chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: patient received second dose of bnt162b2 on 24May2021; Patient tested positive for COVID following completion of the 2 dose series.; Patient tested positive for COVID following completion of the 2 dose series.; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 33-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration on 04Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration on 24May2021 (at the age of 33-year-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient tested positive for covid following completion of the second dose series and patient received second dose of bnt162b2 on 24May2021. Patient underwent lab test and procedure which included sars-cov-2 test positive on an unspecified date in 2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Immunisation, Off label use
Clinical narrative: lowoxygen; exhaustion; received a third dose; received a third dose; couldntot walk more than 10feet; difficulty to breath; This is a spontaneous report from a contactable consumer (the patient). An 87-year-old female patient received the third dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448) via an unspecified route of administration in left arm on 16Aug2021 at age of 87-year-old (age at vaccination) at single dose for COVID-19 immunisation. Medical history included ongoing COPD/emphysema from 2010. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number: EN6199) intramuscular in left arm on 06Mar2021 for COVID-19 immunization; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number: EP7534) intramuscular in left arm on 27Mar2021 for COVID-19 immunization. It also reported the patient previously took FLU vaccine given the same day (the vaccination date was not specified), the patient have no information on it. The patient experienced exhaustion on 18Aug2021, the event was serious with seriousness criteria of persistent/significant disability, important medical event, treatment (additional predinasone) received for the event, the event required visit to-physician office. The patient experienced low oxygen on 25Aug2021, the event was serious with seriousness criteria of persistent/significant disability, life threating, important medical event, treatment (additional predinasone ,3 weeks) received for the event, the event required visit to-physician office. The patient stated about 10 days after combined vaccination oxygen level fell into the 80's. Could not walk more than 10 feet out of breathe (Aug2021). It has been 7 week and still difficult to breathe at times. within 2 day exhausted no energy, then problems breathing them low oxygen, getting better slowly. The outcome of the event(s) "received a third dose" was unknown, of other events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: lowoxygen; exhaustion; received a third dose; received a third dose; couldntot walk more than 10feet; difficulty to breath; This is a spontaneous report from a contactable consumer (the patient). An 87-year-old female patient received the third dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448) via an unspecified route of administration in left arm on 16Aug2021 at age of 87-year-old (age at vaccination) at single dose for COVID-19 immunisation. Medical history included ongoing COPD/emphysema from 2010. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number: EN6199) intramuscular in left arm on 06Mar2021 for COVID-19 immunization; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number: EP7534) intramuscular in left arm on 27Mar2021 for COVID-19 immunization. It also reported the patient previously took FLU vaccine given the same day (the vaccination date was not specified), the patient have no information on it. The patient experienced exhaustion on 18Aug2021, the event was serious with seriousness criteria of persistent/significant disability, important medical event, treatment (additional predinasone) received for the event, the event required visit to-physician office. The patient experienced low oxygen on 25Aug2021, the event was serious with seriousness criteria of persistent/significant disability, life threating, important medical event, treatment (additional predinasone ,3 weeks) received for the event, the event required visit to-physician office. The patient stated about 10 days after combined vaccination oxygen level fell into the 80's. Could not walk more than 10 feet out of breathe (Aug2021). It has been 7 week and still difficult to breathe at times. within 2 day exhausted no energy, then problems breathing them low oxygen, getting better slowly. The outcome of the event(s) "received a third dose" was unknown, of other events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nucleic acid test, Polymerase chain reaction, Vaccination failure
