chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Headache, Pain
Clinical narrative: tested positive for the COVID19; tested positive for the COVID19; body ache; headache; chills; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A male patient of an unknown age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch no/Lot Number/expiration date: not reported) via unknown route of administration on an unknown date in 2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient was fine until the 4th day of vaccination. On an unknown date in Sep2021, when he woke up and experienced body ache, headache, and chills. Patient also tested positive for the COVID-19. Patient wanted to know if it was common to not feel side effects until the 4th day and if it was from the vaccine, he got COVID-19 infection, also wanted to know how long he should quarantine for COVID-19 infection. On an unknown date in Sep2021, the patient underwent lab tests and procedures which included Sars-Cov2-test results positive for Covid-19. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for the COVID19; tested positive for the COVID19; body ache; headache; chills; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A male patient of an unknown age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch no/Lot Number/expiration date: not reported) via unknown route of administration on an unknown date in 2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient was fine until the 4th day of vaccination. On an unknown date in Sep2021, when he woke up and experienced body ache, headache, and chills. Patient also tested positive for the COVID-19. Patient wanted to know if it was common to not feel side effects until the 4th day and if it was from the vaccine, he got COVID-19 infection, also wanted to know how long he should quarantine for COVID-19 infection. On an unknown date in Sep2021, the patient underwent lab tests and procedures which included Sars-Cov2-test results positive for Covid-19. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got his first dose of the Pfizer BioNTech Covid-19 vaccine on 19Aug2021. He got diagnosed with Covid after; got his first dose of the Pfizer BioNTech Covid-19 vaccine on 19AUG2021.  He got diagnosed with Covid after; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received bnt162b2(COMIRNATY, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 19Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got diagnosed with Covid after his first dose of the Pfizer BioNTech Covid-19 vaccine on an unknown date in 2021, and was asking how long he had to wait to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date in 2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Burning sensation, Cerebrovascular accident, Contusion, Discomfort
Clinical narrative: Felt like having a stroke; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; Feet and joint problem. Burning on her feet, flaring joints and toes, a lot of discomfort; She had feet and joint problem; a lot of discomfort; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 31Aug2021 as dose 2, single for COVID-19 immunization. The medical history of the patient included right knee and left ankle reconstruction (partial allograft) in the past 13 months, 2 strokes in the past, overall 17 surgeries over the last 20 years, history of PTSD with ongoing therapy and was immunocompromised. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jul2021 as dose 1, single for COVID-19 immunization. On an unknown date the patient experienced rash on the injection site. It was described as rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color. She had feet and joint problem. Burning on her feet, flaring joints and toes, a lot of discomfort and felt like having a stroke. Caller even mentioned asking for her insurance company for a home support due to the event. Caller also reported that she came to the pharmacy she had her shot and they said that they did not find anything similar to the event she reported. Caller wanted to know on how she can check if she is allergic to the vaccine. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site rash
Clinical narrative: Felt like having a stroke; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; Feet and joint problem. Burning on her feet, flaring joints and toes, a lot of discomfort; She had feet and joint problem; a lot of discomfort; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 31Aug2021 as dose 2, single for COVID-19 immunization. The medical history of the patient included right knee and left ankle reconstruction (partial allograft) in the past 13 months, 2 strokes in the past, overall 17 surgeries over the last 20 years, history of PTSD with ongoing therapy and was immunocompromised. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jul2021 as dose 1, single for COVID-19 immunization. On an unknown date the patient experienced rash on the injection site. It was described as rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color. She had feet and joint problem. Burning on her feet, flaring joints and toes, a lot of discomfort and felt like having a stroke. Caller even mentioned asking for her insurance company for a home support due to the event. Caller also reported that she came to the pharmacy she had her shot and they said that they did not find anything similar to the event she reported. Caller wanted to know on how she can check if she is allergic to the vaccine. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Wrong technique in product usage process
Clinical narrative: red bumps on both of their arms where the injection site was; the lady who administered the vaccine did not go deeper in injecting the vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation; Solution for injection), via an unspecified route of administration, administered in unspecified Arm on 01Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the lady who administered the vaccine did not go deeper in injecting the vaccine and could have been an error on administration on 01Sep2021. Since today, 02Sep2021, the patient experiencing really red bumps on both of their arms where the injection site was. The outcome of event red bumps on both of their arms reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report received from a contactable consumer(patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, at the left  arm, on 21Aug2021 11:00, at dose 1, single for covid-19 immunisation in a pharmacy or drug store. Relevant medical history included blood pressure increased. Concomitant medications in two weeks include gabapentin and unspecified BP medicine. The patient previously took codeine and experienced allergy. The patient did not have other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. In Aug2021 at 03:00, also reported as 01Aug2021, the patient experienced Diarrhea - loose & watery. Therapeutic measure taken in response to the event included administration of imodium. The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Typical muscle aches; slight fever; chills; headache; Swollen painful lymph node in the left armpit.; Swollen painful lymph node in the left armpit.; This is a spontaneous report received from a contactable other health care professional(patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number: FC3182;expiry date was not reported) via an unspecified route of administration, at the left  arm, on 31Aug2021 13:00, at age of 37-year-old ,at dose 2, single for covid-19 immunisation in a pharmacy or drug store. Relevant medical history includes sulfa allergy. Concomitant medications in two weeks include multivitamin (unspecified), fish oil (OMEGA 3), and drospirenone, ethinylestradiol betadexclathrate (YAZ).Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number FA7484, expiry date not reported) via an unspecified route of administration, at the left  arm, on 03Aug2021,13:00, at age of 37-year-old at dose 1, single for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 01Sep2021, the patient experienced typical muscle aches, slight fever, chills, headache and swollen painful lymph node in the left armpit. The patient did not receive treatment in response to the events. The outcome of the events was recovered on an unspecified date in Sep2021..
