chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Pain in both sides of my neck muscles up the back of my head; Temporal headache; Nausea; Vomiting; Increased tiredness; Left arm soreness; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183; Lot number also reported as FF8839) via an intramuscular route of administration in the left arm on 09Oct2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included DM type 2, palpitations, blood pressure (BP) issues, fibromyalgia, hypothyroid, seasonal allergies, gastroesophageal reflux disease (GERD), depression, anxiety and allergy to sulfa drugs (reported as sulf drugs). The patient was diagnosed with COVID-19, prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously took trimethobenzamide hydrochloride (TIGAN) and milnacipran hydrochloride (SAVELLA) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC8839) via an intramuscular route of administration in the left arm on 18Sep2021 at 13:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. On 09Oct2021 at 20:30, the patient experienced pain in both sides of the neck muscles, up the back of the head, temporal headache, nausea, vomiting, increased tiredness and left arm soreness. 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 pain in both sides of the neck muscles, up the back of the head, temporal headache, nausea, vomiting, increased tiredness and left arm soreness were resolving at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pain in both sides of my neck muscles up the back of my head; Temporal headache; Nausea; Vomiting; Increased tiredness; Left arm soreness; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183; Lot number also reported as FF8839) via an intramuscular route of administration in the left arm on 09Oct2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included DM type 2, palpitations, blood pressure (BP) issues, fibromyalgia, hypothyroid, seasonal allergies, gastroesophageal reflux disease (GERD), depression, anxiety and allergy to sulfa drugs (reported as sulf drugs). The patient was diagnosed with COVID-19, prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously took trimethobenzamide hydrochloride (TIGAN) and milnacipran hydrochloride (SAVELLA) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC8839) via an intramuscular route of administration in the left arm on 18Sep2021 at 13:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. On 09Oct2021 at 20:30, the patient experienced pain in both sides of the neck muscles, up the back of the head, temporal headache, nausea, vomiting, increased tiredness and left arm soreness. 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 pain in both sides of the neck muscles, up the back of the head, temporal headache, nausea, vomiting, increased tiredness and left arm soreness were resolving at the time of this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Oral herpes
Clinical narrative: Cold sore (mouth) within one week of having each of the three Pfizer vaccines.; Dose 3; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the right arm on 06Oct2021 at 10:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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-19 vaccine. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN7534) via an unspecified route of administration in the right arm on 18Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 25Feb2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation.  On 10Oct2021, the patient experienced cold sore (mouth) within one week of having each of the three Pfizer vaccines.  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 cold sore (mouth) within one week of having each of the three Pfizer vaccines was not resolved at the time of this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Peripheral swelling
Clinical narrative: Pain under the left arm where shot was given; swelling under the left arm where shot was given; Patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 14Oct2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and it was reported that the patient was not aware of the 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 quinapril (MANUFACTURER UNKNOWN) and rosuvastatin calcium (CRESTOR); both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 19Feb2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021, the patient experienced pain and swelling under the left arm where shot was given. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and swelling under the left arm where shot was given was not resolved at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: flare of her psoriasis/ flare up in her psoriasis/ the patient stated her psoriasis it was mainly on the palms of her hands, but also under her arms, scalp, neck and hair line; This is a spontaneous report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from regulatory authority (manufacturer control number: US-AMGEN-USASL2021156413), license party for etanercept (ENBREL).  A 61-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unknown route of administration on an unspecified date in Sep2021 (at the age of 61-year-old) as dose number unknown (booster), single for covid-19 immunization and also received influenza vaccine (FLU VACCINE VII) via an unspecified route of administration on an unspecified date in Sep2021 (Batch/Lot number was not reported) at unspecified dose for influenza. Patient's relevant medical history included ongoing psoriatic arthritis and ongoing plaque psoriasis. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient had a flare of her psoriasis symptoms and experienced flare of her psoriasis/flare up in her psoriasis. The patient stated her psoriasis it was mainly on the palms of her hands, but also under her arms, scalp, neck and hair line. The patient did use an unspecified steroid cream for a couple of days as treatment. Outcome of the event was unknown.  Regulatory authority comment: This individual case report does not change the safety profile of the product.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Immunisation, Pharyngeal swelling, Swollen tongue
Clinical narrative: Dose 3 received; Swelling of throat; swelling of tongue; Swelling of eyes; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Oct2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 18Oct2021, the patient experienced swelling of throat, tongue and eyes. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included unspecified treatment. The clinical outcome of the events swelling of throat, tongue and eyes was unknown at the time of this report. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chills, Muscle spasms
Clinical narrative: Heart flutters; chest muscles cramping with chills; chills; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm on an unspecified date single dose for covid-19 immunization at 70-year-old. Medical history included inflammatory bowel disease (IBS), osteoporosis, fibromyalgia. No known allergies or covid prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm for covid-19 immunization at 70-year-old. The patient experienced heart flutters and chest muscles cramping with chills on 14Oct2021 04:00 with outcome of recovered, no treatment received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Chills, Headache
Clinical narrative: recurring chest pain the right side of the chest for weeks sharp pain almost like having a heart attack; Fever; headaches; chills; recurring chest pain the right side of the chest for weeks sharp pain almost like having a heart attack; Almost like vaccine raised blood pressure in body; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Oct2021 at 11:00 (Batch/Lot Number: FF2588) (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. The patient has no medical history and no concomitant medications. The patient had no COVID-19 prior to vaccination. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: FF2588), administered in the right arm on 10Sep2021 at 09:00 (at the age of 37-years-old) for COVID-19 immunisation. On 02Oct2021 at 06:00, the patient experienced fever, headaches, chills, recurring chest pain the right side of the chest for weeks sharp pain almost like having a heart attack. The chest pain comes and goes. Almost like the vaccine raised blood pressure in body. Chest pain still occurs at time of this report. The patient did not received treatment for the events. The events resulted in physician office visit. The patient had not tested for COVID-19 post vaccination. Outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pyrexia
Clinical narrative: recurring chest pain the right side of the chest for weeks sharp pain almost like having a heart attack; Fever; headaches; chills; recurring chest pain the right side of the chest for weeks sharp pain almost like having a heart attack; Almost like vaccine raised blood pressure in body; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Oct2021 at 11:00 (Batch/Lot Number: FF2588) (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. The patient has no medical history and no concomitant medications. The patient had no COVID-19 prior to vaccination. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: FF2588), administered in the right arm on 10Sep2021 at 09:00 (at the age of 37-years-old) for COVID-19 immunisation. On 02Oct2021 at 06:00, the patient experienced fever, headaches, chills, recurring chest pain the right side of the chest for weeks sharp pain almost like having a heart attack. The chest pain comes and goes. Almost like the vaccine raised blood pressure in body. Chest pain still occurs at time of this report. The patient did not received treatment for the events. The events resulted in physician office visit. The patient had not tested for COVID-19 post vaccination. Outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Cardiac fibrillation, Immunisation, Off label use
Clinical narrative: Feels like heart is occasionally fibrillating; High fever. 101 and above; Stomach problems; Of course painful arm. But that happened every time.; vaccine was cloudy pinkish in color; bnt162b2 on 19Oct2021 12:30 as third booster dose; bnt162b2 on 19Oct2021 12:30 as third booster dose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Right on 19Oct2021 12:30 (Lot Number: Ff2589) at the age of 65 years old, as third booster dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. The patient previously received bnt162b2, administered in Arm Right on 06Mar2021 (Lot Number: EN6201) at the age of 64 years old, as first dose, single; and on 27Mar2021 14:00 (Lot Number: En6208) at the age of 64 years old, as second dose, single for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient had no known allergies. It was reported that vaccine was cloudy pinkish in color on 19Oct2021 12:30. On 19Oct2021 16:00, the patient experienced high fever: 101 and above, stomach problems, feels like heart is occasionally fibrillating, of course painful arm but that happened every time. The patient did not receive any treatment for all the events. Outcome of the events feels like heart is occasionally fibrillating, high fever 101 and above, stomach problems and painful arm was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Pyrexia
