chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Insomnia, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: I have been nauseous for a week; Ive been throwing up multiple times a day; I am not able to eat or sleep; I am not able to eat or sleep; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01May2021 at 01:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patent had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. On 01May2021, the patient had been nauseous for a week. She had been throwing up multiple times a day. She was not able to eat or sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 07May2021, the patient underwent nasal swab test for COVID-19 and the result was found to be negative. 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 event the patient had been nauseous for a week was resolved on 07May2021. The clinical outcome of the events she had been throwing up multiple times a day and she was not able to eat or sleep 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Sore arm; Body chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. 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: EP6955) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 02:00, the patient experienced sore arm, body chills and headache. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm, body chills and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: High fever; Chills; Joint pain; Throwing up; Throat hurts; Injection site hurts and numb; Injection site hurts and numb; Headache that's not going away; Light headed; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm  on 07May2021 at 02:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 02:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 02:45, the patient experienced high fever, chills, joint pain, throwing up, throat hurt, injection site hurt and numb, headache that was not going away, light headed and nauseous. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events high fever, chills, joint pain, throwing up, throat hurt, injection site hurt and numb, headache that was not going away, light headed and nauseous was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Vaccination site hypoaesthesia, Vaccination site pain, Vomiting
Clinical narrative: High fever; Chills; Joint pain; Throwing up; Throat hurts; Injection site hurts and numb; Injection site hurts and numb; Headache that's not going away; Light headed; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm  on 07May2021 at 02:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 02:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 02:45, the patient experienced high fever, chills, joint pain, throwing up, throat hurt, injection site hurt and numb, headache that was not going away, light headed and nauseous. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events high fever, chills, joint pain, throwing up, throat hurt, injection site hurt and numb, headache that was not going away, light headed and nauseous was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to 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 vaccine. 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 16Apr2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 12:00, the patient experienced fever, headache and chills. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache and chills was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# 8729), at the age of 52, via an unspecified route of administration, in the left arm, on Apr 21, 2021, single dose, for COVID-19 immunisation. Medical history not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. On May 1, 2021, patient had tinnitus in both ears. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of tinnitus in both ears: not recovered (at the time of report). No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inner ear disorder, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: 3 days after the vaccine a sore throat developed; Inner ear problem; 6 hours after the injection arm became very sore.; This is a spontaneous report from a contactable pharmacist, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Apr2021 at 10:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included polycythemia vera and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and omeprazole (PRILOSEC), both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 21Apr2021 at 16:15, 6 hours after, the patient experienced the injection arm became very sore. Pain persisted for 24 hours. On 24Apr2021 at 11:00, 3 days after the vaccine, the patient experienced a sore throat developed and inner ear problem manifested. Attempted to drain ear with a q-tip but made problem worse and had to see physician. The event inner ear problem resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 27Apr2021, the patient underwent PCR amplification test (nasal swab) and the result was negative. Therapeutic measures were taken as a result of inner ear problem which included treatment with ear lavage, antibiotics, hydrocortisone acetate/neomycin sulfate/polymyxin b sulfate (CORTISPORIN), otic solution. The clinical outcome of the event injection arm became very sore was recovered on 22Apr2021 at 16:15, after a duration of 24 hours. The clinical outcome of the event sore throat and inner ear problem was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain, Pyrexia, Swelling
Clinical narrative: Chills; Backache; Fever; Swelling; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06May2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 07May2021, the patient experienced fever, chills, backache, swelling and soreness. 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 fever, chills, backache, swelling and soreness were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; Ringing in ears become worse; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) in the left arm on 02Apr2021 at 10:30 (at the age of 36-years-old) and had received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) in the left arm on 30Apr2021 at 10:30 (at the age of 36-years-old) as a dose for COVID-19 immunisation. The patient had no medical history and 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 ofloxacin otic Solution (MANUFACTURER UNKNOWN) and gummy bear vitamins (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021, may be three weeks after the first dose, the patient experienced ringing in ears. The patient had been having a very minor ear problem checked out during this time, but only for one ear and he had been using the Ofloxacin otic solution drops to help. But both ears had the ringing and after the second dose of the COVID-19 vaccine it had become worse. The patient was convinced that the vaccine did this and he could not make it stop. The event resulted in doctor or other healthcare professional office, clinic visit. Therapeutic measures were taken as a result of event ringing in ears which included the treatment with lipo-flavonoid pills (MANUFACTURER UNKNOWN) on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in ears and had become worse was 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: Chills, Decreased appetite, Headache, Hyperaesthesia, Insomnia
Clinical narrative: Lethargy; Chills; Body aches; Loss of appetite; Fever; General malaise; Headache; Skin pain (hypersensitivity to the surface of "my'' skin on ''my'' arms and legs"); Skin pain (hypersensitivity to the surface of "my skin on my arms and legs"); Nausea; Insomnia; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 07May2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease and IBD (inflammatory bowel disease). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and probiotic (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021, within 3 hours of shot, the patient experienced injection site pain. On 08May2021 at 03:00 (12 hours post shot), the patient experienced insomnia. On 08May2021 at 08:00 (the rest began 17 hours later), the patient experienced lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of her skin on her arms and legs), nausea. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in May2021, the patient underwent saliva test (Other) and the result was negative. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events injection site pain, insomnia, lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of "her skin on her arms and legs") and nausea was recovering 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: Lethargy, Malaise, Nausea, Pain, Pain of skin