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Typical muscle aches; slight fever; chills; headache; Swollen painful lymph node in the left armpit.; Swollen painful lymph node in the left armpit.; This is a spontaneous report received from a contactable other health care professional(patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number: FC3182;expiry date was not reported) via an unspecified route of administration, at the left  arm, on 31Aug2021 13:00, at age of 37-year-old ,at dose 2, single for covid-19 immunisation in a pharmacy or drug store. Relevant medical history includes sulfa allergy. Concomitant medications in two weeks include multivitamin (unspecified), fish oil (OMEGA 3), and drospirenone, ethinylestradiol betadexclathrate (YAZ).Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number FA7484, expiry date not reported) via an unspecified route of administration, at the left  arm, on 03Aug2021,13:00, at age of 37-year-old at dose 1, single for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 01Sep2021, the patient experienced typical muscle aches, slight fever, chills, headache and swollen painful lymph node in the left armpit. The patient did not receive treatment in response to the events. The outcome of the events was recovered on an unspecified date in Sep2021..
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Contusion, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Fever; Severe pain in arm pit with swelling in lymph nodes; Severe pain in arm pit with swelling in lymph nodes; Bruise; Swelling and heat from the injection site; Swelling and heat from the injection site; Tired; Joint pain; Dose 1: 29Jan2021; Dose 2: 01Sep2021; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 01Sep2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was 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-19 vaccine. Concomitant medications included levocetirizine dihydrochloride (XYZAL), bupropion hydrochloride (WELLBUTRIN), citalopram (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all 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: EL9262) via an unspecified route of administration in the left arm on 29Jan2021 at 08:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 02Sep2021 at 08:00, the patient experienced fever, severe pain in arm pit with swelling in lymph nodes, bruise, swelling and heat from the injection site, joint pain and was tired. 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 fever, severe pain in arm pit with swelling in lymph nodes, bruise, swelling and heat from the injection site, tired and joint pain were resolving at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fever; Severe pain in arm pit with swelling in lymph nodes; Severe pain in arm pit with swelling in lymph nodes; Bruise; Swelling and heat from the injection site; Swelling and heat from the injection site; Tired; Joint pain; Dose 1: 29Jan2021; Dose 2: 01Sep2021; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 01Sep2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was 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-19 vaccine. Concomitant medications included levocetirizine dihydrochloride (XYZAL), bupropion hydrochloride (WELLBUTRIN), citalopram (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all 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: EL9262) via an unspecified route of administration in the left arm on 29Jan2021 at 08:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 02Sep2021 at 08:00, the patient experienced fever, severe pain in arm pit with swelling in lymph nodes, bruise, swelling and heat from the injection site, joint pain and was tired. 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 fever, severe pain in arm pit with swelling in lymph nodes, bruise, swelling and heat from the injection site, tired and joint pain were resolving at the time of this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy skin without a rash on arms, hands and legs; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 24Aug2021 at 10:30 (at the age of 62-years-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 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 02Sep2021 at 11:00, the patient experienced itchy skin without a rash on her arms, hands, and legs. On 05Sep2021 (at the time of the report), the patient was still having it. 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 itchy skin without a rash on arms, hands and legs was not resolved at the time of this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus got considerably worse after the second dose; This is a spontaneous report from a contactable healthcare professional, the patient. A 64-year-old non-pregnant female 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 30Apr2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), statin (as reported), allergy to pen (pencillin) and sulfa and ongoing tinnitus. 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: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 at 09:00, as a single dose for COVID-19 immunisation.  The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy.  On an unknown date in Apr2021, the patient experienced tinnitus which got considerably worse after the second dose. The patient went to primary and ear nose throat (ENT) and mentioned about it and primary thought could be an effect from vaccine. ENT said ears looked fine and suggested hearing test however the patient refused at that time. The ringing in ears had not lessened any and was very bothersome. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus got considerably worse after the second dose was not resolved at the time of the report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Periods of fluttering/rapid heart beat; Periods of fluttering/rapid heart beat; Periods of shortness of breath; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in Arm Left on 26Aug2021 12:00 (at the age of 33-year-old) (Batch/Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunization . The patient's medical history and allergies were not reported. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and cetirizine hydrochloride (ZYRTEC). The patient experienced periods of fluttering/rapid heart beat and periods of shortness of breath on 29Aug2021, with outcome of unknown. Therapeutic medications remained unspecified. The patient underwent lab test included Heart rate showed rapid. It was reported that no any other vaccine was administrated in four weeks, the patient didn't have COVID prior vaccination or test post vaccination. The patient was nonpregnant. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Headache