Clinical narrative: tested positive for COVID/persistent cough; tested positive for COVID/persistent cough; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right on 14Jan2021 14:00 (Lot Number: EL3247) as dose 1, single; and administered in arm left on 04Feb2021 13:00 (Lot Number: EL3247) as dose 2, single both via an unspecified route of administration for covid-19 immunisation. Age at vaccination: 60 years old. The vaccine was administered at the workplace clinic. The patient medical history included she was diabetic type 2 from an unknown date. Concomitant medications included lisinopril; linagliptin, metformin hydrochloride (JENTADUETO); ezetimibe (ZETIA); semaglutide (OZEMPIC); and pravastatin; all were taken for an unspecified indication, start and stop date were not reported. She did not have any adverse event during or after her 2 vaccinations, 14Jan2021 or 04Feb2021. She started having a persistent cough on 17Sep2021. On 21Sep2021, she was notified that she was a primary contact of a person who had tested positive for COVID. She was tested on 21Sep2021 and her positive results was reported to her on 22Sep2021. She tested positive for COVID. It was explained that on 15Sep2021, she went to her daughter, home and found her daughter dead. She had passed away after she had talked with her three hours earlier with no indication of feeling bad or sickness. She was picking her up to go with her to an appointment. Her youngest daughter, tested positive for COVID on 21Sep2021 and notified her of this result. She immediately got tested and her results came back the next day (22Sep2021). During this time she was emotional and not thinking clearly about reporting this positive result. She returned to work on 15Oct2021 and then was out again on 18Oct2021. She was still very distraught over the sudden loss of her daughter. No treatment was received for the reported events. The outcome of the events was recovered in 2021.  As per Product Quality Complaint Group on 21Oct2021 it was concluded that the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid this weekend; tested positive for Covid this weekend; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Feb2021 as DOSE 2, SINGLE, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Feb2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, patient tested positive for Covid this weekend. Reporter reported that my husband received the Pfizer vaccine (both doses) back in Feb through his work (with held). The patient underwent lab tests and procedures which included Covid-19 test: result positive on an unspecified date on Oct2021. 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: Angina pectoris, Vaccination site pain, Vaccination site swelling
Clinical narrative: stabbing pain around her heart area; swelling and pain at the injection site; swelling and pain at the injection site; This is a spontaneous report from a contactable consumer. This consumer(mother) reported for a 15-year-old female patient (daughter) that:  A 15-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, NDC/ Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stabbing pain around her heart area and swelling and pain at the injection site. Reporter stated that she did not knew if what she experienced was a side effect of the vaccine, but she was told to call and report any possible side effects. Reporter stated that after receiving the vaccine she started spotting and started having her period again, and she did not have her period in a long time. Asked if this had been reported before. Reporter also stated that both of her girls were 15 years old, and when they got their Pfizer Covid 19 vaccines, they both got swelling and pain at the injection site, but one of them had started to feel a stabbing pain. Clarified that one of her girls had an episode the previous day where she felt a stabbing pain around her heart area. Verified that both girls are 15. Stated, Investigation assessment was not provided. 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Asthenia, Catheterisation cardiac, Chest pain, Computerised tomogram
Clinical narrative: temporal arteritis; severe headaches; near syncope; chest pain; dypsnea on exertion; weakness/fatigue; weakness/fatigue; This is a spontaneous report from a contactable Other HCP (other health professional). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in May2021 at the age of 67-year-old for COVID-19 immunization. The first dose was in Apr2021 at the age of 67-year-old. Medical history included COVID-19, had covid prior vaccination. Concomitant medication was not reported. The covid test post vaccination was no. In May2021, patient experienced temporal arteritis, severe headaches, near syncope, chest pain, dypsnea on exertion, weakness/fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and treatment received. The treatments included steroids. Patient underwent CTA chest, cardiac cath, CT chest and CT head, all unknown results. The outcome of events was not recovered.   The seriousness criteria were hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dyspnoea exertional, Fatigue, Giant cell arteritis, Headache
Clinical narrative: temporal arteritis; severe headaches; near syncope; chest pain; dypsnea on exertion; weakness/fatigue; weakness/fatigue; This is a spontaneous report from a contactable Other HCP (other health professional). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in May2021 at the age of 67-year-old for COVID-19 immunization. The first dose was in Apr2021 at the age of 67-year-old. Medical history included COVID-19, had covid prior vaccination. Concomitant medication was not reported. The covid test post vaccination was no. In May2021, patient experienced temporal arteritis, severe headaches, near syncope, chest pain, dypsnea on exertion, weakness/fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and treatment received. The treatments included steroids. Patient underwent CTA chest, cardiac cath, CT chest and CT head, all unknown results. The outcome of events was not recovered.   The seriousness criteria were hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: temporal arteritis; severe headaches; near syncope; chest pain; dypsnea on exertion; weakness/fatigue; weakness/fatigue; This is a spontaneous report from a contactable Other HCP (other health professional). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in May2021 at the age of 67-year-old for COVID-19 immunization. The first dose was in Apr2021 at the age of 67-year-old. Medical history included COVID-19, had covid prior vaccination. Concomitant medication was not reported. The covid test post vaccination was no. In May2021, patient experienced temporal arteritis, severe headaches, near syncope, chest pain, dypsnea on exertion, weakness/fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and treatment received. The treatments included steroids. Patient underwent CTA chest, cardiac cath, CT chest and CT head, all unknown results. The outcome of events was not recovered.   The seriousness criteria were hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (COMIRNATY) via unspecified route on an unspecified date single dose for covid-19 immunization. The patient medical history included pre-existing conditions (unspecified). The patient's concomitant medications were not reported. The patient experienced died on an unspecified date. The reporter talked to a doctor and the doctor had a patient, who had pre-existing conditions, died. The patient died on an unspecified date. It was unknown 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: died
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: her father passed away after getting the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer sponsored Program Database Support from a non-contactable consumer (patient's child). A male patient of an unspecified age received bnt162b2 (Pfizer 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 immunisation. The patient medical history and concomitant medications were not reported. The consumer wanted to know if the Pfizer covid-19 vaccine is FDA approved. Consumer stated on the call that her father passed away after getting the Pfizer covid-19 vaccine. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: her father passed away after getting the Pfizer covid-19 vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: her arm hurt a little bit, was sore with both vaccines; she got covid Jul2021; she got covid Jul2021; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (COMIRNATY formulation: solution for injection),  via an unspecified route of administration, administered in Left Arm on 02Apr2021 (Batch/Lot Number: E2613, expiry date: unknown) as dose 2, single, and received bnt162b2 (COMIRNATY formulation: solution for injection),via an unspecified route of administration in Left Arm 12Mar2021 (Batch/Lot Number: ER6205 , expiry date: unknown) as dose 1, single for COVID-19 immunisation, lung neoplasm malignant, leukaemia, diabetes mellitus, cardiac disorder, and immunodeficiency. Medical history included ongoing leukaemia, ongoing lung neoplasm malignant ,  and neoplasm malignant. Other Conditions: Commented she is  a cancer patient, has  a couple different cancers diagnosed about 3 yrs ago ,well that's how long she has known. One place knew long before, but never informed. Concomitant medication(s) included topiramate (TOPAMAX) 100mg twice a day taken for seizure. On Jul2021 the patient reported she got covid jul2021 (covid-19), and her arm hurt a little bit, was sore with both vaccine. She has not gotten booster dose yet. She tested positive for covid in Jul2021. She came home from 18Jul2021 and was diagnosed with Covid around 19Jul2021 or 21Jul2021. On unspecific date in Jul2021 the patient underwent lab tests and procedures which included sars-cov-2 test (home test): positive, on unspecific date sars-cov-2 test (pcr): unknown result. She called the doctor and told tested positive with home test. Then she went in for the PCR test so could get Monoclonal antibodies infusion because that was the only way could get it. When she called they could tell she was not sounding like herself. She was sounding rough, it was effecting her. Her lungs were hurting. It took 2-3 days of breathing treatments to kick in. The events resulted in physician office visit. She cannot get the flu shot yet because her arms hurt so bad. Therapeutic measures were taken as a result of she got covid jul2021 (covid-19), she got covid jul2021 (vaccination failure) includes Monoclonal antibodies infusion because it was the only thing that helped. She added, the doctor also gave her breathing treatment, antibiotics, and cough syrup. she is supposed to wait 90 days after the Monoclonal antibodies infusion before getting the infusion. That is why she has not gotten the booster yet because if she got it before she could sicker. The outcome of the event was unknown.   Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart condition; This is a spontaneous report from a contactable consumer. An elderly male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient had pre- existing conditions. The patient's concomitant medications were not reported. The patient experienced heart condition and died. 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: heart condition
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Illness, Productive cough, Secretion discharge
