chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Oropharyngeal pain, Pain in extremity, Pharyngitis streptococcal, Pyrexia
Clinical narrative: then sore throat. It was reported that it almost felt like strep; Sore throat; sore arm; Fever; Lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 25Sep2021 12:30 (Batch/Lot Number: FF2587) (at the age of 28 years, as reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included epilepsy, cyclothymic disorder, bipolar disorder, depression, anxiety, obesity, all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine; lisdexamfetamine mesilate (VYVANSE); quetiapine; desvenlafaxine succinate monohydrate (PRISTIQ); all taken for an unspecified indication, start and stop date were not reported. The patient previously took remeron and experienced drug hypersensitivity. It was reported that on 26Sep2021 10:30, the patient experienced sore throat, no coughing or runny nose, the normal sore arm, fever, lethargy, and then sore throat. It was reported that it almost felt like strep. The patient was negative for Covid. The events occurred almost 22 hours after the first dose vaccine. No treatment was received for the events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Results of tests and procedures for investigation of the patient: COVID Test type post vaccination: Blood test, COVID Test name post vaccination: ID Now, Result: Negative.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: then sore throat. It was reported that it almost felt like strep; Sore throat; sore arm; Fever; Lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 25Sep2021 12:30 (Batch/Lot Number: FF2587) (at the age of 28 years, as reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included epilepsy, cyclothymic disorder, bipolar disorder, depression, anxiety, obesity, all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine; lisdexamfetamine mesilate (VYVANSE); quetiapine; desvenlafaxine succinate monohydrate (PRISTIQ); all taken for an unspecified indication, start and stop date were not reported. The patient previously took remeron and experienced drug hypersensitivity. It was reported that on 26Sep2021 10:30, the patient experienced sore throat, no coughing or runny nose, the normal sore arm, fever, lethargy, and then sore throat. It was reported that it almost felt like strep. The patient was negative for Covid. The events occurred almost 22 hours after the first dose vaccine. No treatment was received for the events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Results of tests and procedures for investigation of the patient: COVID Test type post vaccination: Blood test, COVID Test name post vaccination: ID Now, Result: Negative.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb injury, Pyrexia
Clinical narrative: ran a temperature for 1 day; had chills; her arm hurt; This is a spontaneous report from a contactable consumer reported for himself and his twin sister, this case is for his twin sister. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection;Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated, his twin sister in got it and she said she ran a temperature for 1 day, had chills and her arm hurt on an unspecified date and she's fine. States his niece and nephew are all fine and they all got the Pfizer shot, he doesn't understand. States, that is normal and are told that is what is going to happen and not that you are going to have heart problems. States they are told your arm might be sore and people talk about sore arm and getting chills or slight temperatures and it's no big deal. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac infection, Troponin, Troponin increased
Clinical narrative: heart inflammation; Troponin extremely high; This is a spontaneous report from a non-contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at the age of 15-year-old), dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart inflammation. The lab level of Troponin was extremely high. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Immunisation, Off label use
Clinical narrative: anaphylactic shock; she had the booster; she had the booster; This is a spontaneous report from a non-contactable physician via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 3 (booster) single for covid-19 immunization. Medical history included cancer and patient was on immunotherapy. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single and dose 2, single for covid-19 immunization. The patient experienced anaphylactic shock (medically significant) on an unspecified date. Patient was doing well on her immunotherapy before the booster shot. After she had the booster she had immunotherapy and started having these reactions. It took two or more healthcare professionals to be able to stabilize a patient having an anaphylactic shock and the patient may not have time. Doctor was describing that it was dangerous to have unsupervised home infusions for cancer patients. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event anaphylactic shock and the suspect drug BNT162B2 cannot be excluded. 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: Headache, Immunisation, Off label use, Pain, Pyrexia
