chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller stated that she has seen death as being an adverse event of the Pfizer Covid-19 vaccine (did not specify how many patients or demographic information).; This is a spontaneous report from a contactable consumer. The consumer reported that unknown number of patient (unknown age and gender) received BNT162b2 (COMIRNATY,COVID 19 Vaccine, mRNA), on an unspecified date, via an unspecified route of administration as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The reporter mentioned that she has seen death as being an adverse event of the Pfizer Covid-19 vaccine (did not specify how many patients or demographic information). Reporter asking if there was any information about seizures being a side effect of the Pfizer Covid-19 vaccine and what are the side effects for the orange cap Pfizer Covid-19 vaccine. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number not available. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101557104 Same reporter/ drug, different patients/ events.; Reported Cause(s) of Death: Caller stated that she has seen death as being an adverse event of the Pfizer Covid-19 vaccine (did not specify how many patients or demographic information).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for covid-19; I tested positive for covid-19; sick; This is a spontaneous report from a contactable Other Health Professional (patient). A 68-years-old male patient received BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route, administered in Left Arm on 17Mar2021 at 10:00 (Age at vaccination 68 years-old) as dose 2, single and received first dose via an unspecified route, administered in Left Arm on 17Feb2021 at 10:00 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. Medical history included hypertension and blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine (AMLODIPINE) and atorvastatin (ATORVASTATIN) taken for an unspecified indication. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and did not have Known allergies. The facility type was Health Clinic/Veterans Administration facility where the patient administered vaccine. On 08Nov2021 at 19:00 the patient was sick. On 09Nov2021 the patient tested positive for covid-19 and other vaccination failure. The patient reported that adverse effect was the vaccines did not work and tested positive for covid-19 on 09Nov2021, and I am sick. The patient underwent lab tests and procedures which included sars-cov-2 test positive and sars-cov-2 test positive as per Nasal Swab on 09Nov2021. The patient was quarantine, on bed rest and NyQuil and antibiotics had been taken as treatment. The outcome of the events was not recovered.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: currently (right now) she has covid; Jun2021 as dose 2, single and patient received first dose of bnt162b2 on Jun2021 as dose 1; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown), dose 1 via an unspecified route of administration on an unspecified date in Jun2021 as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she was received both doses of the pfizer covid vaccine back in Jun2021 and currently (right now) she had covid (drug ineffective) on an unspecified date in 2021. patient stated she can't find information what causes of that. She understood there are different strains and a percentage will get it. But she did't understand and can't find any information as to why she had a loss of taste and smell. she had a mild headache and thought it was sinus issue. Monday morning patient realized she can't smell. Patient tested with covid test and it was positive and then she had a loss of taste. She can't find any clinical trials that explains why this happened and what's causing it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Nov2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Doses both given in LEFT arm, but my RIGHT arm has been achy / sore since my first dose.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: F8839) via an unspecified route of administration in the left arm on 01Oct2021 at 10:30(at the age of 25-years-old)  as a single dose for COVID-19 immunisation. The medical history included Crohn's disease, allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The concomitant medications included adalimumab (HUMIRA) and azathioprine (MANUFACTURER UNKNOWN), both from unknown dates for unknown indications and unknown if ongoing. On 01Oct2021 at 12:00, since the first dose, the patient's right arm had been achy / sore. The patient reported that both doses were given in the left arm. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm achy / sore was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 24Oct2021 at 12:30 (at the age 25-years-old) as single doses for COVID-19 immunisation.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingles; Dose 1: 26Dec2020 ; dose 2: 12Jan2021; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration on 12Jan2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration on 26Dec2020 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and was unspecified. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was unknown at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Immunisation, Myalgia, Pain in extremity
Clinical narrative: The injection site hurt very bad as well as the upper left arm for over 2 days; The injection site hurt very bad as well as the upper left arm for over 2 days; Body temperature was slightly increased; Muscle pain over the entire body for more than 2 days; Administration date 10Nov2021 at 17:00, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 10Nov2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history reported as the patient was generally healthy. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did receive other vaccines within four weeks prior to the vaccination. Concomitant medication included influenza vaccine (FLU SHOT) for immunization on 16Oct2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 11Feb2021 (at the age of 32-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 02Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the injection site was hurting very bad as well as the upper left arm for over 2 days, body temperature was slightly increased and muscle pain over the entire body for more than 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site hurt very bad as well as the upper left arm for over 2 days, body temperature was slightly increased and muscle pain over the entire body for more than 2 days was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The injection site hurt very bad as well as the upper left arm for over 2 days; The injection site hurt very bad as well as the upper left arm for over 2 days; Body temperature was slightly increased; Muscle pain over the entire body for more than 2 days; Administration date 10Nov2021 at 17:00, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 10Nov2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history reported as the patient was generally healthy. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did receive other vaccines within four weeks prior to the vaccination. Concomitant medication included influenza vaccine (FLU SHOT) for immunization on 16Oct2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 11Feb2021 (at the age of 32-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 02Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the injection site was hurting very bad as well as the upper left arm for over 2 days, body temperature was slightly increased and muscle pain over the entire body for more than 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site hurt very bad as well as the upper left arm for over 2 days, body temperature was slightly increased and muscle pain over the entire body for more than 2 days was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Felt exhausted the next day (10Nov2021).; Had a fever of 100.7.; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via intramuscular route of administration in the right arm on 09Nov2021(at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, the patient was diagnosed with COVID-19 prior to the vaccination. The patient had no other medical history and no known allergies. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The reporter was a Pfizer colleague and was on a phone call on 11Nov2021 with a friend of his. Reporter's friend stated that his 12-year-old son received the Pfizer COVID-19 vaccine on 09Nov2021 and had a fever of 100.7 and felt exhausted the next day on 10Nov2021. On 10Nov2021, his father stated that the patient went to the school nurse and they treated him with Tylenol and sent him home from school on 10Nov2021. The patient did not go to school on 11Nov2021 also and now at the time of reporting the patient felt back to normal per his father. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYNELOL). On 09Nov2021, the patient underwent body temperature test and the result was 100.7 (units unspecified). Since the vaccination, the patient had been tested for COVID-19. On 10Nov2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was pending. The clinical outcome of the events fever of 100.7 and felt exhausted the next day were resolved on an unknown date in Nov2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive COVID-19 test with symptoms/ running 103.4 fever; This is a spontaneous report from a contactable consumer (reporting for her daughter). An 8-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Nov2021 (batch/lot number: FK5127) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that her daughter got her first COVID vaccine on Saturday (06Nov2021) and on Monday (08Nov2021), she tested positive for COVID and she was running 103.4 fever. She was due for her next COVID shot on 27Nov2021 and she wanted to speak with someone about whether she should get it after these side effect or not. If that is safe or she's going to have another reaction. It was reported that the consumer (parent) took her daughter to the pediatrician. The outcome of the event "positive COVID-19 test with symptoms/ running 103.4 fever" was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Sluggishness, Vaccination site pain
Clinical narrative: Soreness at injection site; Slight headache; Joint pain; Draggy feeling; The patient received a third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 11Nov2021 at 11:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes and heart disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified prescription medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140) via an unspecified route of administration in the left arm on 22Dec2020 at 14:30 (at the age of 77-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 11Jan2020 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 15:00, the patient experienced soreness at injection site, slight headache, joint pain and draggy feeling. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events soreness at injection site, slight headache, joint pain and draggy feeling was not resolved at the time of this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Eye pain
Clinical narrative: Chills; sore left arm; sore muscles in whole body; real sore shoulder and rear neck muscles; real sore shoulder and rear neck muscles; Headache; sinus pain; hurt behind my eyes; dizzy when up moving; Nausea after walking; felt real bad for 36 hours; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 03Nov2021 at 12:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The medical history reported as old age (79) with few things going on. The patient still works a job. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 10Feb2021 at 12:15 (at the age of 77-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 04Mar2021 at 12:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 04:00, the patient experienced chills, sore left arm, sore muscles in whole body, real sore shoulder and rear neck muscles, head ache, sinus pain, hurt behind the eyes, dizzy when up moving, nausea after walking and felt real bad for 36 hours. The patient reported that only thing he didn't have was a temperature and it was 97.2(unknown unit). On the same day, the patient underwent body temperature test and the result was 97.2 (unknown unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, sore left arm, sore muscles in whole body, real sore shoulder and rear neck muscles, head ache, sinus pain, hurt behind the eyes, dizzy when up moving, nausea after walking and was feeling real bad were resolved on an unknown date in Nov2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Immunisation, Myalgia, Nausea