Clinical narrative: constantly having tons of mucus and phlegm; sinus infections; allergies; feels sick on a daily basis; constantly having tons of mucus and phlegm; throws up; it gradually got worse.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 43 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included alopecia areata from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced constantly having tons of mucus and phlegm causing productive cough on an unspecified date with outcome of not recovered, sinus infections causing sinusitis on an unspecified date with outcome of unknown, allergies causing hypersensitivity on an unspecified date with outcome of unknown, feels sick on a daily basis causing illness on an unspecified date with outcome of unknown , constantly having tons of mucus and phlegm causing secretion discharge on an unspecified date with outcome of not recovered, throws up vomiting on an unspecified date with outcome of not recovered and it gradually got worse.leading to condition aggravated on an unspecified date with outcome of not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Vomiting
Clinical narrative: constantly having tons of mucus and phlegm; sinus infections; allergies; feels sick on a daily basis; constantly having tons of mucus and phlegm; throws up; it gradually got worse.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 43 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included alopecia areata from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced constantly having tons of mucus and phlegm causing productive cough on an unspecified date with outcome of not recovered, sinus infections causing sinusitis on an unspecified date with outcome of unknown, allergies causing hypersensitivity on an unspecified date with outcome of unknown, feels sick on a daily basis causing illness on an unspecified date with outcome of unknown , constantly having tons of mucus and phlegm causing secretion discharge on an unspecified date with outcome of not recovered, throws up vomiting on an unspecified date with outcome of not recovered and it gradually got worse.leading to condition aggravated on an unspecified date with outcome of not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 1st of 2 reports.   A 27-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176) dose 1 via an unspecified route of administration, administered in arm right on 21Jul2021 at 18:00 as (at the age 27-years-old) DOSE 1, SINGLE for covid-19 immunization. No relevant medical history was reported. The patient's concomitant medications were not reported. Patient concomitant medication were not reported. Historical vaccine included tetanus shot (had a tetanus shot before Pfizer shot, further clarifications unknown). The patient experienced seizure on 03Oct2021. It was reported that patient took Pfizer vaccine and a while after had a seizure which never had, and patient was over the normal age for somebody to have normal seizure, had to take her to the emergency and they did a CT scan and the Neurologist said that it was not normal to somebody who was 27 years (not clarified) old to have a first-time seizures, It was also reported that patient never had a second shot. The patient underwent lab tests and procedures which included blood test: unknown results on an unknown date in 2021, it was 20th. It's almost 2 weeks, computerized tomogram (CT): unknown results on an unknown date in 2021 when patient was asked the name of tests and stated as they did bunch of tests. Therapeutic measures were taken as a result of event included Keppra 500 mgs, twice a day. Patient was prescribed at their after-emergency room. The neurologist prescribed Keppra (treatment) which was an anti-epileptic and anti-seizure medicine. Patient had been on medicine so that doesn't happen but, she would like to not be on that. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101416172 same product and event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Bipolar disorder, Cerebrovascular accident, Condition aggravated, Diabetes mellitus, Panic reaction
Clinical narrative: stroke; bipolar 1; Raynaud's disease; diabetes; flared up everything with his pre-existing condition.; having panic all night; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on an unspecified date (lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history included stroke, bipolar 1, Raynaud's disease, and diabetes all from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection) received on an unspecified date (lot number not reported), as dose 1, single, for COVID-19 immunisation. On an unspecified date, the second dose of BNT162B2 flared up everything with his pre-existing condition (stroke, bipolar 1, Raynaud's disease, and diabetes). The patient stated that he's experiencing life-threatening reactions, having panic all night, all day from the vaccine because of his pre-existing conditions. The patient wanted to know how long the vaccine is designed to last in our body or is there a way to detox the vaccine out of his body since the vaccine is agitating with his pre-existing conditions. The outcome of the events was not resolved.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: stroke; bipolar 1; Raynaud's disease; diabetes; flared up everything with his pre-existing condition.; having panic all night; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on an unspecified date (lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history included stroke, bipolar 1, Raynaud's disease, and diabetes all from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection) received on an unspecified date (lot number not reported), as dose 1, single, for COVID-19 immunisation. On an unspecified date, the second dose of BNT162B2 flared up everything with his pre-existing condition (stroke, bipolar 1, Raynaud's disease, and diabetes). The patient stated that he's experiencing life-threatening reactions, having panic all night, all day from the vaccine because of his pre-existing conditions. The patient wanted to know how long the vaccine is designed to last in our body or is there a way to detox the vaccine out of his body since the vaccine is agitating with his pre-existing conditions. The outcome of the events was not resolved.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Fibromyalgia, Headache