Clinical narrative: brain bleed; some pain in my head; This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 Immunization. Patient had an ER visit about a week ago in Aug and they said there was some sort of brain bleed or something. Patient had some issues like in Jul some pain in his/her head but then patient went to the ER like in Aug.This is all in 4 months of me having the last vaccination. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Vision blurred
Clinical narrative: Blurred vision; Clogging of both ears; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Sep2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high a1c, blood pressure (BP) and high cholesterol. 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. Concomitant medications were not reported. On 05Sep2021 at 13:30, the patient experienced blurred vision and clogging of both ears 24-48 hours after the shot. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events blurred vision and clogging of both ears was not resolved at the time of this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Lung disorder, Pulmonary pain, Total lung capacity decreased
Clinical narrative: Shortness of lung capacity; Lungs and chest hurt like patient at high altitude and trying to run a marathon / chest and lungs hurt if patient move to fast; Lungs and chest hurt like patient at high altitude and trying to run a marathon / chest and lungs hurt if patient move to fast; feels like asthma; feels like chemical contamination in my lungs; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 27Aug2021 at 17:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included too many injuries to be listed. The patient was allergic to diesel fuel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 07Aug2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 at 10:00, the patient experienced shortness of lung capacity, the patient could breathe fine but his lungs and chest hurt like he was at high altitude and trying to run a marathon. The chest and lungs hurt if the patient moved too fast. The patient was an athlete and it felt like asthma and chemical contamination in his lungs at the same time. 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 shortness of lung capacity, chest and lungs hurt and felt like asthma and chemical contamination in lungs were not resolved at the time of this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform
Clinical narrative: Pimple like rash all over body (was not present on feet, hands, ears, or lips), it was not itchy; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 02Sep2021 at 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish, bee venom and mild latex. 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 medication included black elderberry gummies (NATURE'S TRUTH) for an unspecified indication from an unknown date and unknown if ongoing. On 03Sep2021 at 07:00, the patient experienced pimple like rash all over her body (was not present on feet, hands, ears, or lips) and it was not itchy. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pimple like rash all over body (was not present on feet, hands, ears, or lips), it was not itchy was resolving at the time of the report.    No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site was swollen; Injection site was swollen and painful; Headache; Foggy brain; After 9 days joints still hurt, specifically the injection side; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 27Aug2021 at 20:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, COVID-19 and allergy to sulfa medications. 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 levothyroxine (MANUFACTURER UNKNOWN), colecalciferol (D-3), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (B12) and venlafaxine hydrochloride (EFFEXOR); all for unknown indications from unknown dates and unknown if ongoing. On 29Aug2021 at 00:00, the patient's injection site was swollen and painful, headache, foggy brain and after 9 days the joints still hurt at the time of this report, specifically the injection side. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events injection site was swollen and painful, headache and foggy brain were unknown, while that of joints still hurt, specifically the injection side was not recovered at the time of this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Extremely shaky left arm.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 16Aug2021 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. The patient had no 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. Concomitant medications were not reported. On 19Aug2021, the patient experienced extremely shaky left arm and this effect was not present in right arm. On an unknown date in 2021, the patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) and the result was unknown. Since the vaccination the patient had been tested for COVID-19. 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 event. The clinical outcome of the event extremely shaky left arm was not recovered at the time of report.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Oropharyngeal pain
Clinical narrative: Mild/uncomfortable sore/dry throat; Mild/uncomfortable sore/dry throat; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 24Aug2021 at 15:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune atrophic gastritis and rheumatoid arthritis. The patient had known allergy to pineapple. 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 SKIN BRIGHT, two gummies daily, from an unknown date for an unknown indication and unknown if ongoing. On 26Aug2021 at 08:00, the patient experienced mild/uncomfortable sore and dry throat. 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 mild/uncomfortable sore and dry throat were resolving at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: Oral lesions; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 19Aug2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, hypothyroidism and hiatal hernia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levetiracetam (KEPPRA), levothyroxine sodium (SYNTHROID) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown dates for an unknown indications and unknown if ongoing. On 03Sep2021, the patient experienced oral lesions. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event oral lesions was not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Frequent bowel movements, Maternal exposure during pregnancy
