chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Headache, Myalgia, Oral discomfort
Clinical narrative: Headache with no fever; Coughing; muscle pains; chest discomfort; mucus; Diarrhea; mouth was like glue; got a weird smell and it was a nauseating smell; burning in her stomach; burning in her stomach,and she had some reflux; burning in her mouth; leg muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in right deltoid (Right shoulder) on 24Aug2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not had any medical history and family history. The concomitant medication(s) included oxycodone (OXYCODONE) 5 mg taken 4 times daily taken for an unspecified indication started 7 years ago and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: PAG780), via an unspecified route of administration, administered in left shoulder on 03Aug2021 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced sore arm and hot flashes that lasted a couple of days. The patient did not had any prior vaccination within a four weeks. On 24Aug2021, the patient experienced had some burning in her stomach and she had some reflux anyway and then, some burning in her mouth, and then it was gone. She went home and had some leg muscle aches and chills. She wants to know, her chills lasted for two days. Two days after she got a weird smell and it was a nauseating smell. It could have been the mucus. She clarified as a day later at 2 in the morning Thursday the 26Aug2021. Then everything went away, now yesterday. On 29Aug2021, the patient mouth was like glue. On an unspecified date, the patient reported headache with no fever. All subsided after a few days yesterday the night of the 30Aug2021 and she had a mouth breather and she will take a drink of water and it will be gone. She woke up on Monday night and it was like glue. On 01Sep2021, the patient had diarrhea and on unspecified date, she reported muscle pains, coughing, mucus, chest discomfort, and just sore. Patient reported going for a covid test tomorrow be-cause maybe it was covid. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event for burning in her stomach,and she had some reflux, burning in her mouth, Chills, got a weird smell and it was a nauseating smell, was recovered on Aug2021 and, headache was recovered on 30Aug2021 and outcome of rest all events were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Parosmia, Secretion discharge
Clinical narrative: Headache with no fever; Coughing; muscle pains; chest discomfort; mucus; Diarrhea; mouth was like glue; got a weird smell and it was a nauseating smell; burning in her stomach; burning in her stomach,and she had some reflux; burning in her mouth; leg muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in right deltoid (Right shoulder) on 24Aug2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not had any medical history and family history. The concomitant medication(s) included oxycodone (OXYCODONE) 5 mg taken 4 times daily taken for an unspecified indication started 7 years ago and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: PAG780), via an unspecified route of administration, administered in left shoulder on 03Aug2021 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced sore arm and hot flashes that lasted a couple of days. The patient did not had any prior vaccination within a four weeks. On 24Aug2021, the patient experienced had some burning in her stomach and she had some reflux anyway and then, some burning in her mouth, and then it was gone. She went home and had some leg muscle aches and chills. She wants to know, her chills lasted for two days. Two days after she got a weird smell and it was a nauseating smell. It could have been the mucus. She clarified as a day later at 2 in the morning Thursday the 26Aug2021. Then everything went away, now yesterday. On 29Aug2021, the patient mouth was like glue. On an unspecified date, the patient reported headache with no fever. All subsided after a few days yesterday the night of the 30Aug2021 and she had a mouth breather and she will take a drink of water and it will be gone. She woke up on Monday night and it was like glue. On 01Sep2021, the patient had diarrhea and on unspecified date, she reported muscle pains, coughing, mucus, chest discomfort, and just sore. Patient reported going for a covid test tomorrow be-cause maybe it was covid. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event for burning in her stomach,and she had some reflux, burning in her mouth, Chills, got a weird smell and it was a nauseating smell, was recovered on Aug2021 and, headache was recovered on 30Aug2021 and outcome of rest all events were unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal uterine bleeding, Blood loss anaemia, Disseminated intravascular coagulation, Uterine leiomyoma, Vaginal haemorrhage
Clinical narrative: Other specified abnormal uterine and vaginal bleeding [fibroid] (Final) - Disseminated intravascular coagulation [defibrination syndrome] (Final) - Acute posthemorrhagic anemia (Final) -Subserosal leiomyoma of uterus (Final).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Upper extremity tingling/pins and needles sensation 1 round soluMedrol pack
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood test, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: Provider ordered CT, EKG, and ran bloodwork.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: Provider ordered CT, EKG, and ran bloodwork.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: "SWOLLEN, TENDER AXILLARY, R SUPRACLAVICULAR, AND R ANTERIOR CERVICAL LYMPH NODES GREATER THAN 5 DAYS. IMPROVING WITH MOTRIN 800 mg TID AND WARM COMPRESS"
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Flushing
