chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Goitre, Vaccination site pain
Clinical narrative: Left thyroid gland is somewhatenlarged.; TSH result increased; pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation paroxysmal and cardiac ablation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) 0.375 mg and progesterone (MANUFACTURER UNKNOWN) 100 mg daily, both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 08:00 (at the age of 79-year-old) as a single dose for COVID-19 immunisation and patient experienced vaccination site pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient underwent routine blood test and the result was 8.22 an unspecified unit. On 27Feb2021 the patient experienced pain at the injection site. Therapeutic measures were taken for the reported events of pain at the injection site and treatment are gentle massage. On 01Apr2021 the patient experienced TSH result increased (8.22). On 14Apr2021 the patient experienced left thyroid gland enlarged. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event of pain at the injection site was recovered on 27Feb2021 at the time of one day duration. The clinical outcome of the events of TSH result increased and left thyroid gland enlarged was not recovered at the time of this report   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on left arm (injection arm, spreading to left hand); This is a spontaneous report from a non-contactable consumer, the patient.  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 16:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021, the patient experienced numbness on left arm (injection arm, spreading to left hand). 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. The clinical outcome of the event numbness on left arm (injection arm, spreading to left hand) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 34-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 11Apr2021 at 17:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to food, medications or other products. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE) 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. On 12Apr2021 at 11:30, the patient experienced aches and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of aches and chills and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches and chills was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Full body pain; fever above 102; This is a spontaneous report from a contactable consumer. A 46-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 on an unknown date ( at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications and other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021, the patient experienced full body pain and fever. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 13Apr2021, the patient underwent body temperature test and the result was above 102. The clinical outcome of the event full body pain, fever was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen armpit; This is a spontaneous report from a non-contactable consumer. A patient of unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced swollen armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event swollen armpit was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: itchy rash all over body; Red, itchy rash all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0510), via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: ER2631), via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced red, itchy rash all over body. No therapeutic measures were taken as a result of the adverse events. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red, itchy rash all over body was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Rash pruritic, Tremor, Urticaria
Clinical narrative: Itchy Rash all over back, head, arms, neck, and stomach; Looks like hives covering entire body; Shaky; Weak; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151) via an unspecified route of administration in the arm left on 13Apr2021 at 11:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Mar2021 at 11:00 (at the age of 24-year-old)as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to 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 four weeks prior to the vaccination. On 15Apr2021 at 12:00, the patient experienced itchy rash all over back, head, arms, neck and stomach (looked like hives covering entire body), shaky and weak. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events itchy rash all over back, head, arms, neck and stomach, looked like hives, shaking and weakness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Intense ringing in right ear lasting a minute.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 12Apr2021 at 13:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known drug allergy. Concomitant medications included men's perfect multi (PURITY PRODUCTS), glucosamine; chondroitin sulfate (GC FLEX) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 07:45, the patient experienced intense ringing in right ear lasting a minute. Then subsided to a sustained ringing with sporadic intense bouts. Right ear continued to ring all day. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event intense ringing in right ear lasting a minute was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration on 02Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as N/A. The patient did not have any allergies to food, medications, or other products. Concomitant medication included paracetamol (TYLENOL) for an unknown indication on an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 08:00, the patient experienced vertigo and dizziness. The patient had been feeling dizzy since then. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. On an unknown date patient underwent lab test which included PCR test for COVID-19 and tested negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vertigo and dizziness were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Fatigue, Headache
Clinical narrative: Arm pain; Headache; Fever; Chills; Stomach upset; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 16:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, asthmatic, high blood pressure, depression, anxiety and COVID-19. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), ibuprofen (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (SPRINTEC) and acetylsalicylic acid (ASPIRIN) all for an unknown indication from an unknown date and unknown if ongoing. Prior to 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 four weeks prior to the vaccination. On 14Apr2021 at 12:15, the patient experienced arm pain, headache, fever, chills, stomach upset, fatigue and body aches. 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 arm pain, headache, fever, chills, stomach upset, fatigue and body aches were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Headache; Fever; Chills; Stomach upset; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 16:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, asthmatic, high blood pressure, depression, anxiety and COVID-19. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), ibuprofen (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (SPRINTEC) and acetylsalicylic acid (ASPIRIN) all for an unknown indication from an unknown date and unknown if ongoing. Prior to 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 four weeks prior to the vaccination. On 14Apr2021 at 12:15, the patient experienced arm pain, headache, fever, chills, stomach upset, fatigue and body aches. 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 arm pain, headache, fever, chills, stomach upset, fatigue and body aches were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Photosensitivity reaction