Clinical narrative: Feels like heart is occasionally fibrillating; High fever. 101 and above; Stomach problems; Of course painful arm. But that happened every time.; vaccine was cloudy pinkish in color; bnt162b2 on 19Oct2021 12:30 as third booster dose; bnt162b2 on 19Oct2021 12:30 as third booster dose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Right on 19Oct2021 12:30 (Lot Number: Ff2589) at the age of 65 years old, as third booster dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. The patient previously received bnt162b2, administered in Arm Right on 06Mar2021 (Lot Number: EN6201) at the age of 64 years old, as first dose, single; and on 27Mar2021 14:00 (Lot Number: En6208) at the age of 64 years old, as second dose, single for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient had no known allergies. It was reported that vaccine was cloudy pinkish in color on 19Oct2021 12:30. On 19Oct2021 16:00, the patient experienced high fever: 101 and above, stomach problems, feels like heart is occasionally fibrillating, of course painful arm but that happened every time. The patient did not receive any treatment for all the events. Outcome of the events feels like heart is occasionally fibrillating, high fever 101 and above, stomach problems and painful arm was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Seizure, Syncope
Clinical narrative: fainted; seizure; lost consciousness; pain around injection site; Cold sweat; Dizziness; everything was blurry; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for covid-19 immunization at 32-year-old on 18Oct2021. Medical history included seasonal allergy. No seizure, no epilepsy no history of that whatsoever. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm for covid-19 immunization at 32-year-old on 27Sep2021 and had fainted. The patient had seizure, so essentially it started as pretty typical, pain around the injection site but then cold sweats, dizziness and then he lost consciousness essentially and it was like sensation of not being in control, everything was blurry, he had no control of any of his bodily functions essentially and then after he didn't know a minute or so, he regained consciousness. The patient reported didn't just faint he had a full long seizure. No treatment or lab test. Outcome of events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101407923 same patient and drug, different event separated in time
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: fainted; seizure; lost consciousness; pain around injection site; Cold sweat; Dizziness; everything was blurry; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for covid-19 immunization at 32-year-old on 18Oct2021. Medical history included seasonal allergy. No seizure, no epilepsy no history of that whatsoever. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm for covid-19 immunization at 32-year-old on 27Sep2021 and had fainted. The patient had seizure, so essentially it started as pretty typical, pain around the injection site but then cold sweats, dizziness and then he lost consciousness essentially and it was like sensation of not being in control, everything was blurry, he had no control of any of his bodily functions essentially and then after he didn't know a minute or so, he regained consciousness. The patient reported didn't just faint he had a full long seizure. No treatment or lab test. Outcome of events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101407923 same patient and drug, different event separated in time
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Parosmia, Tinnitus
Clinical narrative: Ears ringing; Ears burning; Facial burning, extremity burning; Phantom smells - Cigarette Smoke; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 12Mar2021 18:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ears ringing, ears burning, facial burning, extremity burning, and phantom smells - cigarette smoke on 13Mar2021. Events resulted to treatment with Prednisone, Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of events was not recovered. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ER8T32, Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 02Apr2021 18:00 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: the patient's diagnosis is Polymyalgia rheumatica; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 Immunization. The patient had inflammation after receiving Pfizer COVID vaccine and is being treated by a rheumatologist. The reporter said the patient's diagnosis is Polymyalgia rheumatica. The outcome of the event was not recovered. Therapeutic measures were taken as a result of event.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. An elderly patient (reported as age range of 81 and 90 years old) of an unspecified gender received the second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single, the first dose via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer reported that her mom who was 88 years old, and her friends got the 2 shots in Feb2021 and somebody (patient) in that age group was known to have gotten COVID-19 on an unspecified date. The patient's outcome was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Computerised tomogram, Electrocardiogram, Myocarditis, Pain