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: Patient received vaccine and immediately after complained of dizziness, weakness, feeling nauseated and sweatiness. Pharmacist on duty gave patient water and some candy and some sugar, in case of low blood sugar. Patient diabetic. Patient waited 15-20 minutes; stated he felt better and went home. We asked that he call the pharmacy later this evening if he had any other issues regarding the vaccination today.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Lethargy, Nausea, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: Patient received vaccine and immediately after complained of dizziness, weakness, feeling nauseated and sweatiness. Pharmacist on duty gave patient water and some candy and some sugar, in case of low blood sugar. Patient diabetic. Patient waited 15-20 minutes; stated he felt better and went home. We asked that he call the pharmacy later this evening if he had any other issues regarding the vaccination today.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: Patient received vaccine and immediately after complained of dizziness, weakness, feeling nauseated and sweatiness. Pharmacist on duty gave patient water and some candy and some sugar, in case of low blood sugar. Patient diabetic. Patient waited 15-20 minutes; stated he felt better and went home. We asked that he call the pharmacy later this evening if he had any other issues regarding the vaccination today.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: no appetite; diarrhea; vomiting; muscle pain; joint pain; nausea; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable consumer. A 77-year-old female patient reported that she received second dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 01Apr2021, as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received first dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on unknown date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced reoccurring muscle pain, joint pain, nausea, diarrhea, tiredness, chills, vomiting, tiredness, no appetite and feeling unwell. At the time of this report the outcome of the events were unknown.  The lot number for BNT162B2, was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: no appetite; diarrhea; vomiting; muscle pain; joint pain; nausea; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable consumer. A 77-year-old female patient reported that she received second dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 01Apr2021, as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received first dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on unknown date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced reoccurring muscle pain, joint pain, nausea, diarrhea, tiredness, chills, vomiting, tiredness, no appetite and feeling unwell. At the time of this report the outcome of the events were unknown.  The lot number for BNT162B2, was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Gait inability, Speech disorder, Tremor
Clinical narrative: unable to walk; cant talk; dizziness; double vision; shakiness; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced dizziness, double vision, shakiness. On an unspecified date, unable to walk, can't talk. It was reported that patient had dizziness inability to talk inability to walk double vision inability to walk shakiness double vision shaky extremities can't talk couldn't walk done. The outcome of all events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days.; Menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of the vaccination and other vaccines within 4 weeks prior to the vaccination. On an unknown date in 2021, the patient experienced menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days. It was reported that the patient used to be very regular and 28-day cycle. This changes after vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, in 2021 the patient underwent COVID-19 test via nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days were not resolved at this time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experiencing burning pain at the vaccine injection site; This is a spontaneous report from a contactable consumer.   A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 28Aug2021 (age at vaccination was 19-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was included covid 19 infection in May/end of April. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 04Aug2021 (age at vaccination was 19-year-old) as dose 1, single for COVID-19 immunisation. Caller reports that since this Sunday (29Aug2021), she has been experiencing burning pain at the vaccine injection site. Caller reports that specifically it doesn't feel like its on the outside but feels like its on the inside. At the time of this report event outcome was unknown.   Lot number for the vaccine, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation
Clinical narrative: tightness in his abdomen; constipation; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself) via Medical Information Team. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Jun2021 as dose 1, single for COVID-19 immunization. Patient medical history included blood pressure. The concomitant medications included blood pressure pills. Patient received the first dose of the Pfizer COVID vaccine around 22Jun2021 and within that same day he had a tightness in his abdomen on 22Jun2021. He stated the only thing he can compare this to was the sensation of overeating and feeling that tightness and when you take a full deep breath you cannot get full expansion without feeling resistance. He stated it increased the next day and lasted for maybe a total of three in a half four days and he also had constipation on an unspecified date in Jun2021 that lasted the same time frame. He stated he would like to know if this had been reported previously and he had asked other people and they said no but the proximity of the COVID vaccine is something that he could not ignore. He stated he spoke to his doctor and he already waived him off saying this was nothing. He stated could his side effects been an interaction although he was not really taking much medications but he takes a blood pressure pill and he was already told that would not been a problem. He was informed that Pfizer cannot assess causality between what he has experienced as being directly related to the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: chest was tight; wheezy /wheezing; headache; exhaustion; chills; lung being foggy; woke up sweating; mild fever; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (BNT162B2; Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration, as dose 1 single on 30Aug2021(at the age of 53 years) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 31Aug2021, the patient experienced chest was tight, wheezy like a mild allergic reaction, but had no trouble breathing. This was the same reaction she has when she eats certain types of avocado. On an unspecified date in 2021, other symptoms she experienced included headache, exhaustion and chills. The patient described what she experienced post-vaccine as wheezing, lung being foggy, no pain but just mild wheezing and it did go away. She had to miss work yesterday and today. She woke up sweating and reported mild fever last night. Patient would like to know if her symptoms will be worse with the second dose of the Pfizer COVID-19 vaccine. The outcome of the events were reported as unknown.  The lot number/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Pyrexia, Wheezing
