXZIDE) and amitriptyline (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 11Feb2021 at 09:30 (at the age of 72-year-old), as a single dose for COVID-19 immunisation. On 05Mar2021 at 04:00, the patient experienced extremely swollen under arm lymph nodes and painful area on left side same as injection side and very small swelling on opposite under arm right. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extremely swollen under arm lymph nodes and painful area on left side same as injection side and very small swelling on opposite under arm right was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Continuous mild headache; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 49-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 16:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. On 28Feb2021 at 12:00, after the second COVID vaccination, the patient experienced continuous mild headache. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event continuous mild headache was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 66,  via an unspecified route of administration, in the left arm, on Mar 7, 2021, at 15:15, single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease and allergy to penicillin. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 7, 2021, at 15:15, patient experienced very sore arm, especially at site of injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, patient has not tested for COVID-19. The outcome of very sore arm (especially at site of injection): recovering (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Arm still hurts at injection site; lymph nodes in  neck are swollen.; Left clavicle started hurting; Swelling above left clavicle; Fatigue; Chills; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 16:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, penicillin allergy, sulfa allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took hydrocodone bitartrate/paracetamol (VICODIN) for unknown indication on an unknown date and experienced drug allergy. On 04Mar2021 at 14:00, 24 hours after vaccination, the patient experienced fatigue, chills, headache, muscle aches and nausea. On 05Mar2021, 48 hours after vaccination, the patient's left clavicle started hurting and developed swelling above it. On 06Mar2021, the next day after that, the patient's lymph nodes in the neck were swollen. On 08Mar2021, 5 days later, the patient's arm still hurt at injection site. The events resulted in doctor or other healthcare professional office/clinic visit. 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 fatigue, chills, headache, muscle aches, nausea, left clavicle started hurting and swelling above it, lymph nodes in the neck are swollen and arm still hurt at injection site were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Swelling, Vaccination site pain
Clinical narrative: Arm still hurts at injection site; lymph nodes in  neck are swollen.; Left clavicle started hurting; Swelling above left clavicle; Fatigue; Chills; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 16:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, penicillin allergy, sulfa allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took hydrocodone bitartrate/paracetamol (VICODIN) for unknown indication on an unknown date and experienced drug allergy. On 04Mar2021 at 14:00, 24 hours after vaccination, the patient experienced fatigue, chills, headache, muscle aches and nausea. On 05Mar2021, 48 hours after vaccination, the patient's left clavicle started hurting and developed swelling above it. On 06Mar2021, the next day after that, the patient's lymph nodes in the neck were swollen. On 08Mar2021, 5 days later, the patient's arm still hurt at injection site. The events resulted in doctor or other healthcare professional office/clinic visit. 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 fatigue, chills, headache, muscle aches, nausea, left clavicle started hurting and swelling above it, lymph nodes in the neck are swollen and arm still hurt at injection site were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, itchy, swollen, hot, painful spot at the injection site; Red, itchy, swollen, hot, painful spot at the injection site; Red, itchy, swollen, hot, painful spot at the injection site; Red, itchy, swollen, hot, painful spot at the injection site; Red, itchy, swollen, hot, painful spot at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 04Mar2021 at 15:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to mango skin which causes poison ivy type rash. 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 bupropion hydrochloride (WELLBUTRIN), buspirone hydrochloride (BUSPAR), vitamins (unspecified) and birth control pills (unspecified); all taken from unknown dates for unknown indications and unknown if ongoing. On 04Mar2021 at 17:00, the patient experienced red, itchy, swollen, hot, painful spot at the injection site. The adverse 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 red, itchy, swollen, hot, painful spot at the injection site was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: "I am" 8 days from my shot 1 Pfizer and "I" woke up with a really itchy red spot on right arm and soreness prior to today "I" did not have any reactions; "I am" 8 days from my shot 1 Pfizer and "I" woke up with a really itchy red spot on right arm and soreness prior to today "I" did not have any reactions; This is a spontaneous report from a contactable consumer, the patient. A 48-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 28Feb2021 at 16:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MOTRIN) and paracetamol (TYLENOL) from an unknown date for an unknown indication and unknown if ongoing. On 07Mar2021 (reported as one day prior to the date of report), the patient had soreness in right arm. On 08Mar2021 at 03:00, 08 days after vaccination, the patient experienced itchy red spot on right arm. The patient did not have any reactions before. 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 itchy red spot on right arm and soreness in right arm was 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck and under arm on the side with the vaccine (5 days following vaccination).; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 17:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included body mass index (more than 30) and superficial bloodclots. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination. The patient previously received oxycodone (MANUFACTURER UNKNOWN) and experienced drug allergy. On 08Mar2021 at 06:30, the patient experienced swollen lymph nodes in neck and under arm on the side with the vaccine (5 days following vaccination). The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in neck and under arm on the side with the vaccine (5 days following vaccination) was not recovered 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: Dizziness, Dysgeusia