Clinical narrative: I had a reaction to the COVID, the booster shot of COVID 19; I had a reaction to the COVID, the booster shot of COVID 19; Fever; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection,Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the reporter stated that the patient had reaction to the COVID, the booster shot of COVID-19. The patient also had experienced fever, body aches, headache which lasted about 20 hours and then resolved. The outcome of the events was recovered 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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dyspnoea, Fatigue
Clinical narrative: dizziness; irregular heartbeat; aches: legs/shoulders; aches: legs/shoulders; tiredness/weakness when moving about; tiredness/weakness when moving about; Breathing at times tight; This is a spontaneous report received from a contactable consumer (patient) reported for himself. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0175, Expiration date was not reported), via an unspecified route of administration in arm left on 13Sep2021 at 14:00 (at the age of 82-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included heart decease and high blood pressure from an unspecified date and unknown if ongoing. Known allergies were reported as none. The patient's concomitant medications in two weeks included omeprazole dr, 20 mg and carvedilol 25 mg and other, all were taken for an unspecified indication. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021 at 12:00 am, three-four days following, the patient experienced dizziness, irregular heartbeat, aches: legs/shoulders, tiredness/weakness when moving about, breathing at times tight but never serious - able to take deep breathes easily. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the events that included heart monitor by cardiologist. On 16Sep2021, the patient underwent lab tests and procedures which included irregular heartbeat (heart rate), resulted as irregular and BinaxNOW/Abbott (SARS-CoV-2 test), resulted as negative, nasal swab on 28Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Pain in extremity, SARS-CoV-2 test
Clinical narrative: dizziness; irregular heartbeat; aches: legs/shoulders; aches: legs/shoulders; tiredness/weakness when moving about; tiredness/weakness when moving about; Breathing at times tight; This is a spontaneous report received from a contactable consumer (patient) reported for himself. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0175, Expiration date was not reported), via an unspecified route of administration in arm left on 13Sep2021 at 14:00 (at the age of 82-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included heart decease and high blood pressure from an unspecified date and unknown if ongoing. Known allergies were reported as none. The patient's concomitant medications in two weeks included omeprazole dr, 20 mg and carvedilol 25 mg and other, all were taken for an unspecified indication. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021 at 12:00 am, three-four days following, the patient experienced dizziness, irregular heartbeat, aches: legs/shoulders, tiredness/weakness when moving about, breathing at times tight but never serious - able to take deep breathes easily. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the events that included heart monitor by cardiologist. On 16Sep2021, the patient underwent lab tests and procedures which included irregular heartbeat (heart rate), resulted as irregular and BinaxNOW/Abbott (SARS-CoV-2 test), resulted as negative, nasal swab on 28Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Off label use, Pain in extremity, Squamous cell carcinoma
Clinical narrative: I have a squamous cell carcinoma the size of a grape on my left hand below my thumb, by the palm of my hand; I got my booster shot two weeks ago; I got my booster shot two weeks ago; I got a big welt on my arm.; It was sore for 1.5 weeks; swelling; I get some deep pain in my shoulder under my clavicle and sharp pain in my hip; I get some deep pain in my shoulder under my clavicle and sharp pain in my hip; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the third dose of BNT162B2 via an unspecified route of administration in Sep2021 at the age of 78-year-old as single dose for COVID-19 immunization. Medical history included squamous cell carcinoma on leg in 2019 and on hand in 2016 and malignant neoplasm of central portion of right female breast. Concomitant medication included palbociclib (IBRANCE) for malignant neoplasm of central portion of right female breast. The patient previously received the second dose and the first dose of BNT162B2 both via an unspecified route of administration on an unspecified date at the age of 78-year-old as single dose for COVID-19 immunization. Patient stated "I've been losing track of days" and "I got my booster shot two weeks ago and I got a big welt on my arm. It was sore for 1.5 weeks". Patient stated "Ibrance is a miracle drug" and "it caught it when my cancer marker was 2400 and got it down in a year". Patient stated "On 10Sep my cancer marker was 110 and the month before it was 107". Patient stated "I am not swelling as much anymore" and "I get some deep pain in my shoulder under my clavicle and sharp pain in my hip". Patient stated "I have a squamous cell carcinoma the size of a grape on my left hand below my thumb, by the palm of my hand". Patient stated "I have to have it removed on 14Oct". Patient stated "I had squamous cell carcinoma on my leg in 2019 and on my hand in 2016". Patient stated "I had to have a CT scan on my body" and "I have to have a bone scan". The outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tumour marker test, Urticaria