Clinical narrative: chest was tight; wheezy /wheezing; headache; exhaustion; chills; lung being foggy; woke up sweating; mild fever; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (BNT162B2; Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration, as dose 1 single on 30Aug2021(at the age of 53 years) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 31Aug2021, the patient experienced chest was tight, wheezy like a mild allergic reaction, but had no trouble breathing. This was the same reaction she has when she eats certain types of avocado. On an unspecified date in 2021, other symptoms she experienced included headache, exhaustion and chills. The patient described what she experienced post-vaccine as wheezing, lung being foggy, no pain but just mild wheezing and it did go away. She had to miss work yesterday and today. She woke up sweating and reported mild fever last night. Patient would like to know if her symptoms will be worse with the second dose of the Pfizer COVID-19 vaccine. The outcome of the events were reported as unknown.  The lot number/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphagia, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: throat sore; feeling like losing her voice; congested; very thirsty; can't swallow; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she took Pfizer COVID vaccine first dose on 25Aug2021, since then experiencing few symptoms but main thing, throat sore and feeling like losing her voice and it was reported as she no longer is feeling this way, "she was congested and very thirsty for one day, drank more water than usual and tired all weekend Saturday and Sunday and can't swallow all on an unspecified date in 2021, she went to get the shot on last Wednesday and she had COVID in May." On an unspecified date in May2021, the patient underwent lab tests and procedures which included COVID test was positive. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: throat sore; feeling like losing her voice; congested; very thirsty; can't swallow; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she took Pfizer COVID vaccine first dose on 25Aug2021, since then experiencing few symptoms but main thing, throat sore and feeling like losing her voice and it was reported as she no longer is feeling this way, "she was congested and very thirsty for one day, drank more water than usual and tired all weekend Saturday and Sunday and can't swallow all on an unspecified date in 2021, she went to get the shot on last Wednesday and she had COVID in May." On an unspecified date in May2021, the patient underwent lab tests and procedures which included COVID test was positive. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Rash
Clinical narrative: Broke out in a rash/all over your arms and legs and torso; woke me up in the middle of night; This is a spontaneous report from a contactable consumer or other non hcp(patient).A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number- not reported), via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported.It was reported that patient received her first dose of the Pfizer COVID vaccine on 04Aug2021 and was wondering if she can skip the second shot and receive the third shot if she qualifies .She was also asking how many weeks was it until she should get the second dose.She also stated, she had a side effect after 2 weeks on Aug2021 after the 1st dose on 04Aug2021. I broke out in a rash while I was sleeping and it woke me up in the middle of the night. I was contributing it to possibly the vaccine. I wanted to ask you if that was typical in side effects all over your arms and legs and torso 2 weeks later on Aug2021 . Should I get the 2nd dose after this adverse effect from the first dose.She also wondering if the second dose will have more severe side effects than the first dose.Patient stated it has been 4 weeks instead of 3 weeks since her first dose and was wondering if that is ok.The oucome of events was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hot flush, Nausea, Pain
Clinical narrative: Diarrhea; hot flashes; body aches; nausea; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 at 12:00 (at the age of 18-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Aug2021 at 00:00, the patient experienced diarrhea, hot flashes, body aches and nausea. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the events diarrhea, hot flashes, body aches and nausea was not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Rash, Vaccination site erythema, Vaccination site pain
Clinical narrative: tingling in the arm and spine; Rash on both chest and stomach with bumps only on the chest.; injection site soreness; injection site redness; headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration Date: Unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she had tingling in the arm and spine. Rash on both chest and stomach with bumps only on the chest. She experienced injection site soreness/redness and headache and noted that she felt that was normal. She has reached out to HCP and was told it does not sound normal and advised her to take Benadryl. Outcome of events was unknown.  Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My dad has been on Pfizer vaccine and he passed away from the complications because of it; He passed away, because of your vaccine; your vaccine, that doesn't work; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) 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. It was reported that on an unspecified date, my dad has been on Pfizer vaccine and he passed away from the complications because of it, he passed away, because of your vaccine. Reporter stated, he passed away, because of your vaccine. He never went to other house. Nobody came to his house. Last time he left the house when he got the vaccine and he died from it. Reporter want all to hold up to your vaccine because your vaccine, that doesn't work. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: My dad has been on Pfizer vaccine and he passed away from the complications because of it; He passed away, because of your vaccine
