chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Temporomandibular joint syndrome
Clinical narrative: Left ear pain several days after vaccine; Left ear pain several days after vaccine, progressed to TMJ; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 01May2021 at 10:00, the patient experienced left ear pain several days after vaccine and progressed to TMJ (temporomandibular joint). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left ear pain several days after vaccine and progressed to TMJ were not resolved 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: Menstruation delayed
Clinical narrative: 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: WE0158) via an unspecified route of administration in the left arm on 16Apr2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 23Apr2021, the patient experienced severely delayed menses. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severely delayed menses was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WE0172) via an unspecified route of administration in the left arm on 07May2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 23Mar2021 at 09:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes, neuropathy and the patient was allergic 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 gabapentin (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY); started on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 04Apr2021 at 09:00, about 2 weeks after the second shot, the patient's arm went numb in the area where she got the injection and if her life with her left arm needles and pins shoot through her upper arm and the upper part of the arm always felt like it was asleep. 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 arm went numb in the area where she got the injection and her left arm needles and pins shoot through her upper arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events her arm went numb in the area where she got the injection and her left arm needles and pins shoot through her upper arm were not resolved 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: Hypoaesthesia
Clinical narrative: Partial numbness in left hand and fingers; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female 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 05May2021 at 00:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication and birth control (unspecified) medication; both from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on an unknown date (age at vaccination-unknown) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced partial numbness in left hand and fingers. 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 partial numbness in left hand and fingers was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disorientation, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: Disorientation; brain fog for several days; fatigue; sore lower back; head pressure; general feeling of just being off; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 22Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, acne and general anxiety disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included thyroid (ARMOUR THYROID), escitalopram oxalate (LEXAPRO), doxycycline (ORACEA) and spironolactone (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 11:15 the patient experienced disorientation, brain fog for several days, fatigue, sore lower back, head pressure and general feeling of just being off. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of sore back included treatment with chiropractic care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events disorientation, brain fog for several days, fatigue, sore lower back, head pressure and general feeling of just being off was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Total arm pain the next day from finger tips to top of shoulder. It felt like the bone and evert joint in my hand was aching.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 08May2021 at 09:00 (at the age of 33-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 COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 17Apr2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 09May2021, the patient experienced total arm pain the next day from finger tips to top of shoulder. It felt like the bone and evert joint in my hand was aching and pain was gone by next day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with ibuprofen (ADVIL) and naproxen sodium (ALEVE) for pain relief. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event total arm pain the next day from finger tips to top of shoulder, It felt like the bone and evert joint in my hand was aching and pain was gone by next day was resolved on 10May2021, after the duration of 1 day.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain in extremity
Clinical narrative: Sore arm; Chills; Headache; "I'' am well but got my second covid vaccine shot Saturday morning and have not been feeling well; This is a spontaneous report from a contactable consumer. An unspecified aged female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08May2021 as a single dose for COVID-19 immunisation. Medical history reported as unknown. It was unknown whether the patient had any allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received other medications within 2 weeks of vaccination. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID-19 vaccine. On 08May2021, the patient experienced sore arm, chills and headache. The patient reported that she was well but got her second COVID-19 vaccine shot on Saturday morning and had not been feeling well since Some better on that day but at the time of report she had a headache. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm, chills, not been feeling well and headache was recovering 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Pain, Skin fissures, Spinal pain
Clinical narrative: 7 days following the vaccine "I" experienced all over body inflammation in my joints; "I" was so fatigued "I" was unable to be up for more than a few minutes without taking a rest hurt from head to toe/ feeling more tired than usual; "My" skin on "my" feet began to split open on "my" heels, the balls of "my" feet, and "my" toes.; Still hurting in "my" spine; hurt from head to toe; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 10Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other 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. The concomitant medications included cetirizine hydrochloride (ZYRTEC) 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: EM6205) via an unspecified route of administration in the left arm on 13Mar2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 07:00, 7 days following the vaccine, the patient experienced all over body inflammation in joints, so fatigued and was unable to be up for more than a few minutes without taking a rest and hurt from head to toe. The patient's skin on her feet begun to split open on heels, the balls of feet, and toes. It had lasted 3 weeks by the time of report, with a little improvement in last few days. The patient's spine was still hurt at the time of report and felt more tired than usual. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events all over body inflammation in joints, skin on feet begun to split open on heels, the balls of feet, and toes, spine was hurt, hurt from head to toe were resolving, while the clinical outcome of the events fatigued/felt more tired than usual and spine was hurt were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme itchiness all over my body; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant 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 vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin D NOS (MANUFACTURER UNKNOWN), collagen (MANUFACTURER UNKNOWN) and resveratrol (MANUFACTURER UNKNOWN); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021, the patient experienced extreme itchiness all over her body. No apparent rash. Lasted over 2 weeks. 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 extreme itchiness all over her body was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Burning sensation, Swelling
