chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Aches; Chills; Sore throat; Ear ache; Cough; Loss of smell; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included severe plaque psoriasis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication included apremilast (OTEZLA); taken for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021 at 07:00, the patient developed a fever, aches, chills, sore throat, ear ache, cough, that lasted a week, loss of smell and taste lasted 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events reported which included treatment with paracetamol (TYLENOL) and an unspecified antihistamine. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent nasal swab polymerase chain reaction (PCR) and rapid COVID test and the result was negative. The clinical outcome of the events loss of smell and taste was recovered on 19 Apr2021 and events fever, aches, chills, sore throat, ear ache and cough was recovered on 24Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Inner ear disorder
Clinical narrative: As soon as I walked out of , both ears popped multiple times. I was able to yawn and pop the left one, but 24 hours later my ear still feels blocked and is buzzing; 24 hours later my ear still feels blocked and is buzzing; My inner ear is extremely swollen; 24 hours later my ear still feels blocked and is buzzing; 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: FW0170) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included dairy allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included birth control and a multi vitamin; both for unknown indication on unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 at 16:00 (at the age of 24-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 22Apr2021 at 13:15, as soon as the patient walked out, both ears popped multiple times. The patient was able to yawn and pop the left one, but 24 hours later her ear still felt blocked and was buzzing. The patient got confirmed at the medical center that it was not an ear infection or allergies, but her inner ear was extremely swollen. 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 prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both ears popped multiple times; was able to yawn and pop the left one, but 24 hours later ear still felt blocked and was buzzing; inner ear was extremely swollen was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Inner ear disorder, Tinnitus
Clinical narrative: As soon as I walked out of , both ears popped multiple times. I was able to yawn and pop the left one, but 24 hours later my ear still feels blocked and is buzzing; 24 hours later my ear still feels blocked and is buzzing; My inner ear is extremely swollen; 24 hours later my ear still feels blocked and is buzzing; 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: FW0170) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included dairy allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included birth control and a multi vitamin; both for unknown indication on unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 at 16:00 (at the age of 24-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 22Apr2021 at 13:15, as soon as the patient walked out, both ears popped multiple times. The patient was able to yawn and pop the left one, but 24 hours later her ear still felt blocked and was buzzing. The patient got confirmed at the medical center that it was not an ear infection or allergies, but her inner ear was extremely swollen. 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 prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both ears popped multiple times; was able to yawn and pop the left one, but 24 hours later ear still felt blocked and was buzzing; inner ear was extremely swollen was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pruritus, Pyrexia, Rash pruritic
Clinical narrative: Fever; Body aches; Similar in pain to shingles, felt mostly in spine (lower back), head; Itchy bumps appearing across body; Intense itching rash on hands and feet; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, pleurisy and adhd. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), lisdexamfetamine mesilate (VYVANSE), vitamin d nos (VIT D), ascorbic acid (VIT C) and fish oil (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 01:00, the patient experienced fever, body aches, similar in pain to shingles, felt mostly in spine (lower back), head, itchy bumps appearing across body and intense itching rash on hands and feet. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of itchy bumps appearing across body and intense itching rash on hands and feet and included treatment with Benadryl from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fever, body aches, similar in pain to shingles, felt mostly in spine (lower back), head, itchy bumps appearing across body and intense itching rash on hands and feet were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Spinal pain
Clinical narrative: Fever; Body aches; Similar in pain to shingles, felt mostly in spine (lower back), head; Itchy bumps appearing across body; Intense itching rash on hands and feet; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, pleurisy and adhd. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), lisdexamfetamine mesilate (VYVANSE), vitamin d nos (VIT D), ascorbic acid (VIT C) and fish oil (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 01:00, the patient experienced fever, body aches, similar in pain to shingles, felt mostly in spine (lower back), head, itchy bumps appearing across body and intense itching rash on hands and feet. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of itchy bumps appearing across body and intense itching rash on hands and feet and included treatment with Benadryl from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fever, body aches, similar in pain to shingles, felt mostly in spine (lower back), head, itchy bumps appearing across body and intense itching rash on hands and feet were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Pyrexia, Rash pruritic