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: severe pain; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (COMIRNATY,solution for injection,Batch/Lot number was not reported,expiry date was not reported), dose 2 via an unspecified route of administration on 31Aug2021 16:30, as DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took first dose of the vaccine 25 days ago bnt162b2 (COMIRNATY,solution for injection,Batch/Lot number was not reported,expiry date was not reported), via an unspecified route of administration on 06Aug2021 , as DOSE 1, SINGLE for covid-19 immunisation. It was reported that caller felt fine before the receiving the dose and feeling fine until 4:00am 01Sep2021 and the patient experienced severe pain, vomiting, diarrhea. Caller reported experiencing similar symptoms as after the first dose and said she has a telemedicine appointment in the morning and is trying to make sure she have done all her research. The hospital beds are so full and she is afraid and have a hard time getting admitted without proof. Caller said she was trying to find out if anyone has had these symptoms. The clinical outcome of the events were unknown.      That information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My best friend just dies after taking the Pfizer Covid shot; 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 medical history was not reported and concomitant medications were not reported. On 31Aug2021, It was reported his best friend just dies after taking the pfizer covid shot. The outcome of event was fatal.; Reported Cause(s) of Death: My best friend just dies after taking the Pfizer Covid shot
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my friend's grandmother died; This is a spontaneous report from a contactable consumer reported for friend's grandmother via a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her friend's grandmother died with the Pfizer COVID 19 vaccine on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: my friend's grandmother died
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Discomfort, Hypertension, Nervousness
Clinical narrative: Heaviness came over body; Blood pressure shot up; Very nervous and over; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1070) via an unspecified route of administration on 12Aug2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal (B/P), blood cholesterol abnormal and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Aug2021 at 09:45, the patient had heaviness which came over body and blood pressure shot up. This made her very nervous and over. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included additional time watch after blood pressure taken by registered nurse. The clinical outcome of the event heaviness came over body, blood pressure shot up and very nervous and over were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Diarrhoea, Fatigue, Heart rate
Clinical narrative: My heart kind of hurts; Diarrhea; I am nauseous; I feel like vomiting; My heart is beating like little bit more fast; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Sep2021, the patient experienced my heart kind of hurts diarrhea, nauseous; and feel like vomiting, heart is beating like little bit more fast, feel very tired and sleepy and no energy. It was reported that patient experienced side effects and don't know if i can go to work tomorrow. I received my dose of vaccine tomorrow and I have side effects today. How can I work tomorrow. I have diarrhea and I am nauseous, I have diarrhea and my heart kind of hurts and I feel very tired and sleepy and no energy. I feel like vomiting, like my body is not reactive to this dose of vaccine and this is my first dose I had yesterday and this is how I feel today and my heart is beating like little bit more fast than usual. The patient underwent lab tests and procedures which included heart rate: fast on 01Sep2021, my heart is beating like little bit more fast. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Somnolence
Clinical narrative: My heart kind of hurts; Diarrhea; I am nauseous; I feel like vomiting; My heart is beating like little bit more fast; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Sep2021, the patient experienced my heart kind of hurts diarrhea, nauseous; and feel like vomiting, heart is beating like little bit more fast, feel very tired and sleepy and no energy. It was reported that patient experienced side effects and don't know if i can go to work tomorrow. I received my dose of vaccine tomorrow and I have side effects today. How can I work tomorrow. I have diarrhea and I am nauseous, I have diarrhea and my heart kind of hurts and I feel very tired and sleepy and no energy. I feel like vomiting, like my body is not reactive to this dose of vaccine and this is my first dose I had yesterday and this is how I feel today and my heart is beating like little bit more fast than usual. The patient underwent lab tests and procedures which included heart rate: fast on 01Sep2021, my heart is beating like little bit more fast. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: Heart palpitations; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 31Aug2021 at 18:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included aortic valve replacement (AVR), asthma, hypertension, diabetes, high cholesterol and allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 09Aug2021 at 18:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVAQUIN) and amiodarone (MANUFACTURER UNKNOWN) and experienced drug allergy. On 31Aug2021 at 12:00 about 6-8 hours after injection, the patient had heart palpitations and rapid heart rate. It still happened on the day of report, but the heart rate was slowing down some. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heart rate and heart palpitations were not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes swelling and have like 6 tumors; concerned getting Booster dose because don't want agitating lymphatic system and Irritation/she got lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non HCP (Patient) reported that A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation; Solution for Injection), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EL9264) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lymphoma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date (Batch/Lot Number: EL3302) for COVID-19 immunisation. It was reported that the "Patient called after her second dose of the Pfizer Vaccine (Covid-19 Vaccine) she got lymph nodes like lymph nodes are swelling and she was little bit concerned about getting her booster dose (Covid-19 Vaccine) because she already had lymphoma. She didn't want agitating her lymphatic system, so she just wanted to report this as well and just wanted the information about her lymphatic system and patient wanted to know if it same or expected irritation, lymph nodes have like 6 tumors, patient was trying to reduce lymph nodes swelling because she didnt want anything happened with her Lymphatic system.". The outcome of events reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia eye, Hypoaesthesia oral, Inappropriate schedule of product administration, Pain, Pain in jaw
Clinical narrative: Abscessed tooth; Numbness around left eye; Swollen left side of face; Numbness around left eye and upper left side of lip; Swelling next to my eye; Sore jaw that hurt all day/ excruciating pain in jaw; Felt overall achy; Dose 1: 12Mar2021 and Dose 2 : 28Jun2021; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 28Jun2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, anxiety, restless leg syndrome and walnuts allergy. 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 bupropion (MANUFACTURER UNKNOWN) and bisoprolol/hydrochlorothiazide (MANUFACTURER UNKNOWN); for unknown indications from unknown dates and unknown if ongoing.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 29Jun2021 (Tuesday) and 30Jun2021 (Wednesday), the patient felt overall achy. On 01Jul2021 (Thursday), the patient woke up with a sore jaw that hurt all day. On 02Jul2021 (Friday), the patient woke to a swollen left side of face, excruciating pain in jaw, numbness around left eye and upper left side of lip. The patient could not move the numb areas and went to a dentist who said it was an abscessed tooth. On 03Jul2021 (Saturday), the patient woke up to more pain and swelling. She went to the walk-in clinic since it was the weekend. That doctor said she did not think it had anything to do with her teeth. She prescribed steroids which finally provided some relief. Two months later, the patient still had some swelling next to her eye. She had seen another dentist since, who said there was nothing wrong with her teeth. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with steroids (unspecified) and over the counter (OTC) (unspecified) pain relief. The clinical outcome of the event swelling next to my eye was not resolved. The clinical outcome of the events felt overall achy, sore jaw that hurt all day/excruciating pain in jaw, swollen left side of face, numbness around left eye and upper left side of lip and abscessed tooth were resolved with sequelae (also reported as resolved with lasting effects) on an unknown date in 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Tooth abscess
Clinical narrative: Abscessed tooth; Numbness around left eye; Swollen left side of face; Numbness around left eye and upper left side of lip; Swelling next to my eye; Sore jaw that hurt all day/ excruciating pain in jaw; Felt overall achy; Dose 1: 12Mar2021 and Dose 2 : 28Jun2021; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 28Jun2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, anxiety, restless leg syndrome and walnuts allergy. 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 bupropion (MANUFACTURER UNKNOWN) and bisoprolol/hydrochlorothiazide (MANUFACTURER UNKNOWN); for unknown indications from unknown dates and unknown if ongoing.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 29Jun2021 (Tuesday) and 30Jun2021 (Wednesday), the patient felt overall achy. On 01Jul2021 (Thursday), the patient woke up with a sore jaw that hurt all day. On 02Jul2021 (Friday), the patient woke to a swollen left side of face, excruciating pain in jaw, numbness around left eye and upper left side of lip. The patient could not move the numb areas and went to a dentist who said it was an abscessed tooth. On 03Jul2021 (Saturday), the patient woke up to more pain and swelling. She went to the walk-in clinic since it was the weekend. That doctor said she did not think it had anything to do with her teeth. She prescribed steroids which finally provided some relief. Two months later, the patient still had some swelling next to her eye. She had seen another dentist since, who said there was nothing wrong with her teeth. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with steroids (unspecified) and over the counter (OTC) (unspecified) pain relief. The clinical outcome of the event swelling next to my eye was not resolved. The clinical outcome of the events felt overall achy, sore jaw that hurt all day/excruciating pain in jaw, swollen left side of face, numbness around left eye and upper left side of lip and abscessed tooth were resolved with sequelae (also reported as resolved with lasting effects) on an unknown date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: given an undiluted dose, so she got 6 times the intended dose.; This is a spontaneous report from a contactable consumer. A 20-years-old female patient (reporter's daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 01Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient was given an undiluted dose, so she got 6 times the intended dose. She weighed 90 pounds, and caller was asking what she needs to be concerned about and look out for. Asked if she needs to take her to the ER (emergency room). The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.