Clinical narrative: Every bowel movement has been that of diarrhea and numerous in times of day; Persistent diarrhea; Weakness; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Aug2021 at 19:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's last menstrual period was on 21Jul2021. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 25Aug2021 at 17:00, the patient experienced persistent diarrhea and weakness from the event date listed to current time of report. Every bowel movement had been that of diarrhea and numerous in times of day. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent diarrhea, weakness and every bowel movement has been that of diarrhea and numerous in times of day was not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Extremely painful injection site for 48hours with swelling; Extremely painful injection site for 48 hours with swelling; Very tired; Slight headache; Mild fever; Nauseous for 48 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 01Sep2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications were not reported. On 01Sep2021, the patient developed extremely painful injection site for 48 hours with swelling. The patient was very tired, had slight headache and mild fever. The patient was feeling nauseous for 48 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely painful injection site for 48 hours and nauseous for 48 hours was resolved on 03Sep2021; while that of the events swelling at the injection site, very tired, slight headache, mild fever was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Extremely painful injection site for 48hours with swelling; Extremely painful injection site for 48 hours with swelling; Very tired; Slight headache; Mild fever; Nauseous for 48 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 01Sep2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications were not reported. On 01Sep2021, the patient developed extremely painful injection site for 48 hours with swelling. The patient was very tired, had slight headache and mild fever. The patient was feeling nauseous for 48 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely painful injection site for 48 hours and nauseous for 48 hours was resolved on 03Sep2021; while that of the events swelling at the injection site, very tired, slight headache, mild fever was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node on left side where injection was given near neck and collar bone with some soreness; Swollen lymph node on left side where injection was given near neck and collar bone with some soreness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8735) via an unspecified route of administration on 02Sep2021 at 15:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. 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. Concomitant medications included nifedipine (PROCARDIA) and vitamin d (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FD8448) via an unspecified route of administration on 11Aug2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 04Sep2021 at 09:45, the patient experienced swollen lymph node on left side where injection was given near neck and collar bone with some soreness. The adverse events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node on left side where injection was given near neck and collar bone with some soreness was unknown at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Swollen right eye lid; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 02Sep2021 at 15:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no 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 medications included fluticasone propionate (FLONASE) and unspecified iron pills; all from unknown dates for unknown indications and unknown if ongoing. On 02Sep2021 at 17:00, the patient experienced swollen right eye lid. 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 event swollen eyelid was resolving at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Bald spot on head/lost hair; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 31Aug2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included cinnamon and penicillin allergy (reported as penicillin family). 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 birth control and unspecified vitamins; both for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 09:00, the patient had bald spot on her head and lost hair. 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 event bald spot on head/lost hair was not resolved at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Unilateral axillary lymphadenopathy; This is a spontaneous report from a contactable physician, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 02Sep2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Aug2021, the patient underwent polymerase chain reaction (PCR) test via nasal swab and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) and unspecified oral contraceptive pill (OCP); both for unknown indications from unknown dates and unknown if ongoing. On 03Sep2021 at 15:00, the patient experienced unilateral axillary lymphadenopathy. 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 (reported as yes). Therapeutic measures were not taken as a result of the event. The clinical outcome of the event unilateral axillary lymphadenopathy was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Missed period after getting vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 13-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 14Aug2021 at 00:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 14Aug2021, the patient missed period after getting vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. On 03Sep2021, the patient underwent COVID-19 rapid test via nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event missed period after getting vaccination 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.