chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Whole body ached; pain in my hands; pain in my hands resulting in me not being able to hold a pen for any amount of time; This is a spontaneous report from a non-contactable consumer, the patient. A 28-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 19Apr2021 at 17:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced whole body ache and pain in hands resulting in not being able to hold a pen for any amount of time. Pain in hands relapsed 2 weeks after the vaccine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with paracetamol (TYLENOL) and Naproxen (MANUFACTURER UNKNOWN) twice daily. Since the vaccination the patient had not been tested for COVID-19. On 03May2021, the patient underwent nasal swab, SARS CoV-2 test and the result was negative. The clinical outcome of the events whole body ache and pain in hands resulting in not being able to hold a pen for any amount of time, pain in hands relapsed 2 weeks after the vaccine were resolving 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache; Chills; Fever; Sore throat; Post nasal drip; Coughing; Sneezing; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 07May2021 at 14:15(at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 13Apr2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced headache, chills, fever, sore throat, post nasal drip, coughing and sneezing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, fever, sore throat, post nasal drip, coughing and sneezing were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, Upper-airway cough syndrome
Clinical narrative: Headache; Chills; Fever; Sore throat; Post nasal drip; Coughing; Sneezing; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 07May2021 at 14:15(at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 13Apr2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced headache, chills, fever, sore throat, post nasal drip, coughing and sneezing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, fever, sore throat, post nasal drip, coughing and sneezing were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 03Apr2021, the patient experienced severe rash on ankles. The events did not result in doctor/other health care 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 taken as a result of the event. The clinical outcome of severe rash on ankles was recovering at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 23Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Epistaxis, Fatigue, Pyrexia
Clinical narrative: 3 bad bloody noses 48 hours of vaccination; Extreme tiredness; Loss of appetite; Fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for birth control from an unknown date and unknown if ongoing. The patient previously received amoxicillin/ clavulanate potassium (AUGMENTIN) for unspecified indication from unknown date and experienced drug allergy. On 07May2021 at 19:00, the patient experienced 3 bad bloody noses in 48 hours of vaccination, extreme tiredness, loss of appetite and fever. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme tiredness, loss of appetite, fever and 3 bad bloody noses was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph nodes thought-out mu entire body. Under left and arm are the worst with my stomach area being the second worst area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clot in spline in Jan2021 and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included apixaban (ELIQUIS), metformin (MANUFACTURER UNKNOWN), calcium citrate (CITRACAL), magnesium (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received neomycin (MANUFACTURER UNKNOWN) and oxybutynin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 11:00, the patient experienced swollen lymph nodes thought-out her entire body. Under left and arm was the worst with stomach area being the second worst area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph nodes thought-out her entire body; under left and arm was the worst with stomach area being the second worst area was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: Extreme fatigue; Slight headache (2/10); Painful lymphadenopathy in left axilla; This is a spontaneous report from a contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient 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 07May2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The medical history included GERD (gastroesophageal reflux disease) and 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 COVID-19 vaccine. The concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 12:00, the patient experienced extreme fatigue, slight headache (2/10) and painful lymphadenopathy in left axilla. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, slight headache (2/10) and painful lymphadenopathy in left axilla were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Skin warm
Clinical narrative: Raised rash all over body; Raised rash all over body. Hot and very itchy. Raised rash all over body. Hot and very itchy. This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-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 06May2021 at 07:45 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. On 08May2021, the patient had raised rash all over body, hot and very itchy. 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 raised rash all over body and hot and very itchy was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Oropharyngeal pain, Tonsillitis
Clinical narrative: acute tonsillitis; First symptoms were various lumps on my face and neck, which have not dissipated. The first were by my lips and on my chin, followed by my neck and jawline.; severe sore throat; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 53 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: CW0167) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot Number: ER3737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included colitis ulcerative from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing Controlled , covid-19 from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported; mesalamine (MESALAMINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced first symptoms were various lumps on the face and neck, which have not dissipated. the first were by the lips and on the chin, followed by the neck and jawline. on 28Apr2021 08:00 with outcome of not recovered , severe sore throat causing oropharyngeal pain on 28Apr2021 08:00 with outcome of not recovered, acute tonsillitis on 07May2021 02:30 with outcome of not recovered. Therapeutic measures were taken as a result of severe sore throat and acute tonsillitis by taking Advil cold & sinus and gargling with hot salt water and antibiotics   Follow-up (11May2021): This is a follow-up spontaneous report from a non-contactable consumer. This consumer reported that:  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: My right big toe started curling upward and stuck there for 5 long scary minutes. All my leg muscles are fine, I could feel except my bended right big toe. Never ever I eas able to flex backward only; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267100001) via an unspecified route of administration in the left arm on 03May2021 at 15:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient was healthy. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 07May2021 at 20:30, the patient experienced her right big toe started curling upward and stuck there for 5 long scary minutes, all her leg muscles were fine, could feel except her bended right big toe, never ever was able to flex backward only one big toe, other toes were fine. 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 reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events her right big toe started curling upward and stuck there for 5 long scary minutes. All her leg muscles were fine, she could feel except her bended right big toe. Never ever she was able to flex backward only one big toe, other toes were fine was resolved on an unknown date in May2021.  No follow-up attempts needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Ear pain, Fatigue, Headache