Clinical narrative: I have a squamous cell carcinoma the size of a grape on my left hand below my thumb, by the palm of my hand; I got my booster shot two weeks ago; I got my booster shot two weeks ago; I got a big welt on my arm.; It was sore for 1.5 weeks; swelling; I get some deep pain in my shoulder under my clavicle and sharp pain in my hip; I get some deep pain in my shoulder under my clavicle and sharp pain in my hip; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the third dose of BNT162B2 via an unspecified route of administration in Sep2021 at the age of 78-year-old as single dose for COVID-19 immunization. Medical history included squamous cell carcinoma on leg in 2019 and on hand in 2016 and malignant neoplasm of central portion of right female breast. Concomitant medication included palbociclib (IBRANCE) for malignant neoplasm of central portion of right female breast. The patient previously received the second dose and the first dose of BNT162B2 both via an unspecified route of administration on an unspecified date at the age of 78-year-old as single dose for COVID-19 immunization. Patient stated "I've been losing track of days" and "I got my booster shot two weeks ago and I got a big welt on my arm. It was sore for 1.5 weeks". Patient stated "Ibrance is a miracle drug" and "it caught it when my cancer marker was 2400 and got it down in a year". Patient stated "On 10Sep my cancer marker was 110 and the month before it was 107". Patient stated "I am not swelling as much anymore" and "I get some deep pain in my shoulder under my clavicle and sharp pain in my hip". Patient stated "I have a squamous cell carcinoma the size of a grape on my left hand below my thumb, by the palm of my hand". Patient stated "I have to have it removed on 14Oct". Patient stated "I had squamous cell carcinoma on my leg in 2019 and on my hand in 2016". Patient stated "I had to have a CT scan on my body" and "I have to have a bone scan". The outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report from a contactable consumer based on information received by Pfizer from the Regulatory Authority (manufacturer control number 2021SA276022). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation and dupilumab (DUPIXENT) subcutaneous from 02Apr2021 and ongoing at 300 mg (once in every two weeks) for dermatitis atopic. Relevant medical history included dermatitis atopic. The patient's concomitant medications were not reported. The patient experienced pericarditis (medically significant) on 08Aug2021 with outcome of recovering. The patient went to emergency room due to pericarditis. It was not reported if the patient received a corrective treatment for the event pericarditis. No action was taken with dupilumab in response to the event.  Reporter casualty: unassessable for pericarditis in case of dupilumab: not reported for pericarditis in case of tozinameran. Company causality: not reportable for pericarditis for both the suspect.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Immunisation, Off label use
Clinical narrative: Blood pressure went high  200/107; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer (patient's husband). An 81-year-old female patient received the third dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the second dose and the first dose of BNT162B2 both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, the patient experienced blood pressure went high 200/107 mmHg. The outcome of events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fully vaccinated with breakthrough CV19 confirmed positive case. PCR test performed 27Sep, results positive 27Sep2021.; Fully vaccinated with breakthrough CV19 confirmed positive case. PCR test performed 27Sep, results positive 27Sep2021; This is a spontaneous report from a contactable other hcp.  A 62-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), Via intramuscular route of administration, administered in left arm on 02Mar2021 (Age at vaccination: 62-years-old) as DOSE 2, SINGLE and first dose via intramuscular route of administration, administered in left arm on 09Feb2021 (Lot Number: EL3247) as DOSE 1, SINGLE for COVID-19 immunization. (Vaccination facility: Workplace clinic). No medical history and no concomitant medications were not reported. Patient was not diagnosed with covid prior to vaccination. It was reported as patient Fully vaccinated with breakthrough CV19 confirmed positive case. PCR test performed 27Sep2021, results positive 27Sep2021. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 Nasal Swab.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events VF and Covid 19 and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: rash all over his body; potential allergies to ingredients in the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history included diabetes mellitus. The patient's concomitant medications were not reported. On an unknown date, the patient experienced rash all over his body and potential allergies to ingredients in the pfizer covid 19 vaccine and had to receive and Epi shot in response to some other unknown agents as well. Despite seeking clarification, caller was unable to identify his allergic reactions to an identified agent/drug. Explained he had a list of ingredients, noted .45ml of excipient. Consumer was interested in receiving vaccination. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  The lot number for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Immunisation, Off label use, Pain