Clinical narrative: experiencing recurring migraines.; experiencing recurring migraines and sensitivity to light.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 13:30(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 11:30, the patient experienced recurring migraines and sensitivity to light. The patient did not receive any treatment for the reported events. The clinical outcome of the events recurring migraines and sensitivity to light were not recovered 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: Anosmia, Body temperature decreased, Headache, Hypersensitivity, Insomnia
Clinical narrative: Headache; literally cant sleep; Severe allergies nasal/throat; itching skin; loss of smell; severe allergies; nausea; puking; hot/cold body temp with low grade temp; Pain in hands and feet; Pain in hands and feet; 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: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 07:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 10Apr2021 at 07:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, type 2 diabetes mellitus, kidney disease, Postural Orthostatic Tachycardia Syndrome (POTS), Ehlers-Danlos Syndrome (EDS) and Interstitial Cystitis (IC). The patient had unspecified allergies. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, the patient experienced headache, literally could not sleep, had severe allergies of nasal/throat and itching skin, loss of smell, severe allergies, nausea and puking, hot/cold body temperature with low grade temperature and pain in hands and feet. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, literally could not sleep, had severe allergies of nasal/throat and itching skin, loss of smell, severe allergies, nausea and puking, hot/cold body temperature with low grade temperature and pain in hands and feet were not resolved 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: Nausea, Pain in extremity, Pruritus, Rhinitis allergic, Vomiting
Clinical narrative: Headache; literally cant sleep; Severe allergies nasal/throat; itching skin; loss of smell; severe allergies; nausea; puking; hot/cold body temp with low grade temp; Pain in hands and feet; Pain in hands and feet; 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: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 07:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 10Apr2021 at 07:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, type 2 diabetes mellitus, kidney disease, Postural Orthostatic Tachycardia Syndrome (POTS), Ehlers-Danlos Syndrome (EDS) and Interstitial Cystitis (IC). The patient had unspecified allergies. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, the patient experienced headache, literally could not sleep, had severe allergies of nasal/throat and itching skin, loss of smell, severe allergies, nausea and puking, hot/cold body temperature with low grade temperature and pain in hands and feet. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, literally could not sleep, had severe allergies of nasal/throat and itching skin, loss of smell, severe allergies, nausea and puking, hot/cold body temperature with low grade temperature and pain in hands and feet were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on legs and torso and they were multiplying; This is a spontaneous report from a contactable consumer, the patient. A 45-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 on 22Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic on an unknown date and ongoing. Concomitant medications included dulaglutide (TRULICITY) for diabetic from an unknown date. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient hives on legs and torso and they were multiplying. Therapeutic measures were not taken as a result of these 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 event hives on legs and torso and they were multiplying was not recovered at the time of this report.   The patient later received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1053) via an unspecified route of administration in the left arm on 12Apr2021 at 17:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19.The patient did not receive any concomitant medications  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced rapid heart rate. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rapid heart rate was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Somnolence
Clinical narrative: Headache; Slight arm pain; Fatigue; Grogginess; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO161) via an unspecified route of administration in the left arm on 12Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included chorionic gonadotrophin (NOVAREL), arginine (L-ARGININE), fish oil (MANUFACTURER UNKNOWN), ubidecarenone; linum usitatissimum seed oil; conjugated linoleic acid (COQ10) and prenatal (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:30, the patient experienced slight arm pain, headache, grogginess and fatigue. The events did not result in doctor or other health care 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 slight arm pain, headache, grogginess and fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Swelling face
Clinical narrative: Facial swelling for several days; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 39-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 09Apr2021 at 13:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 10Apr2021 at 15:00, the patient experienced facial swelling for several days and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with steroid prescription. The clinical outcome of the events facial swelling for several days and heart palpitations were resolving at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tiredness; Pain in arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-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 arm right on 12Apr2021 at 15:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY) and amlodipine (MANUFACTURER UNKNOWN) from an unknown start date for unknown indication. 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 12Apr2021 at 21:00 the patient experienced pain in arm at vaccination site and tiredness. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event pain in arm at vaccination site was recovered on 13Apr2021 after the duration of 24 hours. The clinical outcome of the event tiredness was recovering at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: joint aches; chills; intense tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included discoid lupus. The patient previously received penicillin on an unknown date for an unknown indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on an unknown date in Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), montelukast sodium (MONTELUKAST), multivitamin and allergy medications; all from an unknown date for an unknown indication an unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, approximately 12 hours after receiving 2nd dose, the patient experienced joint aches, 18 hours after 2nd dose, the chills began as well an intense tiredness. These symptoms lasted until about 3pm the day after the 2nd dose (a full 24 hours) before these lessened. First the chills subsided, then the achy joints. The following day, all reactions had subsided completely. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or 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 joint ache, chills and tiredness was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Hordeolum, SARS-CoV-2 test