Clinical narrative: inflammation of heart muscles/tissues; pain around heart; pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via unspecified route on 03Apr2021 single dose for covid-19 immunization at 49-year-old. Medical history included the patient was taken to ER for stroke in Jun2019. No concomitant medications. The patient previously received varenicline tartrate (CHANTIX) for quit smoking from 03Nov2019 and had stroke; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization in Mar2021 at 49-year-old. 09Aug2021, the patient had an ER visit due to pain in chest-CT Scan, EKG, Labs etc. Now on medications for inflammation of heart muscles/tissues, caused admission to hospital. Pain appeared several times throughout the day still. The patient couldn't do simple things without pain around heart. Outcome of the event inflammation of heart muscles/tissues was not resolved, outcome of the other event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: A seizure activity/Shaking uncontrollably that happened on and off; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient (age at vaccination: 33-year-old) received bnt162b2 (COMIRNATY, lot 301358A), via an unspecified route of administration in right arm, on 29Sep2021 (also reported as 01Oct2021) around like 6-7 pm as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included allergy to penicillin; diabetes in family history. There were no concomitant medications. The patient had the dose 1 of the Pfizer Covid vaccine last 29Sep2021 and 3 days later (01Oct2021), he started shaking uncontrollably that happened on and off and was told that this was a seizure activity. He felt like it was worsening because he doesn't know what was going on. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure abnormal, Blood pressure measurement, Heart rate irregular, Investigation
Clinical narrative: Heartbeats irregular; I took an extra blood pressure medication/it's 'like' my blood pressure; This is a spontaneous report from a contactable consumer (patient). A 67 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 10Feb2021 (Batch/Lot Number: EL9265) as 66 years old as DOSE 1, SINGLE, and booster dose via an unspecified route of administration, administered in left arm on 19Oct2021 at 11:00 (Batch/Lot Number: EW0181) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; and lisinopril via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 5 mg (took 10 mg this morning) for blood pressure. Medical history included high blood pressure. The patient's concomitant medications were not reported. No prior vaccination (within 4 weeks). The first vaccination was 10Feb2021 and her 2nd vaccine was in Mar2021 (in left arm, lot/batch number: EN6202). The patient had her COVID vaccine booster, yesterday (19Oct2021) and it's 'like' her blood pressure (Further clarification Unknown) and she had heart beat. The patient clarified she had high blood pressure (Intent: Medical Condition) she take a small 5mg of Lisinopril to control it and its been under control and she took her blood pressure before she went yesterday and it was normal. She got it at 11 clock yesterday AM and she was still experiencing all of those symptoms today (20Oct2021) she just wanted to let you know and she did phone her doctor she seen her doctor 12:30. She was just concerned about her irregular heartbeat. Laboratory test included patient had a comprehensive lab test recently and everything was normal. Her first vaccination she didn't reported but she had all these symptoms as well. Treatment included patient took 2 Ibuprofen (treatment) and she took this morning (20Oct2021) when she wake up she took an extra blood pressure medication, she took extra 5mg this morning so she took 10 mg this morning of Lisinopril. The patient underwent lab tests and procedures which included blood pressure measurement: abnormal, blood pressure measurement: normal, Heartbeats: irregular, comprehensive lab test: normal all on an unspecified date. The action taken in response to the events for lisinopril was dose increased. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Interchange of vaccine products, Off label use