Clinical narrative: Two days later, he passed away.; felt fatigued; fever; achy; got the booster shot; got the booster shot; This is a spontaneous report from a non-contactable pharmacist. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 28Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization (administered in a Pharmacy or Drug store); and influenza vaccine via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the booster shot on 28Sep2021. On 29Sep2021, the patient felt fatigued, fever, and achy. The patient took paracetamol (TYLENOL) and felt a little bit better. Two days later, he passed away. The outcome of felt fatigued, fever, and achy was unknown. It was not reported if an autopsy was performed. The cause of death was not reported. The patient died on 30Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event death and the suspect drug BNT162B2 cannot be excluded.    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.; Reported Cause(s) of Death: Two days later, he passed away.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Two days later, he passed away.; felt fatigued; fever; achy; got the booster shot; got the booster shot; This is a spontaneous report from a non-contactable pharmacist. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 28Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization (administered in a Pharmacy or Drug store); and influenza vaccine via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the booster shot on 28Sep2021. On 29Sep2021, the patient felt fatigued, fever, and achy. The patient took paracetamol (TYLENOL) and felt a little bit better. Two days later, he passed away. The outcome of felt fatigued, fever, and achy was unknown. It was not reported if an autopsy was performed. The cause of death was not reported. The patient died on 30Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event death and the suspect drug BNT162B2 cannot be excluded.    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.; Reported Cause(s) of Death: Two days later, he passed away.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Diverticulum intestinal, Gastrointestinal haemorrhage, Off label use, Product use issue
Clinical narrative: gastrointestinal hemorrhage; It was found to be a diverticula; Flu shot, other vaccine same date vaccine date: 27Sep2021; Flu shot, other vaccine same date vaccine date: 27Sep2021; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 27Sep2021 at 11:00 AM (at the age of 67 years old) (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunisation; and influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration in the right arm on 27Sep2021 (Batch/Lot number was not reported) at an unknown dose, single for influenza. The patient medical history was not reported. The patient has no known allergies. Concomitant medications included unspecified multiple medications received in two weeks. The patient did not receive other vaccine in four weeks. The patient did not have COVID-19 prior vaccination and had not been tested post-vaccination.  The patient previously received first and second dose of BNT162B2 on 30Jan2021 at 10:00 AM and 20Feb2021 at 10:00 AM respectively, both in the left arm for COVID-19 immunisation at the age of 66-years-old. On 27Sep2021 (time of onset was reported as at 08:00 AM and event onset was also reported as 24 hours after Covid booster and flu shot), the patient experienced gastrointestinal hemorrhage and lost large amount of blood and it was found to be a diverticula. It was also reported that the patient received flu shot the same day (27Sep2021) with BNT162B2 vaccine. The patient had to go to emergency room for resuscitation. The patient was hospitalized for three days. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for the events however it was also reported that the bleeding stopped on its own and treatment for "BP". The events gastrointestinal hemorrhage, and diverticula were reported as serious (hospitalization and life threatening). The outcome of the events gastrointestinal hemorrhage and diverticula were recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Ileus, Nausea, Pain
Clinical narrative: admitted with an ileus; pain 10 out of 10; 9-15 Tingling in abdomen and down both legs within minutes of injection; abdominal Cramps; nausea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: FE3592), dose 1 via an unspecified route of administration, administered in left arm on 15Sep2021 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19. No known allergies. Concomitant medication included venlafaxine hydrochloride (VENLAFAXINE SR) at 75 mg, 1x/day. No other vaccine in four weeks. On 15Sep2021, the patient experienced tingling in abdomen and down both legs within minutes of injection, abdominal cramps, nausea. Abdomen cramps and nausea continued and worsened throughout evening. On 16Sep2021, woke up with pain 10 out of 10, went to ER, CAT scan: admitted with an ileus. The patient was discharged on 18Sep2021. Continued abdominal pain, cramps and nausea since discharged. Follow up appointment with GI provider. MRI of abdomen with, without contract is now recommended. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization from 16Sep2021 to 18Sep2021, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included NG placed, IV, pain meds. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Paraesthesia