Clinical narrative: Lethargy; Chills; Body aches; Loss of appetite; Fever; General malaise; Headache; Skin pain (hypersensitivity to the surface of "my'' skin on ''my'' arms and legs"); Skin pain (hypersensitivity to the surface of "my skin on my arms and legs"); Nausea; Insomnia; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 07May2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease and IBD (inflammatory bowel disease). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and probiotic (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021, within 3 hours of shot, the patient experienced injection site pain. On 08May2021 at 03:00 (12 hours post shot), the patient experienced insomnia. On 08May2021 at 08:00 (the rest began 17 hours later), the patient experienced lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of her skin on her arms and legs), nausea. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in May2021, the patient underwent saliva test (Other) and the result was negative. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events injection site pain, insomnia, lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of "her skin on her arms and legs") and nausea was recovering 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: Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Lethargy; Chills; Body aches; Loss of appetite; Fever; General malaise; Headache; Skin pain (hypersensitivity to the surface of "my'' skin on ''my'' arms and legs"); Skin pain (hypersensitivity to the surface of "my skin on my arms and legs"); Nausea; Insomnia; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 07May2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease and IBD (inflammatory bowel disease). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and probiotic (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021, within 3 hours of shot, the patient experienced injection site pain. On 08May2021 at 03:00 (12 hours post shot), the patient experienced insomnia. On 08May2021 at 08:00 (the rest began 17 hours later), the patient experienced lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of her skin on her arms and legs), nausea. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in May2021, the patient underwent saliva test (Other) and the result was negative. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events injection site pain, insomnia, lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of "her skin on her arms and legs") and nausea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Eye swelling, Fatigue, Headache
Clinical narrative: Metallic taste within minutes of injection; Severe headache; Nausea; Dizziness; Fatigue; Slight swelling in face and eyes; Slight swelling in face and eyes; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL); for an unknown indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN), TRIPTANS (unspecified), sulfamethoxazole/ trimethoprim (BACTRIM), sumatriptan (IMITREX) and experienced drug allergy.  On 05May2021, the patient experienced metallic taste within minutes of injection, severe headache, nausea, dizziness, fatigue, slight swelling in face and eyes. 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 metallic taste within minutes of injection, severe headache, nausea, dizziness, fatigue, slight swelling in face and eyes was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Swelling face
Clinical narrative: Metallic taste within minutes of injection; Severe headache; Nausea; Dizziness; Fatigue; Slight swelling in face and eyes; Slight swelling in face and eyes; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL); for an unknown indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN), TRIPTANS (unspecified), sulfamethoxazole/ trimethoprim (BACTRIM), sumatriptan (IMITREX) and experienced drug allergy.  On 05May2021, the patient experienced metallic taste within minutes of injection, severe headache, nausea, dizziness, fatigue, slight swelling in face and eyes. 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 metallic taste within minutes of injection, severe headache, nausea, dizziness, fatigue, slight swelling in face and eyes was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Urticaria
Clinical narrative: Hives on forehead, around the eyes, behind ears; Felt burning; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 09:30 (at the age of 60-years-old) and the second 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 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received pseudoephedrine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 12Feb2021 at 09:45 (as reported in source document), 4 hours after the 1st dose of vaccination, the patient started developing hives on his forehead, around the eyes, behind ears. They felt burning and were about nickel size and was lasted 4 to 5 days. After 2nd dose, the patient had the same allergic reactions, but it started 30 minutes after vaccination. The patient had to stay longer at the clinic under medical supervision, and a doctor follow up his case. Hives lasted about 4 days, and occasionally reappear without known reason. The patient took Benadryl. The events resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  hives on his forehead, around the eyes, behind ears and they felt burning and were about nickel size was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: Rashing at injection site; Welting at injection site; This is a spontaneous report from a contactable healthcare professional. A 35-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 right arm on 07May2021 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, hypereosinophilic syndrome, endometriosis, adenomyosis, hypothyroidism, mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome(POTS). The patient reported allergies to methylprednisolone sodium succinate (SOLUMEDROL) and levofloxacin(LEVAQUIN), diphenhydramine hydrochloride (IV BENADRYL), propofol (MANUFACTURER UNKNOWN) and walnuts. 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 vaccine. Concomitant medications included promethazine (MANUFACTURER UNKNOWN) and ondansetron (ZOFRAN); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 04:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 10:00, the patient experienced rashing and welting at injection site. 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 events rashing and welting at injection site included treatment with antihistamine on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rashing and welting at injection site were not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Diarrhoea, Nausea, SARS-CoV-2 test positive