Clinical narrative: Fever; Body aches; Similar in pain to shingles, felt mostly in spine (lower back), head; Itchy bumps appearing across body; Intense itching rash on hands and feet; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, pleurisy and adhd. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), lisdexamfetamine mesilate (VYVANSE), vitamin d nos (VIT D), ascorbic acid (VIT C) and fish oil (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 01:00, the patient experienced fever, body aches, similar in pain to shingles, felt mostly in spine (lower back), head, itchy bumps appearing across body and intense itching rash on hands and feet. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of itchy bumps appearing across body and intense itching rash on hands and feet and included treatment with Benadryl from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fever, body aches, similar in pain to shingles, felt mostly in spine (lower back), head, itchy bumps appearing across body and intense itching rash on hands and feet were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Severe itching all through my body; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included severe headache. It was not known if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cyanocobalamin (VITAMIN B 12), topiramate (MANUFACTURER UNKNOWN) and galcanezumab (EMGALITY); 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 vaccination. On 13Apr2021 at 19:00, the patient experienced severe itching all through her body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with cetirizine (MANUFACTURER UNKNOWN) and triamcinolone acetonide (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe itching all through her body 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching all through my body; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included severe headache. It was not known if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cyanocobalamin (VITAMIN B 12), topiramate (MANUFACTURER UNKNOWN) and galcanezumab (EMGALITY); 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 vaccination. On 13Apr2021 at 19:00, the patient experienced severe itching all through her body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with cetirizine (MANUFACTURER UNKNOWN) and triamcinolone acetonide (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe itching all through her body 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: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extremely exhausted; Sleeping 15, 16 hours straight; Burning lungs; Severe body aches; Severe tinnitus; 5 full days of illness / "I" am a mess.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0K9) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus that lasted two months and elevated cholesterol. Prior to vaccination, it was unknown whether 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. On 17Apr2021, the patient was extremely exhausted, slept for 15-16 hours straight, had burning lungs, severe body aches and severe tinnitus running 5 days. It was reported that a vaccine should not produce 5 full days of illness and it was too strong. The patient also questioned for how long these effects go on? The patient had to go to work throughout this because no one could replace. It was like having COVID all over again. The patient felt fine before but at the time of reporting was a mess. 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 adverse events. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 21Apr2021, the patient underwent COVID-19 test via nasal and the result was unknown. The clinical outcome of the event extremely exhausted, slept 15-16 hours straight, burning lungs, severe body aches, severe tinnitus, illness was a mess was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: Extremely exhausted; Sleeping 15, 16 hours straight; Burning lungs; Severe body aches; Severe tinnitus; 5 full days of illness / "I" am a mess.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0K9) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus that lasted two months and elevated cholesterol. Prior to vaccination, it was unknown whether 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. On 17Apr2021, the patient was extremely exhausted, slept for 15-16 hours straight, had burning lungs, severe body aches and severe tinnitus running 5 days. It was reported that a vaccine should not produce 5 full days of illness and it was too strong. The patient also questioned for how long these effects go on? The patient had to go to work throughout this because no one could replace. It was like having COVID all over again. The patient felt fine before but at the time of reporting was a mess. 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 adverse events. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 21Apr2021, the patient underwent COVID-19 test via nasal and the result was unknown. The clinical outcome of the event extremely exhausted, slept 15-16 hours straight, burning lungs, severe body aches, severe tinnitus, illness was a mess was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Illness, Lung disorder, Pain, SARS-CoV-2 test
Clinical narrative: Extremely exhausted; Sleeping 15, 16 hours straight; Burning lungs; Severe body aches; Severe tinnitus; 5 full days of illness / "I" am a mess.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0K9) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus that lasted two months and elevated cholesterol. Prior to vaccination, it was unknown whether 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. On 17Apr2021, the patient was extremely exhausted, slept for 15-16 hours straight, had burning lungs, severe body aches and severe tinnitus running 5 days. It was reported that a vaccine should not produce 5 full days of illness and it was too strong. The patient also questioned for how long these effects go on? The patient had to go to work throughout this because no one could replace. It was like having COVID all over again. The patient felt fine before but at the time of reporting was a mess. 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 adverse events. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 21Apr2021, the patient underwent COVID-19 test via nasal and the result was unknown. The clinical outcome of the event extremely exhausted, slept 15-16 hours straight, burning lungs, severe body aches, severe tinnitus, illness was a mess was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: Extremely exhausted; Sleeping 15, 16 hours straight; Burning lungs; Severe body aches; Severe tinnitus; 5 full days of illness / "I" am a mess.