Clinical narrative: Swollen and tender armpit; Swollen and tender armpit; Moving back pain: middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again. Each day is different location; Moving back pain: middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again. Each day is different location; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO175) via an unspecified route of administration on 03May2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 as a single dose for COVID-19 immunisation and received ciprofloxacin (CIPRO) and amoxicillin (MANUFACTURER UNKNOWN); both for unknown indication on unknown date and experienced drug allergy. On 03May2021, post second dose, the patient experienced swollen and tender armpit for first 7 days, each day decreasing and moving back pain, first in the middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again. Each day back pain was in different location. 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 swollen and tender armpit for first 7 days, each day decreasing was resolved on 10May2021 and of the events moving back pain, first in the middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache for many weeks; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced persistent headache for many weeks. 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event persistent headache for many weeks 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Both my ears have been ringing. It is so loud and it just awful. I work in a quiet place. When I get a moment to myself to sit and relax, all I can focus on is the ringing of the ears. it's just awful; It just awful; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic back pain and ankles. 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. On 27Apr2021, the patient's both ears had been ringing. It was so loud and just awful, the patient worked in a quiet place. When patient got a moment to sit and relax, all patient could focus on was the ringing of the ears. The event resulted in doctor or other healthcare professional office/clinic visit. 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 both ears have been ringing, It is so loud and it just awful, can focus on is the ringing of the ears 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: Diarrhoea, Pain
Clinical narrative: I had body aches since the shot; I had diarrhea since the shot; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 05May2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included symptomatic premature ventricular contractions (PVC's), pseudotumor cerebri, colitis, depression, anxiety, weak left ventricle and post-traumatic stress disorder (PTSD) and known allergies to sulfa, penicillin and plastic tape. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rimegepant sulfate (NURTEC ODT) and clonazepam (KLONOPIN); both 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: EW0167) via an unspecified route of administration in the right arm on 14Apr2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 15:45, the patient experienced body aches and diarrhea since the shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and diarrhea since the shot was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Increased Mucus Production/post nasal drip; Increased Mucus Production/post nasal drip; Increased Mucus Production/post nasal drip with expiratory wheezing since the shot; Causes coughing on and off daily and gets worse with physical exertion; Causes coughing on and off daily and gets worse with physical exertion which also causes fatigue; Shortness of breath with increased coughing; This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and COVID-19. The patient was allergic to penicillin. 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 thiamazole (METHIMAZOLE) taken for an unspecified indication from an unknown date and unknown if ongoing. On 01Apr2021 at 16:00, the patient experienced increased mucus production/post nasal drip with expiratory wheezing since the shot, about a month and a half time, caused coughing on and off daily and got worse with physical exertion which also caused fatigue, shortness of breath with increased coughing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02May2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. The clinical outcome of the events increased mucus production/post nasal drip with expiratory wheezing since the shot, about a month and a half time, caused coughing on and off daily and got worse with physical exertion which also caused fatigue, shortness of breath with increased coughing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome, Wheezing
Clinical narrative: Increased Mucus Production/post nasal drip; Increased Mucus Production/post nasal drip; Increased Mucus Production/post nasal drip with expiratory wheezing since the shot; Causes coughing on and off daily and gets worse with physical exertion; Causes coughing on and off daily and gets worse with physical exertion which also causes fatigue; Shortness of breath with increased coughing; This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and COVID-19. The patient was allergic to penicillin. 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 thiamazole (METHIMAZOLE) taken for an unspecified indication from an unknown date and unknown if ongoing. On 01Apr2021 at 16:00, the patient experienced increased mucus production/post nasal drip with expiratory wheezing since the shot, about a month and a half time, caused coughing on and off daily and got worse with physical exertion which also caused fatigue, shortness of breath with increased coughing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02May2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. The clinical outcome of the events increased mucus production/post nasal drip with expiratory wheezing since the shot, about a month and a half time, caused coughing on and off daily and got worse with physical exertion which also caused fatigue, shortness of breath with increased coughing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Inappropriate schedule of product administration, Speech disorder