Clinical narrative: Headache; Fever; Sore arm; Tight chest; Swollen lymph nodes; Exhausted; Shortness of breath; Sore throat; Ear ache; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021 at 16:45, the patient experienced headache, fever, sore arm, tight chest, swollen lymph nodes, exhausted, shortness of breath, sore throat and ear ache. 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 headache, fever, sore arm, tight chest, swollen lymph nodes, exhausted, shortness of breath, sore throat and ear ache was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Headache; Fever; Sore arm; Tight chest; Swollen lymph nodes; Exhausted; Shortness of breath; Sore throat; Ear ache; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021 at 16:45, the patient experienced headache, fever, sore arm, tight chest, swollen lymph nodes, exhausted, shortness of breath, sore throat and ear ache. 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 headache, fever, sore arm, tight chest, swollen lymph nodes, exhausted, shortness of breath, sore throat and ear ache was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: After 2 hours of the vaccine, ''my'' fever went up to 102.9 and it kept going up all day until it reached 104./ a fever of 102.3; After 2 weeks exactly of ''my'' 2nd dose, ''I'' feel very fatigue; No energy at all; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 01May2021 at 10:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 01May2021, after 2 hours of the vaccine, the patient experienced fever which went up to 102.9 and it kept going up all day until it reached 104. On an unknown date in May2021, after 2 weeks exactly of her second dose, the patient felt very fatigue, no energy at all, diarrhea and a fever of 102.3. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever went up to 102.9 and it kept going up all day until it reached 104. After 2 weeks exactly of her second dose, the patient felt very fatigue, no energy at all, diarrhea and a fever of 102.3 was unknown at the time of this report  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 85-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 in Feb2021 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included stage 1 prostate cancer. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included unspecified medication for stage 1 prostate cancer from an unknown date and unknow if ongoing. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Feb2021, the patient experienced pain in upper arms. The event pain in upper arms did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event pain in upper arms was unknown 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: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Insomnia
Clinical narrative: Nausea; upset stomach; chills; headache; dizziness; trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 08:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD) with anxiety panic attacks and migraines. 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 taken within two weeks of vaccination included melatonin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), alprazolam (XANAX) and cetirizine hydrochloride (ZYRTEC); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took gabapentin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. On 08May2021 at 02:30, the patient experienced nausea, upset stomach, chills, headache, dizziness and had trouble sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, upset stomach, chills, headache, dizziness and trouble sleeping was resolved on an unknown date in May2021.   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: Nausea
Clinical narrative: Nausea; upset stomach; chills; headache; dizziness; trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 08:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD) with anxiety panic attacks and migraines. 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 taken within two weeks of vaccination included melatonin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), alprazolam (XANAX) and cetirizine hydrochloride (ZYRTEC); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took gabapentin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. On 08May2021 at 02:30, the patient experienced nausea, upset stomach, chills, headache, dizziness and had trouble sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, upset stomach, chills, headache, dizziness and trouble sleeping was resolved on an unknown date in May2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears sometimes louder in the left ear -vaccine in left arm; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 14:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 09Apr2021 at 16:00, the patient experienced ringing in ears sometimes louder in the left ear. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included ENT visit and hearing test was scheduled. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears sometimes louder in the left ear was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021, the patient experienced the loss of taste and smell for 2 days 3 days after receiving the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent COVID-19 test via nasal swab and the result found to be negative. The clinical outcome of the events loss of taste and smell was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Lymphadenopathy, Stomatitis
Clinical narrative: I developed sores on my tongue and in my mouth; I developed sores on my tongue and in my mouth; Swollen and painful glands; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN), mycins and 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 COVID vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 01Apr2021 at 08:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 06May2021, two weeks after the second dose, the patient developed with sores on her tongue and in her mouth, along with swollen and painful glands. 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 sores on her tongue and in her mouth, along with swollen and painful glands were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Migraine, Premenstrual syndrome