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0K9) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus that lasted two months and elevated cholesterol. Prior to vaccination, it was unknown whether 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. On 17Apr2021, the patient was extremely exhausted, slept for 15-16 hours straight, had burning lungs, severe body aches and severe tinnitus running 5 days. It was reported that a vaccine should not produce 5 full days of illness and it was too strong. The patient also questioned for how long these effects go on? The patient had to go to work throughout this because no one could replace. It was like having COVID all over again. The patient felt fine before but at the time of reporting was a mess. 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 adverse events. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 21Apr2021, the patient underwent COVID-19 test via nasal and the result was unknown. The clinical outcome of the event extremely exhausted, slept 15-16 hours straight, burning lungs, severe body aches, severe tinnitus, illness was a mess was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear; Clogged feeling in right ear; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male 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 01Apr2021 at 08:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included bicuspid aortic valve since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of vaccination. Concomitant medications were not reported. On 20Apr2021, the patient experienced  tinnitus in left ear and clogged feeling in right ear. The 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 taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus in left ear and clogged feeling in right ear were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Tinnitus in left ear; Clogged feeling in right ear; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male 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 01Apr2021 at 08:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included bicuspid aortic valve since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of vaccination. Concomitant medications were not reported. On 20Apr2021, the patient experienced  tinnitus in left ear and clogged feeling in right ear. The 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 taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus in left ear and clogged feeling in right ear were 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, COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: phlegm that was green in the morning; heaviness in his chest; with first dose he had just the sore arm; This is a spontaneous report from a contactable consumer or other non-health professional (patient). This 42-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot number: EP7533) via an unspecified route of administration, in Left arm on, 04Apr2021 at 13:00, as DOSE 1, single for COVID-19 immunisation (age at vaccination:42-years-old).The patient's medical history and concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient laboratory test were not reported. The clinical course was as follows: Patient reported that his experience was unusual with the Pfizer vaccine. With the first dose he just had sore arm. It occurred that day or night and lasted 24 hours, probably not that long. He got his 1st shot exactly 6 weeks ago. Added, exactly 5 weeks, rather. 10 days later he began feeling heaviness in his chest. He had no cough but had phlegm that was green in the morning. He had no cough, no fever, chills or loss of taste. He felt fine, until the second shot. The heaviness in the chest he had since 15Apr2021 and has kind of decreased. He was not short of breath, had no cough, just green phlegm. He never experienced phlegm without a cough or congestion, but it went away before the 2nd shot. The event sore arm recovered on 06Apr2021.The outcome of the event phlegm that was green in the morning was recovered on an unspecified date before the second shot on 25Apr2021. The outcome of the event heaviness in his chest was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Pain in extremity, Sputum discoloured
Clinical narrative: phlegm that was green in the morning; heaviness in his chest; with first dose he had just the sore arm; This is a spontaneous report from a contactable consumer or other non-health professional (patient). This 42-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot number: EP7533) via an unspecified route of administration, in Left arm on, 04Apr2021 at 13:00, as DOSE 1, single for COVID-19 immunisation (age at vaccination:42-years-old).The patient's medical history and concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient laboratory test were not reported. The clinical course was as follows: Patient reported that his experience was unusual with the Pfizer vaccine. With the first dose he just had sore arm. It occurred that day or night and lasted 24 hours, probably not that long. He got his 1st shot exactly 6 weeks ago. Added, exactly 5 weeks, rather. 10 days later he began feeling heaviness in his chest. He had no cough but had phlegm that was green in the morning. He had no cough, no fever, chills or loss of taste. He felt fine, until the second shot. The heaviness in the chest he had since 15Apr2021 and has kind of decreased. He was not short of breath, had no cough, just green phlegm. He never experienced phlegm without a cough or congestion, but it went away before the 2nd shot. The event sore arm recovered on 06Apr2021.The outcome of the event phlegm that was green in the morning was recovered on an unspecified date before the second shot on 25Apr2021. The outcome of the event heaviness in his chest was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Cough, Dizziness, Oropharyngeal pain