Clinical narrative: MS; Fibromyalgia; headache; muscle & joint pain; muscle & joint pain; diarrhea; nausea; just not feeling well; tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Oct2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, the patient experienced multiple sclerosis, fibromyalgia, headache, muscle & joint pain, diarrhea, nausea, just not feeling well and tiredness. The patient was treated with Baclofen and Tylenol as a therapeutic measure of ms and fibromyalgia. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Multiple sclerosis, Myalgia, Nausea
Clinical narrative: MS; Fibromyalgia; headache; muscle & joint pain; muscle & joint pain; diarrhea; nausea; just not feeling well; tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Oct2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, the patient experienced multiple sclerosis, fibromyalgia, headache, muscle & joint pain, diarrhea, nausea, just not feeling well and tiredness. The patient was treated with Baclofen and Tylenol as a therapeutic measure of ms and fibromyalgia. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever; Aches; Fatigue; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient  received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unknown date, as dose 3(booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; lot numbers and expiry dates were not reported) via an unspecified route of administration, on unknown date, as dose 1and dose 2, single for covid-19 immunisation. The patient experienced chills, fever, aches, fatigue and headache for 36 hours after booster. The outcome of the event was recovered on an unspecified date.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of personal independence in daily activities, Ocular hyperaemia, Pruritus
Clinical narrative: itchiness on her face after 15 minutes of dose administration; red eyes; lethargic; Saturday she was "wiped" and "couldn't take a trip"; This is a spontaneous report from a contactable consumer.  A 57-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On May 2021, the patient experienced itchiness on her face after 15 minutes of dose administration and red eyes, including area under the eye. After the reaction did not resolve within 15 minutes, the medic team planned to transport the patient from vaccination area to hospital. patient refused to go to the hospital at that time. The patient reported that next morning, looked pretty much normal, this was a Friday. patient reported that by the later afternoon and early evening, she was lethargic. On that Saturday she was wiped and couldn't take a trip that was planned with her family and she didn't do house chores. Patient was feeling better that Sunday evening. Considering these side effects, caller decided to not get the second shot at the three weeks. They were not dealing with a lot of people and they're taking vitamin D and elderberry, so she is so far so good and believed she had Some protection from the first vaccine so continued to not get the second dose. At the time of reporting the outcome of the events were recovering.   The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This is a spontaneous report from a contactable consumer. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 16-year-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jul2021 at the age of 16-year-old for covid-19 immunization. The patient experienced death on 13Oct2021.  The patient died on 13Oct2021.  The lot number for vaccine (BNT162B2), was not provided and will be requested during follow-up; Reported Cause(s) of Death: death
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Confusional state, Cough, Dyspnoea, Erythema
Clinical narrative: Anaphylaxis event; skin rash; redness; confusion; neck pain; throat pain; coughing; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 01May2021 12:00 (Lot Number: ewo158) as dose 2, single (at age of 32-years-old) for covid-19 immunisation. The patient medical history was not reported. If covid prior vaccination: Unknown. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: ewo172) on 09Apr2021 12:00 PM Location of injection: Arm Left (at age of 32-years-old) for covid-19 immunisation. The patient previously took amoxycillin and experienced allergic to amoxycillin (was allergic to amoxycillin as a child, current tests show he was not allergic to the class). On 10May2021 10:30, the patient experienced anaphylaxis event, skin rash, redness, confusion, neck pain, throat pain, coughing, difficulty breathing. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Therapeutic measures were taken for all events included benadryl, epinephrine, prednisone, intubation. The patient was hospitalized for 1 days. The event clinical course was as follows: initial anaphylaxis event occurred on 10May, second event occurred 12May, ongoing anaphylaxis symptoms have persisted for 3 months controlled only by Benadryl and prednisone. These symptoms included skin rash, redness, confusion, neck pain, throat pain and closure resulting in coughing and difficulty breathing. all other medications, foods, and sources have been eliminated over dozens of tests. symptoms are controlled well by cromolyn sodium, Pepcid, and compound Regimine. The patient underwent lab tests and procedures which included tests: not allergic to the class (was allergic to amoxycillin as a child, current tests show he was not allergic to the class) on an unspecified date, spike protein test: positive (blood test, Nasal Swab) on 01Sep2021. Outcome of the events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Neck pain, Oropharyngeal pain, Rash, SARS-CoV-2 test
