chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: My stomach, back, arms, and legs broke in in rash along with large hives; My stomach, back, arms, and legs broke in in rash along with large hives; This is a spontaneous report from a contactable 37-year-old female nurse reported for herself. A 37-year-old (non-pregnant) female patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL0140, Expiration date: unknown), via intramuscular, administered on right arm on 08Feb2021 01:00 PM (Age at vaccination: 37 Years) as Dose 1, single for COVID-19 immunization at Living Facility. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and  had no Allergies to medications, food, or other products. The patient medical history includes Covid-19 on an unspecified date and concomitant medications include Lisinopril, buspirone hydrochloride (BUSPAR) and ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS). Prior to vaccination patient was diagnosed with Covid-19 and since the vaccination the patient was tested for covid-19 with a negative result. On 08Feb2021 08:00 PM, the patient experienced stomach, back, arms, and legs broke in in rash along with large hives. The events assessed as non-serious. Lab data and other procedures include SARS-CoV-2 test (nasal swab) negative on 03Feb2021. Patient received Claritin and Benadryl as treatment options. The outcome of the events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Pain in left knee making it difficult to walk upon getting out of bed.; Pain in left knee making it difficult to walk upon getting out of bed.; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810 and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:00 (at the age of 76-years-old) as DOSE 1, SINGLE for Covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included lecithin, hormone replacement, CA, D, levothyroxine. Patient had no allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any treatment and diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On an unspecified date the patient experienced pain in left knee making it difficult to walk upon getting out of bed. I had no previous problems with my knee. Patient did not received any treatment for the events. The most recent COVID-19 vaccine was administered at hospital. Non-serious report. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint effusion, SARS-CoV-2 test
Clinical narrative: Join pain bilateral with inflammation and effusion; Join pain bilateral with inflammation and effusion; Join pain bilateral with inflammation and effusion; This is a spontaneous report from a contactable physician (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Arm Left on 28Dec2020 09:00 (at the age of 52-years-old) (Batch/Lot Number: EH9899) as single dose for COVID-19 immunisation. Medical history included covid-19, the patient was diagnosed with COVID-19 prior to vaccination. The patient had no other medical history and no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Since 29Dec2020, the patient experienced join pain bilateral with inflammation and effusion. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The adverse event was treated with NSAIDS. The reporter assessed the event as non serious. The patient underwent lab tests and procedures which included Covid test post vaccination (as reported) (Rapid test, Nasal Swab): Negative on 13Dec2020. Since the vaccination, the patient had been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Vaccination site pain
Clinical narrative: Exhausion; back ache; lightheaded; injection site pain; This is a spontaneous report from a contactable consumer or other non health care professional (patient himself). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration , administered in right deltoid on 05Feb2021 08:45 (at the age of 65-years-old) as a unknown dose, number, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included received within 2 weeks valsartan taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (CCB) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, the patient experienced exhausion, back ache, lightheaded, injection site pain. The patient did not receive any treatment for the adverse event. Seriousness of the case reported as No. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in arm at injection site.; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EL3302) via unspecified route in the left arm, as dose 1, single on 19Jan2021 at 14:30 and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EL3302) via unspecified route in the right arm, as dose 2, single on 09Feb2021 at 14:45 for COVID-19 immunization (at the age of 31-years). The most recent COVID-19 vaccine was administered in the hospital. The patient medical history and concomitant medications were not reported. The patient previously took cephalexin (cefalexin) and amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced soreness in arm at injection site on 20Jan2021 with outcome of recovered. The events were assessed as non-serious. The clinical outcome for the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Bowel movement irregularity, Cold sweat, Decreased appetite
Clinical narrative: dizzy; hot & clammy; hot & clammy; nauseous; dry mouth; loss of appetite; bowel movement; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 06Feb2021 09:30, as dose 1, single for COVID-19 immunisation in hospital. Medical history included mitral valve prolapse. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 01:00, the patient experienced dizzy, hot and clammy, nauseous, dry mouth, loss of appetite, bowel movement. Patient's B.P. was perfect, temp normal. This was about 30 hrs after dose. The patient underwent lab tests and procedures which included Blood Pressure: perfect on 07Feb2021, body temperature: normal on 07Feb2021. The patient did not receive treatment for the adverse events. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Feeling hot, Nausea