Clinical narrative: HCP said she already administered the Pfizer-BioNTech Covid-19 Vaccine to this patient before she even knew she already received the Cansino.; HCP said she already administered the Pfizer-BioNTech Covid-19 Vaccine to this patient before she even knew she already received the Cansino.; has difficulty ambulating or walking; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable nurse reported for female patient. A 72-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, FH8020; Expiration Date: Feb2022) via an unspecified route of administration, administered in arm left on 19Oct2021 (age at vaccination: 72-year-old) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's medical history included bionic knee which was part of the alteration in the way she walks. The patient's concomitant medications were not reported. The patient previously received cansino COVID-19 vaccine via an unspecified route of administration, on unspecified date as dose 1, single for covid-19 immunisation. The patient received Cansino However, reporter said she already administered the Pfizer-BioNTech Covid-19 Vaccine On 19Oct2021, to this patient before she even knew she already received the Cansino. Reporter said this patient had difficulty ambulating or walking, and said she was unsure about Cansino's efficacy. Reporter said that patient heard of symptoms of COVID toe or inflamed toe associated from the vaccine. Reporter doesn't later provide any further details for this. Reporter wants to know if it was okay that she gave the Pfizer-BioNTech Covid-19 Vaccine to this patient considering she already received a different Covid-19 Vaccine. Reporter says patient didn't know about Cansino being a COVID vaccine until then, she didn't know the patient had been vaccinated prior, then realized it after she had already been vaccinated with the Pfizer-BioNTech COVID-19 vaccine. Reporter clarifies that the patient had just received the Pfizer-BioNTech COVID-19 vaccine yesterday. She says she wouldn't have vaccinated the patient with that dose if she knew ahead of time, but she didn't know the names of all of the COVID vaccines. patient doesn't know about the Cansino vaccine, she was trying to be cautious. The outcome of events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster, SARS-CoV-2 test
Clinical narrative: Herpes zoster with ophthalmic complication, unspecified herpes zoster eye disease. Shingles along V1 nerve; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 14Mar2021 08:15 (Lot Number: EN6208) as dose 1, single (at age of 37-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included asthma. No known allergies. There were no concomitant medications. On 17Mar2021 20:30, the patient experienced Herpes zoster with ophthalmic complication, unspecified herpes zoster eye disease. Shingles along V1 nerve. The event required treatment included Valtrex, Prenisolone, Acyclovir, Durezol. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid test (Rapid Antigen Test): negative nasal swab on 24Jun2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious. Outcome of the event was recovered with sequelae in 2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Pruritus, Throat irritation
Clinical narrative: Itching all over my body; coughing like almost asthma attack like; Itching throat; tight chest; asthma attack like; This is a spontaneous report from a contactable consumer.  A 34-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm Right on 20Oct2021 16:15 (Batch/Lot Number: Ff2593) as single dose for covid-19 immunisation.  Medical history included fibromyalgia, arthritis, chronic migraine, known allergies to Iodine, shellfish, latex, mango, fennel, adhesives. Concomitant medications included Vitamins, tramadol; cetirizine hydrochloride (ZYRTEC R); tizanidine; iron and paracetamol (TYLENOL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Oct2021 16:45  the patient experienced itching all over her body, coughing like almost asthma attack like, Itching throat , tight chest. The events resulted in Emergency room/department or urgent care. Treatment received included Benadryl. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Lymphadenopathy, Muscular weakness, Myalgia
Clinical narrative: intense vomiting; muscle aches; no ability to get up and stand on her legs, legs were too weak; her legs were too weak; Headache; Enlargement of lymph nodes; This is a spontaneous report from Pfizer-sponsored program.  A contactable physician (patient) reported that a 70-year-old female patient (age at vaccination: 70-year-old) received bnt162b2 (BNT162B2, lot EW0150) intramuscularly in left deltoid on 16Oct2021 14:00 as dose 3 (booster), single, for Covid-19 immunisation. Medical history included blood pressure high hypertension. She had her dose 1, single of Pfizer Covid-19 vaccine BNT162B2 (lot EM9809; expiry date unknown) via unknown route on 20Feb2021 and had her dose 2, single of Pfizer Covid-19 vaccine BNT162B2 (lot AM6306; expiry date: unknown) via unknown route on 12Mar2021 at age of 70-year-old. Concomitant medication included labetalol for blood pressure high. The patient received her booster on 16Oct2021 and within 12 hours, she was unable to get up and stand on her legs/legs were too weak, had intense vomiting, muscle aches and also had a headache, all were reported as serious disabling. On Oct2021, she reported of enlargement of lymphnodes (also reported as same adverse events happened after she took her second shot). The outcome of vomiting was recovered on 17Oct2021; for other events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events vomiting, myalgia, muscular weakness, dysstasia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: intense vomiting; muscle aches; no ability to get up and stand on her legs, legs were too weak; her legs were too weak; Headache; Enlargement of lymph nodes; This is a spontaneous report from Pfizer-sponsored program.  