Clinical narrative: admitted with an ileus; pain 10 out of 10; 9-15 Tingling in abdomen and down both legs within minutes of injection; abdominal Cramps; nausea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: FE3592), dose 1 via an unspecified route of administration, administered in left arm on 15Sep2021 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19. No known allergies. Concomitant medication included venlafaxine hydrochloride (VENLAFAXINE SR) at 75 mg, 1x/day. No other vaccine in four weeks. On 15Sep2021, the patient experienced tingling in abdomen and down both legs within minutes of injection, abdominal cramps, nausea. Abdomen cramps and nausea continued and worsened throughout evening. On 16Sep2021, woke up with pain 10 out of 10, went to ER, CAT scan: admitted with an ileus. The patient was discharged on 18Sep2021. Continued abdominal pain, cramps and nausea since discharged. Follow up appointment with GI provider. MRI of abdomen with, without contract is now recommended. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization from 16Sep2021 to 18Sep2021, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included NG placed, IV, pain meds. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: two Blood Clot; stroke; This is a spontaneous report from a contactable Consumer. This consumer reported for himself that the 78-year-old male patient received bnt162b2 (BNT162B2, COVID 19 Pfizer) at the age of 77-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 01Jul2021 17:00 (Batch/Lot Number: FA6780) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure, diabetes, arthritis and covid prior vaccination. No Known allergies. Concomitant medications were unknown. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Pfizer, lot Number: EL00185) at the age of 77-year-old on 07Jun202106:15 PM in Left arm for covid-19 immunization. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks but other medications in two weeks.  The patient experienced two blood clot on 11Jul2021 16:00 with outcome of not recovered, stroke on 11Jul2021 16:00 with outcome of not recovered. The patient was hospitalized for two blood clot and stroke for 17 days. Therapeutic measures were taken as a result of two blood clot, stroke and treatment included Medications. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No covid tested post vaccination.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Developed appendicitis 14 days after first shot; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 31Mar2021 16:00 (Batch/Lot Number: ER8737) (at the age of 16 years old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Facility type vaccine was reported as Pharmacy or Drug Store. There were no known allergies and no other medical history. There were no other vaccine in four weeks and no other medications in two weeks. No COVID-19 prior vaccination. On 14Apr2021 00:00 (12:00 AM), the patient developed appendicitis 14 days after first shot. Event resulted in emergency room/department or urgent care, it was life threatening illness (immediate risk of death from the event). Treatment included appendectomy.The patient received BNT162B2 in left arm on 21Apr2021 16:00 (Lot number: ER8736) at dose 2.COVID-19 test post vaccination was Nasal Swab (PCR) on 21Jul2021 with negative result. The outcome of the event was recovered on unknown date.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer (patient's sister) . A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 64-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included immunosuppressed. Concomitant medications were not reported. The consumer stated that her 64-year-old sister had the Pfizer BioNtech covid 19 vaccine and was found dead the next day. No autopsy was done however they said it was likely due to a heart attack. The patient died on an unspecified date.; Reported Cause(s) of Death: it was l kely due to a heart attack
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 1 person to die from the vaccine; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that 1 person to die from the vaccine on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The reporter reported his views about the vaccine. The event was assessed as serious(fatal).   The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2; Reported Cause(s) of Death: 1 person to die from the vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable nurse. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) dose 1, single on 18Mar2021 and dose 2, single on 08Apr2021; both given via unspecified route of administration, at the age of 62-year-old, for covid-19 immunisation. The patient medical history was not reported. The patient had no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks and was not previously diagnosed with COVID. On 02Oct2021, the patient experienced Covid-19. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedures which included nasal swab which showed positive result on 02Oct2021. Therapeutic measures taken in response to the event included administration of monoclonal antibodies. Outcome of the event was not recovered.   The lot number for [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Covid-19" and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Received the Pfizer COVID-19 Vaccine and passed away days later/Unknown cause of death; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer reported that a female patient (aunt) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. The received the Pfizer COVID-19 Vaccine and passed away days later, Unknown cause of death. She passed away after receiving the vaccine, the Pfizer COVID-19 Vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. Case was reported as serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Breast cancer, Death, Hepatic cancer