Clinical narrative: dizzy; hot & clammy; hot & clammy; nauseous; dry mouth; loss of appetite; bowel movement; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 06Feb2021 09:30, as dose 1, single for COVID-19 immunisation in hospital. Medical history included mitral valve prolapse. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 01:00, the patient experienced dizzy, hot and clammy, nauseous, dry mouth, loss of appetite, bowel movement. Patient's B.P. was perfect, temp normal. This was about 30 hrs after dose. The patient underwent lab tests and procedures which included Blood Pressure: perfect on 07Feb2021, body temperature: normal on 07Feb2021. The patient did not receive treatment for the adverse events. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm; extreme soreness of muscles around the shoulders and neck area; This is a spontaneous report from a contactable other HCP (patient herself).   A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EC3302), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 08:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive the any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jan2021, the patient experienced sore arm extreme soreness of muscles around the shoulders and neck area. The patient did not receive treatment for the event. On 08Feb2021, the patient received her 2 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in Left as dose 2, single for covid-19 immunisation. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Day 5 after shot, little itchy rash around injection site; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Feb2021 at 03:00 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alendronate sodium (ALENDRONATE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 14Jan2021 03:00 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation in other facility. On 09Feb2021 at 08:00, day 5 after shot the patient experienced little itchy rash around injection site. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event with self-hemp oil topical, and allergy pill. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Feeling abnormal, Vertigo
Clinical narrative: Severe dizziness, thought it was vertigo, has lasted 2 and a half weeks; Severe dizziness, thought it was vertigo, has lasted 2 and a half weeks; foggy brain; blood pressure measurement: 127/68; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 57-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:30 (57-years-old at the time of vaccination), (Batch/Lot Number: El1283) as DOSE 1, SINGLE for covid-19 immunisation at School or Student Health Clinic. Medical history included drug allergic to penicillin from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jan2021 04:45, the patient experienced severe dizziness, thought it was vertigo, has lasted 2 and a half weeks and foggy brain. The patient underwent lab tests and procedures which included blood pressure measurement: 127/68 on 25Jan2021. Patient did not receive any treatment for the events. The clinical outcome of the events was not resolved.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Lip swelling, Swelling face
Clinical narrative: tightness in chest; Swelling of lips and cheeks; Swelling of lips and cheeks; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). This 39-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: not reported, Expiry date: Unknown) via an unspecified route of administration in Arm Left on an unspecified date (Age at vaccination 39 years) as dose 1, single for COVID-19 immunisation. Medical history included allergies to medications, food, or other products Penicillin and shellfish. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Concomitant medication(s) included metformin (METFORMIN) and pantoprazole (PANTOPRAZOLE). Patient was not pregnant at the time of vaccination. On 03Feb2021 08:00 PM, the patient experienced tightness in chest, swelling of lips and cheeks. Patient was received Benadryl as treatment for events. The clinical outcome of all events were recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear haemorrhage
Clinical narrative: He is on a blood thinner for 10yrs, having a bleeding on his ears; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient experienced he is on a blood thinner for 10yrs, having a bleeding on his ears on an unspecified date. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left leg above knee; This is a spontaneous report from a contactable consumer(patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: El92645121), via an unspecified route of administration, administered in left arm on 04Feb2021 12:45 (at the age of 50-year-old) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, sinusitis and allergies: penicillin. The patient previously took Levaquin, Codeine and had experienced drug hypersensitivity. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZAL); levothyroxine sodium (SYNTHROID); magnesium glycinate; vitamin b complex (VITAMIN B) daily; ascorbic acid (VITAMIN C) daily. On 04Feb2021 12:00, the patient experienced rash on left leg above knee. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Supraventricular extrasystoles
Clinical narrative: fatigue; shortness of breath with light activity; dizziness; heart premature atrial contractions; This is a spontaneous report received from a non-contactable consumer (patient) reported for herself. A 68-year-old non-pregnant female patient received bnt162b2 (formulation: Solution for injection. Lot number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 12:00 as single for covid-19 immunisation. Medical history included hypertension, high cholesterol, valve regurge and anxiety disorder. Known allergies to ibuprofen penicillin and sulfa. The patient received no other vaccine in four weeks. It was unknown if the patient was covid prior to vaccination and no covid tested post vaccination. Concomitant medications included atenolol, amlodipine besilate (NORVASC) and buspirone, all taken for an unspecified indication, start and stop date were not reported. On 06Feb2021 12:00, the patient experienced fatigue, shortness of breath with light activity, dizziness, heart premature atrial contractions. This has been going on now for 6 days. No treatment received for the events. Outcome of the events was reported as not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Illness