Clinical narrative: Chills; sore left arm; sore muscles in whole body; real sore shoulder and rear neck muscles; real sore shoulder and rear neck muscles; Headache; sinus pain; hurt behind my eyes; dizzy when up moving; Nausea after walking; felt real bad for 36 hours; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 03Nov2021 at 12:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The medical history reported as old age (79) with few things going on. The patient still works a job. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 10Feb2021 at 12:15 (at the age of 77-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 04Mar2021 at 12:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 04:00, the patient experienced chills, sore left arm, sore muscles in whole body, real sore shoulder and rear neck muscles, head ache, sinus pain, hurt behind the eyes, dizzy when up moving, nausea after walking and felt real bad for 36 hours. The patient reported that only thing he didn't have was a temperature and it was 97.2(unknown unit). On the same day, the patient underwent body temperature test and the result was 97.2 (unknown unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, sore left arm, sore muscles in whole body, real sore shoulder and rear neck muscles, head ache, sinus pain, hurt behind the eyes, dizzy when up moving, nausea after walking and was feeling real bad were resolved on an unknown date in Nov2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Sinus pain
Clinical narrative: Chills; sore left arm; sore muscles in whole body; real sore shoulder and rear neck muscles; real sore shoulder and rear neck muscles; Headache; sinus pain; hurt behind my eyes; dizzy when up moving; Nausea after walking; felt real bad for 36 hours; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 03Nov2021 at 12:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The medical history reported as old age (79) with few things going on. The patient still works a job. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 10Feb2021 at 12:15 (at the age of 77-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 04Mar2021 at 12:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 04:00, the patient experienced chills, sore left arm, sore muscles in whole body, real sore shoulder and rear neck muscles, head ache, sinus pain, hurt behind the eyes, dizzy when up moving, nausea after walking and felt real bad for 36 hours. The patient reported that only thing he didn't have was a temperature and it was 97.2(unknown unit). On the same day, the patient underwent body temperature test and the result was 97.2 (unknown unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, sore left arm, sore muscles in whole body, real sore shoulder and rear neck muscles, head ache, sinus pain, hurt behind the eyes, dizzy when up moving, nausea after walking and was feeling real bad were resolved on an unknown date in Nov2021.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Sore arm; The patient received the third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 11Nov2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 09:00 (at the age of 29-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU20162) via an unspecified route of administration in the left arm on 15Apr2021 at 09:45 (at the age of 29-years-old), both as a single dose for COVID-19 immunisation. On 12Nov2021 at 05:00, the patient experienced sore arm. The adverse event did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolving at the time of this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Diarrhoea, Faeces discoloured, Pain
Clinical narrative: Chills; Black diarrhea; Black diarrhea; Bullseye rash on abdomen; Aches and pains; Severe pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Nov2021 at 19:00(at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history includes hypertension and hypothyroid. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and liothyronine sodium (CYTOMEL) all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 10Nov2021 at 19:00, the patient experienced chills, black diarrhea, bullseye rash on abdomen, aches and pains and severe pain in armpit. 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 chills, black diarrhea, bullseye rash on abdomen, aches and pains and severe pain in armpit were not resolved at the time of this report.   The lot number for, BNT162b2, was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Chills; Black diarrhea; Black diarrhea; Bullseye rash on abdomen; Aches and pains; Severe pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Nov2021 at 19:00(at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history includes hypertension and hypothyroid. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and liothyronine sodium (CYTOMEL) all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 10Nov2021 at 19:00, the patient experienced chills, black diarrhea, bullseye rash on abdomen, aches and pains and severe pain in armpit. 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 chills, black diarrhea, bullseye rash on abdomen, aches and pains and severe pain in armpit were not resolved at the time of this report.   The lot number for, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient, of unknown age, received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on Nov 11, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date; and received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date; both single dose, for COVID-19 immunisation. On Nov 12, 2021, at 09:30, patient sent an email with the following description: He  got his booster shot on Nov 11, 2021 and was not feeling great. The event did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient has tested for COVID-19. The outcome of 'he was not feeling great:' unknown (at the time of this report). The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Armpit area was swollen; I noticed discomfort in my armpit area/ It was sore; The patient received third (booster) dose of BNT162b2; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via intramuscular route of administration in the right arm on 12Nov2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via intramuscular route of administration in the right arm on 08Jan2021 at 12:00 (at the age of 46-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via intramuscular route of administration in the right arm on 29Jan2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient reported that after her vaccine on 12Nov2021 evening, she felt great. On 13Nov2021 morning and early afternoon no side effects. On the same day at 18:00, early evening, the patient noticed discomfort in her armpit area. It was swollen and sore and on 14Nov2021 morning it still was. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event discomfort in her armpit area, it was swollen and sore was resolving at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Immunisation, Lymphadenitis, Muscle spasms