Clinical narrative: Lightheaded after injection; Strong metallic taste for a brief period, less than 1 minute; This is a spontaneous report from a contactable consumer, the patient. A 39-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 08Mar2021 at 09:45 (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 had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 08Mar2021 at 10:15, the patient experienced lightheaded after injection and strong metallic taste for a brief period, less than 1 minute. 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 lightheaded was resolved on an unknown date in Mar2021, while the event of strong metallic taste was resolved on 08Mar2021 after the duration of less than 1 minute.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Vertigo
Clinical narrative: Vertigo; Feeling nauseated; Lower extremity weakness; This is a spontaneous report from a contactable consumer, the patient. A 63-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 02Mar2021 at 15:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. The patient had allergies to fresh fruits and some tree nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and fluvoxamine (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the patient experienced vertigo, feeling nauseated and lower extremity weakness. 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 all the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, feeling nauseated and lower extremity weakness was 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Fatigue, Insomnia, Somnolence
Clinical narrative: Am extremely unstable getting out of bed; Chills without high temperature; Extreme fatigue; Instantly sleepy, slept for 3 hours upon return home (afternoon naps not normal for me); Sleepless night; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN60262) via an unspecified route of administration in the right arm on 06Mar2021 at 13:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 mellitus, epilepsy, anxiety, osteoporosis, vitamin D deficiency, vitamin B complex deficiency NOS (B deficient), high blood pressure, thyroid function decreased (low thyroid) and high triglycerides. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR), ibuprofen (IBO) and multivitamin (unspecified); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 06Mar2021 at 14:30, the patient experienced extreme fatigue, was instantly sleepy and slept for 3 hours upon return home (afternoon naps were not normal for the patient) and on the same day, the patient was sleepless at night. On 07Mar2021, the following day morning (AM) the patient was extremely unstable to get out of bed and slept in a chair and had chills without high temperature. The events did not result in doctor or other health care professional office/clinic visits, and the 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 extreme fatigue, instantly sleepy and slept for 3 hours upon return home, sleepless night, extremely unstable to get out of bed and chills without high temperature was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysphonia, Fatigue, Vaccination site pain
Clinical narrative: upper back ache; extreme tiredness; voice hoarse; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 04Mar2021 at 15:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included A-Fib (Atrial fibrillation), high blood pressure and bee sting hypersensitivity (allergy to bee sting). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included diltiazem hydrochloride (DILTIZEM), bupropion (MANUFACTURER UNKNOWN), apixaban (ELIQUIS), lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously received dofetilide (TIKOSYN) and clindamycin (MANUFACTURER UNKNOWN); both for an unknown indication on an unknown date and experienced drug allergy. On 05Mar2021 at 06:00, the patient experienced extreme tiredness, voice horse and pain at injection site; Day 2, voice hoarse. On 08Mar2021, day 3, the patient experienced, upper back ache. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events extreme tiredness, voice horse, pain at injection site and upper back ache was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm pain (non-serious AE); This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female 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 02Mar2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, migraine, gastroesophageal reflux disease (GERD), eczema, and environmental/seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient had received other unspecified concomitant medications. On 02Mar2021 at 14:00, the patient experienced mild arm pain (non-serious adverse event). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild arm pain (non-serious AE) was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Upper left arm, where the vaccination was administered was very sore.; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 14:30 (at the age of 40-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the day after vaccination, the patient experienced upper left arm sore, where the vaccination was administered and the patient also had a mild headache for most of the day. 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 upper left arm, where the vaccination was administered was very sore and mild headache were resolved on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large red mark at injection site; It is warm; Swollen and is getting larger; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; Lot Number: EN6205) via an unspecified route of administration in the right arm on 02Mar2021 at 13:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis). 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 vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0269) via an unspecified route of administration on 09Feb2021 at 13:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. On 07Mar2021 at 09:00, 5 days after injection, the patient woke up with large red mark at injection site. It was warm and swollen and was getting larger. At the time reporting, this was approximately 4 inches wide by 6 inches long. 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. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events large red mark at injection site, warm and swollen and was getting larger was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Abnormally tired; Mild soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 5318) via an unspecified route of administration in the left arm on 02Mar2021 at 13:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (ADVIL), paracetamol (ACETAMINOPHEN), colecalciferol (VITA D3) and monolaurate avail (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 02Mar2021 at 19:00, by evening, the patient experienced mild soreness at injection site. Injection site soreness increased overnight and decreased after exercise. On 03Mar2021, the patient woke up abnormally tired. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild soreness at injection site, that increased overnight and decreased after exercise and abnormally tired was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Muscle soreness at injection site; Headache; General fatigue; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 07:00, the patient experienced muscle soreness at injection site, headache and general fatigue, all symptoms resolved after 36 to 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle soreness at injection site, headache and general fatigue were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Arm pain in lower left arm; Extreme fatigue; Chills; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 10:00 (at the age of 71-years old) as a single dose for COVID-19 immunisation. Medical history included asthma, latex allergy and allergic reaction to analgesics (opiates). Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Feb2021, the patient underwent lab tests and procedures which included SARS-CoV-2 (nasal swab) test and the result was negative. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not take any concomitant medications. On 04Mar2021 at 17:00, the patient experienced arm pain in lower left arm, extreme fatigue, chills and was feeling unwell. 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 been tested for COVID-19. The clinical outcome of the events arm pain in lower left arm, extreme fatigue, chills and feeling unwell was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Morning dizziness (vertigo) starting 8 days post vaccine; Morning dizziness (vertigo) starting 8 days post vaccine; This is a spontaneous report from a contactable nurse, the patient. A 38-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 22Feb2021 at 10:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT) for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced morning dizziness (vertigo) starting 8 days post vaccine on 03Mar2021. It was unknown whether therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event morning dizziness (vertigo) starting 8 days post vaccine was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Vaccination site pain
Clinical narrative: throbbing pain from injection site to ring finger; Injection site soreness; Congestion; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the second 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 08.30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergy to medication, food or other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 14Feb2021 at 08:30 as a single dose for COVID-19 immunisation. On 07Mar2021 at 12:00, the patient experienced injection site soreness, congestion, throbbing pain from injection site to ring finger. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness, congestion, throbbing pain from injection site to ring finger were recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Body Aches; Headache; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EL9264) via an unspecified route of administration in the right arm on 03Feb2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease, depression, anxiety and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN); both on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021 at 02:00, the patient experienced body aches, headache and injection site pain. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, headache and injection site pain was recovering at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches; Chills; Headache; Extreme fatigue; This is a spontaneous report from a contactable consumer. An elderly non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and second 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. It was unknown if the patient had any medical history and was unknown if the patient had any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient receive any medication within two weeks of vaccination. It was unknown whether the patient received any other vaccine within four weeks prior to the vaccination. On an unknown date, the patient experienced chills, headache, body aches and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events chills, headache, body aches and extreme fatigue was resolved on an unknown date.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Soreness in injection location; severe headache in half of head on the same side of injection location; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZEREN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 11:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 at 12:00, the patient experienced soreness in injection location and severe headache in half of head on the same side of injection location. 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 soreness in injection location and severe headache in half of head on the same side of injection location was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Dizziness, Flatulence
Clinical narrative: The 3rd day my stomach is very bloated with lots of bubbling.; The 3rd day my stomach is very bloated with lots of bubbling; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; Got light headed the day of the vaccine; Thumb locked up.; The my left hand started hurting and my thumb locked up.  It hurts even to pick; 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: EN6206) via an unspecified route of administration in the right arm on 03Mar2021 at 14:00 (at the age of 61-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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN), chlortalidone (MANUFACTURER UNKNOWN) and bupropion hydrochloride (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN) and sulfa (MANUFACTURER UNKNOWN) taken for an unknown indication. On 03Mar2021 at 14:00, the patient experienced light headed the day of the vaccine. On 05Mar2021, 2 days later the patient experienced headache, stomach cramps, threw up and diarrhea. On 06Mar2021, the 3rd day, the patient stomach was very bloated with lots of bubbling. On an unknown date in Mar2021 the patient's left hand started hurting and thumb locked up.  It was mentioned that it  hurted even to pick up a sheet of paper. 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 light headed, headache, stomach cramps, threw up and diarrhea, stomach was very bloated with lots of bubbling and left hand started hurting and thumb locked up were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint lock, Pain in extremity, Vomiting
Clinical narrative: The 3rd day my stomach is very bloated with lots of bubbling.; The 3rd day my stomach is very bloated with lots of bubbling; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; Got light headed the day of the vaccine; Thumb locked up.; The my left hand started hurting and my thumb locked up.  It hurts even to pick; 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: EN6206) via an unspecified route of administration in the right arm on 03Mar2021 at 14:00 (at the age of 61-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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN), chlortalidone (MANUFACTURER UNKNOWN) and bupropion hydrochloride (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN) and sulfa (MANUFACTURER UNKNOWN) taken for an unknown indication. On 03Mar2021 at 14:00, the patient experienced light headed the day of the vaccine. On 05Mar2021, 2 days later the patient experienced headache, stomach cramps, threw up and diarrhea. On 06Mar2021, the 3rd day, the patient stomach was very bloated with lots of bubbling. On an unknown date in Mar2021 the patient's left hand started hurting and thumb locked up.  It was mentioned that it  hurted even to pick up a sheet of paper. 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 light headed, headache, stomach cramps, threw up and diarrhea, stomach was very bloated with lots of bubbling and left hand started hurting and thumb locked up were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.