Clinical narrative: she got sick; dizziness; lost of appetite; This is a spontaneous report from a contactable consumer or other non health professional. This is a reported received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient also received first dose of bnt162b2 (Solution for injection) via an unspecified route of administration on an unspecified date as 1st dose, single for Covid-19 immunisation. The patient got sick she said she is experiencing dizziness, lost of appetite she wanted to know what she should do. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Erythema, Heart rate
Clinical narrative: chest pain and rash; chest pain and rash; neck and upper chest became red; BP was180/110; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EM9810; Expiration date was not reported), dose 1 intramuscular route of administration in the left arm on 13Feb2021 14:45 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included thyroid disorder, urticaria, hypersesnitivity from an unknown date and unknown if ongoing. Patient gave history of allergies to cipro and levaquin with history of hives. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); levothyroxine sodium (SYNTHROID); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took ciprofloxacin, levaquin and experienced drug hypersensitivity. Patient received vaccine in doctor's office/urgent care. It was reported unknown if patient took other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chest pain and rash, neck and upper chest became red on 13Feb2021 14:45. Patient developed left sided chest pain immediately after being given first dose of covid vaccine. No radiation to neck or jaw. Patient denied any cardiac history, nausea or prb breathing, HR was 90, BP was180/110, pulse oxygen was 96%, unlabored resp. Patient neck and upper chest became red but no edema or facial redness. Patient improved immediately after 0.3 mg epi IM and 50 Mg benadryl injected with resolution of chest pain and rash. Repeated exam showed HR 79 and BP 120/72. Ambulance transported for evaluation of chest pain. AE resulted in Doctor or other healthcare professional office/clinic visit. Clinical outcome of neck and upper chest became red was unknown and other events recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Rash
Clinical narrative: chest pain and rash; chest pain and rash; neck and upper chest became red; BP was180/110; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EM9810; Expiration date was not reported), dose 1 intramuscular route of administration in the left arm on 13Feb2021 14:45 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included thyroid disorder, urticaria, hypersesnitivity from an unknown date and unknown if ongoing. Patient gave history of allergies to cipro and levaquin with history of hives. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); levothyroxine sodium (SYNTHROID); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took ciprofloxacin, levaquin and experienced drug hypersensitivity. Patient received vaccine in doctor's office/urgent care. It was reported unknown if patient took other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chest pain and rash, neck and upper chest became red on 13Feb2021 14:45. Patient developed left sided chest pain immediately after being given first dose of covid vaccine. No radiation to neck or jaw. Patient denied any cardiac history, nausea or prb breathing, HR was 90, BP was180/110, pulse oxygen was 96%, unlabored resp. Patient neck and upper chest became red but no edema or facial redness. Patient improved immediately after 0.3 mg epi IM and 50 Mg benadryl injected with resolution of chest pain and rash. Repeated exam showed HR 79 and BP 120/72. Ambulance transported for evaluation of chest pain. AE resulted in Doctor or other healthcare professional office/clinic visit. Clinical outcome of neck and upper chest became red was unknown and other events recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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.
Sex: U
Vaccine: COVID19
Symptoms: Limb injury, Wrong technique in product usage process
Clinical narrative: flicking the syringe really hard multiple times to get rid of the bubbles was almost the same as shaking it; It actually gets stuck in the patient's arm; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. When drawing up COVID-19 vaccines using the Vanish Point syringes, small bubbles are trapped in the syringes and were hard to get rid of. They would have to be flicked multiple times. Our concern was, if the vaccine was not supposed to be shaken, flicking the syringe really hard multiple times to get rid of the bubbles was almost the same as shaking it, which may then compromise the vaccine was being administered. While administering the vaccine to a patient (needle was already in the patient's arm), the syringe started to leak out the vaccine causing the patient to be revaccinated due to uncertainty of dose administered. When retracting the needle from the patient (by pushing it further as part of its safety feature), it doesn't easily retract like it is supposed to. It actually gets stuck in the patient's arm. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: her blood pressure was up to 138/103.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 (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 patient experienced her blood pressure was up to 138/103 on 16Feb2021. Caller asked if it was ok to take Aspirin after receiving the vaccine. DSU: Potential AE discovered after call, thus, e transmitted. Female consumer received Pfizer's COVID vaccine yesterday on 16Feb2021. She saw the doctor in December where they told her that her blood pressure was normal and advised her to take Aspirin. She said she had been taking inflammatory medications that caused her blood pressure to go high and that the doctor recommended her to take Aspirin. She stated yesterday, her blood pressure was up to 138/103. The patient underwent lab tests and procedures which included blood pressure measurement: high on unspecified date, blood pressure was normal on Dec2020, blood pressure was 138/103 on 16Feb2021. Therapeutic measures were taken as a result of her blood pressure was up to 138/103. The outcome of event was not recovered.   Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysgeusia, Pollakiuria, Urinary tract infection