Clinical narrative: Rashing at injection site; Welting at injection site; This is a spontaneous report from a contactable healthcare professional. A 35-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 right arm on 07May2021 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, hypereosinophilic syndrome, endometriosis, adenomyosis, hypothyroidism, mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome(POTS). The patient reported allergies to methylprednisolone sodium succinate (SOLUMEDROL) and levofloxacin(LEVAQUIN), diphenhydramine hydrochloride (IV BENADRYL), propofol (MANUFACTURER UNKNOWN) and walnuts. 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 vaccine. Concomitant medications included promethazine (MANUFACTURER UNKNOWN) and ondansetron (ZOFRAN); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 04:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 10:00, the patient experienced rashing and welting at injection site. 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 events rashing and welting at injection site included treatment with antihistamine on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rashing and welting at injection site were not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Rashing at injection site; Welting at injection site; This is a spontaneous report from a contactable healthcare professional. A 35-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 right arm on 07May2021 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, hypereosinophilic syndrome, endometriosis, adenomyosis, hypothyroidism, mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome(POTS). The patient reported allergies to methylprednisolone sodium succinate (SOLUMEDROL) and levofloxacin(LEVAQUIN), diphenhydramine hydrochloride (IV BENADRYL), propofol (MANUFACTURER UNKNOWN) and walnuts. 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 vaccine. Concomitant medications included promethazine (MANUFACTURER UNKNOWN) and ondansetron (ZOFRAN); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 04:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 10:00, the patient experienced rashing and welting at injection site. 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 events rashing and welting at injection site included treatment with antihistamine on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rashing and welting at injection site were not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in fingers, wrists, knees and neck; This is a spontaneous report from a contactable consumer, the patient. A 51-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 23Mar2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included methemoglobinemia, tennis elbow, tennis elbow, low back pain, depression and anxiety since an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), duloxetine hydrochloride (CYMBALTA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), rosuvastatin calcium (CRESTOR) and alprazolam (XANAX); all taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took prilocaine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 29Apr2021 at 10:00, the patient experienced joint pain in fingers, wrists, knees and neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event joint pain in fingers, wrists, knees and neck 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Headache, Musculoskeletal stiffness
Clinical narrative: Headache; Chills; Burning in eyes; Body ache; Body stiffness; Painful joints; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Mar2021 at 16:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and borderline diabetic. 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. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN), fish oil (MANUFACTURER UNKNOWN) and glucosamine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 11Apr2021 at 09:00, the patient experienced body ache, body stiffness, painful joints, headache, chills and burning in eyes. 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 body ache, body stiffness, painful joints, headache, chills and burning in eyes was resolved with sequelae (also reported as recovered with lasting effects) on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Chills; Burning in eyes; Body ache; Body stiffness; Painful joints; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Mar2021 at 16:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and borderline diabetic. 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. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN), fish oil (MANUFACTURER UNKNOWN) and glucosamine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 11Apr2021 at 09:00, the patient experienced body ache, body stiffness, painful joints, headache, chills and burning in eyes. 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 body ache, body stiffness, painful joints, headache, chills and burning in eyes was resolved with sequelae (also reported as recovered with lasting effects) on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 04May2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gliclazide (CLARITIN), acetylsalicylic acid (81MG ASPIRIN) and CENTRUM SILVER daily vitamins; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 13Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 09:00, the patient experienced tinnitus. 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 tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 101.5 degrees F; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 07May2021 at 15:00 in the left arm (at the age of 31-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. 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 08May2021 at 08:00, one day after the second dose of the vaccination, the patient experienced fever up to 101.5 degrees Fahrenheit. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever up to 101.5 degrees Fahrenheit was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Migraine
Clinical narrative: Extreme migraine; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old 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 04May2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. It was unknown whether the patient was pregnant at the time of this report. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and montelukast (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. 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 12Apr2021 at 16:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 05May2021, the patient experienced extreme migraine and loss of taste, it was day 5 after vaccination and still could not taste things (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme migraine and loss of taste 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: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable physician, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK57c3) via an unspecified route of administration in the left arm on 18Dec2020 at 12:00 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the right arm on an unknown date (age at vaccination- unknown); as a single dose for COVID-19 immunisation. Medical history included hypertension. 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. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and indapamide (MANUFACTURER UNKNOWN) both for unknown indication and ethinylestradiol / levonorgestrel (ALESSE) as oral contraceptive; all from unknown date and unknown if ongoing. On 24Dec2020 at 16:00, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nasopharyngitis, Poor quality sleep, Rhinorrhoea
Clinical narrative: very sick; In bed sleeping for 2-3 days.; Mega cold like symptoms; Mega cold like symptoms that started with sinus infection.; Very tired for over 7 days; Restless sleep at night; Lots of mucus; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 15Apr2021 at 11:00 (at the age of 35-year-old) as a dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication taken within two weeks of vaccination 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 vaccination. On 17Apr2021 at 11:00, the patient was very sick, in bed sleeping for 2-3 days, mega cold like symptoms that started with sinus infection, very tired for over 7 days, restless sleep at night and lots of mucus. 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, and emergency room/department or urgent care. The clinical outcome of the events very sick, in bed sleeping, mega cold like symptoms that started with sinus infection, very tired, restless sleep at night and lots of mucus was resolved with sequelae 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.