Clinical narrative: Anaphylaxis event; skin rash; redness; confusion; neck pain; throat pain; coughing; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 01May2021 12:00 (Lot Number: ewo158) as dose 2, single (at age of 32-years-old) for covid-19 immunisation. The patient medical history was not reported. If covid prior vaccination: Unknown. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: ewo172) on 09Apr2021 12:00 PM Location of injection: Arm Left (at age of 32-years-old) for covid-19 immunisation. The patient previously took amoxycillin and experienced allergic to amoxycillin (was allergic to amoxycillin as a child, current tests show he was not allergic to the class). On 10May2021 10:30, the patient experienced anaphylaxis event, skin rash, redness, confusion, neck pain, throat pain, coughing, difficulty breathing. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Therapeutic measures were taken for all events included benadryl, epinephrine, prednisone, intubation. The patient was hospitalized for 1 days. The event clinical course was as follows: initial anaphylaxis event occurred on 10May, second event occurred 12May, ongoing anaphylaxis symptoms have persisted for 3 months controlled only by Benadryl and prednisone. These symptoms included skin rash, redness, confusion, neck pain, throat pain and closure resulting in coughing and difficulty breathing. all other medications, foods, and sources have been eliminated over dozens of tests. symptoms are controlled well by cromolyn sodium, Pepcid, and compound Regimine. The patient underwent lab tests and procedures which included tests: not allergic to the class (was allergic to amoxycillin as a child, current tests show he was not allergic to the class) on an unspecified date, spike protein test: positive (blood test, Nasal Swab) on 01Sep2021. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Flushing, Ocular hyperaemia, Skin discolouration
Clinical narrative: eyes are all red; eyes are swollen; her cheeks are flushed; there is a red dot on skin under her eyes; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/ Lot number: Not available) via an unspecified route of administration on unspecified date as dose 3 (BOOSTER), single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Historical vaccine included the patient previously received BNT162B2 (COMIRNATY, solution for injection, Batch/ Lot number: Not available) via an unspecified route of administration on unspecified date as dose 1, and dose 2, single for COVID-19 immunization. On unspecified date the patient experienced her eyes are all red, there is a red dot on skin under her eyes, eyes are swollen, and her cheeks are flushed. She wants to know if anyone has reported similar experience. She stated that it could be coincidental but she has never woken up with that eyes before. She said she is putting ice on, like a cold cloth which is easing up the discomfort and is planning on taking half of a Benadryl. The outcome of 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: Death
Clinical narrative: she passed away less than 24 hrs; This is a spontaneous report from a contactable consumer (patient parent). A 28-year-old female patient (daughter) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Oct2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer reported that her 28 year old daughter received her 2nd pfizer vaccine dose on 15Oct2021 and she passed away less than 24 hrs. The medical examiner was conducting a thorough review. The patient died on 16Oct2021. An autopsy was performed and results were not available.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away less than 24 hrs
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Fast heart rate; Blood pressure, increase in blood pressure which she thinks that she got that from the vaccine; This is a spontaneous report from a Pfizer sponsored program via contactable female pharmacist (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported and 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. The patient experienced pulmonary embolism, fast heart rate and lood pressure, increase in blood pressure which she thinks that she got that from the vaccine on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: increased on an unknown date, heart rate: fast on an unknown date. Outcome of the events was unknown.  Lot/batch number is not available. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Pulmonary embolism and BNT162B2.  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: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: causing distruction and death; This is a spontaneous report from a Pfizer-sponsored program Database Support from a non-contactable consumer.  A female patient 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 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced sleep at night that is causing destruction and death that Pfizer is causing.The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: causing distruction and death