Clinical narrative: Urinary tract infection; Frequent urination; amber to brown urine; Everything I put into my mouth tasted bitter for a day; This is a spontaneous report from a non-contactable consumer (patient). A 66-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration in left arm on 16Feb2021 at 12:15 as single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines in four weeks of vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 Immunization. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID post vaccination. On an unspecified date, the patient felt like she had UTI, frequent urination, amber to brown urine and everything she put into her mouth tasted bitter for a day. She stated that she had a shot on Sunday and everything still tastes bitter till Tuesday. The patient did not received treatment for the events. The outcome of events was not recovered.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225127 same reporter/drug with different patient, similar AE
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Upper respiratory tract infection
Clinical narrative: throat infection; Upper Respiratory Tract Infection; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patient) reported, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, received the first dose of Covid-19 vaccine on 03Feb2021 and asked for the time of appointment for a second dose due on 25Feb2021. On an unspecified date, she mentioned that she had a throat infection last week, had Upper Respiratory Tract Infection. Outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Headache, Nausea
Clinical narrative: her blood pressure increased yesterday; nauseous as all crap; had a minor headache; arm pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 58; unit unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), dose 2 via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunisation. Medical history included sinusitis (natural sinus trouble) from an unknown date and unknown if ongoing, blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included clonidine taken for blood pressure abnormal (1 clonidine in the morning and night), start and stop date were not reported. Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation and experienced arm pain with her first injection and placed a heat pack on it, in which the pain subsided. The patient received the second dose of the Covid vaccine on 02Mar2021 (yesterday). The patient stated that she got up on 02Mar2021 (last night) to do her newspaper route and felt ''nauseous as all crap, had a minor headache, and arm pain''. The arm pain subsided once she placed a heat pack on her arm as therapeutic measure for arm pain. The patient also experienced arm pain with her first injection and placed a heat pack on it, in which the pain subsided. The patient was taking ''blood pressure medicine (1 clonidine in the morning and night)''. The patient stated that her normal blood pressure was 140/90 and her normal temperature was 96.7 degrees Fahrenheit. The patient wasn't having any trouble before the vaccine and only had natural sinus trouble. The patient stated that her blood pressure increased on 02Mar2021 (yesterday) and she took her second dose of clonidine a little early around 3 o'clock as therapeutic measures, in which her blood pressure went down. The patient asked if there was any evidence of blood pressure increasing after receiving the vaccine or could her pain cause her blood pressure to increase. The outcome for arm pain was recovered in Mar2021, and for her blood pressure increased yesterday was recovered in Mar2021, outcome for rest all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her blood pressure increased yesterday; nauseous as all crap; had a minor headache; arm pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 58; unit unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), dose 2 via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunisation. Medical history included sinusitis (natural sinus trouble) from an unknown date and unknown if ongoing, blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included clonidine taken for blood pressure abnormal (1 clonidine in the morning and night), start and stop date were not reported. Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation and experienced arm pain with her first injection and placed a heat pack on it, in which the pain subsided. The patient received the second dose of the Covid vaccine on 02Mar2021 (yesterday). The patient stated that she got up on 02Mar2021 (last night) to do her newspaper route and felt ''nauseous as all crap, had a minor headache, and arm pain''. The arm pain subsided once she placed a heat pack on her arm as therapeutic measure for arm pain. The patient also experienced arm pain with her first injection and placed a heat pack on it, in which the pain subsided. The patient was taking ''blood pressure medicine (1 clonidine in the morning and night)''. The patient stated that her normal blood pressure was 140/90 and her normal temperature was 96.7 degrees Fahrenheit. The patient wasn't having any trouble before the vaccine and only had natural sinus trouble. The patient stated that her blood pressure increased on 02Mar2021 (yesterday) and she took her second dose of clonidine a little early around 3 o'clock as therapeutic measures, in which her blood pressure went down. The patient asked if there was any evidence of blood pressure increasing after receiving the vaccine or could her pain cause her blood pressure to increase. The outcome for arm pain was recovered in Mar2021, and for her blood pressure increased yesterday was recovered in Mar2021, outcome for rest all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dizziness, Heart rate increased