Clinical narrative: Major change in the monthly cycle after 25+ years of cycle routine. Major PMS enhancement; Major PMS enhancement.; A normal headache changed to major migraines and cramping for each cycle since the Vaccine.; A normal headache changed to major migraines and cramping for each cycle since the Vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient included was allergic to sulfa drugs. The patient did not take any concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an intramuscular route of administration in the left arm on 04Feb2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Mar2021, the patient experienced major change in the monthly cycle after 25 plus years of cycle routine, major PMS enhancement. A normal headache changed to major migraines and cramping for each cycle since the vaccine. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events major change in the monthly cycle after 25 plus years of cycle routine, major PMS enhancement. A normal headache changed to major migraines and cramping for each cycle since the vaccine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major change in the monthly cycle after 25 plus years of cycle routine, major PMS enhancement was, a normal headache changed to major migraines and cramping for each cycle since the vaccine was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymph node pain, Swelling
Clinical narrative: Left armpit and shoulder swelled significantly; Left armpit and shoulder swelled significantly; Lymph nodes were painful to movement or touch; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history (reported as not applicable (n/a)) and known allergies. 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 medication included unspecified birth control medication (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 23:30, after second dose, the patient's left armpit and shoulder swelled significantly and lymph nodes were painful to movement or touch and reported that took several days for swelling to subside. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left armpit and shoulder swelled significantly and lymph nodes were painful to movement or touch was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling under arm and on my side 24 hours after the injection. Not at injection site, but under the arm and in the armpit; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021, at 11:00 (at the age of 61-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 take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021, at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, 24 hours after the injection, the patient experienced swelling under arm and on her side and not at injection site, but under the arm and in the armpit, with no fever. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 24 hours after the injection, the patient experienced swelling under arm on side and not at injection site, but under the arm and in the armpit was resolved on 27Apr2021, which was lasted for 4days.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Stiffness in my neck on my right side; Unusual sensation start up through my neck/ below my ear in my gland area and into my jaw line/ slightly numb but not totally numb; This is a spontaneous report from a contactable pharmacist, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 27Apr2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid lobectomy on May 2019 as a result of a follicular neoplasm which was identified post op as malignant. 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-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), levonorgestrel (MIRENA) and beta glucan (WELLMUNE); all from an unknown date for unknown indication and unknown if ongoing. On 27Apr2021 at 10:45 (also reported approximately 6 minutes post vaccine), the patient started to notice stiffness in neck on right side, same side as vaccine shot. At first, patient thought it was just from a workout the day previous but then had an unusual sensation start up through her neck, below her ear in her gland area and into her jaw line. The patient reported that she would describe it similar to the sensation post being to the dentist as an anesthetic was wearing off and she experienced slightly numb but not totally numb. The patient stated that, it never got worse over the course of the day and wasn't bad enough to warrant to seek medical treatment. The patient further stated that, it took 48-72 hours to fully clear. 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 stiffness in my neck on my right side and unusual sensation start up through my neck, below the ear in the gland area and into my line, slightly numb but not totally numb were resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: My resting heart rate for years averages 60, but almost immediately after receiving the vaccine, it has steadily increased.  It peaked at 73 and now is coming down.; Also, my right leg is stiff and a bit swollen.; Also, my right leg is stiff and a bit swollen.; This is a spontaneous report from a contactable healthcare professional, the patient. A 67-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 29Apr2021 at 12:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Apr2021, the patient experienced that his resting heart rate for years averaged 60, but almost immediately after receiving the vaccine, it had steadily increased and it peaked at 73 and then it was coming down and also, the patient's right leg was stiff and a bit swollen. On 29Apr2021, the patient underwent lab test which included heart rate test and the result was 73 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events resting heart rate for years averaged 60, but almost immediately after receiving the vaccine, it had steadily increased and it peaked at 73 and now was coming down and right leg was a bit stiff and swollen was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Osteoarthritis, SARS-CoV-2 antibody test
Clinical narrative: Numbness on left side of face; Degenerative arthritis in joints; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: RP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and basal skin cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cefixime (BIOXIN) and levofloxacin (LEVAQUIN) and experienced drug allergy. On 10Apr2021, the patient experienced numbness on left side of face and degenerative arthritis in joints. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Apr2021, the patient underwent antibody test (blood test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event experienced numbness on left side of face and degenerative arthritis in joints was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on an unknown date in May2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, hashimoto's disease and patient was allergic to sulfa (sulfonamide). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine 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: EW0161) via an unspecified route of administration in the right arm on an unknown date in 2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.  On 08May2021 at 03:00 the patient experienced fever highest 101.7, vomiting, muscle aches, cramping, headache, weak and tired. On same day the patient underwent body temperature and the result was 101.7 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever highest 101.7, vomiting, muscle aches, cramping, headache, weak and tired were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.