Clinical narrative: Patient received third/booster dose 3, BNT162b2; Pain at injection site; Chills during evening; Under arm lymph nodes inflammation; Severe body pain; Stiffness; Joint pain; Muscle spasms; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33038RD) via an unspecified route of administration in the left arm on 13Nov2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, atherosclerosis and endometriosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine influenza vaccine (MANUFACTURER UNKNOWN) on18Oct2021 for immunisation. Concomitant medications included atorvastatin calcium (ATORVASTIN), ethinylestradiol/ etonogestrel (NUVARING), fexofenadine hydrochloride (ALLEGRA) and ibuprofen (ADVIL); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin/clavulanic acid (AUGMENTIN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 41-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, at 03:00 the patient experienced pain at injection site, chills during evening, under arm lymph nodes inflammation, severe body pain and stiffness, joint pain and muscle spasms. 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 at injection site, chills during evening, under arm lymph nodes inflammation, severe body pain and stiffness, joint pain and muscle spasms were not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: Patient received third/booster dose 3, BNT162b2; Pain at injection site; Chills during evening; Under arm lymph nodes inflammation; Severe body pain; Stiffness; Joint pain; Muscle spasms; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33038RD) via an unspecified route of administration in the left arm on 13Nov2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, atherosclerosis and endometriosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine influenza vaccine (MANUFACTURER UNKNOWN) on18Oct2021 for immunisation. Concomitant medications included atorvastatin calcium (ATORVASTIN), ethinylestradiol/ etonogestrel (NUVARING), fexofenadine hydrochloride (ALLEGRA) and ibuprofen (ADVIL); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin/clavulanic acid (AUGMENTIN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 41-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, at 03:00 the patient experienced pain at injection site, chills during evening, under arm lymph nodes inflammation, severe body pain and stiffness, joint pain and muscle spasms. 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 at injection site, chills during evening, under arm lymph nodes inflammation, severe body pain and stiffness, joint pain and muscle spasms were not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Have had intermittent tinnitus after receiving first vaccine; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 20Sep2021 (at the age of 53-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in 2021, after receiving the first vaccine, the patient had intermittent tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intermittent tinnitus was not resolved at the time of this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Have feelings of tingling like needles in my hands and knees; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the right arm on 30Oct2021 at 22:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19. It was unknown whether the patient had any allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received the first dose of influenza vaccine (FLU VACCINE) in the left arm on 21Oct2021 for immunization. The patient received unspecified concomitant medications for unknown indication from an unknown date and unknown if ongoing. On 30Oct2021 at 23:30, the patient had feelings of tingling like needles in his hands and knees. It was not constant but it did happen a lot throughout the days (at the time of this report). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had feelings of tingling like needles in his hands and knees was not resolved at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Intermenstrual bleeding, SARS-CoV-2 test
Clinical narrative: Patient received third dose/booster dose; Heavy breakthrough menstrual bleeding 4 weeks after second Pfizer dose and again 5 weeks after third Pfizer dose.; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Jan2021 (at the age of 37-years-old) and received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Oct2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ongoing ethinylestradiol/norethisterone acetate (JUNEL) for birth control from an unknown date and famotidine (PEPCID) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Dec2020 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 18Feb2021, 4 weeks after second dose and 5 weeks after third dose, while the patient was on birth control she experienced heavy breakthrough menstrual bleeding. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent PCR-SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the event heavy breakthrough menstrual bleeding was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node in right armpit.; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the right arm on 10Nov2021 at 18:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 23Mar2021 (at the age of 30-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 13Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 01:00, the patient experienced swollen lymph node in right armpit. The patient got vaccine on Wednesday and was not better even on Sunday. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event swollen lymph node in right armpit was not resolved at the time of this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Mild soreness at vaccination site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old male patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 11Nov2021 at 17:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included timolol maleate, brimonidine tartrate (COMBIGAN) and latanoprost, netarsudil mesilate (ROCKLATAN), both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 53-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 12Nov2021, the patient experienced mild soreness at vaccination site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild soreness at vaccination site was resolved on an unknown date in Nov2021.   No follow-up attempts are possible. No further information is expected.