Clinical narrative: Chill; Low fever; My heart started to race and felt dizzy within 5 min. of the vaccine on 28Feb; blood pressure 190 over 100; My heart started to race and felt dizzy within 5 min. of the vaccine on Feb 28; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: lot/batch number: unknown) on 28Feb2021 at 12:00 pm in the right arm as a single dose for COVID-19 immunization. The patient's medical history included breast cancer 1999, lung cancer 2012, allergies to fire ant bites, penicillin, sensitive to EPI. The patient's concomitant medications were not reported. Patient's other medications four weeks prior vaccination was none. Other medications in two weeks prior vaccination included: alendronate70, levothyroxine88, rosuvastatin5. The patient stated that her heart started to race and she felt dizzy within 5 minutes of the vaccine on 28Feb2021 at 12:00 pm, blood pressure was 190 over 100 (came down to 140 after about 20 minutes). The patient stated that on 04Mar2021, around 3:30am the same happened again. The patient stated that her heart was pounding faster than 1st time and blood pressure went up to 200 over 115. The patient stated that she went to ER and her blood pressure came down to 140 after 2 hours. The patient also stated that she had a similar episode on the evening of 04Mar around 10:30, 170 over 97, accompanied by chill and low fever. The patient confirmed that she had not prior history of high blood pressure. The patient did not receive any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: Chill; Low fever; My heart started to race and felt dizzy within 5 min. of the vaccine on 28Feb; blood pressure 190 over 100; My heart started to race and felt dizzy within 5 min. of the vaccine on Feb 28; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: lot/batch number: unknown) on 28Feb2021 at 12:00 pm in the right arm as a single dose for COVID-19 immunization. The patient's medical history included breast cancer 1999, lung cancer 2012, allergies to fire ant bites, penicillin, sensitive to EPI. The patient's concomitant medications were not reported. Patient's other medications four weeks prior vaccination was none. Other medications in two weeks prior vaccination included: alendronate70, levothyroxine88, rosuvastatin5. The patient stated that her heart started to race and she felt dizzy within 5 minutes of the vaccine on 28Feb2021 at 12:00 pm, blood pressure was 190 over 100 (came down to 140 after about 20 minutes). The patient stated that on 04Mar2021, around 3:30am the same happened again. The patient stated that her heart was pounding faster than 1st time and blood pressure went up to 200 over 115. The patient stated that she went to ER and her blood pressure came down to 140 after 2 hours. The patient also stated that she had a similar episode on the evening of 04Mar around 10:30, 170 over 97, accompanied by chill and low fever. The patient confirmed that she had not prior history of high blood pressure. The patient did not receive any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Flushing, Heart rate
Clinical narrative: Feeling flushed; Anxiety (include misc mental health); Elevated blood pressure; This is a spontaneous report from a non-contactable other hcp. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience feeling flushed, Vaccine related Anxiety (include misc mental health) elevated blood pressure. Patient received treatment included water, snacks and ice pack. Patient observed approx. 30 minutes. Patient improved in symptoms after rest, food, water and ice pack. Her BP was coming down. HR and RR normal. Patient felt better. She wanted to leave as staying there was making her more anxious. Recommended that she monitor her bp at home. If persisted to be elevated of 140/90 that she follow up with her PCP. On an unspecified date, the patient underwent lab tests and procedures which included BP: elevated of 140/90 and coming down, HR (Heart rate): normal, RR (respiratory rate): normal. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate
Clinical narrative: Feeling flushed; Anxiety (include misc mental health); Elevated blood pressure; This is a spontaneous report from a non-contactable other hcp. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience feeling flushed, Vaccine related Anxiety (include misc mental health) elevated blood pressure. Patient received treatment included water, snacks and ice pack. Patient observed approx. 30 minutes. Patient improved in symptoms after rest, food, water and ice pack. Her BP was coming down. HR and RR normal. Patient felt better. She wanted to leave as staying there was making her more anxious. Recommended that she monitor her bp at home. If persisted to be elevated of 140/90 that she follow up with her PCP. On an unspecified date, the patient underwent lab tests and procedures which included BP: elevated of 140/90 and coming down, HR (Heart rate): normal, RR (respiratory rate): normal. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic foot infection
Clinical narrative: he got a foot infection will be in hospital, he is diabetic and has ulcers for months; This is a spontaneous report from a contactable consumer (patient wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 (at the age of 76-years-old) as single dose for COVID-19 immunisation. Medical history included diabetic and had ulcers for months. The patient's concomitant medications were not reported. It was reported that the patient got the covid vaccine 3 weeks ago (Feb2021) and tomorrow he would get another dose, but he got a foot infection and would be in hospital, he was diabetic and had ulcers for months and now they had to go to hospital to get it cleaned. They wanted to know how long they could wait to get the second dose. Outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Potentiating drug interaction
Clinical narrative: I am getting desperate here; This is a spontaneous report from a contactable consumer(patient).  A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she was getting desperate here got her 2 Pfizer shots. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.