Clinical narrative: Stye on right eye; Left ankle pain; Right foot bruising; This is a spontaneous report from a contactable consumer, the patient. A 24-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 arm left on 11Mar2021 at 14:00(at the age of 24-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 08Apr2021 as a single dose for COVID-19 immunisation. Medical history included 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 were not reported. The patient had no known allergies. On 31Mar2021 at 09:00 the patient experienced, stye on right eye, left ankle pain and right foot bruising. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent nasal swab and the test result was negative and on 29Mar2021, the patient underwent COVID-19 virus test and test result was negative. The clinical outcome of the event stye on right eye, left ankle pain and right foot bruising was not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00(at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not have a medical history. The patient was not allergic to food, medication or other product. Concomitant medications included ferrous sulfate/folic acid/zinc (PRENATAL) and fish oil/rosmarinus officinalis/tocopherol (ULTIMATE OMEGA) both are started from an unknown date and unknown if ongoing for an unknown indication. 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 12Apr2021 at 14:00 the patient experienced diarrhoea. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event diarrhoea was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Rotator cuff syndrome
Clinical narrative: Then my right knee was hurting like i had tore something there to for 7 day; Starting an hour after the vaccine, For 5 days it felt like i had tore my rotator cuff in my left arm. After that went away,; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 15:00, starting an hour after the vaccine, the patient felt like he had a tore in his rotator cuff in his left arm for 5 days. After that it went away. On an unknown date in Apr2021, the patient experienced that his right knee was hurting like he had torn something there for 7 days. No therapeutic measures were taken for the reported events. The clinical outcome of the events rotator cuff tear in his left arm was recovered on an unknown date in Apr2021 and the clinical outcome of the event right knee hurting like he had torn something there was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Rash, Swelling face
Clinical narrative: Severe rash covered 25% of body --head to mid-chest/back.; Face swelled; Lips swelled/tingled; Lips swelled/ tingled; This is a spontaneous report from a contactable consumer, the patient. A 30-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 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamin d nos (VIT D), ascorbic acid (VIT C), sodium ascorbate, vaccinium macrocarpon, lactobacillus acidophilus, lactobacillus rhamnosus, bacillus coagulans, fructooligosaccharides (VH ESSENTIALS PROBIOTICS WITH PREBIOTICS & CRANBERRY) and withania somnifera root (ASHWAGANDHA ROOT) for unknown indication from an unknown date.  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 09Apr2021 at 00:00, the patient experienced severe rash covered 25% of body - head to mid chest/back, face swelled, lips swelled and tingled. No apparent stimulus for reaction, the patient last ate 6hrs before event and had only drank water since. Managed to get it under control after 2 days of regular Benadryl dosing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with 2 days of regular diphenhydramine (BENADRYL). The clinical outcome of the events severe rash covered 25% of body - head to mid chest/back, face swelled, lips swelled and tingled was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sleep paralysis, Somnolence, Vaccination site pain
Clinical narrative: sleep paralysis; Tiredness; sleepiness; soreness at injection site; This is a spontaneous report from a contactable healthcare professional. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as not available. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included fluconazole (MANUFACTURER UNKNOWN) from unknown date for unknown indication. 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 12Apr2021 at 11:00, the patient experienced tiredness, sleepiness, sleep paralysis, soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tiredness, sleepiness, sleep paralysis, soreness at injection site was resolving 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Dry hive  like patches that started on  arm, back, chest and torso.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0153) via an unspecified route of administration in the arm left on 06Apr2021 at 15:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date to unknown date. Concomitant medications included restylane filler (MANUFACTURER UNKNOWN) started on 04Feb2021 for unknown indication. The patient had no known allergies. Prior to 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 four weeks prior to the vaccination. On 09Apr2021, the patient experienced dry hive like patches on arm which extended to back, chest, and torso. The event 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 this event. The clinical outcome of the event dry hive like patches on back, chest, and torso was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Headache, Pain, Pyrexia
Clinical narrative: fever (99.2); headache; stomach upset; body aches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 08:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 22Mar2021 at 08:45 as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient underwent test for body temperature and the result was fever with 99.2. The patient had no known allergies. On 12Apr2021 at 20:00, the patient experienced body aches, headache and stomach upset. On 13Apr2021 at 01:00 the patient experienced fever. The patient did not receive any treatment for the event. The adverse event did not result in visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events general body pain, headache and stomach upset were recovering and of the event fever was resolved.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Numbness and tingling in leg; Numbness and tingling in leg; Throbbing pain in same leg.; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 15:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), vortioxetine hydrobromide (TRINTELLIX) and montelukast sodium (SINGULAIR), all from unknown dates and for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 18:30, the patient experienced numbness and tingling in leg and throbbing pain in same leg. The patient did not receive any treatment for the reported events. The adverse 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 the event numbness, tingling and throbbing pain in leg 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder
Clinical narrative: Bumps appeared on lmy ips; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 12Apr2021 at 14:30 in the left arm (at the age of 49-years-old) as single dose for COVID-19 immunisation. The medical history of the patient included possible penicillin allergy. The patient did not receive other medication within 2 weeks of COVID-19 vaccine. The patient did not receive other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 25Mar2021 at 13:30 (at the age of 49-years-old) in the right arm as single dose for COVID-19 immunisation. Post the vaccination, the patient was not tested for COVID-19. On 12Apr2021, the patient was not certain what caused this but she had not experienced this before. Bumps appeared on her lips. She thought it was a cold sore at first but there was no itching tingling. One that had grown in the last couple of days on the lower lip and many smaller bumps on the upper lip not responding to Abreva, which was what she would usually use on a cold sore as soon as she felt the tingling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included Abreva (MANUFACTURER UNKNOWN). The clinical outcome of the event bumps appeared on lips was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.