Clinical narrative: died 2 days after getting that booster; blindness; serious cancers, like breast and liver cancer; serious cancers, like breast and liver cancer; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA A VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as Dose 3 (Booster), Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as Dose 1, Single and via an unspecified route of administration on an unspecified date as Dose 2, Single for COVID-19 immunization. The reporter stated that, the patient got that booster shot. On an unknown date, the reporter stated that the patient died 2 days after getting that booster. The reporter mentioned that the patient health was terrible. The reporter do not wanted to talk about patient because it was depressing. The reporter mentioned that the patient had blindness and serious cancers, like breast and liver cancer. At the time of the death, outcome of the events blindness and serious cancers, like breast and liver cancer was unknown. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: One of them died 2 days after getting that booster
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away days later; This is a spontaneous report from a Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 vaccines, lot unknown), via an unspecified route of administration on an unspecified date at dose unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She took the Pfizer Covid-19 vaccine and passed away days later (unspecified date). It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Reported Cause(s) of Death: passed away days later
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Borderline personality disorder, Cerebral disorder, Fatigue, Feeding disorder, Malaise
Clinical narrative: took an entire bottle of Tylenol PM. I wanted to die; emotionally unstable even suicidal; emotionally unstable even suicidal; Emotions became violently unable to control/a day where I was PURE rage; feel sick and run down; feel sick and run down; Throwing up; unable to eat; The dreams of my ex abuser I escaped are prominent in my mind and dream's again now too; I genuinely feel the vaccine did something to my brain/chemical balance/emotional state; Other vaccine same date product: Covid-19/moderna, 06Sep2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history was reported as none. No COVID prior to vaccination. Not tested for COVID post vaccination. No known allergies. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 07Sep2021 03:00, the patient took an entire bottle of Tylenol PM reporting that "I wanted to die." At the same time, the patient became emotionally unstable even suicidal, emotions became violently unable to control, there was a day where I was pure rage, feel sick and run down, throwing up everyday for no reason, unable to eat for days, had dreams of my ex abuser I escaped are prominent in my mind and dream's again now too and the patient genuinely feel the vaccine did something to her brain/chemical balance/emotional state. The patient added that "I know it sounds crazy but there's no other correlation, nothing else odd happened to me. Can a shot do that to me?" The patient considered the events as life threatening and have case disability or permanent damage. The events required emergency room visit. No treatment was given for the events. It was also reported that other vaccine same date product: covid-19/Moderna on 06Sep2021. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nightmare, Product use issue, Suicidal ideation, Suicide attempt, Violence-related symptom
Clinical narrative: took an entire bottle of Tylenol PM. I wanted to die; emotionally unstable even suicidal; emotionally unstable even suicidal; Emotions became violently unable to control/a day where I was PURE rage; feel sick and run down; feel sick and run down; Throwing up; unable to eat; The dreams of my ex abuser I escaped are prominent in my mind and dream's again now too; I genuinely feel the vaccine did something to my brain/chemical balance/emotional state; Other vaccine same date product: Covid-19/moderna, 06Sep2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history was reported as none. No COVID prior to vaccination. Not tested for COVID post vaccination. No known allergies. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 07Sep2021 03:00, the patient took an entire bottle of Tylenol PM reporting that "I wanted to die." At the same time, the patient became emotionally unstable even suicidal, emotions became violently unable to control, there was a day where I was pure rage, feel sick and run down, throwing up everyday for no reason, unable to eat for days, had dreams of my ex abuser I escaped are prominent in my mind and dream's again now too and the patient genuinely feel the vaccine did something to her brain/chemical balance/emotional state. The patient added that "I know it sounds crazy but there's no other correlation, nothing else odd happened to me. Can a shot do that to me?" The patient considered the events as life threatening and have case disability or permanent damage. The events required emergency room visit. No treatment was given for the events. It was also reported that other vaccine same date product: covid-19/Moderna on 06Sep2021. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.