Clinical narrative: Everything was going faster and speech was accelerated; The patient felt like she was on Speed. Everything was going faster and her speech was accelerated. No heart collocation and no temp (just felt like her whole world was racing); BNT162B2 was administered 59 days after the primary dose.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 10May2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included left anterior descending coronary artery stenosis (RA. Stint placed at the LAD) from an unknown date in 2005 and unknown if ongoing and COVID-19. The patient had known allergies to sulfa drugs, injection iodine and penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received morphine (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and experienced drug allergy. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 12Mar2021 at 12:00 (at the age of 66-years-old)as a single dose for COVID-19 immunisation. On 10May2021 at 16:45, it was reported that the patient felt like she was on speed, everything was going faster and her speech was accelerated, no heart collocation and no temperature (just felt like her whole world was racing).  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like the patient was on speed, everything was going faster and speech was accelerated was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Late period like a clock 27-29 days and was 2weeks late which was extremely unusual; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on an unknown date (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum state (Overall healthy. 7mo postpartum (period was back 1mo postpartum with consistently 27-29 days length, except after the vaccine). 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 were not reported. On an unknown date in May2021, the patient experienced late period. she usually like a clock 27-29 days and was 2 weeks late which was extremely unusual. There were no other changes in lifestyle, diet, stress level or exercise. It was the first time in life. The patient was this late and could not think of anything else but the effect of covid vaccine. The patient wishes more trials has been done that focus on the effects on women's health. 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 late period. she usually like a clock 27-29 days and was 2 weeks late which was extremely unusual was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Low grade fever; Chills; Sweats; Headache; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 04May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The reporter was made aware of the events following the second dose. On 04May2021, the patient experienced low grade fever, chills, sweats and headache. It resolved within a day. There were no events noted after receiving the first dose. The reporter was informed of this event on 05May2021 at approximately 21:00. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events low grade fever, chills, sweats and headache was resolved within a day on 05May2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Constipation, Headache, Nausea
Clinical narrative: High grade fever ranging from 99 to 103 degrees F for 4 days; Chills; Body aches; Headache; Nausea; Constipation; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Apr2021 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient did not have any 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 lisinopril (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for unknown indication, from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced high grade fever ranging from 99 to 103 degrees Fahrenheit for 4 days, chills, body aches, headache, nausea and constipation. It was reported that symptoms started two days after shot was received. On an unknown date in Apr2021, the patient underwent body temperature test and the result was found to be 99 to 103 degrees Fahrenheit. 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 high grade fever, chills, body aches, headache, nausea and constipation was recovering 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: High grade fever ranging from 99 to 103 degrees F for 4 days; Chills; Body aches; Headache; Nausea; Constipation; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Apr2021 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient did not have any 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 lisinopril (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for unknown indication, from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced high grade fever ranging from 99 to 103 degrees Fahrenheit for 4 days, chills, body aches, headache, nausea and constipation. It was reported that symptoms started two days after shot was received. On an unknown date in Apr2021, the patient underwent body temperature test and the result was found to be 99 to 103 degrees Fahrenheit. 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 high grade fever, chills, body aches, headache, nausea and constipation was recovering 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Minor hives; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on an unknown date (at the age of 25-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. On an unknown date, the patient experienced minor hives. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event minor hives was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever between 100-102 degrees; Nausea; Headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05May2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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 were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 05May2021, after 12 hours of vaccination, the patient experienced headache and chills. On 07May2021 at 12:30, the patient experienced nausea and fever between 100-102 degrees through the following two days. 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 event. On 07May2021, the patient underwent body temperature test and the result was 100-102 degrees (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, nausea and fever between 100-102 degrees were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt sick; This is a spontaneous report from a non-contactable nurse. A 17-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 on 06May2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history or any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown if the patient received any medication within two weeks of vaccination. 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 on an unknown date as a single dose for COVID-19 immunisation. On 06May2021, the patient received 2nd dose and felt sick.  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 felt sick was not resolved 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: Tinnitus
Clinical narrative: Very strong tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and a little prone to blood clots. 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 fosinopril (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), carvedilol (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for unknown indication since an unknown date and unknown if ongoing. On 21Apr2021, the patient experienced very strong tinnitus which patient had never experienced before. Therapeutic measures were not taken as a result of the event very strong tinnitus which the patient had never experienced before. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very strong 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eustachian tube obstruction
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 43-years-old) as a single 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 COVID vaccine. The patient did not receive any concomitant medication. On 11Apr2021, the patient experienced blockage in the eustatian tube (ear). The patient had no allergies or recent cold which could have caused this and diagnosis was completed by an ENT doctor. The event resulted in doctor or other healthcare professional office or clinic visit. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event blockage in the eustatian tube (ear) which included treatment with flonase (MANUFACTURER UNKNOWN) nasal spray to clear the blockage. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blockage in the eustatian tube (ear) was not resolved at the time of this report. The patient had received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.