Clinical narrative: Sore throat 12 hours after injection; Cough 12 hours after injection; Chills; Dizziness; Weakness10 minutes after injection.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), retinol (VITAMIN A), vitamin b complex (VITAMIN B) and ascorbic acid (VITAMIN C); all for unknown indication from unknown date and unknown if ongoing. The patient previously took citric acid (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy.  On 23Apr2021 at 09:55, the patient experienced chills, dizziness, weakness 10 minutes after injection and sore throat, cough 12 hours after injection. 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 chills, dizziness, weakness, sore throat and cough was not recovered 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: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 08Apr2021 at 23:00, the patient experienced tinnitus. 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. 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 required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 08Apr2021 at 23:00, the patient experienced tinnitus. 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. 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 required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Swelling, Swelling face
Clinical narrative: Swelling of the eyebrows; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 24Apr2021 at 16:45 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known allergy to penicillin. 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 amlodipine (MANUFACTURER UNKNOWN) 10mg for unknown indication from an unknown date and unknown if ongoing. On 24Apr2021 at 20:45, the patient experienced swelling of the eyebrows. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of the eyebrows was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of the eyebrows; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 24Apr2021 at 16:45 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known allergy to penicillin. 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 amlodipine (MANUFACTURER UNKNOWN) 10mg for unknown indication from an unknown date and unknown if ongoing. On 24Apr2021 at 20:45, the patient experienced swelling of the eyebrows. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of the eyebrows was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Lethargy, Pain, Pain in extremity
Clinical narrative: Day of the shot developed chills and lots of numbness in hand/arm.; Fatigue; Day of the shot developed chills; Lethargy; Severe headache. Headache has been off and on ongoing since shot, sometimes severe reoccurrences; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 10:45 (at the age of 35-years-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 known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Apr2021 at 10:45, on the day of the shot, the patient experienced chills and lots of numbness in hand/arm. Day after worsened chills, fatigue, lethargy, severe headache. Headache had been off and on ongoing since shot, sometimes severe reoccurrences. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event chills and lots of numbness in hand/arm, fatigue, lethargy, severe headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Day of the shot developed chills and lots of numbness in hand/arm.; Fatigue; Day of the shot developed chills; Lethargy; Severe headache. Headache has been off and on ongoing since shot, sometimes severe reoccurrences; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 10:45 (at the age of 35-years-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 known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Apr2021 at 10:45, on the day of the shot, the patient experienced chills and lots of numbness in hand/arm. Day after worsened chills, fatigue, lethargy, severe headache. Headache had been off and on ongoing since shot, sometimes severe reoccurrences. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event chills and lots of numbness in hand/arm, fatigue, lethargy, severe headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Lethargy
Clinical narrative: Day of the shot developed chills and lots of numbness in hand/arm.; Fatigue; Day of the shot developed chills; Lethargy; Severe headache. Headache has been off and on ongoing since shot, sometimes severe reoccurrences; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 10:45 (at the age of 35-years-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 known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Apr2021 at 10:45, on the day of the shot, the patient experienced chills and lots of numbness in hand/arm. Day after worsened chills, fatigue, lethargy, severe headache. Headache had been off and on ongoing since shot, sometimes severe reoccurrences. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event chills and lots of numbness in hand/arm, fatigue, lethargy, severe headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Painful, large, circular rashes around both armpits approx. 26 hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 32-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 24Apr2021 at 10:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other concomitant medications within two weeks of vaccination. On 25Apr2021 at 12:30, the patient experienced painful, large, circular rashes around both armpits approximately 26 hours after injection. The events did not result in doctor or other health care professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful, large, circular rashes around both armpits was unknown 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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood lactate dehydrogenase, Blood test, Chest X-ray, Chills, Differential white blood cell count
Clinical narrative: Chills; Night sweats; bodyaches; Fatigue; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 07Apr2021 at 16:15(at the age of 59-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 16:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 10:00, the patient experienced chills, night sweats, body aches, fatigue and low grade fever. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was negative. The patient also underwent unspecified tests on an unknown date. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which include treatment with NSAIDs. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, night sweats, body aches, fatigue and low grade fever were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.