A contactable physician (patient) reported that a 70-year-old female patient (age at vaccination: 70-year-old) received bnt162b2 (BNT162B2, lot EW0150) intramuscularly in left deltoid on 16Oct2021 14:00 as dose 3 (booster), single, for Covid-19 immunisation. Medical history included blood pressure high hypertension. She had her dose 1, single of Pfizer Covid-19 vaccine BNT162B2 (lot EM9809; expiry date unknown) via unknown route on 20Feb2021 and had her dose 2, single of Pfizer Covid-19 vaccine BNT162B2 (lot AM6306; expiry date: unknown) via unknown route on 12Mar2021 at age of 70-year-old. Concomitant medication included labetalol for blood pressure high. The patient received her booster on 16Oct2021 and within 12 hours, she was unable to get up and stand on her legs/legs were too weak, had intense vomiting, muscle aches and also had a headache, all were reported as serious disabling. On Oct2021, she reported of enlargement of lymphnodes (also reported as same adverse events happened after she took her second shot). The outcome of vomiting was recovered on 17Oct2021; for other events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events vomiting, myalgia, muscular weakness, dysstasia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fluid retention, Hydrothorax, Immunisation
Clinical narrative: A lot of fluid under arm, on chest and down rib cage.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; 3rd day after injection, significant swelling in the arm pit,  lymph nodes and chest.; 3rd day after injection, significant swelling in the arm pit,  lymph nodes and chest.; A lot of fluid under arm, on chest and down rib cage.; dose received: 3; dose received: 3; This is a spontaneous report from a contactable consumer (patient).  A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Oct2021 17:30 (Batch/Lot number was not reported) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Medical history was none; no known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 08:00 AM (Batch/Lot number was not reported) age at vaccination of 57-years-old, as single dose, for covid-19 immunisation. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 08:00 AM (Batch/Lot number was not reported) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation.  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Oct2021 (3rd day after injection), patient experienced significant swelling in the arm pit, lymph nodes and chest; a lot of fluid under arm, on chest and down rib cage; extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest. No treatments were given for the events. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was considered recovered with lasting effects on an unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: A lot of fluid under arm, on chest and down rib cage.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; 3rd day after injection, significant swelling in the arm pit,  lymph nodes and chest.; 3rd day after injection, significant swelling in the arm pit,  lymph nodes and chest.; A lot of fluid under arm, on chest and down rib cage.; dose received: 3; dose received: 3; This is a spontaneous report from a contactable consumer (patient).  A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Oct2021 17:30 (Batch/Lot number was not reported) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Medical history was none; no known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 08:00 AM (Batch/Lot number was not reported) age at vaccination of 57-years-old, as single dose, for covid-19 immunisation. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 08:00 AM (Batch/Lot number was not reported) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation.  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Oct2021 (3rd day after injection), patient experienced significant swelling in the arm pit, lymph nodes and chest; a lot of fluid under arm, on chest and down rib cage; extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest. No treatments were given for the events. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was considered recovered with lasting effects on an unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Jun2021 13:00 (Lot Number: ewo178), at the age of 59-year-old, as dose 2, single for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive other vaccines in four weeks. The patient had no relevant medical history. The patient did not have COVID-19 prior vaccination. There were no concomitant medications. The patient was not pregnant. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20May2021 13:00 (Lot Number: ewo172), at the age of 59-year-old, as dose 1, single for COVID-19 immunisation. On 21Aug2021 the patient experienced appendicitis. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit and Hospitalization. The appendicitis was removed, appendectomy was performed on 03Sep2021 and the patient was hospitalized for 4 days. The event was considered resolved on 03Sep2021. The patient was tested for COVID-19 post vaccination: Nasal Swab was negative on 01Sep2021.    Follow-up attempts are completed. No further information is expected.